NBT Jan 2011 by Paul Howells

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New for

2011

GOED Report and Legal Issues

Volume 7 Number 1 January/February 2011

Ingredient Focus CoQ10, glutathione and hydroxytyrosol

Health Management Vitamin D, whey protein and clean functionality

Narrowing the Pharma-Nutrition Gap

The Antioxidant Debate Which Way Next? •

ingredients • functional foods • nutraceuticals • supplements • raw materials •

Volume7 Issue1

contents

January/February2011Contents

Guest Editorial 05 The Pharma-Nutrition Interface: Narrowing the Gap Johan Garssen

18 26

03 40

GOED Report 10 Brain Claims Headache Adam Ismail and Harry P. Rice

Legal Issues 12 IP Basics Steve P. Hassid

Antioxidants 14 The Proven Benefits of Coenzyme Q10 David Hart and Anat Solomon

18 The Antioxidant Debate: Which Way Next?

Health Management 40 Filling a Gap with Vitamin D: An Opportunity for the Food Industry Hannah Theobald and Paulina Erceg

Dr Kevin Robinson with Matt Phillips

20 Glutathione: The Key to Repairing Damaged Cells Lise Alschuler

22 Mighty Hydroxytyrosol Paolo Pontoniere

Bone and Joint Health

46 Clean Functionality: A Recipe for Success Adrian Short

Last Word 48 Sales and Service: Best of Friends or Wary Partners? Alison Morris

30 Oral Hyaluronic Acid (HA) Supplementation

Regulatory Affairs

Cristina MartÌnez

Usual author

50 PAC Analysis Validated

33 Vitamin K2: A Traditional Route to Strong Bones Maider Gutierrez

Weight Management 36 Doin’ it for the Kids Corey E. Scott

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Madrid, Spain

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Volume 7 Issue 1 January/February 2011 ISSN 1745-8307

Contributors

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Editorial Advisory Board Susanne Fässler Marketing Communication Manager Frutarom Switzerland Ltd

ANTIOXIDANT & VASODILATING PROPERTIES

Training Performance Recovery

Jörg Grünwald President Analyze & Realize ag Dr Michelle H. Jones Manager, Regulatory and Scientific Affairs Archer Daniels Midland Company John Kurstjens Event Manager Lipid Nutrition Chris Lee Event Director IIR Exhibitions Ulla Freitas Manager Scientific Affairs, Nutrition Lonza AG

Theodor Graser Head Pharma Industry DSM Nutritional Products Ltd Denzil Phillips Founder Denzil Phillips International Pedro Vieira Marketing Manager Kemin Health Europe Robin Ward Managing Director Excelsa Pharmaceuticals Sagl John Wilkinson Consultant Phytochemist and Director Herbal Sciences Int. Ltd Dr Paul Berryman Chief Executive Leatherhead Food International Norbert Weitkemper Managing Director Vital Solutions GmbH

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The Pharma-Nutrition Interface

Narrowing the Gap Most pharmacologists will acknowledge that nutrition is important for good health and well-being; however, at the same time, it is also considered to be a chemical nightmare with unknown effects. This has not always been the case! In the past, connections between pharmacology and nutrition have been more intimate, as Hippocrates once stated: ‘‘Let food be thy medicine and let medicine be thy food. Only nature heals, provided it is given the opportunity.’’ Indeed, the ancient Greeks divided medicine into three categories: diet, pharmaceutical and surgical medicine. They were not the only ones; many so-called traditional medicinal systems followed this thinking — with nutrition being used as a normal part of health prevention therapy.

n more recent times, however, particularly in the western world, nutrition and pharmacology have developed as rather separate disciplines. Faced with a rapidly developing world, nutrition has had to provide safe, healthy food with limited resources to an ever-expanding population. Even today, malnourishment is still a harsh reality for millions of people worldwide, while many more suffer from the deficiencies of bad nutrition. Pharmacology, having strong roots in experimental physiology, developed in the western world into a field in which biologically active compounds of either natural or synthetic origin were investigated for their properties to change organ and bodily functions. Following the rapid developments in synthetic chemistry during the last century, its main focus shifted towards single compounds with high selectivity and potency. Yet, for a number of years, the gap between the two disciplines has been narrowing, a movement that is being driven from both sides. Pharmacologists are increasingly realizing that the “one disease, one target, one drug” concept does not always provide the most successful cure, particularly for chronic and degenerative diseases. This has led to new strategies for

therapy and drug development, including system biology-based approaches, the principles of multi-target pharmacology and the use of “dirty” or “promiscuous” drugs. When it comes to understanding the subtle regulation of metabolic diseases and the complexity of pathological disturbances, pharmacology can benefit from nutrition science. Vice versa, nutrition science is realizing that the principles of pharmacokinetics and pharmacodynamics provide mechanisms to understand the effects of both essential and non-essential components in our diet. The increased scientific and commercial interest in functional foods and food supplements has further intensified research and development in this area. Many food companies are actively engaged in finding new bioactive compounds that can be used in food products. Some discovery programmes in the food industry resemble those approaches used in the pharmaceutical world, starting with molecular targets that are not infrequently derived from drug targets. Furthermore, translational research using in vitro, in vivo and clinical studies has become the standard in both nutritional and pharmaceutical companies. Last, but by no means least, the clinic has become

increasingly aware of the power of nutrition in improving the outcome of disease or therapy. A gross distinction between foods and drugs follows from the primary goal of nutrition, which is to maintain — or if possible — to improve health. This is an essential difference with pharmaceuticals, which are generally developed to cure or to prevent disease. This principle is forming the basis for the regulatory framework that is being applied to evaluate health claims on food products, including so-called functional foods and food supplements within the EU and many other countries. However, there are also exceptions, such as in specialized and clinical nutrition. A more fundamental issue is that a distinction between health and disease can become complicated; in many cases, the boundaries are not very sharp. The rapid developments in “omics” technologies and systems biology have not only provided better diagnostics tools but have also shown that there is often a continuum between a healthy state and disease.

For more information Johan Garssen, PhD Pharma-Nutrition Conference Chairman (www.pharma-nutrition.com) and Professor of Immunopharmacology and Nutrition, University of Utrecht, the Netherlands.

January/February 2011 www.nutraceuticalmag.com

news

Herbal Remedies to be Banned From 1 May 2011, hundreds of traditional herbal medicinal products will be banned from sale in Britain under an EU Directive requiring all such products to be licensed or prescribed by a registered herbal practitioner. Janet Knowles, Partner and Head of the Life Sciences team at international law firm, Eversheds (www.eversheds.com), comments: “The Directive came into force in April 2004 and producers of traditional herbal medicines have had 7 years to prepare for the changes. Even though some products have been sold for a long time, they can still cause health problems or interact adversely with other drugs; for example, St John’s Wort can interact with some immunosuppressant medicines. A 2005 report from the Medicines and Healthcare Products Regulatory Agency (MHRA) said that it received around 70 suspected adverse drug reaction reports relating to herbal medicines each year. The Directive created a harmonized position across the EU, which frees up markets for producers. In recognition of long-standing traditional herbal medicines’ there is a simplified registration procedure within the EU where producers must demonstrate the safety and efficacy of their herbal medicine through traditional use for at least 15 years within the EU, or 30 years outside the EU. Those that cannot meet the 30 year rule, or where producers are not prepared to register them, will have to be withdrawn and it is important to balance this against the safety of individuals.”

ONC Announces Strategic Alliance with Wilmar International Ocean Nutrition Canada Limited (ONC) is pleased to announce that it has entered into an exclusive long-term strategic agreement with Wilmar International Limited (Wilmar), based in Singapore. Wilmar is Asia’s leading agribusiness and a global leader in omega-3 foods. The collaboration between these two market giants has resulted in the launch of Wilmar’s new Arawana 3A+ premium cooking oil containing MEG-3 fish oil. “Partnering with Ocean Nutrition Canada is strategically important because they not only offer the most highly trusted source of omega-3 EPA/DHA, but also superior service and ongoing support. We continue to invest and expand our manufacturing and distribution infrastructure, and this alliance is a significant long-term exciting endeavour for both parties,” said Mr Lee, Chairman of Yihai Kerry Foodstuffs Marketing Co., Limited, a wholly owned subsidiary of Wilmar International. Martin Jamieson, President and CEO of Ocean Nutrition Canada Limited, said: “We are thrilled to partner with Wilmar International, one of the world’s great food companies.” Jamieson continued: “Not only do they offer superior products, Wilmar management and staff are dedicated and innovative. We look forward to what the future holds in this partnership, providing consumers with healthy, high-quality products.”

www.nutraceuticalmag.com January/February 2011

Beyond Resveratrol: The World’s First Pterostilbene Supplement Biotivia has released the world’s first high potency pterostilbene supplement, PteroMax. Pterostilbene, identified as the molecule in blueberries responsible for their health and medical benefits, is being called the next generation resveratrol and has exhibited potential cognitive, chemopreventive and cholesterol lowering properties that are even superior in some respects to those of pure resveratrol. Combined with Biotivia’s proprietary trans-resveratrol, polydatin and a complex of OPCs and fruit extracts, PteroMax is the first true stilbene complex supplement. It is bioenhanced by the addition of a complex of polyphenols from red wine grapes, green tea and Polygonum cuspidatum. Biotivia has gone a quantum step further by making PteroMax the first multi-stilbene, multi-polyphenol complex modelled on the work of the world’s top stilbene and resveratrol biologists, physicians and biochemists. James Betz, founder and CEO of Biotivia, said: “PteroMax is unquestionably the platinum standard of chemoprotective longevity supplements. Pterostilbene is the most exciting and promising molecule to be investigated since the landmark study at Harvard on resveratrol. PteroMax is the only pterostilbene supplement designed by health scientists to match the specific proportions and concentrations of this molecule shown to be most effective in published scientific studies.” Both pterostilbene and polydatin are known to have synergistic effects when combined with resveratrol. The polyphenols in PteroMax are powerful antioxidants that greatly increase the bioavailability of resveratrol in the blood and tissues and improve the potency and efficacy of polydatin and pterostilbene. They also provide anti-free radical support and extraordinary antiinflammatory and immune modulatory effects. To read more about PteroMax, visit www.biotivia.com/pteromax.html.

Positive Opinion for Oat Beta-Glucan A scientific panel of the European Food Safety Authority (EFSA) published its positive opinion on a disease risk reduction health claim dossier for oat beta-glucan in December, following an application from CreaNutrition AG submitted pursuant to Article 14 of the EC regulation on nutrition and health claims. According to the positive opinion of the EFSA panel for dietetic products, nutrition and allergies (NDA), foods providing 3 g of oat beta-glucan per day can bear the health claim: “Oat beta-glucan has been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of heart disease.” The health claim still needs to be approved by the EU Commission. Bioactive oat beta-glucan is the cholesterol-lowering constituent of CreaNutrition’s OatWell oat bran ingredients. CreaNutrition is pleased about the positive opinion published by EFSA, with its acknowledgment of a strong scientific approach: “The evidence presented indicates that the cholesterollowering effect of oat beta-glucan may depend on the increased viscosity in the small intestine that reduces the reabsorption of bile acids, increases the synthesis of bile acids from cholesterol and reduces circulating (LDL) cholesterol concentrations.” A daily intake of 3 g of bioactive oat beta-glucan in foods that can be reasonably consumed is recommended as part of a healthy diet and lifestyle. The eligible natural oat sources not only contain beta-glucan, but also insoluble fibres, protein, polyunsaturated fatty acids, antioxidants and plant sterols. This EFSA statement concerning the naturally occurring oat beta-glucan found in oat bran is the first positive cereal-based, disease-risk reduction opinion (www.oatwell.com).

January/February 2011 www.nutraceuticalmag.com

news

Rising Demand for Chocolate Pieces Whether it’s for muesli, ice cream or yoghurts, growing numbers of food manufacturers are adding chocolate pieces to enhance the appeal of their products. “At the moment, there is enormous demand for pebbles or nuggets,” reports Andreas Broocks, Factory Manager at HERZA Schokolade (www.herza.de), a leading producer of small chocolate shapes for the food industry. “These chocolate chips vary in shape and size so that they appear to have been hand made. We originally created these products for the makers of muesli mixes. We are now also selling relatively large quantities to ice cream producers.” Because the nuggets are not only mixed into the ice cream, but also used as decorations, the products are available with a shiny finish or coating. But that’s not all: “Right now, variations on the coating theme are a hot topic,” says Andreas. “To encourage shoppers to keep buying their products, manufacturers are keen to make them look different — with pieces of chocolate covered in a gold or silver coating, for example.” Special effects can also be achieved with two-tone products. For example diamonds, where one side is made of light and the other side of dark chocolate. HERZA’s normal business is to supply a wide range of small chocolate pieces in every shape and size imaginable. The portfolio ranges from standards such as shavings, air cushions, flowers, matchsticks and leaves to second-bite chocolate pieces featuring, for example, coffee-flavoured brittle, biscuit or fruit chips, to melt-in-the-mouth nougat and truffle products, caramel, yoghurt and dairy confectionery pieces. New additions are chocolate sticks in varying lengths. These are between 10 and 15 mm wide and up to 38.5 cm long. “We have developed these sticks especially for the baking industry,” says Broocks. “The advantage is that the bakeries can break the chocolate to the length they require. For example, the baking-stable sticks can be inserted into croissants before they are baked.”

Partnership to Address Vitamin A Deficiency in India SIGHT AND LIFE and Vitamin Angels, two independent humanitarian organizations dedicated to fighting malnutrition, are teaming up in an effort to attack vitamin A deficiencies in India. Both organizations strongly feel that by combining the unique strengths of each into one co-ordinated effort to address this issue, much more can be accomplished. SIGHT AND LIFE’s mission is to ensure a sustainable and significant improvement in human nutrition, health and wellbeing through its commitment to fighting micronutrient deficiencies amongst the world’s poor. Vitamin Angels aims to mobilize and deploy private sector resources to advance the availability, access and use of vitamin A by newborns, infants and children in need. Together, these two organizations intend to build on their individual advantages to foster local ownership of the problem of 210 xvitamin 99mmA deficiency in India and catalyse a locally sustainable supply and

Cyvex Nutrition Acquired by Omega Protein Corporation Cyvex Nutrition announced in December that it has been acquired by Omega Protein Corporation, a leading producer of omega-3 fish oil and specialty fishmeal. Matthew Phillips, Cyvex’s President and Chief Operating Officer, will continue with Cyvex as its new Chief Executive Officer. Gilbert Gluck, founder and former owner of Cyvex, will continue to work with the ingredient supplier as a consultant. “I have spent the last 26 years building Cyvex into the industry’s leading provider of proprietary, condition-specific ingredients. Now, I would like to spend more time pursuing other interests,” stated Gluck. “Being acquired by Omega Protein Corporation will allow Cyvex the opportunity to grow its KriaXanthin marine oil business within the fish oil market, as well as provide me with a new set of opportunities.” Joe von Rosenberg, Omega Protein’s Chairman of the Board, President and Chief Executive Officer, added: “The acquisition of Cyvex provides Omega Protein with a strong line of non-marine based products and a stronger omega-3 distribution network for OmegaPure, our proprietary refined menhaden fish oil,” said “Cyvex provides us with an immediate presence in the human health and wellness segment and we now will have access to the top supplement retailers who purchase a variety of ingredients, including fish oil.” Visit www.omegaproteininc.com for more information.

Expanded Horizons for Rosemary Portfolio

Beta Glucan Scores at HiE Madrid

Vitiva (www.vitiva.eu) is proud to announce that the rosemary extracts sold under the VivOX, INOLENS and SyneROX brands are in compliance with the new EU Directives (2010/ 67/ EU and 2010/ 69/ EU), which define purity criteria and application ranges for rosemary extracts as antioxidants. ”Adding rosemary extract to approved food additives in the antioxidant category significantly expands the horizons of its use and brings the benefits of this natural and potent ingredient to a wide EU audience, which is constantly looking for friendly label products with a natural image,” says Ohad Cohen, CEO of Vitiva. “The long-awaited move of the EU legislation community to accept carnosic acid and carnosol-based rosemary extract as a safe natural alternative to synthetic antioxidants will allow food manufacturers to significantly expand their food portfolio by launching high quality and innovative products with a natural image. Now that our customers are finally able to complete important projects and lauch new products with our extensive oxidation management systems, I anticipate a large number of new product launches in Europe during 2011. Throughout the years, Vitiva has been developing a high value-added rosemary extract portfolio and customized solutions for all food applications. “Versatility, quality, active ingredient standardization and the proven benefits of Vitiva’s rosemary extracts are well known to a wide customer base all over the world,” adds Cohen. “As a leader in this category, Vitiva sees a significant new potential coming its way, bringing new opportunities for strong business development and growth.”

Following its successful US launch at Supply Side West, Biovelop’s PromOat beta glucan received an equally enthusiastic response from Madrid audiences when it appeared in the New Business Pavilion at the Health Ingredients Europe show. PromOat, which is the only clean-label soluble fibre from oats, bestows the well-recognized health benefits of oats on a wide variety of products but without the taste or colour of oats. It is also a highly versatile, functional ingredient that can be used as a fat-replacer or emulsifier. “We were delighted to receive such a warm welcome in Madrid,” said Biovelop spokesman, David Peters. “New Product Development teams are looking for natural ingredients that combine substantiated health claims with strong functionality, and PromOat ticks all these boxes.” Made using locally sourced Swedish oats, PromOat is rich in oat beta glucan (35%) and enables products to access the EFSA- and FDA-approved health claims linking oat beta glucan to the maintenance of healthy cholesterol levels. PromOat differentiates itself from competitor ingredients by containing no insoluble oat fibre or oat protein, the components that can compromise the flavour and aesthetics of finished products. This makes PromOat an extremely versatile ingredient and opens up opportunities for the wider application of oat-based beta glucans in a range of food and drinks not previously associated with oats. “One of the most exciting aspects of HiE for us was the incredibly diverse range of applications for PromOat that our clients are coming up with,” commented Peters. PromOat enables them to extend the health benefits of oats across a very broad spectrum of food and drink products without having to worry about masking the oat taste or graininess.” PromOat also performs some powerful technical functions, as it can be used as an effective fat-replacer, water-binder and emulsifier. In addition, it imparts the sort of creamy, indulgent mouthfeel normally found only in full-fat products (www.promoat.com).

distribution system in India. “Through this partnership, SIGHT AND LIFE’s advocacy and technical expertise and Vitamin Angels’ successful implementation of universal vitamin A supplementation projects aims to reach millions of people in India who have to date not had access to life-saving vitamin A,” said Dr Klaus Kraemer, Director of SIGHT AND LIFE. Some 535 million children around the world suffer from moderate to severe vitamin A deficiency, making it a global public health problem; 37% of these children live in India, making addressing vitamin A deficiency in India a critical component of the global challenge to eliminate micronutrient deficiencies. With the signing of this partnership, both partners hope to engage other international and Indian for-profit, non-profit and government entities to mobilize support and participate in this initiative, to sustainably tackle the vitamin A deficiency epidemic in India and improve the lives of millions of infants, children and women (www.sightandlife.org).

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GOED report

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100% Krill Oil Small Size No A ertaste No Burps Traceability More Bio-Eﬃcient Greater Stability Healthy Skin Healthy Heart Healthy Joints Healthy Brain

Brain Claims Headache

Eco-Friendly From the

Portions of the nutraceutical industry have long lamented the restrictions that regulators put on their ability to make claims. However, at the end of the day, when health claims are reviewed and approved by regulators, they are supposed to reflect the best scientific advice of experts who review the evidence. The omega-3 industry has been fairly successful under the new European claims regime, with more positive opinions from the European Food Safety Authority (EFSA) than any other nutrient. Yet, recent developments on omega-3 brain development claims seem to suggest that Member States are not heeding EFSA’s scientific advice.

riginally, two Article 14 (disease risk reduction) claim applications had been submitted in Europe to support claims that alphalinolenic-acid (ALA) and docosahexaenoic acid (DHA) contributed to brain development in children. EFSA initially treated these claims differently, issuing a positive opinion to ALA on the basis of its essentiality without direct clinical evidence, and denying the DHA claim because the data were “insufficient to establish a cause and effect relationship.” This has led to a very long debate between scientists and regulators on omega-3s and, if nothing else, may have educated some politicians about the benefits of omega-3s! The main issue facing the industry today is that, during the course of this debate, EFSA conceded that direct consumption of DHA will give children the same brain development benefit that it believes ALA confers by being essential, because the benefits of ALA are derived from its conversion in the body to the longer-chain DHA. In fact, the European Commission (EC) asked EFSA to clarify the situation and EFSA responded with an official letter clarifying that “DHA has a structural and functional role in the brain … and

www.nutraceuticalmag.com January/February 2011

therefore a claim on ‘DHA contributes to brain development’ is supported.” At the end of May 2010, the EC convened an Ad Hoc Working Group on Omega-3 Claims to discuss this issue, among others. The group included key stakeholders such as GOED and other associations. At this meeting, EFSA very clearly and directly said that, in its opinion, any claim approved for ALA related to brain health should also apply to DHA. Now fast forward to today. The European Member States are getting tired of constantly debating the merits of omega-3s; after all, they have considered nutrition claims, dietary reference values, multiple Article 13 claims and these Article 14 claims. They have specifically been working for more than a year on the Article 14 claims and have been unable to gain a consensus. So it appears that, in frustration, the Member States have said that they will revert to the original claim opinions by EFSA and adopt them with a few modifications. What this means is that there will be no brain development claims for DHA for any age group, but there will be a claim for ALA’s role in brain development that could end up applying to products targeting children from 0–18 years of age.

If this situation does not change, the Member States will effectively be ignoring EFSA’s advice that DHA is important in brain development. Even more strangely, the European Commission was specifically directed to get this extra advice by the Member States; so, they will essentially be sending EFSA the signal that they did not like the advice they received. GOED has strongly disagreed with this process all along, recommending that the scientific evidence for all omega-3s be assessed in a consistent manner. Given the latest developments, GOED has also urged each individual Member State to heed EFSA’s advice. EFSA is under attack from the industry regarding many of its claims opinions, but this is a situation in which, even when EFSA has the support of industry, politics can trump science.

For more information Adam Ismail, Executive Director and Harry Rice, VP, Regulatory and Scientific Affairs Global Organization for EPA and DHA Omega-3s (GOED) 1075 East Hollywood Avenue Salt Lake City, Utah 84105, USA. Tel. +1 801 746 1413 www.goedomega3.com

Purest Waters on Earth

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Superba™ Krill Omega-3 Phospholipid EPA/DHA

Superba™ Krill Oil is an excellent, pure source of marine omega-3 fa y acids. The omega-3’s EPA & DHA from krill are present in the highly bio-efficient phospholipid form, which provides unique health benefits. Superba™ Krill Oil is also extremely tolerable and free of repeating or “fishy burps.” Omega-3 Phospholipid EPA & DHA are important building blocks for healthy cell membranes. The ratio of EPA & DHA to other fa y acids in the membrane is called the Omega-3 Index – a strong indicator of cardiovascular health. In a recent human study, Superba™ Krill Phospholipid EPA & DHA had a significantly improved Omega-3 index compared to ordinary fish oil. Aker BioMarine is the only krill harvester that has been awarded the prestigious Marine Stewardship Council certification for its eco-friendly harvesting and traceability from sea to shelf.

www.superbakrill.com superba@akerbiomarine.com Phone: +47 24 13 00 00 January/February 2011 www.nutraceuticalmag.com

legal issues

IP Basics For my first column, I thought it would be helpful to briefly discuss some intellectual property (IP) basics and answer questions frequently asked by my clients in the nutraceutical industry. Future columns will delve into the details of the different types of intellectual property and discuss new and interesting IP developments as they relate to functional foods and drinks. Different Types of IP Intellectual Property (IP) covers creations of the mind. My clients in the nutraceutical industry most often seek patent and trademark protection. There are other forms of IP, such as trade secrets and copyrights. So, what is a patent? In the United States, a patent gives the patent owner the right to exclude others (usually for 20 years from the filing date) from making, Steve P. Hassid using, offering for sale and/or selling the inventions claimed in the patent, both throughout the United States as well as its importation into the United States. For example, suppose Company X recently received two patents, one on a new composition for weight loss and one on a method of manufacturing a particular compound. Anyone wanting to legally use either newly patented invention would have to obtain a license or purchase the patents from Company X. If either patent is infringed, Company X could bring suit requesting the court award damages and/or an injunction. Because patent rights can prevent competitors from practicing the invention, they are often considered to be valuable and powerful. A patent may be licensed, sold, assigned or transferred, potentially generating profits for its owner.

Different Types of Patents There are three basic types of patents: utility, design and plant. Utility Patents are the most common type of patent. As the name suggests, this protects the utility of an invention (the way an article or process is used or works). Methods and processes, machines and compositions of matter can all be protected using a utility patent. Clients in the nutraceutical field often patent new molecules, compounds and formulations, manufacturing processes and methods that give them a competitive advantage. For a utility patent to be granted, the owner must file an application meeting the various requirements of US law and demonstrate to the US Patent and Trademark Office that the invention claimed is novel, useful and not obvious in light of what has been done previously. Design Patents protect the ornamental design of an article (the way an article looks). For example, suppose Company X recently received design patents covering the unique look and shape of its bottles, caps and patterns used on certain items they sell. Anyone wanting to legally use the newly patented designs would have to

legal issues

Nutrition

obtain a license or purchase the patents from Company X. Company X could bring suit requesting the court award damages and/or an injunction if any of their design patents are infringed. Plant Patents protect a distinct and new variety of asexually reproduced plants and are not often used by clients in the nutraceutical industry.

What’s a Trademark? A trademark is a word, phrase, symbol or design, or a combination of words, phrases, symbols or designs, that identifies and distinguishes the source of the goods of one party from those of others. Trademarks protect a client’s investment in distinguishing themselves and their products from others and in building brand recognition. In the United States, a trademark must be used in commerce before it can be registered. Having a federally registered US trademark, designated by the ® symbol can prevent counterfeiters from profiting from the goodwill, image and brand of a company and its products. The general statements provided herein are provided for informational purposes only and do not constitute legal advice. Consult your intellectual property attorney for specific guidance.

For more information Steve P. Hassid, Partner at Silicon Edge Law Group LLP, is a registered US Patent and Trademark attorney who specializes in advising clients regarding worldwide intellectual property matters. Tel. +1 310 634 1717 steve@siliconedgelaw.com

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antioxidants

The Proven Benefits of

Coenzyme Q10

Coenzyme Q10 (CoQ10, ubiquinone) is a naturally occurring fat-soluble antioxidant. CoQ10 is found in virtually every cell in the human body, comprising part of the mitochondria, the energy generating mechanism of the cell. Being a critical component of this machinery, it plays a key role in cells with high energy requirements, and is found in the greatest quantities in the heart, liver, kidney and pancreas. Since its discovery in 1957, CoQ10 has been studied intensively and has been found to be related to many physiological and pathological processes.

lthough the benefits of CoQ10 have long been established, the main challenge that stands before the nutraceutical industry is getting this highly sought after molecule into the body. As the CoQ10 molecule contains side chains that are highly fat-soluble, it is practically insoluble in water, thus making it hard to be absorbed in the gastrointestinal system when administered orally. Ultrasome technology offers an innovative and improved delivery system for CoQ10, as well as other lipophilic compounds. The consumption of CoQ10 as a dietary supplement has been increasing greatly in recent years and is becoming even more recommended as further research and clinical trials are conducted, revealing the benefits of CoQ10 in multiple biological pathways. The fundamental role of CoQ10 in mitochondrial bioenergetics and its well acknowledged antioxidant properties constitute the basis for its clinical applications. Although CoQ10’s advantages are still being explored in many areas, some benefits are already well established and commonly agreed on in the medical community. Among them are Antiageing and skin protection effects: Skin damaged by solar UV radiation exhibits wrinkles, pigmented spots, dryness and tumours. This damage is mediated by various mechanisms, several of which can be influenced by CoQ10. UV radiation, both UVA and UVB, can cause DNA damage and thus encourage tumour formation. Another harmful mechanism is the excess formation of reactive oxygen species (ROS), which initiate processes leading to the degradation of fibre components in the dermis of the skin, leading to wrinkle formation. CoQ10 has been

www.nutraceuticalmag.com January/February 2011

shown to reduce ROS production and DNA damage triggered by UVA irradiation in human keratinocytes (skin cells) in vitro.1 Another suggested mechanism for CoQ10’s role in skin antiageing is the protection of the epidermis (external layer of skin) against oxidative stress and the enhanced production of epidermal components that aid regeneration.2 Reduction of exercise-induced muscular injury and performance enhancing effects: Intensive physical exercise may cause muscular injury and increase oxidative stress. As CoQ10 is known to be a potent antioxidant, its function in reducing muscular injury has been studied and confirmed

The recognition of CoQ10 as an important nutrient has not only increased in the scientific community, but also amongst the general public — and demand is on the rise.

in many clinical trials. In several studies performed on healthy volunteers, CoQ10 supplementation was tested against a placebo treatment. After several weeks of treatment, intense physical exercise was performed and several parameters were measured. Compared with the placebo group, subjects who received CoQ10 supplementation showed lower levels of muscle injury biomarkers and lower plasma oxidative damage.3,4 Furthermore, CoQ10 supplementation has been suggested to enhance physical performance and decrease fatigue during exercise in healthy individuals owing to its central role in cellular energy processes. CoQ10 has been suggested for use as an ergogenic aid.5,6 Prevention and treatment of cardiovascular disease and blood lipid profile: CoQ10 has profound positive effects on both the heart and the vascular system. In the heart, CoQ10 is crucial because of the high energy requirements of cardiac cells. Cardiac cells are extremely sensitive to CoQ10 deficiencies produced by diseases and other conditions, including a decrease in CoQ10 synthesis with age and statin use. Thus, CoQ10 has a potential role in the prevention and treatment of heart ailments by improving cellular bioenergetics. In multiple clinical trials, significant improvement has been observed in clinical and haemodynamic parameters and in exercise tolerance in patients given adjunctive CoQ10 in doses from 60–200 mg daily in trials conducted in patients with heart failure, hypertension, ischemic heart disease and other cardiac illnesses.7 High levels of lowdensity-lipoprotein (LDL), commonly known as “bad cholesterol,” are a major risk factor

for atherosclerosis. LDL is considered to be harmless until it is oxidized by free radicals and enters the blood vessel wall to create a plaque. CoQ10 as an antioxidant inhibits LDL oxidation and thus the progression of atherosclerosis.8 Clinical trials that tested the effects of antioxidants, including CoQ10, have shown that antioxidant supplementation causes a beneficial vascular effect, via increased artery elasticity, improvement in glucose and lipid metabolism as well as a decrease in blood pressure.9

The Bioavailability Challenge As discussed above, the benefits of CoQ10 are well established. Although CoQ10 can be manufactured within the human cell, synthesis decreases substantially with age and with certain medical conditions, especially the use of cholesterol-lowering statin drugs. It was found that in most organs, including the heart, liver and kidney, CoQ10 reaches its highest concentration at the age of 20, followed by a continuous decrease upon further ageing.10 And, whereas food is a source of exogenous CoQ10, it cannot compensate for these deficiencies. CoQ10 is a lipophilic compound with a relatively high molecular weight that’s insoluble in water and poorly soluble in lipids. Because of these properties, the enrichment of most food products is not easily achievable and the absorption of CoQ10 in the gastrointestinal tract is very poor.11 Bioavailability, which is the amount of active component that enters circulation after oral ingestion, was tested numerous times for CoQ10. The rate of absorption varies greatly depending on the formulation. However, typical absorption rates are in the range of 1–5%,

making it necessary to use very high daily doses to achieve a significant change in CoQ10 plasma concentration. Another factor that should be taken into account is the doseresponse curve: absorption of CoQ10 shows a non-linear curve, meaning that the efficiency of absorption decreases as the dose increases.12 For this reason, simply increasing the dose cannot fully compensate for the low absorption rate and better formulations with higher bioavailabilities are a necessity.

A Clinically Proven, High Absorption Solution Herbamed has developed a unique patented technology (Ultrasome) for the enhanced oral bioavailability of lipophilic compounds such as CoQ10. Ultrasomes are a new type of lipid particle — considered to be an intermediate or “hybrid” formation between liposomes and oil-in-water emulsions (micelles). Ultrasome particles have a new type of lipid assembly comprising a hydrophobic core, as in standard oil-in-water emulsions, but surrounded and stabilized by phospholipid bilayers as in liposomes. Liposomes are microscopic vesicles composed of a bilayer of phospholipids or any similar amphipathic lipids that contain a polar head group covalently attached

January/February 2011 www.nutraceuticalmag.com

antioxidants

to one or two hydrophobic hydrocarbon tails. When these lipids are exposed to an aqueous environment, interactions between themselves (hydrophilic interactions between polar head groups and van der Waals interactions between hydrocarbon chains and hydrogen bonding with water molecules) lead to the spontaneous formation of closed bilayers. These structures can encapsulate and effectively deliver both hydrophilic and lipophilic substances. The Ultrasome technology represents a new entity as a lipoidal drug vehicle and its successful development was achieved by the incorporation of a relatively high phospholipid content, the use of triglycerides that are solid at room temperature and the utilization of high-pressure emulsification. The combination of the specific lipid composition and manufacturing technology results in the formation of stable lipid particles in the submicron range. The efficacy of the formulation was tested in vitro and in vivo by Herbamed. In vitro research tested the release patterns of CoQ10 from an Ultrasome-CoQ10 formulation and from a generic CoQ10 product in simulated gastric fluid. After 3 hours, 92% was released from the Ultrasome-CoQ10 formulation, compared with a much lower release (10%) from the generic CoQ10. After capsule disruption in the stimulated gastric fluid, large aggregates or clusters of CoQ10 were observed, which may explain the low CoQ10 dissolution into the release medium. As particle size is a limiting factor in the rate and extent of drug absorption from the gastrointestinal tract, this result indicates low oral bioavailability of CoQ10 from the commercial product compared with the Ultrasome-CoQ10 formulation. In vivo research included a clinical trial to test the absorption of a single dose of Ultrasome-CoQ10 compared with a generic CoQ10 product. The trial was conducted on a population of geriatric patients. The intersubject baseline variability was minimized by selecting individuals with prestudy endogenous CoQ10 plasma levels of 0.3 µL/mL. The population study included 30 patients (14 males and 16 females) aged between 64 and 93. Each subject received a single dose of 90 mg of CoQ10 in hard gelatin capsules of either Ultrasome-CoQ10 or generic CoQ10 (control group). Maximal concentrations of CoQ10 in the plasma were reached 4 hours after receiving the capsule. The UltrasomeCoQ10 group showed a maximal change over baseline of 0.35 µg/mL, compared with only

www.nutraceuticalmag.com January/February 2011

strap

For more information

References

David Hart, Marketing Manager and Dr Anat Solomon, R&D Manager Herbamed Ltd Science Park Kiryat Weizmann Rehovot, Israel. Tel. +972 8 940 9648 Herbamed@Herbamed.co.il www.herbamed.co.il.

1. M. Inui, et al., “Mechanisms of Inhibitory Effects of CoQ10 on UVB-Induced Wrinkle Formation In Vitro and In Vivo,” Biofactors 32(1–4), 237–243 (2008). 2. K. Muta-Takada, et al., “Coenzyme Q10 Protects Against Oxidative Stress-Induced Cell Death and Enhances the Synthesis of Basement Membrane Components in Dermal and Epidermal Cells,” Biofactors 35(5), 435–441 (2009). 3. M. Kon, et al., “Reducing Exercise Inducing Muscular Injury in Kendo Athletes with Supplementation of Coenzyme Q10,” Br. J. Nutr. 100, 903–909 (2008). 4. P. Tauler, et al., “Supplementation with an Antioxidant Cocktail Containing Coenzyme Q Prevents Plasma Oxidative Damage Induced by Soccer,” Eur. J. Appl. Physiol. 104(5), 777–785 (2008). 5. K. Mizuno, et al., “Antifatigue Effects of Coenzyme Q10 During Physical Fatigue,” Nutrition 24, 293–299 (2008). 6. H. Gökbel, et al., “The Effects of Coenzyme Q10 Supplementation on Performance During Repeated Bouts of Supramaximal Exercise in Sedentary Men,” J. Strength Cond. Res. 24(1), 97–102 (2010). 7. A Kumar, et al., “Role of Coenzyme Q10 (CoQ10) in Cardiac Disease, Hypertension and Meniere-Like Syndrome,” Pharmacol. Ther. 124, 259–268 (2009). 8. F. Rosenfeldt, et al., “Systematic Review of Effect of Coenzyme Q10 in Physical Exercise, Hypertension and Heart Failure,” Biofactors 18, 91–100 (2003). 9. M. Shargorodsky, et al., “Effect of LongTerm Treatment with Antioxidants (Vitamin C, Vitamin E, Coenzyme Q10 and Selenium) on Arterial Compliance, Humoral Factors and Inflammatory Markers in Patients with Multiple Cardiovascular Risk Factors,” Nutr. Metab. (Lond). 7, 55 (2010). 10. A. Kalén, E.L. Appelkvist and G. Dallner, “Age-Related Changes in the Lipid Compositions of Rat and Human Tissues,” Lipids 24(7), 579–584 (1989). 11. H.N. Bhagavan and R.K. Chopra, “Coenzyme Q10: Absorption, Tissue Uptake, Metabolism and Pharmacokinetics,” Free Radic. Res. 40, 445–453 (2006). 12. H.N. Bhagavan and R.K. Chopra, “Plasma Coenzyme Q10 Response to Oral Ingestion of Coenzyme Q10 Formulations,” Mitochondrion 7(Suppl.), S78–S88 (2007). 13. J. Gindin and S. Amsalem, “Enhanced Bioavailability of Ultrasome-CoQ10 Compared with Generic CoQ10 Among Elderly Hospitalized Patients in a Randomized Double-Blind Controlled Study,” unpublished results (Department of Geriatric Education and Research, Kaplan- Herzfeld Medical Center and Pharmos Ltd, Rehovot, Israel). 14. M. Berman, et al., “Coenzyme Q10 in Patients with End-Stage Heart Failure Awaiting Heart Transplantation: A Randomized Placebo-Controlled Study,” Clin. Cardiol. 27, 295–299 (2004).

0.141 µg/mL in the control group. Analysis of variance (ANOVA) showed a statistically significant difference (p<0.035) between the two groups. This study demonstrates that UltrasomeCoQ10 has a high drug-tapping efficacy and improved oral delivery of CoQ10, even in hospitalized, geriatric patients that may have poor absorption of coenzyme Q10. Unpublished results have shown a much higher (10 fold) improved bioavailability in young patients, compared with a generic product.13 Three more clinical trials were conducted to assess the effect of Ultrasome-CoQ10 on different medical conditions. In a double-blind, placebo-controlled, randomized study, 32 patients with end-stage heart failure awaiting cardiac transplantation received a daily dose of 60 mg/day of Ultrasome-CoQ10 or a placebo. The group that received Ultrasome-CoQ10 showed a significant improvement in functional status, clinical symptoms and quality of life.14 In proprietary research, Ultrasome-CoQ10 also showed positive results in healing chronic skin lesions, in rehabilitation following the surgical repair of hip fractures and as a potential protection against Parkinson’s disease (PD) and other neurodegenerative diseases, all without side-effects.

Conclusion Extensive research has proven the health benefits of CoQ10, not only for an elderly population but also for young and middleaged persons. The recognition of CoQ10 as an important nutrient has increased not only in the scientific community, but also amongst the general public — and demand is on the rise. As more proof of its benefits is collected, and as it becomes better known, the demand for CoQ10 products is expected to grow much further in the coming years. To supply the increasing demand, producers of functional food, beverages and dietary supplements will need a high quality, stable, easy-to-handle CoQ10 formulation that has an inherent advantage compared with other products. Herbamed’s Ultrasome-CoQ10 answers this demand, with a powder-form, high bioavailability product.

When the heat is

This Cool It gets a lot of

Attention

Hot red pepper ingredient receives 2009 SupplySide Scientific Excellence Award

Ideal for use in:

■

CMY

■

Weight management Diet control ■ Sports nutrition

In animal and human studies, Capsicum and Capsaicinoids have been shown to: Help manage appetite* ■ Support healthy metabolism to burn calories* ■ Help induce thermogenesis* (increase in energy expenditure in the body)* ■ Help reduce body mass and body fat* ■

The thermogenic power of OmniActive Health Technologies’ red hot pepper extract Capsimax is capturing the attention of the nutrition industry. A bonafide category creator, OmniActive’s Capsimax won the SupplySide Scientific Excellence Award, alongside GNC’s WELLbeING® be-ENERGIZED™ Calorie Burning Formula, in which Capsimax is the primary ingredient. Capsimax utilizes a breakthrough beadlet technology that delivers the metabolic boost of capsicum—without the burn! A proprietary formulation, Capsimax encapsulates a highly-concentrated natural capsicum fruit extract, manufactured from the active principles of hot red peppers (a global diet staple for centuries). The encapsulation technology delivers highly-effective levels of active capsaicinoids without the oral or gastric irritation associated with unprotected hot red pepper.

1-866-588-3629 *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Watch an informative 3-minute video at www.capsimax.com January/February 2011 www.nutraceuticalmag.com

antioxidants

The Antioxidant Debate

Which Way Next?

During the past three decades, Cyvex Nutrition has emerged as a leading supplier of science-supported fruit, vegetable and botanical antioxidants that address a wide range of health conditions. Dr Kevin Robinson spoke with Cyvex President, Matt Phillips, about the challenges of marketing antioxidants to consumers, how EFSA’s opinion will affect this category and what’s on the horizon for antioxidant offerings. NBT: How have you marketed your wide range of antioxidant ingredients during the past two decades? MP: By emphasizing quality and credibility! Our customers and, ultimately, consumers want scientific evidence about the claimed health benefits. The products we sell have to be able to pass the test of time. This can be achieved through an ingredient’s scientific portfolio and history. The periwinkle plant extract, vinpocetine, for example, has 25 years of consumer usage, clinical data and scientific studies behind its ability to support overall cognitive function. It is difficult to argue with facts, so we introduce and sell products that have strong supporting science. Our newest product, Cognisetin, a fisetin-based flavonoid for neuroprotection was licensed from the renowned biological research organization, the Salk Institute for Biological Studies in San Diego (California, USA). This ingredient continues to show benefits for memory enhancement in scientific studies, including its ability to generate neuron cells in the presence of damage. NBT: Today, antioxidants have almost become a “dirty word” in the industry. How do you see the market for antioxidant ingredients evolving in 2011? MP: Cyvex was founded in 1984. It was around this time that scientists discovered why people whose diets were rich in fruits in vegetables had a lower incidence of developing diseases associated with free radical damage. This discovery led the scientific community to further research the theory that antioxidants may be beneficial in counteracting cell damage caused by a disease or simply from the ageing process. Since that time, a barrage of antiageing products and diets has been created on this health premise. The slightest hint of some possible benefit prompted the release

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Matt Phillips

of a new “hot” antioxidant. This behaviour resulted in more than 300 new antioxidants being released in the first half of 2010. For an ingredient to have long-term success and gain general acceptance with consumers, there has to be commitment through continued use, along with a wealth of established and ongoing information that substantiates any health claims. As consumers become increasingly educated and sophisticated in what to look for and what’s pure hype in health-promoting products, the antioxidant category will evolve accordingly.

NBT: With the European Food Safety Authority (EFSA) rejecting several health claims related to antioxidants, do you feel this market will shrink significantly or disappear altogether? MP: No, regulation is not always bad. There are two ways to view regulation: you can either rise to the regulatory standards or you can fall short. When the US FDA implemented GMP standards, many companies were discarded because of the heightened demands on quality. GMP standards are only detrimental to companies that do not follow

them, whereas companies adhering to them actually benefit. Overall, this is positive for the industry because it demands more credibility. EFSA only rejected claims that did not have enough scientific support to show the causal link between the antioxidant in question and the claimed health benefit. EFSA’s actions can be looked at as positive or negative. It is negative in that it reduces the number of claims some nutraceutical companies use to market and sell products. However, on a positive note, it strengthens the products and their associated claims that are approved by EFSA. Consumers will ultimately have more confidence in a system that is selective.

NBT: Will the US market follow suit? MP: In my opinion, it really does not matter. If your product has the scientific research and results behind it, people will use it. We should all be worried if EFSA — or even the FDA — accepted all of the health claims submitted by nutraceutical companies. When the bar is set higher, suppliers have to perform to those higher expectations. Products and companies become better with higher expectations and the best products and companies survive. This is why quality and longevity are crucial in this industry. NBT: You offer a range of antioxidant ingredients that target specific health conditions. How do you navigate this changing landscape in which health claims are being increasingly scrutinized? MP: Cyvex only makes health claims that are backed up by scientific data and evidence. Our role is more as a messenger. We do not create any extravagant messages about health claims but rather deliver messages based on fact. Cyvex has to be discriminating when choosing ingredients. It is much easier to deliver a message or a health claim when the ingredient or antioxidant has a proven

Consumers are doing their homework and becoming educated about the health benefits of certain antioxidants. health benefit. Cyvex also combines the health benefits of individual antioxidants to create “blends,” which may have a synergistic effect on the body.

NBT: Which health claims do you feel are still viable? MP: As it relates to our product portfolio, Euro Black Currant to support eye health and our BioVin full spectrum grape extract for cardiovascular health. A clinical study published in the Journal of Medicinal Food illustrates the beneficial role of BioVin polyphenols in enhancing the antioxidant capacity of the serum and protecting proteins and LDL cholesterol against oxidative damage.1 These outcomes can significantly reduce the risk of chronic diseases such as cancer and coronary heart disease. These are two ingredients that have significant scientific information and human clinical study results to substantiate their claims. In general, antioxidants are substances or nutrients in our foods that can prevent or reduce oxidative

damage to our body. Preventive medicine is growing in popularity worldwide, and if thorough scientific investigation can show a potential health benefit, people will continue to pay attention.

NBT: Do consumers have a strong enough understanding of which antioxidants deliver a targeted health benefit, without specifically identifying it on a label? MP: With healthcare systems becoming more complex and expensive, consumers have quickly become their own health advocates. Through research, consumers are doing their homework and becoming educated about the health benefits of certain antioxidants. There is plenty of information that is easily accessible on the Internet that can provide consumers with both the pros and cons for any antioxidant. To improve consumer awareness, Cyvex is moving toward a closer association of a particular antioxidant or ingredient with a specific health benefit, especially through online education. For example, our website for Chirositol, an extract of carob pods that can help manage blood glucose levels, has been very successful in educating visitors about the health benefits of D-chiro-inositol. This is because consumers conduct research based on a health condition or concern, not necessarily on a specific antioxidant. NBT: Despite the challenges that face the antioxidant market in the years ahead, what ingredients do you feel will continue to thrive? Or are there any new offerings that may emerge? MP: Quality ingredients that have scientific evidence to support health claims will

pass the test of time. An ingredient we are focusing on with significant potential is Super C-3-G, which was developed from black rice. Black rice has a long history of traditional use. The extract is obtained from black rice (Oryza sativa L. indica) grown in Korea, which has the same dark pigment found in other types of antioxidant-rich foods, such as berries. Unlike berries, however, black rice extract has an anthocyanin content of greater than 25%. The anthocyanins are composed of 90% cyanidin-3-glucoside (C-3-G). This is important because the amount of C-3-G appears to be directly proportional to the amount of antioxidant activity. Not only does black rice extract have the highest ORAC compared with other berry anthocyanin extracts, it also contains other valuable antioxidants such as vitamin E, tocotrienol and carotene. With such high ORAC levels, there are quite a few studies, both concluded and currently being conducted, on its benefits for eye health and other conditions.

Reference 1. A.V. Rao, et al., “Bioabsorption and In Vivo Antioxidant Properties of Grape Extract BioVin®: A Human Intervention Study,” J. Med. Food 3(1), 15–22 (2000).

For more information Matt Phillips President and Chief Operating Officer Cyvex Nutrition, Inc. 1851 Kaiser Avenue Irvine, California 92614, USA. Tel. +1 949 622 9030 matt@cyvex.com www.cyvex.com

January/February 2011 www.nutraceuticalmag.com

antioxidants

Glutathione

is typically dosed between 100–300 mg daily. Despite opinions about the poor absorption of glutathione, oral glutathione is, just like other proteins, absorbed orally. There is a significant body of data that documents the bioavailability of glutathione from oral dosing.

The Key to Repairing Damaged Cells

Until Death Do Us Part: Antioxidants

At any given moment, thousands of our cells are dying. In fact, the saying, “We begin to die the moment we are born” is, in a matter of speaking, true. And, as paradoxical as it may seem, the cellular death that we experience is essential to living. This seemingly contradictory process is, in actuality, a brilliantly engineered survival strategy. At the core of this strategy lies the fact that our cells can become damaged. A damaged cell must either repair itself or, if the damage is too overwhelming, must be deleted so that it will not compromise the health of the tissue of which it is a part. Apoptosis, or programmed cell death, efficiently and tidily removes these damaged cells.

poptosis refers to a cell-initiated process of destruction and death. It is often referred to as cellular suicide because the process starts within the damaged cell. Apoptosis is the most efficient and least inflammatory way to remove damaged cells. In response to cellular damage to critical parts of the cell’s DNA or organelles, molecules released as part of the damage activate repair genes. These repair genes code for certain proteins that are used to repair damage. However, if the cell cannot be functionally repaired, suicide — or apoptotic — genes are activated. These genes initiate a cascade of events within the cell that ultimately cause the cell to involute and cease to function. It is then engulfed by roving phagocytic immune cells and completely digested.

Stimulators of Apoptosis The main trigger for apoptosis is DNA damage. In fact, DNA damaging agents such as ionizing radiation and chemotherapy rely upon apoptosis to be effective treatments against cancer. These damaging agents cause enough DNA damage to initiate apoptosis in cancerous (and some other) cells. Other agents that, when present to a sufficient degree, cause sufficient physical damage to initiate apoptosis are heat, cold, physical trauma and oxidative damage from compounds such as alcohol, tobacco smoke, industrial pollutants, infections and UV exposure. These agents damage DNA and, if the damage is too great for repair, apoptotic proteins are released.

www.nutraceuticalmag.com January/February 2011

Antioxidants and Apoptosis We typically think of antioxidants as agents that prevent cell damage by neutralizing oxidative or free radical compounds. This function of antioxidants is fundamentally important. Given the constant exposure to oxidants in the environment, as well as the oxidative compounds released as a part of core activities such as eating, breathing and exercising, we would quickly be overwhelmed with cellular damage without the neutralizing defence of antioxidants. There is, however, an additional protective role of antioxidants that is perhaps less widely realized. Whereas apoptosis is initiated by oxidative stress, antioxidants initiate and preserve apoptosis. Antioxidants then serve a dual role; they prevent oxidative damage and, when damage has occurred, they stimulate and chaperone the apoptotic process. The major endogenous (within the body) antioxidants involved in neutralizing free radical damage, as well as in preserving apoptosis, are glutathione, ubiquinol, SOD and catalase. Of these, glutathione is the most ubiquitous antioxidant in the human body. Glutathione is a tripeptide composed of glutamate, cysteine and glycine. It is found throughout the body and is particularly concentrated in the liver where detoxification activities are paramount. Glutathione enables apoptosis in two key ways: it defends the DNA against free radical damage, thereby preventing damage to pro-apoptotic genes; and glutathione preserves the structure and function of key cellular proteins that signal apoptosis. Without glutathione, apoptosis would be unlikely to occur. Glutathione levels

are highest for about 6 hours after each meal. Our lowest level of glutathione is in the morning before our first meal. Although healthy children and young adults tend to have sufficient glutathione, its production decreases as we age. Once we reach the age of 45, we begin to produce less glutathione. Add to this any glutathione-depleting activities, and our glutathione stores can become seriously low. Lifestyle choices that deplete glutathione include chronic excessive alcohol consumption, dietary deficiencies and constant, excessive stress. Alcohol consumption creates oxidative damage that, in turn, leads to DNA damage, thus stimulating cell repair or apoptosis. However, chronic alcohol consumption ultimately depletes glutathione, which results in impaired apoptosis. The result of this depletion is survival of alcohol-damaged cells. The proliferation of these damaged cells ultimately manifests itself in liver disease, neurological diseases, cancer and heart disease — all health conditions of alcoholism. A glutathione deficient diet is, unfortunately, far too common. Studies have found that Americans only consume from 3–150 mg of glutathione per day. The average intake is 35 mg per day. An optimal intake of glutathione is more than 250 mg per day, so the average person’s diet is deficient. Additionally, foods such as cereals, bread, tea, coffee and dairy products not only lack glutathione, they destroy it. Chronic stress is another sure-fire way to deplete glutathione. Chronic neuroendocrine stress leads to the elevation of stress hormones and an increased metabolic rate,

The two fundamental processes that protect us from developing chronic diseases such as cancer, heart disease and neurological diseases in the face of oxidative damage are cell repair and apoptosis. Antioxidants are required for both of these protective pathways and, thus, essential for healthy life. Glutathione is perhaps the most important antioxidant in our bodies and sufficient glutathione will usher the destruction of damaged cells and preserve the repair and survival of healthy cells, ultimately supporting long-term vitality.

Cellular Suicide which is frequently accompanied by oxidative damage and depleted antioxidants. High levels of stress hormones also promote lipid storage in organ fat rather than subcutaneous fatty tissue. Fat cells secrete several proinflammatory cytokines, which increase oxidation and deplete glutathione. The result of this process is cell injury, organ damage and disease.

Glutathione Restoration The importance of glutathione to apoptosis and, therefore, cellular viability and tissue health requires daily replenishment. Glutathione is found in a variety of foods, particularly fruits, vegetables and meats. Foods rich in glutathione include asparagus, spinach, garlic, avocado, squash, zucchini (courgette), potatoes, melons, grapefruit, strawberries and peaches. Herbs such as turmeric, cinnamon and cardamom contain flavonoid compounds that, in turn, increase glutathione production. There are also dietary precursors of glutathione. Brazil nuts, meat and seafood contain high amounts of selenium: just one or two Brazil nuts daily supplies sufficient selenium for most people to support glutathione production. Alpha lipoic acid will increase the production of glutathione and is found in red meat, organ meats (such as liver) and yeast (particularly Brewer’s yeast). Riboflavin, found in sunflower seeds, spinach and avocados, is required for glutathione production. Glutathione production is dependent upon its sulphur-containing precursor amino acid, cysteine. Eggs and

garlic are good sources of sulphur-containing amino acids. In addition to diet, certain lifestyle interventions will restore glutathione to more optimal levels. In particular, activities that reduce stress have the greatest impact. One such activity is yoga. A clinical trial was conducted on healthy male volunteers from the Indian Navy who were divided into two groups — a yoga group and a control group. The yoga group was trained in yoga for 6 months. The yoga schedule consisted of prayers, asana, pranayama and meditation. The control group practiced routine physical training exercise for 6 months. Glutathione levels increased significantly (p<0.05) in the yoga group compared with the control group after completing the training. In a similar study, meditation was found to increase glutathione. In this study, 42 Sudarshan Kriya meditation practitioners and 42 normal healthy controls who did not practice yoga were recruited for the study. The meditators had a better antioxidant status, better stress regulation and up-regulation of repair and antiapoptotic genes. Another viable strategy for glutathione restoration is oral supplementation with a glutathione dietary supplement. Because glutathione is naturally low in the morning, in those with insufficient overall glutathione, the early morning represents a time of very low glutathione. This translates into a window of vulnerability to oxidative insult. Supplementing glutathione, particularly in the morning, may reduce this risk. Glutathione supplementation

One way to think about apoptosis is with an analogy. Let’s say there is a forest of hundreds of oak trees, most of which are healthy. However, in the midst of this forest, there are several diseased and sickly trees. These trees are peppered throughout the forest. One way that the forest remains healthy is because those diseased trees, unable to grow and thrive like their healthy neighbours, become shaded from the sun, cannot grow their roots as deep or wide and eventually die. An opportunistic logger might then come and fell that dead tree and haul it away. This process is analogous to apoptotic cell death. The other option for the forest is if the diseased tree remains alive and spreads its disease to its neighbouring trees. Ultimately, the forest becomes weakened from disease and prone to destruction by pests or fire. This latter process is analogous in the human body to a process called necrosis. Necrosis is a process of cellular death and tissue damage initiated typically by the molecules of inflammation. Necrosis is messy, potentiates inflammation and can ultimately lead to serious illness and death. One can begin to understand the criticality of apoptosis to health and survival. In fact, defects in apoptosis can lead to cancer, autoimmune disease, chronic viral infections, atherosclerosis and neurodegenerative disorders. All of these disorders, incidentally, are characterized by tissue necrosis.

For more information Dr Lise Alschuler, ND, FABNO, is a naturopathic physician with board certification in naturopathic oncology. She has been in practice for more than 16 years, is the Vice President of Quality and Education at Emerson Ecologics and practices naturopathic oncology with Naturopathic Specialists, LLC. Dr Alschuler co-authored The Definitive Guide to Cancer: An Integrative Approach to Prevention, Treatment and Healing, Third Edition. For more information, visit www.cancerthrivers.net.

January/February 2011 www.nutraceuticalmag.com

antioxidants

event preview

Mighty

IN ASSoCIAtIoN wItH

Hydroxytyrosol

Hydroxytyrosol is a powerful antioxidant that has been part of the diet of populations from the Mediterranean Basin for millennia. In recent years, the traditional Mediterranean diet has received an increasing amount of attention for its protective effects against heart disease, certain cancers, skin ailments and a good number of today’s stress and ageing related health problems. That protective function comes in large part from the antioxidant polyphenols at the basis of this kind of diet. Hydroxytyrosol (HT), the most active of these polyphenols, is found in olives and olive oil and is now credited for most of the beneficial effects of a Mediterranean style of eating.

ydroxytyrosol occupies a unique place among the healthy phytomolecules derived from fruits and vegetables. For one thing, HT is the only phenol that is able to cross the Blood Brain Barrier, allowing it to not only perform its vitally important free radical scavenging activity in the bloodstream, but also throughout the nervous system. As a metabolite of dopamine, HT may also exert a neuroprotective effect and plays a positive role on mood disposition. Recently, researchers have determined that hydroxytyrosol is active at the mitochondrial level, suggesting that it may play a more foundational role in the basic biochemistry of human cells than had been previously understood. Interestingly enough, this understanding, which for long time had been restricted exclusively to companies doing cutting edge research in the realm of phytomolecules — such as Creagri Inc., a California-based nutraceutical supplier — has also recently been creeping into articles published by industry related magazines such as Functional Ingredients.

www.nutraceuticalmag.com January/February 2011

Writing about polyphenols in the June 2010 issue of Functional Ingredients, although not discussing HT directly, David Mark, PhD, President of DMark Consulting LLC, explored the role played by these molecules in the basic biochemistry of mammalian life. He observed that even after prolonged consumption, the presence of polyphenols in the blood circulation of subjects studied for research purposes is only transitory, and that this data should compel researchers to modify their traditional understanding of the role played by these compounds into the antioxidative process. Mark concluded that rather than a direct physiological — or justly physiological — role, these substances play a more intriguing function at the molecular level, intervening of all places into gene modulation — as proven by studies conducted at the Harvey Research Institute — and consequently into lowering the production of endogenous pro-oxidants, as demonstrated by researchers at the University of Tokushima. Acting indirectly as antioxidants, but more importantly as anti-inflammatory agents,

polyphenols would therefore exert a more vital effect, boosting the cell’s own immunity and well-being processes. However, although much attention has been given by the media to the health effects of phytomolecules, very little attention has been paid to the benefits that the consumption of more bioavailable forms of these active ingredients could provide to health conscious consumers, and therefore to the growing amount of research being done internationally with hydroxytyrosol. Trials with HT are under way around the globe in countries such as Spain, the Netherlands, Germany, Italy, India, China, Australia and the USA. This phytomolecule is being tested for applications in the treatment of osteoporosis, arthritis, psoriasis, endometrial cancer, cancer of the prostate and of the breast, obesity, cardiovascular disease, Alzheimer’s, macular degeneration and epilepsy. Besides Creagri, which has been at the forefront of research in the realm of hydroxytyrosol derived from olives, and whose portfolio includes 16 patents for the use and the production of HT from the juice of organic olives, patents

A Celebration of Food Innovation Via Connect and NBT magazine, in association with Vitafoods Europe, are delighted to announce the launch of The Nutraceutical Business and Technology Awards (NBTA) and business roundtable. The NBTA will recognize excellence in R&D, marketing, business and technology in the areas of ingredients, finished products, applications and business practices. The business roundtable will feature some of the world’s major health, nutrition and wellness companies in a lively debate about overcoming the barriers to commercial success. Panellists will discuss the trials and tribulations of getting consumers to adopt and accept functional food and drink products. For more information on NBTA and business roundtable sponsorship opportunities, please contact: Christopher Watt christopher.watt@viaconnect.co.uk Samuel Thangiah samuel.thangiah@viaconnect.co.uk Tel. +44 207 801 6320

LAUNCH EXCLUSIVE THE NUTRACEUTICAL BUSINESS AND TECHNOLOGY AWARDS & BUSINESS ROUNDTABLE 11 MAy 2011, GENEVA, SwItzErLANd

AwArd CAtEGorIES 2011 • Most Innovative Ingredient • Outstanding Application in Health Management • Most Effective Strategic Product Development • Most Effective Marketing Campaign • Environmental Excellence • Most Improved Product Safety and Quality • Best New Plant/Process/Technology • Best New Finished Product

To request an entry form or CLoSING dAtE Fo r E N for further details, please 14 FEBrUAtrryIE2S0:11 contact Awards Director, Miranda Docherty, on +44 1372 364 122 or email miranda.docherty@via-medialtd.com

www.nbtawards.com www.nutraceuticalmag.com – www.vitafoods.eu.com

antioxidants

corporatre profile

Because it can be utilized with proven efficacy to formulate remedies with benefits ranging from skin protection and beauty to bone and joint wellness, hydroxytyrosol is the perfect ingredient for all sorts of applications. for various applications of HT are also being sought by international industry leaders such as DSM International and from academic institutions such as the Instituto de La Grasa in Spain. The quest is not only for healthy ingredients with innate benefits, but also for compounds that are natural, safe and whose health claims can be safely printed onto a product’s label. Because it can be utilized with proven efficacy to formulate remedies with benefits ranging from skin protection and beauty to bone and joint wellness, and from cardiovascular health to mental alertness, energy and performance, hydroxytyrosol is the perfect ingredient for all sorts of applications, including dietary supplements, food and beverage products, cosmeceuticals and pharmaceuticals. Currently, hydroxytyrosol is being marketed for use in many different areas. In addition to the functional food industry, which according to BCC Research is set to reach the $177 billion revenue mark by 2013, HT is being integrated into an increasing number of dietary supplements, nutraceutical products, cosmetics and pharmacy recommended remedies, and many companies are still actively looking for ways to integrate it into many new products and formulations. In Malaysia, consumers can enjoy the benefits provided by Olivenol Plus, a dietary supplement containing HT marketed by Creagri International. In the USA, consumers have recently been benefiting from the introduction of the HA formulation for joint health, a dietary supplement containing Creagri’s proprietary formulation of HT (Hidrox).

Eco-Harvesting Most of the hydroxytyrosol available on the market today has been extracted from the olive, either from the leaves, the bark of the

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tree or the juice of its fruit. To obtain their HT, many companies need to initiate new production cycles — either harvesting leaves or stripping olive trees of their bark — but Creagri Inc. has devised a natural, renewable and ecofriendly method of harvesting HT from olive juice (technically defined as olive milling water) produced during the production of olive oil. This proprietary and renewable process is called the “Integrale” and has been conceived with the intent to not only reduce waste but also to eliminate a sizeable amount of olive milling water from the environment. An industrial byproduct, olive milling water (OMW) is traditionally deemed to be non-disposable — and must be handled using appropriate and strict waste management procedures. Using the Integrale, Creagri is able to totally eliminate these waters from the waste stream, transforming them into vapour and a healthy and nutritional ingredient. And, because the olives are pitted before being crushed, Creagri not only obtains a better olive oil with a lower acidity, but also produces less waste, as the enzymes contained in the crushed pits contribute to the polluting activity of those waters. This may seem to be an irrelevant detail; but, if Creagri’s production practices were adopted industry wide by olive oil producers, almost 1.4 billion of barrels of polluting liquid could be eliminated from the global waste stream. To put things into perspective, one should consider that the recent BP/Deepwater Horizon disaster of 2009 caused the damaged oceanic platform to spill more than 176.4 million gallons of oil into the Gulf of Mexico. This quantity amounts to about 12.6% of the polluting wastewater produced by the olive milling process on a global basis each year. In 2005, the amount of OMW produced in

the Mediterranean Basin and the Middle East was six times larger than the amount of oil spilled by the infamous Exxon Valdez oil spill. Because of its high phenolic content, which is more than 300 times that of olive oil, OMW is resistant to bacterial degradation. In addition, pitting the olives before crushing them not only improves the quality of the oil yielded and reduces the polluting activity of the waters, but also transforms the pits and excess pulp into a biofuel and a biological fertilizer. Creagri, for instance, uses them to fertilize the 7000 organic trees growing at Rancho Supremo, its 160 acre olive grove located in the foothills of the California Sierras. Among the various kind of formulations of HT available on the market today, Hidrox occupies a place all of its own; not only because for the ecosustainable way in which it is produced, but also because it is the only formulation containing polyphenols derived from the juice of organic olives. In addition, it has been granted GRAS certification, it is Halal, Kosher and its claims are backed by a decade of scientific studies and research, both in human and animal models, demonstrating its wide ranging health efficacy and potent rejuvenating powers.

For more information Paolo Pontoniere, Director of Communication for Creagri, Inc., has been a science writer for more than 20 years. A foreign correspondent for various Italian media, Pontoniere has written extensively about the biotechnology industry, nutraceuticals and the ongoing quest to discover new powerful super foods and leverage their biochemical properties. Tel. +1 510 732 6478 info@creagri.com www.creagri.com A complete set of references to support the research presented in this article is available from the author.

BIOIBERICA is a Spanish company whose main business activity is the development, manufacturing and marketing of branded active ingredients and finished products for the pharmaceutical and nutraceutical industry. Focus on Osteoarthritis therapeutic area, it is worldwide expert in the research of sulphated Glycosaminoglycans, and one of the leading manufacturers of Chondroitin Sulfate, Glucosamine and Hyaluronic Acid. Vertical integrated, from the research and development of ingredients to the finished product, the company is present in the nutraceutical market with a range of innovative and scientific based finished products for Joint Health.

Major Products/Services Nutraceutical range of products: – Branded ingredients: Acti-Joint®, CSBio-Active® – Finished products: • Hyal-Joint® caps (supports joint mobility) • T endoactive® (for tendon health and recovery) • Hialsorb® (Joint massage)

BIOIBERICA, S.A Plaza Francesc Macià, 7 08029 Barcelona - Spain • T. +34 93 490 49 08 • F. +34 93 490 97 11 • E. cmartinez@bioiberica.com • W. www.bioiberica.com • W. www.hyal-joint.com • W. www.csbioactive.com January/February 2011 www.nutraceuticalmag.com

joint and bone health

Consumer Awareness of Health Ingredients: Walking the Fine Line of Innovation Between Foods and Drugs The customer is king! Innovations in food ingredients offer a plethora of opportunities to be tackled by different industry players. But, with the European Food Safety Authority (EFSA) about to publish the third batch of its health claim assessments, such progress is being seen as a double-edged sword. Even though this development is fostering innovation — as it sets a legal framework — communicating the functional benefits of ingredients will remain a challenging task in the future. Therefore, regulatory frameworks, as well as consumer awareness at the B2B level, are ever more important hurdles to consider before R&D funds are spent.

Foods

Food with a natural health effect

industry between food and pharma” show that these opportunities will trigger more R&D and product innovations in the future. Nestlé has set itself a very ambitious goal; the area between food and pharma needs competencies from both industries. Moreover, product approval and the communication of health benefits often seem to consume multiple resources. This is because the health benefits of these hybrid products need to be backed up by sound science. Accordingly, industry convergence has a tendency to focus on the technological level and the application of the same technologies. Likewise, they increasingly manifest themselves at the regulatory level in similar regulatory requirements, such as the clinical trials required by EFSA as part of the assessment of health claims. Initially, more than 44,000 dossiers were submitted to EFSA to obtain a health claim. And, of the consolidated package of 4637 generic

health claims that were submitted, industry experts assume that only 5% will be approved. What does that mean for the development of food ingredients

Dietetic food

So far, only a few innovations have turned out to be successful. Why is that? One key success factor for new products is consumer acceptance. New products on the market can only be successful if the consumer understands the product’s positioning and its health claim. Therefore, consumer acceptance plays a pivotal role and needs to be assessed carefully before a new product is launched. But how can you predetermine the consumer acceptance of a new product that carries a certain health claim? The basis of consumer acceptance is influenced by a number of endogenous and exogenous factors. Endogenous factors concern the relevant consumer characteristics that have an impact on the acceptance and, later on, their willingness to pay for a functional health benefit. These consumer-specific factors are accompanied by external influences, such as the purchasing situation and external recommendations of the product.

Functional food Food supplement Food for particular nutritional purposes

Consumer Market Complexity

High

he market for food ingredients has changed rapidly in recent years. But, both legislation — such as health claims regulation (EC 1924/2006) — and industry structure is evolving only slowly. At the same time, health and well-being is the most influential current food trend, opening up a wellspring of innovation opportunities for the food, specialty chemicals and pharmaceutical industries. In particular, convergence and the gradual overlap of the food and the pharmaceutical industries are leading to a new inter-industry segment at the border between foods and drugs (Figure 1). This new inter-industry segment is no longer “just” an academic playing field to analyse competitive behaviour. Nowadays, innovation strategies in the functional food sector have become more evident and are shaping the industry itself. Nestlé’s recent announcements regarding the creation of “Nestlé Health Science SA” and the “Nestlé Institute of Health Sciences” to confidently “pioneer a new

Enteral/ parenteral nutrition

Low

Drugs

Low

Technological Complexity

Figure 1: The convergence of foods and drugs.

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High

with health properties? In those cases when a health claim under EC 1924/2010 is approved — be it a generic claim based on existing science (Article 13), a new claim involving novel science (Article 13.5) or a more detailed risk reduction claim or one pertaining to children (Article 14) — the legal way to communicate health benefits has then been established. If that is not the case, there might be an option to use a nutritional claim based on the policies given in the annex of the health claims regulation. However, in those cases when a food supplier only uses the word “contains,” it then depends solely on the consumer’s individual degree of involvement, or their ingredient-relatedknowledge and awareness, to perceive a benefit from the product or not.

The Importance of Consumer Acceptance and Awareness

The “consumer characteristics” influence factor concerns the health status of the consumer and their individual knowledge about ingredients, leading to specific ingredient awareness (Figure 2). With “purchasing situation” being the second factor influencing consumer acceptance, the consumer’s familiarity with a certain company or brand plays an important role. This is followed by the impact of key opinion formers, such as health professionals, which may influence consumer acceptance by recommending certain products regarding their functional health benefits. Another factor that needs to be taken into account is the “product characteristics” themselves. This third dimension presents a multifaceted phenomenon; product characteristics such as taste and other olfactory properties can only be experienced ex post by the consumer. Therefore, the focus is on the initial purchasing situation and only takes into consideration search items such as the impact of the specific health claim and other attributes including quality and ingredient effectiveness claims.

I. Consumer characteristics • health status • ingredient awareness II. Purchasing situation • familiarity • recommendation

Consumer acceptance and willingness to pay

Consumer awareness

III. Product characteristics (a) reason to believe (claim) (b) quality attribute (naturality) (c) effectiveness (fast acting) Figure 2: Influencing factors of consumer acceptance.

High

Ingredient Awarenss

Low Healthy Healthy unconcerned

Unhealthy

Health Status Slightly unconcerned

Sometimes feeling stiff

Supplement takers (self medication)

Under medical treatment

Awareness Case Study Given the necessity of consumer acceptance for the adoption of new functional health ingredients by the market, the aim of this study was to explore the impact of the three criteria detailed in Figure 2. These include the purchasing power of consumer characteristics, such as their health status and personal ingredient awareness, the influence of the purchasing situation, as well as the product characteristics. In this study, the surveys were centred on NEM, an active ingredient for joint health derived from natural eggshell membrane, which is manufactured by ESM Technologies, LLC. First of all, it is very important to know how consumers categorize their joint health, because personal attitudes influence the acceptance of certain products and their ingredients. Within this study, most of the interviewed German adults (aged 40 years or older) are at least “concerned” about their joint health. Considering the age distribution, it has to be mentioned that the older the consumer gets, the more joint health becomes a problem. The interviewees showed a rather limited awareness of joint health ingredients. However, the study revealed that the more joint health becomes a problem, the higher the consumer awareness of relevant health ingredients is (Figure 3), whereas users of non-prescribed drugs knew most about the products available. This may be because of them having the highest degree of involvement and/or the

Figure 3: Personal health status in combination with the awareness of joint health ingredients. amount of effort and time they spend to actively search out remedies and supplements. Interestingly, as soon as the consumer is under medical treatment, the awareness declines, possibly as a result of the patient relying on the doctor to look after everything, leading to a lower level of research and investigation. Product characteristics vary tremendously between different product categories. In this study, the focus was put on one special product for maintaining joint health. An important finding is that nothing seems to be more important to German consumers than a product recommendation given by health professionals. It was also found to be important to German consumers that all the natural health ingredients contained in the product are declared on the package. Of most interest was the relevance of the effectiveness of a functional ingredient that was tested with the statements, “fast action on pain reduction” and “fast action on increased flexibility.” These two “fast action” claims were rated as having higher-thanaverage importance by the respondents. This shows a high differentiator among consumers within different world areas as well. When the same effectiveness statements were compared with dosing size in North America, consumers favoured a “one a day” dosing claim as opposed to the “fast action” message.

Assessment and Product Positioning As noted previously, scientific support is certainly required to develop claims to explain the benefits of functional ingredients and build a case for EFSA approval. But, to position any new product, consumer assessment may help to verify the target group and potential communication strategies. As an ingredient supplier, this is one value-added part of the overall puzzle and a significant step towards fully understanding how the ingredient’s product development will progress and how, ultimately, it will deliver consumer benefits.

For more information Prof. Dr. Stefanie Bröring University of Applied Sciences Osnabrück Osnabrück, Germany. s.broering@hs-osnabrueck.de www.chainnovation.de Michael Faber European Business Manager Stratum Nutrition Berlin, Germany. Michael.Faber@StratumNutrition.com www.StratumNutrition.com The NEM consumer relevance study was conducted by the University of Applied Sciences Osnabrück for Stratum Nutrition, an ESM Technologies joint venture partner, to advance the brand of NEM.

January/February 2011 www.nutraceuticalmag.com

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Oral Hyaluronic Acid (HA) Supplementation As our population has aged and become more overweight, and the impact of sport takes its toll, the prevalence of osteoarthritis (OA) has increased significantly. It is expected that this trend will continue in the foreseeable future.

or those affected with arthritis, their quality of life often declines. Pain, stiffness and inflammation can lead to decreased voluntary activities, such as exercise or recreational endeavours. This indirectly results in a host of conditions including depression, obesity, heart disease, diabetes, work and/or relationship problems, among many others. For most people, life is just not as enjoyable with OA. Osteoarthritis is a dynamic process that may progress episodically. It remains unclear what triggers the onset of the disease and its course cannot be reliably predicted. Its etiology is multifactorial and can include both systemic and local biomechanical factors.1 Risk factors such as age, sex, trauma, overuse, genetics and obesity can all contribute to the injury process. Such risk factors can serve as initiators that promote abnormal biochemical processes involving the cartilage, bone and synovium, which, during a period of years may result in the characteristic features of OA. The good news is that the high prevalence of arthritis has led to increased awareness and greater research efforts. New treatment options have become available that allow for improvement in pain, function and inflammation while having a better safety profile compared with earlier treatments.

HA and Joint Function Hyaluronic acid (HA) represents one of the main components of synovial fluid and contributes to its elasticity and viscosity.2 It is well known that in osteoarthritic joints, the synovial fluid contains a lower concentration and molecular weight of HA than in healthy ones.3 Thus, HA seems to play an important role in either joint function or OA treatment and prevention. And, for this reason, hyaluronans are used for the viscosupplementation of joints. In the joint disease, osteoarthritis, several things go wrong. The cartilage on the end of the bones slowly erodes, the bone underlying the cartilage changes (leading to bone spurs and pain) and the fluid in the joint changes in character. In severe osteoarthritis,

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the level of hyaluronic acid in the joint fluid may decrease by 75% or more. This can lead to both mechanical and chemical changes within the joint. From a mechanical standpoint, as HA serves as a shock absorber and lubricator, it’s no wonder that such a decrease in this important molecule results in adverse consequences such as a “creaking” or “grinding” sensation, pain or even something called “movie-goers knee.” Movie-goers knee, which sounds funny but is a real medical condition, occurs when sitting with the knee bent at a sharp angle for a prolonged period of time without movement, such as sitting at a 2-hour movie or driving a car. Upon arising, a sudden, sharp, stabbing pain can occur in the knee. The pain usually goes away after walking a few steps as the remaining fluid in the knee coats the surfaces of the cartilage.

Synovial Fluid Role for HA One of the most recent and remarkable advances in the field of osteoarthritis is understanding the relationship between inflammation of the synovial membrane and the acute symptoms experienced by osteoarthritis sufferers. This inflammation — termed synovitis — is directly correlated with the level of pain and dysfunction: low levels are usually associated with mild symptoms, and large amounts of synovitis are almost always associated with pain, swelling, warmth and dysfunction. About 50% of osteoarthritis sufferers experience synovitis-derived pain. A number of studies also suggest a relationship between synovial inflammation and the progression of structural damage. Both clinicians and researchers can directly measure and quantify the level of synovitis. Diagnostic ultrasound and MRI scans provide precise information about the location and extent of synovitis. One form of HA, concentrated from avian origin (brand name Hyal-Joint), was recently studied to gauge its effects on treating people who were suffering from synovitis-derived osteoarthritis pain.

Those who had taken 80 mg of Hyal-Joint oral HA daily had a rapid (1 month) and significant reduction in pain and an objective reduction in synovitis (as measured by ultrasound) compared with those who had taken 500 mg of acetaminophen per day. This kind of high quality evidence may signal a major new advance in osteoarthritis treatment. The dietary supplement, Hyal-Joint, is a natural extract of chicken comb with a high content of hyaluronic acid, hydrolysed proteins (mainly collagen) and other mucopolysaccharides. The clinical efficacy of Hyal-Joint has been demonstrated in a number of ways: Reduced pain and improved quality of life: The results obtained in both in vitro and in vivo experiments done in animal models suggest that Hyal-Joint’s effect on joint function may have an impact on the quality of life of patients with joint problems or osteoarthritis. Both effects were confirmed in a pilot study in patients with osteoarthritis of different degrees (grade ≥2 on the Kellgren/Lawrence scale).4 This was a random, double-blind, placebo-controlled study involving 20 patients with osteoarthritis of the knee. Ten patients received Hyal-Joint (80 mg/d) and 10 received a placebo for 8 weeks. In both groups, the patients showed improvements in levels of pain, stiffness, functional subscales and overall WOMAC scores. However, the improvement was greater in the group treated with HyalJoint than in the placebo group. Similarly, when the SF-36 quality of life survey was evaluated, the patients treated with Hyal-Joint showed significant improvements compared with the placebo group on different subscales (physical role and body pain). Reduction of synovial effusion and inflammation in 1 month: Hyal-Joint was demonstrated to be particularly effective for the treatment of patients with OA/synovitis. In an observational retrospective cohort study involving 71 consecutive outpatients with knee OA, the evolution of synovial effusion and pain were studied during a period of 6 months.5 The course of synovitis was measured in the

suprapatellar recess using ultrasonography (US) equipment with a high frequency linear array. The maximal synovial thickness and effusion depth were measured in millimetres using the longitudinal scale (clinical synovial effusion was defined as present in results ≥4 mm). It was noted that treatment with Hyal-Joint reduced the prevalence of patients with clinical synovial effusion compared with treatment with paracetamol at an analgesic dose (500 mg/d). Interestingly, the results were statistically significant from the first month of treatment. Similarly, joint pain assessed using the Huskisson’s scale decreased more quickly during the study in the Hyal-Joint group compared with the paracetamol one, showing that pain and synovial effusion are strongly correlated. Although these results need to be confirmed in a prospective double-blind placebo-controlled clinical trial, the evidence suggests that Hyal-Joint could be a useful tool for the treatment of OA coursing with synovitis. The specific effect that Hyal-Joint has on the evolution of synovitis implies that the product could theoretically delay the onset of OA (synovitis is considered to be an independent risk factor of OA progression).6 Regulation of HA metabolism in synovial fluid: The results obtained in vitro were confirmed in two in vivo studies done in different animal models. In a double-blind, placebo-controlled study conducted in young horses diagnosed with osteochondritis dissecans, treatment with Hyal-Joint oral supplements for 60 days reduced the level of synovial effusion and, as a result, increased the concentration of hyaluronic acid in the synovial fluid.7 In a study in rats in which osteoarthritis had been induced, the administration of Hyal-Joint significantly reduced inflammation, the destruction of cartilage and bone reabsorption. A modulating effect of Hyal-Joint on the endogenous synthesis of hyaluronic acid was observed in arthritic rats; treatment with Hyal-Joint made it possible to maintain the concentration and speed of synthesis of hyaluronic acid at the same levels as in healthy rats, thereby preventing abnormalities in HA metabolism associated with acute joint inflammation.8 Reduced use of pain relievers: Reduced joint inflammation and the regulation of HA metabolism results in the control of joint pain.2 As a result, the use of drugs to control pain should be significantly reduced in individuals treated with Hyal-Joint. The overall results clearly suggest that treatment with Hyal-Joint is safe, well tolerated and should be taken into account as a new tool for the treatment of OA.

For more information Cristina Martínez Product Manager Bioiberica Tel. +34 93 490 4908 cmartinez@bioiberica.com www.bioiberica.com/www.hyal-joint.com

References 1. C .J.L. Murray and A.D. Lopez, “The Global Burden of Disease,” World Health Organization (Geneva, Switzerland, 1996). 2. H . Bothner and O. Wik, “Rheology of Hyaluronate,” Acta Otolaryngol. 442, 25–30 (1987). 3. E . Balazs, “The Physical Properties of Synovial Fluid and the Specific Role of Hyaluronic Acid,” in A.J. Helfet (Ed.), Disorders of the Knee (J.B. Lippincot, Philadelphia, Pennsylvania, USA, 1982) pp 61–74. 4. D .S. Kalman, et al., “Effect of a Natural Extract of Chicken Combs with a High Content of Hyaluronic Acid (Hyal-Joint) on Pain Relief and Quality of Life in Subjects with Knee Osteoarthritis: A Pilot Randomized Double-Blind Placebo-Controlled Trial,” Nutr. J. 7, 3 (2008). 5. I . Möller, D. Martinez-Puig and C. Chetrit, “Oral Administration of a Natural Extract Rich in Hyaluronic Acid for the Treatment of Knee OA with Synovitis: A Retrospective Cohort Study,” Clinical Nutrition Suppl. 4(2), 171 (2009). 6. P . Conhagan, et al., “EULAR Report on the Use of Ultrasonography in Painful Knee Osteoarthritis. Part 2: Exploring Decision Rules for Clinical Utility,” Ann. Rheum Dis. 64, 1710–1714 (2005). 7. J .U. Carmona, et al., “Effect of the Administration of an Oral Hyaluronan Formulation on Clinical and Biochemical Parameters in Young Horses with Osteochondrosis,” Vet. Comp. Orthop. Traumatol. 22(6), 455–459 (2009). 8. V . Castillo, et al., “Effects of Oral Administration of Hyal-Joint® in 17 Day Rat Developing Type II Collagen Arthritis,” Osteoarthr. and Cartil. 18(2), S244–S245 (2010).

January/February 2011 www.nutraceuticalmag.com

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bone and joint health

Vitamin K2: A Traditional Route to Strong Bones Novel Food approved and supported by EFSA opinions, the highly bioavailable Vitamin K2 MK-7 ingredient, uniK2, is suitable for bone health formulas.

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hanks to comfortable, technologically advanced lifestyles and high quality medical care, the large majority of today’s population lives longer than they would have even just a few decades ago, and most people pursue an active life to a ripe old age. But, the blessings of this positive development have a darker flipside: the human body was not originally designed to function smoothly for 80 or 90 years, or even longer, and this means that most people start to experience health-related problems when they reach a certain stage of life. One of the main health issues in this context is osteoporosis. Its literal meaning stems from the Greek expression for “porous bones” and it describes a state of decreased bone mineral density (BMD) that is linked to a higher risk of fractures. The disease affects both women and men, although postmenopausal women are most likely to be affected because of hormonal imbalances. In these women, the condition is described as postmenopausal — or primary type 1 — osteoporosis. Primary type 2 or senile osteoporosis occurs in people aged 75 and older and is seen in females and males in a 2:1 ratio. A third type — secondary osteoporosis — can occur at any age. It affects men and women equally and is caused by the chronic or prolonged use of certain medications and the presence of predisposing medical problems or disease states. Osteoporosis itself does not have any symptoms, other than increased bone fragility. However, bone fractures are responsible for considerable pain, decreased quality of life, lost work days and disability. But this is just one side of the story; the other is an enormously strained healthcare system. It is difficult to rebuild bone that has been weakened by osteoporosis, which means that prevention is actually the most effective treatment. As well as making lifestyle changes such as quitting smoking, cutting down on alcohol intake and exercising regularly, a healthy, balanced diet forms the basis of an effective osteoporosis prevention strategy. It is well known that vitamin D and calcium are important in maintaining a high BMD. Equally important, but less well known, is vitamin K2, which is essential for building and maintaining healthy bones. Various studies have shown that a chronic

Finished Products Expo

January/February 2011 www.nutraceuticalmag.com

bone and joint health

deficiency of vitamin K leads to enhanced bone loss and soft tissue calcification. However, because the vitamin K intake from regular diets is widely insufficient in the Western population, supplementation is strongly recommended. Frutarom, a manufacturer of versatile functional herbal ingredients, offers the Novel Food approved vitamin K2 MK-7 ingredient, uniK2, which is completely derived from Japanese natto, a food that has been consumed in Asia for centuries. Traditionally, natto is produced by the fermentation of soy beans wrapped in rice leaves. A bacterium that is present on the leaf surface, Bacillus natto, is responsible for the development of a sticky bulk around the beans. During the fermentation process, the vitamin K2 content increases several times, making this traditional food one of the richest natural sources of the vitamin. Frutarom’s uniK2 is also derived using Bacillus natto and originates from Japan, where it is produced by J-Oil Mills Inc.

Vitamin K2: How Does it Work? uniK2 provides vitamin K2 as menaquinone-7 (MK-7), the most bioavailable and bioactive form of vitamin K. Menaquinones belong to the same family of structurally similar fat-soluble naphtaquinones as phylloquinones, which are found in plants. It is also structurally similar to synthetic menadiones. Menaquinones are derived from bacteria and exist in various forms with side chains of different lengths, each offering different availabilities of the vitamin within

www.nutraceuticalmag.com January/February 2011

the human body. The high bioactivity of MK-7 (whereby “7” describes the chain length) is mainly due to a very long half-life in blood, which means that it remains active in the body for longer. MK-7’s biochemical mode of action is closely connected to an enzyme called carboxylase, which is responsible for transmitting carboxyl groups in biochemical systems. Vitamin K2 acts as a cofactor for carboxylase by catalysing the carboxylation of glutamate residues in certain proteins to form gammaglutamate residues (Glaresidues). These carboxylated forms are involved in binding calcium and are essential for the biological activity of all known Gla-proteins. One of these proteins is osteocalcin, also known as bone Gla-protein (BGP), which is involved in bone mineralization. As part of the bone matrix, it binds to calcium and is thus involved in incorporating this important mineral into the bones. Increased levels of not completely carboxylated osteocalcin are linked to a decrease in BMD and thus to the development of osteoporosis. To achieve a state in which osteocalcin is fully carboxylated, high levels of vitamin K are required. This means that regular supplementation with vitamin K2 MK-7 can act as an efficient preventer of osteoporosis because it activates osteocalcin and results in optimal binding of calcium in the bones. Thus, on the one hand, bone formation is promoted and, on the other, bone resorption decreases. These facts are strongly supported by clinical data — as are vitamin K2’s safety and mode of action.1–3

On the Safe Side In July 2010, uniK2 received Novel Food status from the European Commission. It is noted as being substantially equivalent to the vitamin K2 authorized by Commission Decision 2009/345/ EC in terms of composition, nutritional value, metabolism, intended use and content of undesired substances. This means that uniK2 is available for use in foods and food supplements. When it comes to the key question of what to claim on packaging, uniK2 is strongly supported by EFSA Article 13 opinions on bone health claims. A broad range of different claims is therefore possible — from “MK-7 is a highly bioavailable form of vitamin K that helps to maintain healthy bones” to “Vitamin K is required for the normal structure of bone” and “Vitamin K contributes to bone mineralization” or “Helps to improve bone health.”

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What For and How Much? uniK2 can be used for a wide range of products, particularly classic dietary supplements such as capsules, tablets or powders with a bone health positioning. It might also be possible to create “all-in-one” bone health products that combine different BMD-promoting ingredients with different modes of action, such as calcium or vitamin D. Functional food applications such as beverages, dairy products, nutrition bars and bakery products are possible, too. Thanks to its excellent technical properties, the extract can be used to enrich a wide variety of added-value foods. uniK2 is available in two different concentrations, in powder form and as an oil. The recommended daily dose of MK-7 powder (0.2%) is 22.5 mg/day, whereas the 0.15% oil has a recommended daily dose of 30 mg. This equals a daily intake of 45 µg, as recommended and supported by scientific data. With its roots and origins in Japan — a fact that can also be claimed on packaging — as well as with its naturalness, uniK2 offers a safe and efficient solution for everyone, including those who are skeptical about conventional medications. Positioning possibilities are far reaching: bone health products appeal to both women and men as they grow older, postmenopausal women and “golden agers.” Younger people can be targeted, too, because it’s never too early to start thinking about maintaining healthy bones for life.

References 1. Y. Tsukamoto, et al., “Intake of Fermented Soybean (Natto) Increases Circulating Vitamin K2 (Menaquinone-7) and Carboxylated Osteocalcin Concentration in Normal Individuals,” J. Bone Miner. Metab. 18, 216–222 (2000). 2. L.J. Schurgers, M.H.J. Knapen and C. Vermeer, “Vitamin K2 Improves Bone Strength in Postmenopausal Women,” International Congress Series 1297, 179–187 (Elsevier BV, Amsterdam, the Netherlands, 2007). 3. M. Van Summeren, et al., “The Effect of Menaquinone-7 (Vitamin K2) Supplementation on Osteocalcin Carboxylation in Healthy Prepubertal Children,” Br. J. Nutr. 102, 1171–1178 (2009).

For more information Maider Gutierrez Product Manager, Health Business Unit Frutarom Netherlands BV Landjuweel 5 NL-3905 PE Veenendaal, the Netherlands. mgutierrez@nl.frutarom.com www.frutarom.com

January/February 2011 www.nutraceuticalmag.com

weight management

Doin’ it for the Kids New research shows potential to

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he increasing trend in children to be overweight and suffer from childhood obesity will have a significant impact on the public health of future generations. Worldwide, the prevalence of overweight youngsters and childhood obesity rates is on the rise. For example, the incidence of childhood obesity in school age children between 2006 and 2010 rose from 13.2% to 15.2% in the United States and 7.9% to 10.0% in Europe.1 Being overweight and obese during childhood is associated with a high probability of being obese in adulthood.2 Obesity or excessive weight gain in adulthood (which is largely a result of excessive fat mass) is associated with a substantial breadth of health problems, including 1.2

Changes in BMI

1 0.8 0.6 0.4 0.2 0 P = 0.04

Placebo

Clarinol

Figure 1: Six month supplementation with chocolate milk containing Clarinol CLA significantly reduced the increase in Body Mass Index (BMI)

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an increased risk of coronary heart disease, hypertension, and diabetes.3,4 Therefore, it is imperative to establish strategies to halt the trend of weight gain and obesity and help children to achieve and maintain a healthy body weight. Numerous factors have been identified that potentially contribute to both childhood and adult weight gain, such as reduced or lack of physical activity, food choices of high caloric value and excessive food intake. Although increasing physical activity and monitoring caloric and food intake may indeed prove to be effective strategies to prevent excessive weight gain in children, another effective and novel strategy may be the use of active ingredients to help at-risk children maintain a healthy weight. A new study suggests that one ingredient with the potential to help children at risk of becoming overweight or obese to achieve and maintain a healthy body weight is conjugated linoleic acid (CLA). CLA is a naturally occurring polyunsaturated 18-carbon compound that’s most commonly present in dairy and beef products — mostly as the cis-9, trans-11 (c9,t11) isomer. The human dietary intake of CLA is approximately 130–440 mg/day.5 CLA in larger quantities can also be derived from safflower oil, which mainly contains the cis-9, trans-11 and trans-10, cis-12 (t10,c12) isomers. These are considered to be the most physiologically active isomers and those that show weight management effects. CLA has been available as a weight management supplement for more than 15 years and, recently, as a food ingredient in the United States, European Union and other territories. In July 2008, CLA was FDA GRAS (Generally Recognized As Safe) approved for its use in a wide range of food applications. More than 2500 studies during the past 20 years have been done, of which 27 published human clinical trials have shown that CLA supplementation can positively influence body composition by

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Total Fat Mass %

The use of an active food

ingredient along with a healthy

diet and exercise may be an

0.5

effective tool to help at-risk

0 Placebo

Clarinol

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children achieve and maintain a healthy body composition.

P = 0.01

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weight management

0.6 0.4 0.2 0 -0.2 -0.4 -0.6 -0.8 -1 -1.2 -1.4

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Figure 2: Six month supplementation with chocolate milk containing Clarinol CLA significantly reduced total fat mass, abdominal fat mass and peripheral fat mass percentage. 0.6

Change in Lean Tissue Mass %

0.4 0.2 Placebo

Clarinol

-0.2 -0.4 -0.6 -0.8 -1 -1.2 -1.4 P = 0.001

Figure 3: Six month supplementation with chocolate milk containing Clarinol CLA significantly increased lean mass percentage compared with the placebo.

significantly decreasing fat mass and increasing lean body mass in adults (independent of diet and exercise). Two recent meta-analyses confirmed the effects of CLA supplementation on decreased fat mass and increased lean body mass in adults.6,7 The total fat loss produced by CLA supplementation at the recommended 3.2 g daily dosage is approximately 2 kg after treatments of 1 year, which is equivalent to 90 g of fat loss per week. CLA supplementation was also found to produce a 1% increase in lean body mass as well. Thus, CLA is an effective ingredient to help

www.nutraceuticalmag.com January/February 2011

achieve and maintain a healthy body weight and body composition. Although the improved body composition effects of CLA have been observed in many clinical studies in adult populations, the effects on improving body composition in children at risk of being overweight or obese have not been explored. As such, a recent study was undertaken to evaluate the effects of Clarinol CLA on children at risk of being overweight or obese. For this study, 53 children aged 6 to 10 years old who were at risk of being overweight or obese (at or above the 85th percentile for BMI) were evaluated in a double blind placebocontrolled trial. The children were randomized into two groups: a group that consumed chocolate milk with 3 g of Clarinol (CLA group, n = 28) and a group that consumed chocolate milk with 3 g of sunflower oil (placebo group, n = 25). The milks were consumed once per day for 6 months and there were no dietary or physical activity interventions given. The measurements of the study included body composition (fat mass and lean mass) determined by Dual Energy X-ray absorptiometry (DEXA), weight and BMI. After 6 months, the children consuming the chocolate milk with Clarinol CLA showed a significant improvement of BMI and body composition compared with the placebo group. In the growing children, the increase in BMI was

0.5 kg/m2 in the CLA group compared with 1.1 kg/m2 in the placebo group (Figure 1). This attenuation of BMI increases was largely caused by decreases in fat mass. The percentages of total fat, abdominal fat and peripheral fat all significantly decreased in the children consuming chocolate milk with Clarinol CLA (Figure 2). In addition, lean body mass percentage significantly increased in the CLA group, whereas lean body mass percentage decreased in the placebo group (Figure 3). The chocolate milk with Clarinol CLA was well tolerated and there were no differences in adverse events between the groups. CLA has long been known to improve body composition in adults; however, this is the first study to show positive effects on body composition with CLA as a food ingredient for children at risk of being overweight or obese. A unique attribute of CLA, compared with many other weight management ingredients, is that CLA has a dual effect on improving body composition in that it decreases fat mass while also increasing lean body mass. In at-risk children, this attribute, even if modest, may have profound long-term benefits for both overall health and energy metabolism; the degree of fat mass in the body is linked to several chronic diseases and adding lean mass helps to burn more calories. Ultimately, as endeavours are undertaken to improve the health of at-risk children, nutritional interventions may prove to be effective strategies to help reverse the trend of childhood obesity. As this is the first study to evaluate the effects of CLA in at-risk children, further research is needed. Given the initial results, the use of an active food ingredient along with a healthy diet and exercise may be an effective tool to help at-risk children achieve and maintain a healthy body composition. A5 quer-4c-D-F-E:Layout 1 07.09.2010 15:23 Uhr Seite 3

References 1. Y. Wang and T. Lobstein, “Worldwide Trends in Childhood Overweight and Obesity,” Int. J. Pediatr. Obes. 1(1), 11–25 (2006). 2. S. Abraham and M. Nordsieck, “Relationship of Excess Weight in Children and Adults,” Public Health Rep. 75, 263–273 (1960). 3. J.L. Baker, L.W. Olsen and T.I. Sorensen, “Childhood Body Mass Index and the Risk of Coronary Heart Disease in Adulthood,” N. Engl. J. Med. 357, 2329–2337 (2007). 4. H.O. Mossberg, “40 Year Follow-Up of Overweight Children,” Lancet 2, 491–493 (1989). 5. K.L. Ritzenthaler, et al., “Estimation of Conjugated Linoleic Acid Intake by Written Dietary Assessment Methodologies Underestimates Actual Intake Evaluated by Food Duplicate Methodology,” J. Nutr. 131(5), 1548–1554 (2001). 6. L.D. Whigham, A.C. Watras and D.A. Schoeller, “Efficacy of Conjugated Linoleic Acid for Reducing Fat Mass: A Meta-Analysis in Humans,” Am. J. Clin. Nutr. 85, 1203–1211 (2007). 7. D.A. Schoeller, A.C. Watras and L.D. Whigham, “A Meta-Analysis of the Effects of Conjugated Linoleic Acid on Fat-Free Mass in Humans,” Appl. Physiol. Nutr. Metab. 34(5), 975–978 (2009).

For more information Corey E. Scott, PhD Nutrition Manager Lipid Nutrition BV PO Box 4 NL-1520 AA Wormerveer, the Netherlands. corey.scott@lipidnutrition.com www.lipidnutrition.com This study was published in the American Journal of Clinical Nutrition (Racine, et al., Am. J. Clin. Nutr. doi: 10.3945/ajcn.2009.28404).

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Filling a Gap with Vitamin D

An Opportunity for the Food Industry Vitamin D has caught everybody’s attention, from academics and nutritionists to the media. Almost every week, a new research paper is published on this nutrient of the moment, building on the ever-expanding scientific knowledge base. Some of this research, in turn, makes it into the media wherein the health benefits of this versatile nutrient are extolled. But why so much interest and excitement? It’s because scientists now understand that vitamin D is about more than bone health. Research points to a link between vitamin D and possible benefits as far ranging as cancer prevention to cognition. But, whilst scientists are discovering more and more about this dynamic nutrient and the need for it, it is a different story when it comes to public health. Vitamin D is also in the spotlight because of concerns that many people simply aren’t getting enough. A solution is therefore required. This article summarizes the current knowledge of the role that vitamin D has in health, the vitamin D status across the globe and ways in which the food industry can act to improve that situation. www.nutraceuticalmag.com

January/February 2011

Not Strictly a Nutrient Vitamin D is an unusual nutrient because it doesn’t actually have to be consumed in the diet! Strictly speaking, therefore, it’s not a vitamin as the body can synthesize vitamin D itself. Indeed, food sources of vitamin D are few and far between and, as a result, the diet only accounts for a small amount of the vitamin D in the body (~10%). Instead, we make most vitamin D cutaneously following exposure of the skin to UVB radiation in sunlight (wavelength 209–315 nm). So, in theory, with sufficient endogenous synthesis, dietary vitamin D should not be required. However, the body can only synthesize vitamin D if the wavelength of sunlight is right. It’s only possible to produce vitamin D naturally at certain times of the day: even then, in many countries, sunlight isn’t strong enough to trigger vitamin D production all year round. That’s because the further away you get from the equator, the less opportunity there is to produce vitamin D, owing to differences in the angle at which the sun’s rays reach the ground.

For example, in the UK, vitamin D synthesis only occurs between April and September when the angle is right. In such countries where the capacity to synthesize vitamin D is seasonal, a vitamin D winter is said to occur, whereby, vitamin D status falls during the winter and early spring months when the body relies on the diet as a source of vitamin D. Geography and season, however, are not the only factors that impact on the body’s capacity to synthesize vitamin D. A number of unmodifiable factors inhibit synthesis; for example, pollution and cloud cover transiently impact synthesis, as they both block UVB radiation, whilst skin pigmentation and age also have an effect. The skin pigment, melanin, acts as a natural sunscreen, so the more pigmented the skin, the less efficient the body is at synthesizing vitamin D (as such, darker skins produce less vitamin D than lighter skins when exposed to the same amount of UVB). Also, the older we become, the thinner our skin becomes and, in turn, its capacity to produce vitamin D cutaneously diminishes. Lifestyle, which is modifiable, also greatly impacts vitamin D synthesis. Other than perhaps a fortnight’s holiday in the sun, many people don’t actually spend much time outdoors on a daily basis; instead, most people spend their

days working inside. Then when we do step outside, we’re encouraged to cover up and use sunscreens that block the sun’s rays and inhibit vitamin D synthesis; unfortunately, radiation of the same wavelength that stimulates vitamin D synthesis is also responsible for skin burning and the promotion of skin cancers. With less opportunity, therefore, to synthesize vitamin D in the body, there becomes an increasing reliance on the diet to provide adequate vitamin D to maintain vitamin D status. However, eating more vitamin D is not as simple as it sounds. That’s because few foods naturally contain vitamin D. Those limited foods that do provide vitamin D include oily fish, fish liver oils, eggs (vitamin D is found in the yolk), some meats and liver and (bizarrely) mushrooms grown under UVB radiation (which you are currently unlikely to find at your local market or supermarket). With limited natural sources of vitamin D, fortified foods become a valuable source of this nutrient. But again, the range of foods fortified with vitamin D is somewhat limited at present and intakes in the UK average less than 5 µg/day. Therefore, low dietary intakes and limited synthesis of vitamin D from sunlight leads to poor vitamin D status, which can have adverse effects on health.

Health Benefits of Vitamin D It has long been understood that vitamin D plays an important role in skeletal health. Vitamin D is essential for the absorption and utilization of calcium and phosphorus, nutrients that play a critical role in the formation and maintenance of healthy bones. Without sufficient vitamin D, skeletal deformities can occur: in childhood, vitamin D deficiency manifests in skeletal deformities in the form of rickets in the most severe cases; in adults, once the skeleton has formed, deficiency results in painful bones. Vitamin D, however, not only plays a role in calcium and phosphorus homeostasis and bone health, it is also essential for normal cell division and immune function — helping to protect against infection and disease. Vitamin D also seems to play a role in helping to prevent chronic disease; or, rather, having an adequate vitamin D status offers this protection. There is some evidence that a higher vitamin D status is associated with a reduced risk of breast, skin and colorectal cancer; however, more research is required to confirm or refute such observations. Despite promising observations, the evidence base has been described as equivocal. That said, a recent meta-analysis reported that higher vitamin D status was

January/February 2011 www.nutraceuticalmag.com

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How Much Vitamin D is Safe? With more and more calls to increase dietary intakes of vitamin D, the safety of higher intakes needs to be taken into account. Safe upper levels (SUL) for vitamin D from the diet and supplements have been set in Australia/New Zealand, Europe and the US. In Europe, the European Food Safety Authority (EFSA) set the SUL as 50 µg/day, whereas 80 µg/day was deemed to be the SUL in Australia/New Zealand and in the US.

associated with a reduced risk of colorectal adenoma, a risk factor for colorectal cancer.1 With respect to cardiovascular disease, vitamin D supplementation may reduce the overall risk and lower blood pressure (systolic but not diastolic), as shown in recent metaanalyses.2–4 Scientific studies also suggest that vitamin D plays a role in muscle function, something that becomes most apparent in older people. Supplementation with vitamin D has been shown to reduce the risk of falls in the elderly, with falls being a major cause of bone fracture and death in later life.5 Vitamin D deficiency is associated with muscle wasting and body sway, increasing the risk of fall as the body cannot correct itself when imbalanced; indeed, improvements in muscle strength and stability in the elderly have also been seen with vitamin D supplementation. The role of vitamin D and health doesn’t stop there, though; it also appears to play an important role in the central nervous system too. Epidemiological evidence points to an association between vitamin D and protection against multiple sclerosis, and it has been suggested that vitamin D deficiency may play a role in depression and cognitive function, although such research is in its infancy and needs to be further investigated to understand what role, if any, vitamin D may play.6 Given the wide range of putative benefits of vitamin D in health, it is no wonder that vitamin D is the focus of much research; and, as more research is conducted, academics will gain a broader understanding of its role in health and the detrimental effect that inadequate status may have on long-term health.

Vitamin D Status and Dietary Recommendations Whether vitamin D is consumed in the diet or synthesized via the action of sunlight on the skin, it is metabolized in the liver to 25-hydroxyvitamin D (25OHD) before being ultimately metabolized in the kidneys to the

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active form: 1,25-dihydroxyvitamin D. Vitamin D can be present in the diet as either vitamin D2 (ergocalciferol) or vitamin D3 (cholecalciferol); both forms follow the same metabolic pathway to eventually become 1,25-dihydroxyvitamin D. Although 1,25-dihydroxyvitamin D is the biologically active form of vitamin D, it is not the major form in the body and cannot be used to measure vitamin D status. Instead, the measurement of the transport form of vitamin D in the blood, 25OHD, which is the predominate form of vitamin D, is used to determine vitamin D status. The story surrounding vitamin D is made all the more interesting because scientists are only starting to understand how much vitamin D we actually need for optimal health. Currently, there is no global consensus regarding what cut-offs for 25OHD should be used for the assessment of vitamin D status. However, historically, deficiency has been defined as a 25OHD concentration of ≤25 nmol/L, a level below which rickets presents, whilst there is ongoing debate amongst the experts as to what level of 250HD is desirable for all round health. Typically, a 25OHD level of between 50–75 nmol/L is thought to be sufficient for bone health; but, with increasing understanding of the role of vitamin D in health, it is believed that a higher level offers greater health benefits.7 When it comes to the vitamin D status of a population, the situation is less than ideal in many countries around the world, ranging from those in Northern Europe where vitamin D winters occur, to tropical countries such as Malaysia and India.8 Given that vitamin D status is inadequate in many countries and a growing health problem, some governments are now starting to reassess dietary recommendations for vitamin D, as exposure to UVB radiation is insufficient to maintain sufficient vitamin D status. However, as no consensus on the definition of optimal vitamin D status exists,

January/February 2011

it is difficult to make recommendations on dietary intakes. Indeed, in the UK, no dietary recommendation exists for individuals aged 5–60 years, despite the fact that the UK experiences a ‘vitamin D winter’ and vitamin D deficiency and insufficiency is common, especially in Scotland.9 In contrast, the Institute of Medicine, which sets dietary recommendations for the US and Canada, is currently reviewing the dietary recommendations for vitamin D and it is anticipated that dietary recommendations for vitamin D will increase to take into consideration the fact that sunlight exposure is not routine throughout the year and that skin pigmentation will also influence synthesis. The current dietary recommendation for vitamin D in the US and Canada is 5 µg/day for adults aged 19–50 years, 10 µg for adults aged 51–70 years and 15 µg for those above 71 years of age, but these recommendations are still considered to be conservative. There have been numerous calls for an increase in dietary recommendations for vitamin D in recent years as, clearly, there is a gap between the actual and desirable vitamin D status for health. Last year, for example the International Osteoporosis Foundation made new recommendations regarding vitamin D intakes for older adults, suggesting that 20–25 µg/day is a far more appropriate intake for the elderly to maintain vitamin D status, and higher intakes would be required to ensure that all elderly adults exceeded a 25OHD concentration of 75 nmol/L, owing to individual variations in status; however, they cautioned that intakes above 20–25 µg/ day had not been extensively evaluated with respect to bone health and falls in clinical trials, so recommendations regarding higher intakes could not be made.10 Academics have called for changes in vitamin D policy across the globe to reflect current knowledge, making this an exciting time for

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Epidemiological evidence points to an association between vitamin D and protection against multiple sclerosis, and a role in depression and cognitive function. those working in academia, government and food manufacture alike, whilst such changes are implemented.11

Increasing Intakes and Filling the Gap Given that natural sources of vitamin D are few and far between, there becomes an increasing need to fortify foods with vitamin D to ensure adequate intakes on a population basis. Fortified food, therefore, can contribute a useful amount to dietary intake and, in some countries, fortified foods have been a useful part of the diet for a number of years. For example, milk has been fortified in the US since the 1930s, when a fortification programme was introduced to eradicate rickets. Since then, vitamin D has been added to an increasingly wide range of foods across the globe, including other dairy products, margarine, breakfast cereals, breads and bakery products, soya milk, fruit juices and Horlicks, a malted food drink. Vitamin D is a fat-soluble vitamin, and foods that contain fat tend to be the vehicles for food fortification, although this is not always the case. In a number of countries, certain foods are required by mandate to be fortified with vitamin D (margarine in the UK and milk in the US and Canada); however, most foods fortified with vitamin D are done so on a voluntary basis. A role also exists for dietary supplements to ensure adequate intakes. Filling the vitamin D gap, therefore, provides an exciting opportunity for the food industry from a public health point of view.

Broadly speaking, vitamin D used in food fortification and food supplements can come from two sources: animal or non-animal sources. Vitamin D2 (ergocalciferol), used in food supplements and food fortification, is derived from a non-animal source. The two most common sources are fungi and yeast that have been exposed to UVB radiation. This form of vitamin D is most commonly added to milk and found in most dietary supplements, particularly in the American and Canadian markets. The most commonly used type of yeast for sourcing vitamin D is torula yeast, the name being derived from its biological name, Torulopsis utilis. Torula yeast, owing to its flavour and bulking properties can be readily used in processed foods, meaning that it has the potential for widespread use, particularly as it is suitable for vegetarians and vegans. However, introducing yeast is classed as an allergen and its use triggers the need for allergen labelling. Vitamin D3 (cholecalciferol), by contrast, is of animal origin and is derived either from sheep’s wool (lanolin) or fish oil. It is produced industrially through the extraction of 7-dehydrocholesterol from wool or fish tissue. Purified 7-dehydrocholesterol is then irradiated with UV light to produce vitamin D3. Given its origin, fish oil–derived vitamin D is not suitable for vegetarians, vegans or those allergic to fish; however, wool sourced vitamin D3 is considered to be suitable for vegetarians, but not vegans, as the animal is not harmed, only sheared. Vitamin D3 from fish oil is more commonly used in supplements as opposed to being used as a fortificant, owing to the strong flavour that it imparts and its associated taste implications. In addition, the stability of fish oil-derived vitamin D3 is also an issue, and thus the range of products in which it can be used is limited. When it comes to selecting a food to fortify, both the food and the source need to be considered: if the food is being marketed as being suitable for vegetarians or vegans, then the source of vitamin D must be acceptable to the end consumer. Further, it must be technically feasible to add/blend/ mask vitamin D in the good vehicle, so as not to provide an aftertaste or other undesirable sensory property. These are all challenges for successful food fortification, but challenges that can be overcome for success.

inadequacy. One such solution to improving vitamin D status on a global basis would be to encourage individuals to spend time in the sun to allow for increased vitamin D synthesis; however, such a practice should only be encouraged in moderation because of the risk that sun exposure brings to cancer. As a result, diet has become the major focus for improving vitamin D status and, with natural sources being limited, there exists an opportunity for the food industry to provide vitamin D fortified foods and supplements to improve vitamin D status. There also exists an opportunity to develop seasonal products to diminish the seasonal decline in the winter months of Northern Europe.

Conclusions

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There is a clear need for both additional research in the field of vitamin D and health and for more solutions to tackle vitamin D

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References 1. V. Fedirko, et al., “Blood 25-Hydroxyvitamin D3 Concentrations and Incident Sporadic Colorectal Adenoma Risk: A Pooled Case-Control Study,” Am. J. Epidemiol. 172(5), 489–500 (2010). 2. J. Parker, et al., “Levels of Vitamin D and Cardiometabolic Disorders: Systematic Review and Meta-Analysis,” Maturitas 65(3), 225–236 (2010). 3. L. Wang, et al., “Systematic Review: Vitamin D and Calcium Supplementation in Prevention of Cardiovascular Events,” Ann. Intern. Med. 152(5), 315–323 (2010). 4. S.H. Wu, S.C. Ho and L. Zhong, “Effects of Vitamin D Supplementation on Blood Pressure,” South. Med. J. 103(8), 729–737 (2010). 5. R.R. Kalyani, et al., “Vitamin D Treatment for the Prevention of Falls in Older Adults: Systematic Review and Meta-Analysis,” J. Am. Geriatr. Soc. 58(7), 1299–1310 (2010). 6. A. Ascherio, K.L. Munger and K.C. Simon, “Vitamin D and Multiple Sclerosis,” Lancet Neurol. 9(6), 599–612 (2010). 7. H.A. Bischoff-Ferrari, “Optimal Serum 25-Hydroxyvitamin D Levels for Multiple Health Outcomes,” Adv. Exp. Med. Biol. 624, 55–71 (2008). 8. P. Lips, “Worldwide Status of Vitamin D Nutrition,” J. Steroid Biochem. Mol. Biol. 121(1–2), 297–300 (2010). 9. E. Hypponen and C. Power, “Hypovitaminosis D in British Adults at Age 45 y: Nationwide Cohort Study of Dietary and Lifestyle Predictors,” Am. J. Clin. Nutr. 85(3), 860–868 (2007). 10. B. Dawson-Hughes, et al., “IOF Position Statement: Vitamin D Recommendations for Older Adults,” Osteoporos. Int. 21(7), 1151–1154 (2010). 11. A.W. Norman and R. Bouillon, “Vitamin D Nutritional Policy Needs a Vision for the Future,” Exp. Biol. Med. (Maywood) 235(9), 1034–1045 (2010).

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Jon Wright

Anna Richey

Head of Open Innovation and Supplier Alliances Unilever Head of Retailing Research Euromonitor

Clas Petersson

Vice President Global R&D Godiva Chocolatier

Research & Innovation Director, Functional Ingredients Coca-Cola European Union Group

Head of Innovation Two Chicks

Franco Beer Founder Ador Foods

The following key themes will be addressed: • • • •

Godiva Chocolatier Case study - Expanding the brand by launching new innovation platforms Food Simplicity - Developing a clean label portfolio to engage with consumers Eating for Change - Launching new products for increasingly health conscious consumers Creating and Communicating a Successful Health Policy to Fully Engage with Consumers - Successful sodium reduction and reformulation strategies

• •

Collaboration Vs. Open Innovation Strategies - Creating mutually beneficial partnerships to stimulate fresh innovation Understanding The New Consumers and How They Redefine Value - Targeting post recession savvy consumers

Included in the package is the Budelpack Poortvliet Innovation Tour

For more information call our booking hotline +44 (0) 207 202 7690 or visit the event website www.foodinnovate.com Researched and Produced by:

www.nutraceuticalmag.com

January/February 2011

January/February 2011 www.nutraceuticalmag.com

health management

Clean Functionality A Recipe for Success Clean functional foods are tipped to be one of the hottest trends for 2011, spurred on by their increasing popularity with health-conscious consumers. Here, Andrew Ulrick, Director of the UK’s leading developer and supplier of clean label ingredients, Ulrick & Short Ltd, gives his view on how this fast-growing market is evolving.

unctional foods that claim to have healthpromoting benefits or disease preventing properties above and beyond their usual nutritional values have been around since the mid-1980s. Shortly after their introduction, the clean label movement developed to promote the additive-free ingredients that soon became one of the main driving forces behind product innovation. The clean and functional food revolution is redefining the boundaries between food, medicine and health. The positive sea change in nutritional developments has played a huge role in the evolution of functional foods and this, coupled with clever marketing, has put the need for functional and clean ingredients hand in hand, which has helped clean label businesses to flourish. Formed in 2000, Ulrick & Short Ltd is at the forefront of this movement. The company started out by essentially getting rid of anything that sounded like a chemical and worked towards

creating products that help to condense the list of ingredients as much as possible. It is important to be aware that the term “functional” can have two meanings to food producers. The first is in terms of performance and the second is in delivering enhanced nutritional benefits. We have focused heavily on ensuring that our ingredients have process functionality, so matching the multifunctional characteristics of more traditional ingredients has been our main focus. Our next innovation stream is to link system and dietary functionality. For example, our clean label starches are not only additive free and untainted by genetic modification (GM), but they are also an important source of crop-based protein and carbohydrate. A more complex example of increasing nutritional functionality, which we have begun to explore, is enriching starch with vegetableorigin omega-3 (derived from flax), which would

be suitable for the bakery, cereal and beverage markets. Depending on the level of omega-3 contained within the starch, food manufacturers would then be able to make claims such as “a source of” or “product contains a high level of” omega-3. We are also looking at other innovative ingredients such as sweet potato and arrowroot, which are traditionally safe crops as their environment means that there is no fear of cross-contamination with GM chemicals. GM is an extremely important area and, although there is no proof that GM is harmful to health, we have chosen to remain committed to delivering non-GM ingredients. It is by carefully selecting crops, agronomy, geography and processing technology that we can continue to guarantee small-to-medium sized food manufacturers the security of having a non-GM supply of high quality clean label ingredients for many years to come. Despite

Food manufacturers must consider the complexity of the food substance and the effects that the health-enhancing ingredients will have on the food product as a whole. www.nutraceuticalmag.com January/February 2011

this, we are aware that the introduction of GM foods is probably unavoidable and many farmers view GM as a cost-effective way to secure their future sustainability. However, consumers are still extremely sceptical about GM and food manufacturers will need to source non-GM ingredients if they are to meet consumer demands.

Research is Development In developing clean nutritional ingredients, we want to create a portfolio that will help food manufacturers to identify natural and functional compounds, whilst conjuring up new innovative and healthy products that are competitive as well as appealing. During the last few years, there has been overwhelming interest in the health enhancing roles of specific ingredients and food components. Consumers have developed their own health and wellness vocabulary and have been bombarded with buzzwords such as wholegrain, wholesome, superfoods and ‘natural.’ We believe that research into functional foods will not be able to advance public health unless the benefits are based on sound scientific criteria. Food manufacturers must consider the complexity of the food substance and the effects that the health-enhancing ingredients will have on the food product as a whole. Research

is absolutely essential to substantiate the potential health benefits and must be supported effectively and communicated to consumers without embellishment. However, sceptics believe that although clean ingredients might have been introduced to get rid of chemicals, they are basically all about increasing profits. This has come about by products being misrepresented; that is, displaying health claims with no scientific proof. We believe that, through careful research and development, the opportunities for developing nutritionally enhanced clean label ingredients

are endless. We have been working closely with nutritional experts — including Hull York Medical School — to develop a range of functional clean ingredients. Clean label ingredient solutions for all food products are set to continue to rise in popularity. Those at the forefront of clean label innovation will be looking to develop solutions that have added health properties, making them not only clean but functional as well. Ulrick & Short is committed to this forward thinking approach and has already identified nutragenomics as the next ingredient movement. Nutragenomics focuses on the relationship between genetics and diet, with the potential to significantly enhance the longevity and the quality of life. The chemical properties and the scientific aspects of ingredients will continue to fascinate both food experts and consumers alike, and the industry can expect innovation boundaries to be pushed to new levels during the coming years.

For more information Adrian Short Ulrick & Short Walton Wood Farm, Thorpe Audlin Pontefract WF8 3HQ, UK. Tel. +44 1977 620 011 adrian@ulrickandshort.com www.ulrickandshort.com

calendar A round-up of events, trade shows and conferences in the global nutraceutical and functional foods sector during the coming months 31 – 1 February

29–31 March

11 May

European Food Manufacturing and Safety Forum 2011 Amsterdam, Netherlands www.foodmanufacturingevent.com

in-cosmetics The Global Business Platform for Personal Care Ingredients Milan, Italy Contact Reed Exhibitions Limited, UK T. +44 208 271 2122 F. +44 208 910 7926 E. incos.helpline@reedexpo.co.uk W. www.in-cosmetics.com

The Nutraceutical Business & Technology Awards A Celebration of Food Innovation Geneva, Switzerland Contact Via Media UK Ltd, UK T. +44 1372 364 122 F. +44 1372 364 121 E. miranda.docherty@via-medialtd.com W. www.nbtawards.com

2–4 May

10–12 May

SupplySide East Where Innovation Begins Secaucus, New Jersey, USA Contact Virgo Publishing, USA T. +1 480 990 1101 F. +1 480 990 0819 E. twillis@vpico.com W. www.supplysideshow.com

Vitafoods The Global Nutraceutical Event Geneva, Switzerland Contact IIR Exhibitions Ltd, UK T. +44 207 017 7027 F. +44 207 017 7818 E. vitafoods@iirx.co.uk W. www.vitafoods.eu.com

1-2 March 9th Annual World Food Technology and Innovation Forum Brussels, Belgium Contact World Trade Group, UK. Tel. +44 207 202 7690 Fax +44 207 202 7600 info@wtgevents.com www.foodinnovate.com

January/February 2011 www.nutraceuticalmag.com

last word

Sales and Service: Best of Friends or Wary Partners?

A recent study of senior sales and marketing executives, undertaken on behalf of Huthwaite International, has found that almost one quarter of sales and business development teams have seen the amount of face-to-face selling time fall compared with 2 years ago.

t first glance, this might seem to be no more than a natural reaction to the current economic climate and therefore not in itself very newsworthy. Yet, it would appear that the primary reason for this shift in the buyer/seller landscape is very different. Surprisingly, for almost two thirds of those suffering less contact, the main driver is a change in procurement strategies, with decision making responsibility moving away from the traditional customer or customers centralizing the way in which they are buying goods and services. By contrast, only 12% believed that it was because of spending cutbacks that their customers were less willing to see salespeople. This shift in responsibility and power has been recognized by many in the life sciences and healthcare industries, and has been the basis for new approaches and changed job roles in many organizations. However, it appears that some companies are still not making the best use of their customer-facing personnel. The survey suggests that, at the same time as ‘sales’ time is diminishing, customer-facing but not sales-focused staff — described in the broadest terms as ‘service’ personnel’ — may increasingly be getting more ‘air time’ with influencers in the buying organization. However, many employers have yet to take full advantage of this valuable contact, as these customer-facing staff may not yet recognize their potential to contribute directly to the sales effort. As the purchasing process changes, with the increasing involvement of procurement or purchasing professionals, sales professionals have reduced access to key decision makers. This means fewer occasions when they can have an open and meaningful dialogue about their customers’ clinical or business needs and how best to address them. In short, salespeople have less opportunity to create value and decisive differentiation for their business.

www.nutraceuticalmag.com

A Progressive Approach

Alison Morris

Fundamental Change The findings have significant implications for every provider of goods or services, and some are already reconsidering their whole sales approach in this new world of purchasing. For the sales team, in particular, the need to develop highly effective value creation, negotiation and account development skills becomes even more important, as the business has to get the best they can out of a decreasing number of formal sales opportunities. However, there is a broader need for all staff with direct customer contact, who are not directly involved in sales, to recognize that they have a vital role in the sales process as they can add tangible value at every touch point. This will become even more important as, increasingly, they have more opportunities to talk to key influencers than their sales colleagues do. The total number of non-sales staff with the potential to advance the sales process in some way often exceeds that of the direct sales team. The survey found, for example, that two thirds of support staff — such as after-sales, clinical research, education and training or technical support — have direct customer contact, as do one third of administrative staff.

January/February 2011

This does not mean ‘service’ personnel have to become salespeople. Service and sales is not an ‘either/or’ state with clear dividing lines. Rather, it can be seen as a continuum along which employees can be encouraged to progress, as they may be in a better position to help the business to recognize and develop sales opportunities than some salespeople. A number of ‘stages’ can be identified along this continuum. At one end is pure service, wherein customers get what they have asked for, no more and no less. This progresses through outstanding service — often called ‘going the extra mile’ — to a position of sales awareness, when the ‘service’ person starts to look beyond the immediate service issue and actively seeks to create, or even capture, potential tangible sales value. At the next stage, that of sales through service, the individual not only identifies the customer’s need but also starts to offer solutions to them. The key here is that the value of any additional solution identified in this way is ‘sold,’ not simply given free to the customer. Finally, there is what could be termed the full-blown sales role, which is fully focused on identifying customer needs and creating value for both organizations. The key here is that each organization and, if necessary, each individual, can progress as far as his or her capabilities and willingness allow. In this way, service moves closer to sales, but in a way that meets the organization’s culture and needs. Unfortunately, however, there is a problem. Many businesses have a long way to go to achieve this ‘one company’ approach to customer development. More than three quarters of service staff continue to see their role purely in terms of meeting or exceeding customer expectations, with no understanding or desire to go any further in recognizing or developing customer needs. Often, the structure of the salesperson’s business does little to encourage any change of attitude

here. In the majority of organizations, sales and service/customer support teams work together on an informal basis only and, in more than one in ten, the two departments work totally independently.

Rich Rewards The survey demonstrates a clear correlation between the organization and the service employee in their attitude and approach to sales. Put simply, if the culture of the business doesn’t promote a link between the two functions, then it will not happen. For those who have risen to the challenge, the payoff in terms of business benefit has been extraordinarily powerful. In one of the survey’s most outstanding findings, one quarter of respondents have seen an increase in sales leads and activity resulting in improved bottom-line performance, with a further 51% identifying an increase in sales leads and activity. Most outstandingly, for those who have benefited from better profitability, almost one third have seen gains of more than 20%, with more than two thirds registering an improvement of at least 5%. Even if it is accepted that some companies taking part in the survey will have started from a low base regarding their employees’ position on the service/sales continuum, these survey results indicate that the reward for changing the corporate culture in this way is potentially huge. It may be significantly greater than many other management initiatives designed to improve sales performance and competitiveness. Equally importantly, it is the positive perception among those companies undergoing successful change as much as the level of improvement itself that offers a strong indication that this is an initiative with a long-term future within the business, as it delivers attractive and tangible benefits for the organization, its staff and its customers. In short, those businesses that grasp the nettle early and encourage staff across the business to play a more proactive role in contributing to the customer development process are likely to see a demonstrable and worthwhile improvement in bottom-line profitability. By contrast, businesses maintaining a silo approach to selling and continuing to rely on the individual skills and expertise of the sales team will increasingly struggle within the purchasing process, with less influence on the buying criteria and restricted opportunities to differentiate their sales proposition other than on price. Rarely has the difference in potential outcomes between action and inaction been so stark.

Businesses that grasp the nettle and encourage staff to play a more proactive role in the customer development process are likely to see an improvement in bottom-line profitability.

For more information Alison Morris Business Director Healthcare Huthwaite International (www.huthwaite.co.uk).

January/February 2011 www.nutraceuticalmag.com

regulatory review

PAC Analysis Validated

he DGCCRF (French Directorate General of Competition, Consumption and Fraud Repression) has confirmed the exclusive use of the DMAC method for the quantitation of the daily dose of 36 mg of cranberry (Vaccinium macrocarpon)-derived PACs (proanthocyanidins) in dietary supplements that refer to the AFSSA (French Food Security Agency) claim: “Contributes to the decreased adherence of certain E. coli to the walls of the urinary tract” (Information Note 2010-218 of 20 December 2010). Pharmatoka, producer of the dietary supplement, URELL/ELLURA, who originated the AFSSA Opinion dossier regarding the protection delivered by cranberry to the urinary tract, has announced that the DGCCRF recently published a Note of Information specifying the conditions required to allow a product to refer to this claim (validated by AFSSA in its Opinion dated 6 April 2004, as well as two subsequent Opinions concerning the same issue). Since April 2004, the credibility provided by the AFSSA Opinion has instigated strong development in this market in France — jumping from €1 million in 2004 to the present level of more than €25 million — and the launch of numerous cranberry based dietary supplements.

Invalidated Methods of Analysis The company notes, however, that there are large variations in the composition of marketed cranberry based dietary supplements that refer to the AFSSA claim. These differences are explained by

the use of different methods of analysis to quantify the daily dose of 36 mg of PACs required to comply with the conditions of use described in the claim assessed by AFSSA. In particular, we have to highlight that the DGCCRF laboratory has discarded the Euracran method of analysis, which is currently the most widely used one in France. It was excluded from this investigation after preliminary results delivered — beyond doubt — a blatant overestimation because of a lack of specificity towards the researched cranberry PAC. The DGCCRF Laboratory in Strasburg has tested 39 products sold on the French market, using seven different analysis protocols. Their conclusions demonstrate that the DMAC method of analysis (protocols PAC003 or BL-DMAC) is the most specific when it comes to measuring cranberry PACs. It is the method used in the Pharmatoka dossiers. DGCCRF DMAC

Pharmatoka 5 Januar y 2011 French Govern

The recently published note of information • recommends that all consumers pay the highest attention to the quality of the products offered on the market, taking into account that, currently, almost all producers do not use the DMAC method (www.dmacasso.org) but cannot hide behind the AFSSA claim without deceiving the consumer. • concludes that, at this stage, only products containing 36 mg of cranberry (Vaccinium macrocarpon) PAC measured by the DMAC method can make a reference to the AFSSA Opinion about the urinary tract. Gunter Haesaerts, President of Pharmatoka, expresses the hope that the publication of this note of information will quickly end the present anarchy among cranberry based dietary supplements, so that consumers can benefit from risk-free access to secure and efficacious cranberry products (www.pharmatoka.com).

NOTE

ment Informat

ion Note of 20

Dear All

December 2010

We would like to inform you abou t a major breakt will spread thro hrough in Fran ughout Europe ce — that and beyond — ab for cranberr y pr out the quantit ation method oanthocyanidin s (PACs). The 20 specifies that a 04 Health claim dose of 36 mg of in France cr anberr y proant physiological ef hocyanidins is fect of bacteria re quired for the l anti-adhesion against certain in the urinar y tract. There ha P-fimbriated E. s been a long di coli scussion regard use: HPLC, DM ing which metho AC, vanillin, bu tanolysis, etc. d to Af ter a series of comparative an alyses of 39 pr methods, the Fr oducts by seve ench Governm n different ent has now co nfirmed that th Pharmatoka in e method used the initial doss by ier, the DMAC method, is the method to quan one and only va titate cranberr lid y PACs. We hope researchers to that this confirm choose the right ation will help products when they prepare th Let us not forg eir clinical stud et that it all go es back to the ies. old tradition of of cranberr y ju ice cocktail a da drinking 10 ou nces y, which contai BL -DMAC met ns 36 mg of PA hod. That sam Cs measured by e quantity — 36 the mg — is the sam one small UREL e L/ELLURA caps amount found in ule, which has since 2005. been produced by Phar matok a Please let us kn Best regards

ow if we can as

Gunter Haesae rts President Pharmatoka

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Confirmation of the BL-DMAC Method

January/February 2011

sist you with fu

rther informat

ion.