Nutraceuticals Now Winter 2014

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Nutraceuticals Now

Available by subscription only

Winter 2014

Barry Callebaut reformulates sweet solutions Healthier snacks for a healthier Europe

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stability of oils and fats


foreword Chris Lee, Portfolio Director, Vitafoods Europe, 6-8 May 2014, Geneva

I’m sure no one would argue with the assertion that scientific research is the backbone of the nutraceutical industry – not only does it drive ingredient and product innovation, but it also plays a crucial role in securing validated health claims that appeal to consumers’ biggest concerns.

In the seven years that I’ve been Portfolio Director for Vitafoods, I have seen just how much science shapes the nutraceutical industry and enables manufacturers to stay ahead of the curve in what has become a highly competitive market. There has never been such an exciting time to be working in our industry, with Transparency Market Research predicting that the global nutraceutical product market will reach $204.8 billion by 2017, growing at a CAGR of 6.3% – but to ensure this growth is sustainable, it is my belief that we must continue to be at the forefront of scientific research and innovation. Translating scientific breakthroughs into products that respond to current and future demand is essential. As pressures on health services around the world continue to mount due to ageing populations and the obesity epidemic, I see ample opportunity for the nutraceutical market to bridge the widening gap between what health providers offer and what consumers can do at home to protect against disease. At the same time, it’s clear that trends such as sports nutrition and beauty from within will continue to recruit consumers as they continue to pursue their quest for health and wellbeing. At Vitafoods Europe our goal is deliver the latest scientific thinking in an easy-to-digest way, so that manufacturers and suppliers can leverage new research to create ingredient and product offerings that respond to consumers’ personal concerns, as well as nations’ biggest health problems. This year the Vitafoods Europe Conference, which runs alongside the exhibition on 6-8 May in Geneva, will have a brand new modular format which we believe makes it even easier for delegates to access sessions that are relevant to their businesses. For added flexibility, two streams have been devised,

with attendees able to select modules on industry-relevant topics from the breadth of the two-day programme. And to ensure presentations are of the highest level, this year’s submissions were peer-reviewed blind by the Executive Advisory Board with only the most scientifically robust making the cut. I’m sure most would agree that having a crystal ball to predict what the future holds would make life a lot less stressful. While we can’t provide this, the conference will open with a keynote panel discussion on the future of nutraceuticals. With panel members including Victor Ferrari, CEO, Horphag Research, Simon Pettman of EAS Strategic Advice and Hubert Weber, Executive Vice President of Mondelèz Europe, I’m sure we’re in for an animated discussion that will offer plenty of food for thought. Following on from this, the sessions split into the two streams with each module including multiple papers presented by representatives from leading universities, ingredient suppliers and manufacturers, as well as research scientists. For those interested in specific health issues, stream A investigates and evaluates the latest scientific updates on seven of the hottest topics including cognitive, reproductive, heart and eye health. Stream B meanwhile outlines key markets with high growth potential, ingredients that are set to become big news and practical advice on regulatory challenges. All delegates are also invited to a closing panel at the end of day two where EAB members will debate and discuss topics from across the conference programme. The session will explore the outcomes of the conference, as well as offer different perspectives on the future of the nutraceutical industry. We always receive positive feedback on the quality of the science and research presented in the Vitafoods Europe Conference and the new customised format will mean even more delegates are able to take advantage. Staying ahead of the competition means staying on top of scientific and market developments and I’m very much looking forward to seeing and hearing what this year’s edition of Vitafoods Europe has to offer. For more information on the Vitafoods Europe Conference Programme and to book your attendance, visit http://www.vitafoods.eu.com/Conference. Prices start from €250 per module. nutraceuticals now

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contents 03 Foreword 07 Vitafoods South America uncovers the trends and topics shaping the nutraceutical industry 08-09 Stability of oils and fats 10-11 Barry Callebaut reformulates sweet solutions 14-15 Healthier snacks for a healthier Europe 16-17 Health claims: Consumer perceptions, compliance and the challenges of cognitive performance at NutraFormulate 2014 18-19 Lecico - the Lecithin and Phospholipid experts 20-22 Lallemand: Celebrating 80 years of probiotic expertise 22 DuPont nutrition and health to present trend- focused ingredient solutions at Vitafoods Europe 24-25 Fibrex®- the functional fibre 27 The battle to educate consumers is ongoing 28-29 Mitochondrial medicine 30-31 Negative studies focusing on Omega-3 in 2013 32 Vitamin K2, the “missing vitamin” 33 Consumer protection from misleading marketing 34 New bright and stable colored film-coating

advertisers 02 Food Matters 05 Beneo 06 NutraFormulate 09 RSSL 12 Barry Callebaut 13 Sabsinsa 15 Sulzer 17 Leatherhead 19 Lecico 23 Vitafoods South America 26 Fibrex 35 Nexira 36 Neptune

24-25 Editor: Charles Faulkner Operations Manager: Dan Peacock Accounts: Steve Clark Designer: Al Knight Published by: Tel: Fax: Email: Website:

Printed by: Harrisons Available by subscription only Nutraceuticals Now is a technical review providing the latest information on functional products and ingredients which are defined as having a disease preventing and/or health promoting benefit in addition to their nutritional value. It is targeted at manufacturers of food and drink, who are producing finished products aimed at the ever increasingly health conscious consumer. Any views and/or opinions expressed in the articles in this magazine are entirely those of the individual authors and do not necessarily express the views of the editorial staff. ISSN -1478-6605

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Vitafoods South America uncovers the trends and topics shaping the nutraceutical industry In the last decade, South America has emerged as a key market for the nutraceutical industry. The region has been booming, creating a growing middle class that has more purchasing power than ever before. For the nutraceutical industry the opportunities are ripe. Not only is general health and wellness becoming a major preoccupation for consumers when making food and drink choices, but issues such as obesity and an ageing population are driving people to seek out products that help keep specific conditions at bay. In Brazil alone, advances in healthcare and education have led to life expectancy increasing from 45 in 1950 to 74 today with the proportion of the population aged 60 years and over expected to double to 22% in 2025. This means age-related problems such as macular degeneration, joint health, sarcopenia and hypertension are becoming a bigger focus for consumers today, subsequently opening up doors for manufacturers operating in this area. Changes in diet due to an influx of fast-food chains also means obesity is becoming a big problem in Latin America. The weight management category is well positioned to respond to demand for products that offer satiety benefits or aid healthy weight loss. Vitafoods South America, which runs 8-9 April this year, brings together professionals to discuss and debate how manufacturers can tap into this flourishing market, as well as how Latin America is emerging as an influencer behind global nutraceutical trends. In what will be the show’s most dynamic event to date, suppliers showcase their latest innovations with Capusgel, Gelita Do Brazil, and Quimdis just some of the names already confirmed. Upwards of 3,000 industry professionals will converge on the two-day event to see exciting new products and ingredients, as well as uncover the industry’s most significant issues and trends.

Innovation on display Visitors to Vitafoods South America will not be short of opportunities to discuss product innovation with suppliers from countries as diverse as Brazil, China, France and the USA. In addition to the product innovation on display at exhibitor stands, the New Product Zone acts as a guide to the latest finished product launches in functional food, drink and dietary supplements to help inspire concept and product development. As part of this Graminex presents its Collegen PE supplements that provide nutrients for skin, hair and nails, as well as its PolliFruit Capsules that deliver different nutrients for consumers lacking adequate nutrition. Robinson Pharma showcases Probiotic-6, an innovative probiotic formula, and ThyroSlend, specially formulated and supported by clinically tested ingredients to help maintain a healthy thyroid. Tapping into demand for fruit and plant extracts, Changsha Huakang Biotechnology Development offers Acanthopanaz Senticosus Extract, Fructus Tribuli P.E. and Cranberry P.E. all of which provide unique nutritional benefits. Keeping on top of the latest trends is central to ensuring new product development matches consumer demand. The Seminar Theatre at Vitafoods South America features free-to-attend keynote speeches and presentations from industry leaders including Datamonitor, Innova Market Insights and Leatherhead Food Research to help improve skills and market knowledge. EAS Strategic Advice is also running a Health Claims Workshop in the Seminar Theatre which guides companies through key regulatory steps to be followed when launching food supplements and functional products that bear nutrition and health claims. Chris Lee, Vitafoods Portfolio Director, commented: “Rapid urbanisation, a booming economy and higher individual aspirations mean consumers in the region have come to demand food and drink products that are more sophisticated. In addition to this, concerns over issues such as obesity and ageing populations are resulting in an influx of innovative products that deliver health and wellbeing benefits. Vitafoods South America is the region’s only event dedicated to the nutraceutical, functional food and drink and dietary supplement industries, providing visitors with a unique opportunity to source ingredients that will help them build strong product offerings across a range of categories.” Exclusive insights The South American nutraceutical market is complex with trends and regulations differing from country to country. To help fine-tune their product development and marketing strategies, the Vitafoods South America Conference this year covers regulatory affairs, marketing and science. A new Regulatory Panel investigates regulatory affairs relating to ingredients, bioactive compounds and labelling through a series of interactive panel discussions created to give delegates intelligence on complying with regional legislation. Experts from Nestlé, Cargill and Danone debate issues such as how to minimise mistakes on preparing health claims documentation, new ingredient claims, nutrition labelling and nutritional harmonisation in South America, providing delegates with critical information on how to quickly access the market and transform their business. Following on from the Regulatory Panel at the start of each day, the Conference splits into two streams – the Marketing stream and Scientific stream. A series of workshops have been devised for the Marketing Conference that take a look at the latest issues and trends driving innovation in the industry so that marketers can ensure products and campaigns hit the mark with their target consumer base. Sessions include Top 10 Trends in functional foods & nutraceuticals by Euromonitor International, Most popular functional foods in Brazil by Kantar Worldpanel, How to explain the health claims of your products run by Unilever and Equilibrium Consultoria and Marketing to different consumer groups – children, women, med and the elderly by Sanavita. Taking place alongside the Marketing sessions, the Scientific Conference focuses on research developments that have major implications for food and drink product development. Coordinated by Professor Franco Lajolo from The University of São Paulo, the Conference features experts from leading universities and institution, covering topics such as Inflammation, Food & Nutrition for an Ageing Population, Future Challenges: Research & Opportunities and New Insights into Bioactive Compounds. Chris Lee concluded: “We’re looking forward to another event where scientific excellence and innovation will abound. Through our world-class exhibitor base and comprehensive Conference programme we are sure Vitafoods South America 2014 will be a stand out event.” To register your attendance at Vitafoods South America, visit http://www. vitafoodssouthamerica.com/register

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Stability of oils and fats By Robert Griffiths, RSSL

There are many oils and fats that have great potential as functional ingredients and nutritional supplements, omega-3 oils being the most obvious example. More generally, oils and fats are necessary ingredients in many food products or in cooking processes. Moreover, there are fat containing foods, such as margarines, which are often used as carriers for other functional ingredients, as in the case of the cholesterol-reducing spreads that contain sterols. Although some fats have received negative publicity, it is far from the case that all fats are bad. Indeed there are many fats that are necessary for health, and there are many products that exploit our dietary requirement for the essential fatty acids i.e. those that the body cannot produce for itself. However, whilst many oils and fats are desirable, they also often have the undesirable characteristic of being prone to oxidation. Oxidation is essentially a series of chemical reactions involving oxygen that degrades their quality and eventually produces rancidity, with accompanying off flavours and odours. Any product that contains oil or fat can be affected by this problem, and every attempt must be made to understand whether instability is an issue for a particular product, and what can be done to arrest the oxidation process, both during manufacture and afterwards during distribution and final storage by the consumer. Indeed, manufacturers may wish to work with suppliers to reduce oxidation during actual production of the oil and fat raw materials to ensure these are of the optimum quality for their product.

Oxidation explained

Oxidation is not one single reaction. It is a complex series of reactions involving a series of breakdown products in stages. The primary oxidation products are hydroperoxides, which breakdown to produce the secondary products (carbonyls, aldehydes). The rate of oxidation depends on factors such as temperature, light, availability of oxygen, and the presence of moisture and metals (such as iron) and also the quality of the oil to begin with. The type of oil also influences the rate of oxidation. Marine oils, for example, are highly susceptible to oxidation due to the large number of polyunsaturated fatty acids (PUFA) they contain. These unsaturated fatty acids have reactive double bonds between their carbon atoms, which make them especially vulnerable.

Arresting oxidation

There are a variety of ways to slow the rate of oxidation, including use of antioxidants (themselves attractive as functional ingredients) or encapsulation or the use of oils and fats that are less prone to oxidation. However in all cases, it is essential to determine how any of these approaches impact on the quality of the ingredients at the end of shelf life. This can be particularly important where a label claim is being made against a specific active ingredient, for example omega 3 fatty acids, in order to be able to substantiate labelling claims. It is never safe to assume that the approach that works well in one formulation is necessarily going to work in a different formulation.

Stability studies

Stability studies are therefore an essential part of the product development process, and their design can have a profound impact on the time it takes to get a product to market. Given their crucial role in food and supplement development, it is perhaps surprising that there are no universally agreed standards that dictate how a stability study should be carried out, and all companies have different ways of addressing this key requirement. A fundamental requirement is to get the protocol right so that every outcome can be properly examined and understood. After all, it is ultimately the purpose of a stability trial to discover whether there is any inherent instability in a specific combination of ingredients in the finished product or if the processing of the product, e.g. forming an aerated product, compromises the stability. The study will also assess the effectiveness of the packaging system. So any trial has 08

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to allow for a worst case scenario at the outset, giving the scientists enough opportunity and enough samples to work with so that they can understand the implications of the study. The storage conditions (different combinations of temperature, humidity, timescales) selected should therefore reflect the potential for distributing and selling the product and its packaging in all target markets. However, even where the product is only intended for mild climate markets there is an argument for storage at the extremes. After all, in reality we also have to consider the end-user, and ask how do they store the product at home? It is also crucial to select the right tests to monitor oxidation in the product during the shelf life study. Some of the traditional tests used to monitor the progression of oxidation during a shelf life study are described later. Some methods might not be suitable for testing of certain products and might be affected by other ingredients in the product. It is also a good idea to set alarm limits for every test. These are limits that are within the specification for oil/fat oxidation, but act as a warning system that the results might be heading towards a failure.

Rancimat instrument

The Rancimat is an instrument that is used primarily to measure the oxidative stability or resistance to oxidation of pure oils and fats. This resistance to oxidation depends on the degree of saturation of the fatty acids, level of antioxidants (natural or added) and the initial low level of oxidised material that might already be present. Within the test, oxidation proceeds slowly until resistance is overcome but then increases rapidly. The time taken before the accelerated oxidation occurs is the called the ‘induction period’ and this is used to make relative assessments of the oxidative stability. Hence this technique can be used compare the relative stability of different oils and fats or blends or the efficiency of different antioxidants and the dosage that needs to be added to any given oil or fat to prevent oxidation. In more complex matrices, the oxidative stability can be greatly affected by other ingredients, and in this case, the Oxipress instrument is more relevant.

Oxygen Absorption (Oxidograph) using the Oxipress Instrument

This instrument uses a modification of the ‘oxygen bomb method’, which is an accelerated test that measures oxidative stability of oils and fats (and finished products). It can be used to give an indication of the effect of using different fats or antioxidants on the oxidative stability in finished products. The measurement is based on measuring the consumption of oxygen by the sample held at elevated temperature. The Oxipress produces an oxidation curve and induction time that is similar to that described for the Rancimat and can be used to assess relative stability of different samples and formulations. The technique cannot directly give the shelf life of the product but can give an indication of stability relative to a control sample with a known shelf life i.e. indicating better or worse stability.

Traditional techniques

The methods described above are accelerated tests that can be used to initially screen different formulations to select the most promising few that can then be put through a full shelf life study. During the shelf life study samples will be taken at different time points and analysed using sensory and / or some of the traditional analytical methods. The most common of these analytical methods are the determination of peroxide value (PV), anisidine value and thiobarbituric acid (TBA) analysis. The peroxide value is essentially a measure of the primary products of oxidation. A high PV value indicates that an oil or fat is in the early-stage of oxidation. However, the PV value drops as oxidation moves to the secondary phase, and the peroxides degrade to aldehydes and ketones. Hence a low PV value does not necessarily indicate minimal oxidation and a high quality of oil. This is where the anisidine value and / or TBA methods come in to play. These tests measure the aldehydes and other secondary products produced during the oxidation of oils and fats. The aldehydes produced can also be directly measured by GC-MS methods, however this does involve the use of expensive and specialised instrumentation and interpretation. Each of these methods has their positives and negatives and these must be assessed to determine the most appropriate method.

Conclusion

Certain oils and fats have great potential for use as functional ingredients in foods and nutraceuticals. But their vulnerability to oxidation can make them difficult to handle as ingredients, and might make them unacceptable to consumers. To make best use of these ingredients it is essential to understand how their stability can be managed, and rapid screening techniques, along with more formal stability studies, will provide the data needed to achieve formulations that are acceptable to consumers and that meet regulatory requirements on claims substantiation.

Investigating instability

Clearly, the preferred outcome of any stability study is a clean sheet of unremarkable test results, with no evidence of significant oxidation, and nothing out of specification and nothing out of trend. Unfortunately, that isn’t always the outcome, although it is not always the case that an out of specification test result signifies an actual problem with stability. Formal investigation is always required to verify an out of specification result. At the very least, this is to exclude the possibility that it may have been the test itself, rather than the product/packaging that was compromised.

Rapid screening

There is seldom time or money available to evaluate all possible product variants through a full shelf life study. Therefore it is useful to apply rapid screening techniques to a wide range of potential formulations. Such screening can give a quick indication of the relative performance of changes in formulation and allow developers to narrow down the likely end formulation before this is put through a full shelf life study. There are small number of instruments available that can help in this area, with two of the most useful being the Rancimat and the Oxipress.

Oxidative Stability Index (OSI) using the nutraceuticals now

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In the face of this rather daunting prognosis, many people are quick to point the finger at sugar. The WHO (World Health Organisation) commissioned a review on sugar and obesity published in 2013 which concluded that “any link to body weight is due to overconsumption of calories and is not specific to sugars”. Luckily there is a company not waiting around for it to surface. In fact, Barry Callebaut has invested heavily in developing a plethora of viable alternatives to sugar in its wide range of chocolate, cocoa and related products. And that, well before statistics like those quoted above ever made it into print. As a result of that research, the window has been cast wide open upon a whole host of possibilities from sugar-reduced, without added sugar to sugarfree, fat reduced, reduced in saturated fat, calorie reduced and protein enriched and many other varieties of chocolate and chocolate applications. Sounds complicated? It needn’t be! And to help food producers navigate this new and burgeoning landscape, we’ve decided to offer you an overview of the options available in this editorial. Before we get there, however, we’d like to reassure you of one, crucial thing: not one of the solutions developed by Barry Callebaut compromises on the celebrated and unrivalled taste, aroma and mouth feel of genuine, natural chocolate. Glad we got that straight from the start!

LESS SWEET?

Barry Callebaut reformulates sweet solutions There’s no use sugar-coating it: there are some alarming statistics currently being thrown about in the media. According to recent data from WHO, 1 in 10 people around the world today qualify as obese while 1 in 4 are overweight. More than 347 million people suffer from diabetes worldwide. And if you thought such afflictions were akin only to the indulgent West, 80% of the latter are said to be found in low to middle-income countries. And if you add to all that, the already well documented phenomenon of population ageing and the picture for public health in the rapidly-approaching future is bleak to say the least. 10

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The food industry is coming under increasing pressure from all quarters. Consumer groups, retailers, governments and various governmental and nongovernmental bodies and organizations are calling on manufacturers to take responsibility for the current state of affairs. And as the healthcare costs related to the escalating prevalence of sugar-related illnesses such as obesity and diabetes continue their astronomical rise, governments are focusing on finding solutions. Some awareness campaigns are predictably having a noticeable effect on consumer demand. Consumer interest in low or no-sugar alternatives to traditional sweet treats has been steadily growing for several years now.

TOO MUCH SUGAR FOR A DIME

In the midst of the hiatus around whether or not obesity can be linked to the use of sugar, and how to offer scientific proof given the diversity of contributing factors, Barry Callebaut, decided long ago to take matters into its own hands. Indeed, the company launched its first without added sugar chocolate around 20 years ago. And 8 years ago, it launched a comprehensive

- Products reduced in calories - Protein- and fibre-enriched products - Products with reduced glycaemic load - Waterbased products

THE PROOF OF THE PUDDING

development program focusing on rebalancing the nutritional profile of chocolate to boost its general permissibility and authenticity. Barry Callebaut has always maintained that chocolate is and should remain an indulgent ingredient. Together with cocoa, chocolate is an important flavor enhancer for many sweet products. And if consumed in moderation, there is no reason it cannot occupy a place in a wellbalanced diet. With that in mind, it also becomes clear that sugar is just a small part of a much bigger picture and a more sweeping trend in the marketplace towards, for instance, more natural foods, certified organic products and origin ingredients. Foods and ingredients, in other words, with cleaner labels and without those dreaded e-numbers! So what options are available to food producers looking to answer the ever-louder call for better balanced and sugar/calorie-reduced foods and beverages? Many of the solutions offered by Barry Callebaut involve replacing sugar with low-calorie or intense sweeteners such as polyols, fibres and Stevia extract. However, the end goal of reducing glycaemic load can also be achieved by rebalancing the nutritional profile. Whatever the solution, however, the real skill lies in preserving the taste, aroma and mouth feel of traditional chocolate. And that is where Barry Callebaut employs its many decades of chocolate-making experience.

Depending on the specific requirements or constraints of their products, Barry Callebaut offers a full range of solutions for its customers which either partially or completely replace the sugar content with alternatives from a natural source. Take the patented Sweet by Fruits™ range, for instance, the first chocolate with 100% natural sugars, straight from fruits such as apples and grapes, in which the sugar is replaced by up to 30% with natural, dietary fibres. Then there are the so-called intense sweeteners like Steviol Glycosides (better known as Stevia extract), Barry Callebaut offers several special chocolate recipes containing this intense sweetener, resulting in chocolate that contains no added sugar and yet offer so much more. Great news too for consumers looking for an alternative to artificial intensive sweeteners such as aspartame, acesulfame-K and sucralose! And because sugar is not the only thing that provides calories, Barry Callebaut also offers chocolate-based ingredients that are reduced in fat and/or saturated fat , subsequently, balancing/lowering the caloric content. Whatever the chosen formula is, this extensive range of sweet solutions allows customers a great deal of flexibility when rebalancing their products for the healthconscious market of the future. However, the real competitive edge offered by the world’s largest chocolate maker has as much to do with its knowhow as its “know what”, so to speak. For Barry Callebaut also offers several value-added services which guide manufacturers throughout the process: from custom-developed recipes, full legal advice, full nutritional information as well as extensive R&D expertise, all aimed at helping customers reformulate their end products. Most importantly, however, Barry Callebaut brings it all together in a way which preserves the unique taste of each and every product or ingredient. Extensive consumer research showed external acceptance of its sweet solutions. Proving that there is still a sweet future ahead for chocolate and all those who love to eat it. For more information: www.barry-callebaut.com

Callebaut’s reformulated solutions

- Sugar reduced products - Products sweetened with fruit sugars (Sweet by Fruits™) - Without added sugar products - Sugarfree products - Products with steviol glycosides(stevia extract) - Fat reduced products - Products reduced in saturated fat nutraceuticals now

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Healthier snacks for a healthier Europe There can be no replacement for proper meals and balanced nutrition when it comes to achieving a healthy lifestyle. However, it is undeniable that snacking is an important pastime in Europe. Thomas Schmidt, Marketing Manager BENEO explains how food and drink manufacturers can make the most of current trends. The research company Datamonitor reports that consumers are increasingly looking for healthy snack alternatives, with 42 percent of consumers globally choosing healthy snacks. However, market data also shows that 36 percent of them feel guilty after snacking. Non-communicable diseases (NCD) – such as diabetes, cardiovascular diseases and obesity – are on the rise. Consumers are increasingly aware that a healthy lifestyle starts with a balanced nutrition. As such, healthy snacks – with reduced sugar or fat or fibre-enriched recipes – present a great opportunity for food producers in Europe. They are now looking for food ingredients that help to improve products’ nutritional profiles but without sacrifices on taste and texture.

Major trends in snack production

There are four key trends we are seeing in the snack market in Europe and around the world. • All natural, clean labelling – Manufacturers are increasingly interested in having “cleaner” labels. Naturally derived texturiser such as rice starches are thus of growing interest. The vegetal origin of rice starches contributes to optimised textures, such as improved creaminess in fatreduced dairy products with natural positioning but also helps to replace artificial whiteners in confectionery. • Sustained energy release – Consumers today need a lot of energy to get through their busy lives. Many (used to) resort to quick snacks or caffeine for that instant energy boost when they start to flag in the middle of the day. Today, they are increasingly looking for snacks that give them a constant energy supply and help them to get through the day, rather than those that give a quick burst of energy that drastically increase blood sugar levels only to have it drop just as quickly. This presents an opportunity for manufacturers to deliver snacks with low glycaemic and fully digestible carbohydrates. • Low fat/sugar or fat-free/sugar-free – With 1.6 billion overweight and obese people worldwide and 50 per cent of both men and women in the WHO European Region being overweight, weight management still is one of the most important topics within the food industry. Providing more balanced nutritional properties with less fat and sugar or even no fat and sugar at all are thus of great interest for food and beverage manufacturers alike. • Wholegrain and fibres – To reach the recommended level of dietary fibre intake and to maintain good digestive health, a good combination of natural fibre, such as wholegrains, vegetables and fruits, along with fibre-enriched food is needed. Food, such as cereals and snack bars fortified with fibre, offer quick and easy options for consumers looking to reach the daily required intake. 14

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Healthier snacks for a healthier Europe

The question is: are healthier snacks possible in Europe? BENEO believes that it is possible if we follow the SNACK approach. Europe is a region which embraces all sorts of snacks: snack/cereal/energy bars, wheat and grain based snacks, corn-based and also fruit snacks. BENEO is developing functional ingredients from the natural vegetable sources chicory roots, sugar beet and rice. Its ingredients enable food manufacturers to improve the nutritional profile of any snack category, whether it is fat or sugar reduction, fibre enrichment, or low glycaemic that is required. BENEO’s expertise in functional carbohydrates, prebiotic fibres and rice specialties from nature is combined with applications, such as dairy, beverages, bakery and cereals, soups and sauces or confectionery to help food manufacturers deliver healthier snacks without sacrificing appearance, texture, taste, and convenience. What BENEO also brings to the table is a connected chain of expertise which supports customers in the development of new products from lab to shelf. The BENEO-Institute, which is a network of minds bringing together BENEO’s expertise from nutrition science, nutrition communication and regulatory affairs, provides decisive insights into nutrition science and legislation. To complement this, the BENEO-Technology Center provides consultation in application technology including recipes, formulation advice and if necessary on-site support. It brings together BENEO’s long-standing food application and technical expertise to enhance and encourage product innovation within the bakery and cereal, baby foods, beverages, confectionery and dairy sectors. By combining the experience of specialists within BENEO’s different application fields, customers have access to a wide knowledge base for BENEO’s ingredients in their main applications.

Finally, BENEO’s marketing team offers strong market intelligence and consumer insights. All together a holistic innovation process is given that takes the product from the lab to the shelf. One example of how a new product idea was brought to life through a BENEO-customer partnership was the development of sugar-reduced and fibre-enriched candies from a German confectionery manufacturer. Following a presentation showing concept ideas of new candies, the customer decided to produce sugar-reduced and fibre-enriched candies with BENEO’s oligofructose, isomalt and stevia. The team at BENEO-Institute provided support on nutritional communication and labeling, the BENEO-Technology Center gave advice on the recipe as well as during the manufacturing process. The team not only presented the initial idea but also supported the communication of the product.

Great snacks galore

BENEO ingredients can be used by food manufacturers in a variety of snack applications, including: • Fruit juice drink with Palatinose™ – Palatinose™ is a low glycaemic but fully digestible carbohydrate derived from sugar beet and thus has a sugar-like sweetening profile. Palatinose™ provides the full carbohydrate energy in a balanced sustained way, delivering energy over a longer period. • Fruit or cereal bars with oligofructose – The prebiotic fibre oligofructose has a mild sweet taste and no effect on blood glucose levels. It helps to add fibre and partially replace sugar at the same time. It also masks the undesired aftertaste sometimes associated with high intensity sweeteners. When BENEO’s oligofructose is used in fruit or cereal bars many benefits can be achieved, such as improved digestion and regularity as well as fibre-enrichment and calorie reduction. Additionally oligofructose enhances the fruit flavour in a product. • Savoury cracker snack with inulin, rice bran, rice starch and rice flour – Using BENEO’s prebiotic fibre inulin and rice ingredients, the cracker is high in fibre and wholegrains while having a crunchy texture. It can be combined with the fatreduced and creamy spreadable cheese which contains rice starch and inulin. Both ingredients contribute to a creamy texture and fat-like mouthfeel. • Dairy alternative drink, with BENEO’s rice blend Nutriz – Combining the goodness of rice in one ready-to-use compound, Nutriz has a neutral taste and white colour. It gives the end product a creamy texture and balanced taste. BENEO’s Nutriz is suitable for non-dairy milk or yoghurt-type beverages, smoothies or fermented drinks. • Fat-reduced sausages with inulin – While enhancing a product’s fibre content, BENEO’s prebiotic fibre inulin also imitates the mouthfeel of fat particles and is thus ideal to reduce the fat and calorie amount in high quality sausages. Texture and taste are not affected. nutraceuticals now

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Health Claims: Consumer Perceptions, Compliance and the Challenges of Cognitive Performance at NutraFormulate 2014 Consumers buy benefits. When a food manufacturer claims that their product contains an ingredient which can reduce post-prandial glycaemic responses they promise the consumer that those health benefits are achievable. The European Commission Regulation on Nutrition and Health Claims permits health claims for certain nutrients, substances, food and food categories. Part of the reason the Regulation exists is to enable consumers to make informed choices about the food they purchase and consume. In addition to various claims relating to post-prandial glycaemic responses, ‘Vitamin A contributes to the maintenance of normal mucous membranes’, ‘consumption of products high in slowly digestible starch (SDS) raises blood glucose concentration less after a meal compared to products low in SDS’ and ‘zinc contributes to the protection of cells from oxidative stress’ have been permitted for use under European legislation, providing conditions are met. But, how realistic is it to assume that the average consumer really understands how their health can benefit from reducing post-prandial responses and blood glucose concentration; and to what extent do they understand why protecting cells from oxidative stress or maintaining normal mucous membranes is a good thing? One could argue that consumers do not need to fully understand claims to buy the products to which they relate. Indeed, products bearing health claims may simply attract consumers to buy them over other products that do not make health claims. But, if consumer choices are not informed, their relationship with a specific manufacturer or their products are not sustainable; there is nothing to stop them purchasing products that make the same claims or other claims that they don’t fully understand. The challenge for the food manufacturer/marketer is to find ways to reword authorised health claims in a way that is both compliant with the original meaning and resonates with the consumer. Another challenge for the food industry is establishing exactly what kind of evidence is worth submitting to The European Food Safety Authority (EFSA), which is

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responsible for verifying the scientific substantiation of submitted health claims. Those applying for the authorisation of a health claim must submit robust scientific evidence including a strong methodological rationale to meet EFSA’s requirements for substantiation. But, what about those health benefits for which no ‘gold standard’ test exists? This is the case for cognitive function and mental performance, including memory, attention, alertness, learning, intelligence, problem solving and language. Whilst EFSA provides guidance on the scientific requirements for health claims relating to psychological function, there is little consensus or consistency as to the appropriateness, sensitivity or validity of using specific tests to measure different cognitive functions. At NutraFormulate this year, experts from Leatherhead Food Research have teamed up with The Healthy Marketing Team to address the issues that the industry faces when putting health claims on a product. Leatherhead will be presenting on these topics and conversing on the issues at roundtable and workshop discussions.

Louise Brunger RD, joined Leatherhead’s Nutrition department in January 2013 as part of a two-year Knowledge Transfer Partnership (KTP) project with the University of Sussex. Louise is currently working on a new service to be offered by Leatherhead, covering the effects of food and drink products on mood and cognitive performance. She graduated from the University of Surrey with a BSc (Hons) in Applied Psychology & Sociology in 2006 and a second BSc (Hons) in Nutrition & Dietetics in 2012. Louise will be delivering a presentation entitled ‘Feeding the Mind’ at NutraFormulate that will cover consumer/market demands, EFSA guidelines and health claims substantiation, as well as information relating to the cognitive tests currently used in research and the challenge for nutrition-related testing. During the roundtable she will also cover ‘Cognitive Testing & Nutrition Research’ and give a demonstration of Leatherhead’s satiety and mood application and a selection of cognitive performance tests on the latest handheld technology. Discussions will include the following topics: • How can the challenges in nutrition research relating to cognitive performance be addressed? • How to select a cognitive test – specific or scattergun approach? • What is a type 1 error and how does this relate to nutrition research?

Dr. Roberta Re, Nutrition Research Manager, works in Leatherhead’s Nutrition department, which performs human intervention studies for efficacy and health claims substantiation in the areas of satiety, glycaemic response and weight management as well as routine GI testing. In collaboration with The Healthy Marketing Team, Roberta will be running a workshop entitled ‘Don’t Forget the Consumer: How to Develop a Successful Health Benefit Communication Strategy’ which will include interactive sessions on energy and active nutrition for the everyday consumer, as well as reduced/low/light vitamin and mineral fortification. Solutions to the issue of differentiating health claims from competitors will also be provided.

Georgia Taylor, whose previous experience includes investigating advertising complaints for the UK’s Advertising Standards Authority (ASA), recently joined Leatherhead Food Research as a Marketing and Claims Advisor. She provides advice and consultancy to clients on compliance issues regarding food advertising and marketing, in addition to the usual regulatory support in food law matters provided by the Global Regulatory department. Georgia will be running a ‘Nutracreativity’ session at NutraFormulate, which will include looking at case studies of how the Nutrition and Health Claims Regulations have been put into practice in UK advertising, identifying cases covering health claims, including those relating to the reduction of disease risk, and nutrition claims, common compliance issues and the challenges food advertisers face and guidance on compliance.

For further information, please contact: Dr Roberta Re, Nutrition Research Manager Leatherhead Food Research

Visit Leatherhead Food Research on Stand 238 at NutraFormulate 2014 to learn how we can help you to develop health claims that are both compliant with the original meaning and which resonate with the consumer.

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What else does it do? Well, it also benefits other brain activities like coping with stress and fighting depression. In young and healthy men, it lowered the production of stress hormones linked to strenuous exercise and eased stressrelated mood symptoms in the elderly. In summary, the research demonstrates the benefits of PS for people of all ages. It is the nutrient of choice to improve cognitive functions and to help people to cope with stress, hyperactivity and attention deficits.

The science behind SerinAid

LECICO . . . The Lecithin and Phospholipid Experts Every day, over 800 million people use products that contain lecithin. So regardless of your area of business, The Lecithin Experts find tailor-made solutions for your company: from concept to trials to finished product. Take advantage of LECICO’s strong Know How in lecithin application, the expertise comes from more than 30 years of experience in developing, producing and marketing lecithin and special phospholipids. Lecithin is a natural product with emulsifying and dispersing properties, which interacts with other substances such as proteins or starches to produce synergetic effects. This significantly improves the quality characteristics of a multitude of food and nonfood products in many ways. Lecithin does not only provide technical advantages in the production of food products but is also a highly valuable part of daily nutrition. Lecithins so are a fascinating synergy of interesting technological functions combined with an attractive range of health benefits. 18

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Every day, over 800 million people use products that contain lecithin. So regardless of your area of business, The Lecithin Experts find tailor-made solutions for your company: from concept to trials to finished product. Take advantage of LECICO’s strong Know How in lecithin application, the expertise comes from more than 30 years of experience in developing, producing and marketing lecithin and special phospholipids. Lecithin is a natural product with emulsifying and dispersing properties, which interacts with other substances such as proteins or starches to produce synergetic effects. This significantly improves the quality characteristics of a multitude of food and nonfood products in many ways. Lecithin does not only provide technical advantages in the production of food products but is also a highly valuable part of daily nutrition. Lecithins so are a fascinating synergy of interesting technological functions combined with an attractive range of health benefits.

Cells are the building blocks of life. No matter where they are in humans, plants or animals, they are of similar design, and their principal elements are membranes – the external cell membrane that encloses the cell, and a wide variety of membrane structures inside the cell. Phospholipids play a key role in these membranes. They not only ensure the structural integrity of the membrane, but also exert an essential influence on the function of enzymes, transport proteins and receptors. These in turn control a large number of metabolic processes, including the supply of nutrients to the cells and cell-to-cell communication. PS is primarily located on the inside of the cell where it acts as an organiser for the transport proteins and enzymes of the cell membrane. The cell needs these in order to be active, carry on communication, and convey substances from outside to inside and vice versa. PS also plays a particular role in nerve cell communication by stimulating the release of neurotransmitters: acetylcholine (for clear thinking), noradrenaline (antagonist of adrenaline), dopamine (hormone regulator) and serotonin (‘well-being’ hormone). The neurotransmitters are assembled in small vesicles at the nerve ends. Their release may be retarded by a wide variety of factors (like stress, overstrain, age and so on). PS restores the flow. If our diet does not contain sufficient PS, the effect is rather like a car with the ignition not working properly. Although

there is enough fuel available, there is no spark and the neurotransmitters are not sent on their way from one nerve end to another. The message gets lost. PS does not only influence the major transmitter systems to produce an overall harmonising effect on the brain. It also helps the brain to process energy. Our brains require massive amounts of energy to carry out their functions properly and positron emission tomography shows that energy turnover in human brains is drastically affected following oral intake of PS. It has also been shown that PS can regenerate the density of our nerve cell communication network which usually deteriorates during aging, but by no means least, SerinAid lowers cortisol, a catabolic stress hormone that injures brain cells and negatively affects body composition.

Phosphatidylserine – a Brain Nutrient for all Ages

SerinAid is just such a substance. It is a safe, natural dietary supplement which has been proven to support and enhance the brain’s activity across a number of areas, as well as preventing cognitive decline. It offers many exciting and promising health applications, opening up huge potential new markets for marketers and formulators with vision.

Research proves the extensive benefits

SerinAid is phosphatidylserine (PS), a naturally-occurring phospholipid derived from soy lecithin. Phospholipids are the main components of all the membranes of our body cells but PS has particular importance as it is highly specialised and found in nerve and brain cells. The role of PS is extremely well documented. It has been researched in more than 50 human clinical studies over a period of more than 20 years in North America and Europe. The studies cover benefits for conditions like age-related cognitive disorders, stress resistance among students, and attention deficit hyperactivity disorders among children. Seventeen double-blind, placebo controlled clinical trials and more than 2,800 research papers prove beyond doubt its considerable value as a dietary supplement. This is a nutrient that can revitalise memory, learning, concentration and even vocabulary skills – all functions which decline with age. nutraceuticals now

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Lallemand: Celebrating 80 years of probiotic expertise! 2014 marks the eightieth anniversary of Institut Rosell, a pioneer in probiotics research and application at the origin of the Human Nutrition and Health Division of the Lallemand group: Lallemand Health Solutions. If history has proven true our founders’ vision that probiotics hold a great potential for human wellbeing and health, our goal today is to look forward at the future of probiotics, to better understand their modes of action and potential benefits in emerging areas. We also take the opportunity of this celebration to thank our trusted partners to have contributed to our success and our development over the past 80 years and hope to open the way to new partnerships to continue writing together the history of tomorrow!

MAKING HISTORY

Microbiologists at work: Dr Brochu and Rosell in the 1930s.

For 80 years, the company has continuously dedicated its efforts to innovation, either in probiotic fundamental and clinical research, or protective and formulation technologies to deliver high-quality, state of the art probiotics to answer a dynamic market. Most of this research is performed in-house, in particular when it comes to the identification and characterization of our proprietary strains collections such as Rosell, Lafti and Harmonium Strains (see boxed text). In addition, the company has 20

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of the Lactobacillus helveticus Rosell-52 and Lactobacillus rhamnosus Rosell-11. Today, no less than 22 clinical trials and numerous in vitro and pre-clinical studies describe its health benefits and major modes of action. Lacidofil® shows benefits in several specific areas: Antibiotic-Associated Diarrhea in children and adults, H. pylori eradication, acute gastroenteritis in children, IBS, lactose intolerance. A second axis of probiotic research that has emerged more recently is the modulation of the body immune defences. There is now sufficient scientific evidence and growing clinical results showing the ability of certain selected strains to modulate either the innate or acquired immune response. Lallemand has dedicated a research program to the immunological evaluation of its strains. Several strains and blends show interesting immune modulating properties. In human studies, a synbiotic formula containing an optimal combination of Lactobacillus helveticus Rosell-52, Bifidobacterium bifidum Rosell-71 and Bifidobacterium infantis Rosell-33, with a prebiotic, has showed the ability to significantly reduce the incidence of common winter infections in children as compared to placebo, resulting in fewer sick days (Figure 1).

Lallemand strains systematically undergo a five-step process of probiotic characterization:

The history of Institut Rosell began with the story of a visionary man — Jose Maria Rosell. After earning his medical degree in Barcelona, Dr. Rosell went on to complete doctoral studies under the supervision of an eminent group of European microbiologists. It was a time when the science of microbiology was at its pinnacle, with Pasteur discovering the first rabies vaccine. Later on, Dr Rosell moved to Canada, and in 1934 he co-founded with Canadian microbiologist Dr Edouard Brochu the Institut Rosell, at Oka’s Agricultural Institute. Initially dedicated to the microbiological study of dairy products, Institut Rosell soon focused on human health and pursued the exciting works on health benefits of probiotics initiated by Nobel Prize Metchnikoff. The company then oriented its research activities toward the development of lactic acid bacteria cultures as well as various fermented dairy products. In the forties, to answer a particular medical need, researchers at Institut Rosell applied freeze-drying to preserve frozen cultures of lactic bacteria. This revolutionary technology opened the door to a wealth of new possibilities for probiotics. As time went by, Institut Rosell’s fields of interest widened to meet the needs of the food supplement and pharmaceutical sectors. In 1998, its acquisition by Lallemand Inc. allowed Institut Rosell to increase its potential for innovation and customer service in an ever-growing market. In 2001 and 2002, the company’s R&D efforts for the advancement of probiotic applications were recognized with the presentation of Frost and Sullivan Award for the application of enteric coating technology to lactic bacteria capsules (STAR® technology), conferring probiotics with improved resistance to gastric acidity. In 2012, the company joined forces with Harmonium International, a Canadian-based manufacturer of probiotic bacteria with a leading position in North America. 2013 saw the birth of Lallemand Health Solutions, a unique probiotic player in the global arena that can provide its customers and partners a wealth of solutions from fermentation and lyophilization all the way to finished product capabilities: a true one stop shop probiotic solutions provider.

A research-centric company

built a strong network of research partnerships which include Canadian universities (McGill University, Montreal University...) pharmaceutical laboratories and world-renowned research centres located primarily in North America and Europe (INRA, TNO, University of Florida...). In particular, since 2009, the screening and characterization of all Harmonium strains is performed in partnership with Maisonneuve Rosemont Hospital in Montreal. Such partnerships are essential to bring the best in the areas of strain grading, pharmacological and action mode analysis, toxicological assessment, pharmacokinetics, pre-clinical and clinical trials, to the company’s strains and formula. Further down the line, the company’s internal R&D capabilities focuses on the constant optimization of the probiotic (bacteria & yeast) production processes, strains stability, microencapsulation, galenic forms, packaging… resulting in an integrated offer of probiotic strains and blends or custom formulations produced to the highest quality standard. As a result, Lallemand Health Solutions has developed one of the largest portfolios of probiotic strains, with a large panel of benefits. Today, we have a collection of 38 proprietary strains, fully identified and characterized for their safety and stability profiles: lactobacilli (helveticus, casei, acidophilus, rhamnosus, plantarum, salivarius...), Bifidobacteria (breve, bifidum, infantis, longum, animalis), yeast (Saccharomyces cerevisiae var boulardii, Pharma grade), but also heat resistant Bacillus subtilis, Enterococcus faecium, Streptococcus thermophilus, Lactococcus, Propionibacterium...

1. Microbiological Identification and Strain Characterization Genetic fingerprinting, resistance to gastric acidity and bile, ability to inhibit the growth of other bacteria. 2. Microbiological Security Absence of antibiotic-resistant genes (over 180 genes tested), virulence factors and genes encoding enterotoxins. 3. Detection and Enumeration of Microbes in Complex Environments 4. Host Cellular Response to Bacteria In vitro co-culture with human cells, effects on gene expression with microarrays (e .g. immunity specific DNA chip) 5. In vivo modes of action Animal pre-clinical studies, human clinical studies.

Exploring new applications, in and beyond gut health...

In the early days of our company, digestive health and the maintenance of the gut microflora balance were the primary fields of investigation for the development and documentation of probiotics. All probiotic strains at Lallemand are screened for their ability to adhere to the gut epithelial surface, a prerequisite to a true “barrier effect”, protecting the gut lining from the attachment of potential pathogens. They are also screened for their ability to secrete lactic acid or other compounds known to inhibit the growth of major pathogens. Another interesting property is the ability of certain probiotics to stimulate the production of mucus by the gut epithelium, or even anti-inflammatory cytokines. Such focus has lead to the documentation of many specific strains with a potential in digestive health, which can be used independently or in combination to design specific formulas. Twenty years ago, the company has developed its flagship probiotic formula in digestive health: Lacidofil®, a combination

Figure 1: Effect of ProbioKid® formula on the number of schoolday loss due to winter infections (P<0.05) (Cazzola et al., 2010). In the past few years, the interaction of the microflora with the brain-gut communication (the ‘brain-gut axis’) has gained momentum among the scientific community. Lallemand was one of the first companies to seriously look into this “gut-bugs-brain” triangle (Figure 2): in 2008, the company dedicated its first multi-disciplinary scientific symposium to this topic, gathering microbiology, nutrition and cognitive science experts. At this occasion was unveiled the first human study on probiotics and stress! A study on chronically stressed volunteers showed that a probiotic formula developed by Lallemand (Probio’Stick®, a specific blend of Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175), was able to alleviate gastro-intestinal symptoms linked to stress, mainly abdominal pain and nausea. In 2010, a new study was published, looking into this probiotics’ effects on psychological symptoms, using a range of psychological tests as well as a biomarker for stress and anxiety (cortisol). This unique study concluded to our strains’ beneficial effects on general signs of anxiety and depression (Figure 3), making Probio’Stick® the first probiotic solution proven to alleviate both physical and psychological symptoms of stress in human. These effects are supported by several pre-clinical studies, the latest being published in 2014. nutraceuticals now

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While our R&D programs pursue the investigations into probiotics benefits and modes of actions in those areas, we are also working on other innovative areas of applications, paving the way for the future of probiotics.

Conclusion

Figure 2: Proposal of gut-brain-microflora interactions (adapted from S. Collins).

Backed by a rich history and strong expertise in probiotic research and development, Lallemand Health Solutions is ready to tackle the challenges of tomorrow and explore new areas of probiotic applications, offering a full line of ready-to-market probiotic formula and helping its partners to design their own custom formulation. Because, from the lab to the shelf, Lallemand Health Solutions controls the overall manufacturing process of its products, the company can ensure customers are receiving the highest quality standard of probiotic formulation. In addition, our company is committed to bring its customer the full support they need to develop, register and market their products in their own market, making of Lallemand Health Solutions a complete probiotic solutions provider.

Figure 3: Effects of Probio’Stick® on median HSCL-90 (Hopkins Symptom Checklist-90) scores between baseline and after one month of treatment (Messaoudi et al., 2011)

COMPANY NEWS • COMPANY NEWS • COMPANY NEWS • COMPANY NEWS

DuPont nutrition & health to present trend-focused ingredient solutions at Vitafoods Europe DuPont Solutions Aimed at Key Consumer Health Needs on Display at Vitafoods Europe 2014, 6-8 May, Palexpo, Geneva, Stand 21025 COPENHAGEN, Denmark, 17 February, 2014 – DuPont Nutrition & Health will showcase an array of ingredient solutions addressing key areas in focus for today’s health- and wellness-minded consumers at Vitafoods Europe 2014. Visitors to the DuPont stand (#21025) will be presented with illustrative product concepts that support consumers’ desire for immune health, digestive health and effective weight management. Featured solutions include finished formats in Dietary Supplements as well as Food & Beverage prototypes based on the comprehensive portfolio that makes up the DuPont™ Danisco® range of ingredients. “DuPont helps manufacturers respond to consumer trends with new and relevant product offerings that support key aspects of health and wellness,” said Craig F. Binetti, president, DuPont Nutrition & Health. “By combining our market insights, broad ingredient portfolio and technical and nutrition science expertise, we deliver complete solutions to help customers build nutrition strategies that satisfy the needs of consumers worldwide.” This year, the DuPont presence at Vitafoods will be divided into three principal areas, each highlighting the company’s focus on ingredient solutions that respond to consumer needs 22

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in a specific area of health. Featured at this year’s event will be: • Immune Health – The HOWARU® Protect probiotic range has been clinically documented to help maintain natural immune defenses, and DuPont has developed formulations to meet the specific needs of children (HOWARU® Protect Kids), adults (HOWARU® Protect Adult) and sports enthusiasts (HOWARU® Protect Sport). • Digestive Health – Within the DuPont™ Danisco® range, support for digestive health includes HOWARU® Restore probiotics, which help maintain optimal gut microbiota during periods of gastrointestinal stress, and OsmoAid™ Lactitol, an affordable, well-tolerated product that works gently to promote gut mobility in constipated individuals. • Weight Management – DuPont also will highlight ingredient solutions that can improve nutritional profiles without asking consumers to sacrifice enjoyment or convenience. These include adding fibre and protein: using Litesse® polydextrose and SUPRO® soy protein to deliver satiety benefits in beverage and bar applications. DuPont formulation expertise helps manufacturers adapt these value-adding ingredients to effectively address a variety of consumer segments such as child nutrition and sports nutrition. Focus on Health The combined resources within DuPont Nutrition & Health help manufacturers create products with a healthier profile and that actively promote good health to address consumer needs in digestive health, immune health, heart health, muscle health and weight management. The company’s capabilities are applied with a focus on the specific needs of key industry segments, including bakery, beverages, bars and snacks, dairy, and dietary supplements. nutraceuticals now 11


Sugar Beet Fibre

from the sugar beet. The pulp is dried by overheatedsteam under pressure in a patented drying method that optimises temperature, pressure and time to minimisetaste and odour in the end product. We believe in the natural beige or off-white colour in our product as a more natural and safer image. That means that we have abstained from bleaching the product with chlorine or hydrogen peroxide with whatever risk this could mean in terms of residual radicals or peroxides.

Physiological effects & clinical studies Production

During the sugar production the sugar beets are washed, thinly sliced, and the sugar is extracted from the beets by hot water. The watersugar solution obtained in this process is then further process to crystallize pure sugar. The remaining beet pulp leaves the sugar production at this point. Freshly pressed pulp is transported to our dedicated plant where it is further sieved, controlled and dried at high temperature and pressure. The result is Fibrex, a natural dietary fibre with high fibre content.

Concentrated

Fibrex consists of 73% dietary fibre, 10% protein, 5.5% sugar, 4% mineral substances and 0.5% fat. This means – for a natural fibre – high concentration of dietary fibre in the end product.

Dietary fibre

Fibrex®the functional fibre

Composition

Today‘s intensive discussion about dietary fibre started at the end of the 1960-ies when Dr. Burkitt from England had been to South Africa to study the eating habits and the diseases among the natives there. He found that they rarely suffered from the so called Western world diseases, like high blood pressure, coronary heart disease, cardioscular problems in general, diabetes, constipation, diverticulosis, colon cancer etc. One of his conclusions was that this was directly related to their eating habits – they ate a lot more dietary fibre, (both soluble and insoluble.)

The dietary fibre content in Fibrex is approximately 73% of the product, or almost 80% of dry matter, when calculating the fibre as the difference after analysis of all other substances (as per 100g; protein 8g, sugar 6g, fat 1g and ash4 g). The main fibre types in sugar beet fibre are insoluble hemi cellulose and soluble pectin, but also small amounts of cellulose and lignin. When measured with the AOAC method, the total fibre content is 67% of the product as not all small fiber fractions is caught.

Health products

Fibrex high fibre content and unique composition of soluble and insoluble fibre makes it a natural choice when it comes to fibre intake. Fibrex is suitable for tablets, granola bars, fibre enrichment of musli and other health related products. Fibrex is by nature free from gluten, which means that it is an excellent dietary fibre source for people suffering from celiac disease (“gluten intolerance”).

Soluble and insoluble fibre

Facts

What is Fibrex®?

Fibrex is a dietary fibre from the sugar beet fields of Southern Sweden. The composition of the sugar beet is about 76% water, 18% sugar, and the rest, 6% is the cell walls. After the sugar extraction, the rest of the sugar beet is transported to the Fibrex plant where the water content is dried out with overheated steam. The result is Fibrex, a natural dietary fibre with a high fibre content. 73% with a natural balance between insoluble and soluble fibre.

The factory

Located in Kopingebro in Southern Sweden is our dedicated Fibrex plant build in 1986. The patented method of steam treating sugar beet pulp is carried out in the 800m tubes on the outside of the factory. The dried beet pulp is then milled to different fractions and packed, all within the factory, eliminating the risk of contamination or quality reduction. The factory is managed according to ISO 9001, 14001, 22000 and HACCP.

The product line

Fibrex is available in many different ground fractions with particles from <32μ to flakes. This gives us the possibility to offer just the right fraction for your application and your needs. All fractions are produced in the same natural way without addition of any chemicals and with the same high content of dietary fibre (73%) and water holding capacity.

Key words Natural

Natural means no chemicals added or used after the sugar extraction

When dieticians or physicians talk about fibre enrichment of food products, such enrichment should be made in such a way that it does not change the “natural” balance between soluble and insoluble fibre that humans would “normally” consume. Going back to our forefathers they, allegedly, would eat a balance of 2/3 of insoluble fibre (coming mainly from cereals and root vegetables) and 1/3 of soluble fibre (coming from fruits, vegetables and root vegetables). A change towards too much of only insoluble fibre (that are merely functioning as laxatives) is not desirable. It has to be remembered, that it is only soluble fibre that is nutritionally “active” in terms of influence on cholesterol, blood sugar etc. This statement from dieticians and physicians was one of the reasons for Danisco Sugar AB to go into the Fibrex project in the late 1970 with the aim to upgrade the use of beet pulp from cattle feed to a dietary fibre for human consumption. We were pioneers in this field.

Unique water holding capacity

The cell structure of the sugar beet is unique. Each cell is “opened up” just enough to extract the sugar (and molasses) content but not to extract the approx. 22% pectin contained in the cell walls. This “emptied” cell structure is dried by clean steam and shrinks together. When this dried particle is soaked in water, the water will “stiffen up” the cell structure again. Water will be soaked into the empty cells, where it will gel with the pectin creating a cell structure with small water “depots” surrounded by cell walls. This describes the unique water holding capacity (WHC) of Fibrex. Fibrex used e.g. in bakery products binds 3.5 times its own weight of extra water in the dough/bread with unchanged water activity in the product (even during baking and freezing). Fibrex retains that extra water also in the end product.

Gluten free

Fibrex is by nature free from gluten, which means that it is an excellent dietary fibre source for people suffering from celiac disease (“gluten intolerance”).

Phytic acid

Phytic acid, normally contained in e.g. cereal products (like bran and flour) will form very strong chemical complexes with iron and zinc and consequently impair or reduce the natural absorption of these essential minerals in the human body. Fibrex contains no phytic acid.

Fibrex -a safe and natural source of fibre ®

In the bakeries

milled fractions for the use in a variety of products.

Convenience food and meat applications

Fibrex high fibre content and unique composition of soluble and insoluble fibre makes it a natural choice when it comes to fibre intake. Fibrex is suitable for tablets, granola bars, fibre enrichment of musli and other health related products. Fibrex is by nature free from gluten, which means that it is an excellent dietary fibre source for people suffering from celiac disease (“gluten intolerance”).

Fibrex, the natural fibre in the bakery, prolongs the shelf life of your bread and will keep your frozen dough from drying out. Fibrex will work for you during the whole baking process – in the easiest way possible. As an ingredient in different types of ready meals and minced meat products, Fibrex offers a natural way of keeping juiciness, achieving a nice chewiness and a better yield. Fibrex is offered in a number of

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Health products

Dietary fibre in general Dietary fibre is a generic term that characterises carbohydrate components (non-starch polysaccharides) which are neither digested nor absorbed in the human small intestine, and pass to the large intestine practically unaffected. The EU definition today also includes non-digestible carbohydrates with 3 to 9 monomeric units, like fructooligosaccharides, polydextrose and resistant dextrins=starch. Examples of common fibres are pectin, cellulose and hemicellulose. The importance of dietary fibre for the bowel function has been known for a long time. However, research during the past decades has shown that food rich in fibre is not only important in maintaining a normal bowel function and preventing gastrointestinal symptoms, such as constipation – it can also affect our metabolism. There is convincing evidence that an increased intake of dietary fibre has a protective effect against several present-day lifestyle-associated diseases. The structural properties of different fibres are of importance for their physiological effects. Viscous, water-soluble fibres may reduce or delay the uptake of carbohydrates and cholesterol, which can prevent or have beneficial effects on cardiovascular disease and type 2 diabetes. Soluble fibres can also be fermented by health-promoting bacteria in the colon, leading to protection against inflammation and colorectal cancer. Insoluble dietary fibres are mainly associated with a healthy bowel function by accelerating the passage of foods through the digestive

system and by increasing stool weight. Authorities in most industrialized countries are recommending an almost doubled target intake of dietary fibre. The European Food Safety Authority has set a daily target intake of 25 grams based on the evidence on bowel function but also acknowledges that there are health benefits associated with a higher intake through fibre such as reduced risk of coronary heart disease, type 2 diabetes and weight management and the U.S. Department of Agriculture and the U.S. Department of Health and Human Services recognize that dietary fibre naturally occurring in plants is important in promoting a healthy laxation and helps to provide a feeling of fullness and recommend a daily intake of 25 grams for women and 38 grams for men.

Advantages with Fibrex

Compared to many conventional natural sources of dietary fibre, such as cereal products and fruits. • Fibrex has higher content of dietary fibre, with a perfect balance of 2/3 insoluble fibre. • Fibrex contains no phytic acid. Cereal products, such as bran and flour, contain phytic acid which forms strong chemical complexes with iron and zinc and consequently impair or reduce the natural absorption of these essential minerals in the human body. • Fibrex is by nature free from gluten, which means it is an excellent dietary fibre source for people suffering from gluten intolerance.

Physiological effects of sugar beet fibre The high dietary fibre content in sugar beet fibre in combination with water absorption leads to low energy density, thus reducing the energy content of a meal. The fibres provide increased bulk which promotes digestive health, contributes to satiety and can prevent or reduce obesity.

The soluble fibre pectin

Sugar beet fibre contains approximately 22% of the water soluble fibre pectin. Pectin is recognised for its potential to give health effects in the body, such as lowering blood cholesterol and leveling out the blood-glucouse curve. These effects are likely to depend on the ability of pectin to form viscous solutions. An increased viscosity in the small intestine slows down the mixing and diffusion of intestinal contents. This can, in turn, reduce or delay the uptake of carbohydrates which leads to lower blood concentrations of glucose and consequent insulin after a meal. It can also reduce cholesterol uptake, or the reabsorption of bile acids from cholesterol and hence reduce the level of bad (LDL) cholesterol in the blood. Non-lignified cell walls and water holding The cell wall material of the sugar beet has, due to its function in the plant, characteristics

different from those of cereal bran fibres. Since the task of cells in bran is to protect the seeds, these are hard and lignified (Figure 1). On the opposite, the cells walls in sugar beets are mainly assigned to store nutritional reserves, and are not lignified to the same extent (Figure 2). These differences in cell structure give sugar beet fibre not only a unique fibre composition, with 1/3 soluble and 2/3 insoluble fibres, but also interesting physical properties, like thermostable water holding. In the drying process of Fibrex the cell structure collapses. When water again is added, the cells resume their original form, taking up water and retaining it within the cell wall structure (Figure 3). The water uptake capacity is approximately 7-8 g per gram of Fibrex. That is the amount of water absorbed by Fibrex, if it is allowed to soak in water, and retained, when the fluid has been allowed to drain off. The water holding capacity (water retained at a pressure of 10 kPa) is approx. 3.5-4 g per gram of Fibrex. That is how much water Fibrex retains in most foodstuffs, where several components “compete” for the water. The water holding properties of sugar beet fibre contribute to increased viscosity. In the gastrointestinal tract, the viscosity may decrease or delay nutrient uptake, leading to normalised blood glucose levels after a meal and healthy cholesterol levels in the body.

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The battle to educate consumers is ongoing . . . tackling misconceptions and influencing legislation. It’s all in a day’s work for FAIA Ask the public at large what they think about E numbers, and the response will usually be that they’re ‘bad for you’ or ‘not natural’. Then tell the same people that there are, for example, several E numbers in a tomato, and that some of the most common food ingredients that have been used for centuries have E numbers – baking soda is E500 and Vitamin C E300 – and wait for their jaws to hit the floor.

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The battle to educate not just consumers, but teachers, students and health professionals is ongoing – but one that the Food Additives and Ingredients Association (FAIA) is determined to win. FAIA was set up in 1977 with the initial aim of providing a vital and much-needed link between food additive manufacturers and the regulatory authorities. Over the years, however, the association has evolved and now operates under a far wider remit – that is, to help improve the business climate in which additive and ingredients manufacturers operate. Equally, important, though is its desire to improve the understanding of food additives and ingredients among the wider population. “There is so much misinformation in the press,” says FAIA Executive Director Michelle Maynard. “The trouble is, certain media outlets refuse to let sound science get in the way of sensationalist, scaremongering headlines. “However, when people do come to us for advice and information, we’re happy to impart our knowledge,” she adds. “It’s great to be able to set the record straight, and help sort fact from fiction. “It’s important, too, that we convey the message that ‘synthetic’ or ‘artificial’ does not necessarily mean damaging, just as ‘natural’ doesn’t necessarily mean a product is good for you.” Education aside, another part of FAIA’s role is to lobby on behalf of its members. “FAIA has, over the years, developed a good working relationship with both the Food Standards Agency and the Department of Health. This enables us to closely monitor and influence changes in legislation,” explains Michelle. “However, in order to successfully influence regulatory change, we also have many other points of entry to the decision-making process. “FAIA is a member of the Federation of European Speciality Ingredients Industries, better known as ELC. Based in Brussels, ELC has close formal links with the European Commission, as well as good access to key

members of the European Parliament. “We’ve been heavily involved in the smoke flavouring discussions, and recently called a meeting with the Department of Health to discuss the Foods for Specific Groups (the replacement for Parnuts) legislation. “In Europe, we lobby through ELC, and are working on the EFSA re-evaluation of additives. Currently, we’re lobbying for more contact with EFSA, and a more pragmatic and speedy system. “We’re also working with the Commission and EFSA on the various intake methodologies and are trying to promote the use of FACET, which gives a more realistic result than the systems currently in use. “We’re also addressing sustainability, processing aids and the use of additives in phosphates.” Membership of FAIA is open to all UK companies or UK-based subsidiaries of international companies manufacturing or marketing food additives, ingredients, colours and flavours. Companies currently in membership include BASF, Cargill, Colorcon, CSM, DSM, McCormick, Ingredion, Univar Food Ingredients, Fibrisol, TasteTech and Roha. “The support offered by the FAIA, especially with its regular food legislation updates, has been invaluable,” says David Berry, Technical Manager at LycoRed and soon-to-be FAIA Chairman. “It also offers the opportunity to meet and network with like-minded professionals.” Paul Whitehead, Technical Manager at Fibrisol, agrees. “FAIA is more than just a source of information,” he says. “It provides us with a direct link into all that’s happening at both UK and EC level that may affect our industry. “It gives us an active voice in these discussions, and a chance to lobby the relevant authorities to safeguard our industry and our business.” To find our more about FAIA and the benefits of membership, visit www.faia.org.uk or email michelle@faia. org.uk nutraceuticals now 27


Furthermore, Ubiquinol helps to suppress the accumulation of mitochondrial DNA damage caused by free radicals, which results in accelerated aging.

Supportive therapy in children with autism

Mitochondrial medicine

. . . first steps in a promising direction

Review of current studies recommends further investigation in the field of mitochondrial disease and adjuvant therapy with Ubiquinol, but evidence shows positive results Mitochondrial medicine is a relatively new but fascinating field. It deals with diseases that are related to mitochondrial dysfunction triggered by a number of causes, including genetic mutation induced by free radical damage. A primary feature of mitochondrial dysfunction is impaired cellular bioenergetics so, to put it plainly, the problem is one of energy production. Inside almost every cell in the human body are thousands of mitochondria – minuscule organelles that are responsible for the respiratory chain. This biochemical process provides energy required to sustain life and support growth by creating Adenosintriphosphate (ATP). Within this process, coenzyme Q10 and its active form Ubiquinol act as important electron carriers. The body cannot substitute a lack of this vitaminlike micronutrient with anything else, and without Ubiquinol, mitochondrial cells are damaged and even die within minutes. If this process is repeated throughout the body, whole systems begin to fail. 28

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Established diseases that are connected with mitochondrial disorders include autism, Parkinson’s, Alzheimer’s, Chronic Fatigue Syndrome (CFS) and certain learning disorders. There are currently no cures for any of these. Treatments can only alleviate symptoms and slow down their progression. One of the leading researchers in the field of mitochondrial medicine is Anna Gvodzdjáková, Professor of Medical Chemistry and Biochemistry at the Charles University in Prague. Professor Gvodzdjáková has also edited a review of mitochondrial medicine1 based on collected data from clinical and experimental research in various fields, including mitochondrial cardiology, neurology, diabetology, nephrology, immunology, rheumatology, reproductive medicine, sports medicine, and chronobiology. Although Professor Gvozdjáková and other scientists engaged in the field of mitochondrial medicine are investigating different potential treatments, one common denominator is their focus on Ubiquinol. The active form of coenzyme Q10 is essential for generating energy and has a powerful ability to fight oxidative stress at a cellular level. A recent clinical study has shown that in a mice model, nutritional supplementation with Ubiquinol activates mitochondrial functions – through the expression of sirtuin genes or so called long life genes – and protects against the progression of aging and symptoms of age related disease2. The micronutrient therefore holds promising potential in the field of mitochondrial medicine.

Ubiquinol – A vital role in energy production

As one of its basic components, Ubiquinol is essential for the body’s respiratory chain. This vital process produces more than 95 per cent of our energy and supplies it to the heart, brain, muscles and everywhere else that energy is needed. Ubiquinol is therefore indispensable for high level performance – mentally as well as physically. The human body is able to produce its own Ubiquinol, although our natural levels decline with age and are affected by illness and lifestyle factors. In addition, animal data has shown that the body’s capacity to reduce coenzyme Q10 to Ubiquinol decreases with age3. Ubiquinol is also naturally present in many foods, including meat, fish and nuts. Unfortunately, however, it is virtually impossible to compensate for any losses via diet alone. Used as a supplement to replenish the body’s natural supplies, the electron-rich Ubiquinol has a more rapid and better effect than its precursor coenzyme Q10 since it does not have to be converted into an active form by the body. Ubiquinol is taken up more quickly and efficiently than traditional coenzyme Q10 (CoQ10) and therefore has much better bioavailability. Ubiquinol is a strong antioxidant: It protects cell membranes from free radical damage and it contributes to their elasticity and flexibility. Within the inner mitochondrial membrane, this protection is especially important because reactive oxygen compounds called free radicals can occur here in high numbers during energy production.

One area of mitochondrial medicine of particular interest is autism. A range of complex neurodevelopmental disorders with multifactorial causes, autism generally manifests itself within three years of birth. Affected individuals display behavioral problems such as hyperactivity, self-harm and aggression, as well as sleeping and eating disorders. The condition may be caused by genetic, metabolic or endocrinological factors. With her particular interest in this area, Professor Gvozdjáková4 conducted a clinical trial with the aim of developing a new diagnostic test and examining the effect of supplement therapy with Ubiquinol on the behavior, physiological functions, antioxidant status and lipid peroxidation in children with autism. The study included 24 children between four and six years of age who satisfied the criteria of the international classification of disease (ICD-10) and the Childhood Autism Rating Scale (CARS). At the beginning and the end of the trial, the children were examined physically and mentally: total levels of antioxidants in their blood plasma (CoQ10, γ-tocopherol, α-tocopherol, β-carotene) were measured, and their neurological and psychological status was tested5. Eighteen children were given Ubiquinol for three months – at a dose of 50 mg Ubiquinol per day for the first week, then 100 mg per day from the second week onwards. At the end of the trial, significant improvements in autistic symptomology were observed when the plasma level of total CoQ10 increased to more than 2,15 mg/ml. There was no significant decrease in TBARS, a measure of oxidative stress. Nearly all of the children showed improvements in verbal communication, interests, activities, sleep and eating. Thus, for the first time, a beneficial effect was demonstrated, and it was shown that plasma concentration of total CoQ10 and lipid peroxidation could be used as metabolic markers for autism in children. As this study only involved a small number of participants, further investigation is needed to confirm its promising findings.

Ubiquinol helps to fight Chronic Fatigue Syndrome (CFS)

Chronic fatigue syndrome (CFS) is a condition that is affecting a growing number of people. Characterized by extreme tiredness, insomnia and joint as well as muscle pain, the cause of CFS is unknown, but it is believed that oxidative stress acts as a pathophysiological agent in the syndrome. There is currently no known cure for CFS. However, nutritional supplementation with Ubiquinol could be a suitable adjuvant therapy, as indicated by an open-label pilot study carried out by a group of Japanese scientists6. The researchers treated 20 patients suffering from CFS with 150 mg Ubiquinol per day. After eight weeks, levels of oxidative stress decreased and symptoms of depression, sleep duration as well as performance in arithmetical tasks all improved significantly. According to the scientists, these improvements were linked to increases in plasma CoQ10 levels. The results correspond to the findings of Prof. Yasuyoshi Watanabe from Osaka University7.

Ubiquinol ameliorates juvenile fibromyalgia

fybromyalgia (FM). Fybromyalgia is characterized by chronic musculoskeletal pain disorders and fatigue of unknown etiology, but oxidative stress is assumed to play a role in its pathology. To evaluate this assumption, a scientific team from Tokyo University, led by Takako Miyame8, conducted a trial with 10 patients suffering from FM and a control group of 67 healthy individuals. The study found that plasma levels of free cholesterol and cholesterol esters were raised in the FM group, suggesting that hypercholesterolemia plays a role in this disease. In contrast, Ubiquinol plasma levels were significantly lower in the FM group than in the healthy participants, suggesting that FM is associated with coenzyme Q10 deficiency and increased oxidative stress. The Tokyo team then conducted three sequential doubleblind follow-up phases: treatment with 100 mg Ubiquinol per day for 12 weeks, treatment with placebo for eight weeks and then further treatment with Ubiquinol for eight weeks. This resulted in an increase in blood plasma levels of CoQ10 and an increase in Ubiquinol ratio reflecting an improvement in oxidative status. In contrast, lowered cholesterol and cholesterol ester levels demonstrated an improvement in fat metabolism. The most important findings were the changes in fatigue levels, which showed enhancements as measured by the Chalder Fatigue Scale.

Continuing to solve the puzzle

Although data has been gathered from more than 30 years of clinical and experimental research, further investigation is needed to clarify the existing basic approaches and define the most successful means of Ubiquinol therapy. But one of the most interesting preliminary insights is that adjuvant nutritional therapy with Ubiquinol has various beneficial effects – and this paves the way for new treatment options for a number of mitochondrial diseases. As Ubiquinol is natural, completely safe and has no known side effects, it already offers hope for those who suffer the symptoms of these incurable diseases.

References

1. Gvozdjáková, Anna (Ed.): Mitochondrial Medicine, Springer 2008. 2. Tian, G, et al., Ubiquinol-10 supplementation activates mitochondria functions to decelerate senescence in senescence accelerated mice. Antioxidants & Redox Signaling (2013). 3. Lopez-Lluch et al., AGE 27: 153 (2005). 4. Gvozdjáková, A, et al. Effect of Ubiquinol on oxidative stress, antioxidants and psychological manifestations in children with autism. 7th Conference of the International Coenzyme Q10 Association, Seville, Spain. November 8-11th, 2012. 5. Tests referred to the criteria of DSM IV (Diagnostic and Statistic Manual of Mental diseases, USA) and CARS (Screening Test for Autism) 6. Fukuda, S, et al. Dietary intake and intake of ubiquinol improves symptoms of chronic fatigue syndrome. 7th Conference of the International Coenzyme Q10 Association, Seville, Spain. November 8-11th, 2012. 7. Press Release Kaneka Corporation Japan: Effect of Ubiquinol (Reduced form of coenzyme Q10) on chronic fatigue syndrome. 2012; Press Release Kaneka Corporation Japan: Effect of Ubiquinol (Reduced form of coenzyme Q10) on chronic fatigue syndrome. 2013 8. Miyamae, T, et al. Increased oxidative stress and coenzyme Q10 deficiency in juvenile fibromyalgia: amelioration of hypercholesterolemia and fatigue by ubiquinol-10 supplementation. Redox Rep. 2013;18(1):12-9.

Another disease with somewhat similar symptoms to CFS is nutraceuticals now 29


Negative Studies Focusing on Omega-3 in 2013 Greg Weatherhead, Lead Applications Scientist, Croda Europe Ltd

The omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) have grown rapidly in popularity over recent times, which is largely due to the vast growing body of scientific evidence supporting their benefits for a range of different health outcomes. From the first studies conducted in the 1970s assessing the omega-3 rich diets of the Greenland Inuit to the large scale randomised controlled trials used to develop the blockbuster pharmaceuticals available today, the strength and depth of the literature supporting both dietary and supplemental intakes of EPA and DHA is virtually unrivalled in the nutraceutical market (see Figures 1 and 2). They even compare favourably to pharmaceuticals available on the market, with more clinical data supporting the use of EPA and DHA than commonly used drugs such as ibuprofen and simvastatin (see Figure 3).

secondary prevention of arrhythmia, as demonstrated in the GISSI-Prevenzione study1. However CVD is a complex and multi-faceted disease and we are only beginning to uncover the full role EPA and DHA have to play in this. One of the areas where the science is still inconclusive is for the prevention of atrial fibrillation (AF), a condition which causes a fast and erratic heartbeat. The complex relationship between EPA, DHA and AF was highlighted by two studies published this year, the first of which was a randomised, placebo controlled trial by Macchia et al supplementing over 500 participants with a previous history of AF with either 1g of omega-3 PUFA or placebo daily2. On the whole this was a well-designed study and the results seem to suggest that short term supplementation of EPA and DHA does not have any beneficial effects on AF, with no statistically significant differences observed between the control and the active groups. However we should not rule out a benefit of EPA and DHA in AF altogether as we do not know whether or not the supplementation period was too short to demonstrate a benefit and in fact a longer term trial may have proved to be beneficial. Additionally the study did not take into account background EPA and DHA intakes or EPA and DHA tissue levels, making it difficult to accurately assess the impact supplementation had on the participants. This study was shortly followed up by a meta-analysis by Mozzafarian et al also looking into the impact of omega-3 on AF, focusing on post-operative AF3. Yet again this analysis failed to demonstrate any significant benefits of EPA or DHA. The study was methodologically sound and seems to confirm the results from previous studies. However it is important not to make the same mistake as so many sectors of the media have made and conclude that as short term supplementation has not been demonstrated to be beneficial in this small area of cardiac health that it is not beneficial for cardiac health on the whole. There is still a wealth of data demonstrating their beneficial effects for altering a variety of CVD risk factors, including reducing the secondary incidence of arrhythmia, lowering triglyceride levels, lowering blood pressure levels and reducing total cholesterol levels among other things.

Prostate Cancer

Figure 1 Figures 1 and 2. New scientific papers and randomised controlled trials published on EPA and DHA between 1967 and 2012 (source: Pubmed, cited by GOED). The increased popularity means that there is also an increased media awareness surrounding new studies looking into the benefits of EPA and DHA, including both negative and positive press. Unfortunately certain segments of the media will create headlines based solely on the conclusions drawn from a study without any consideration for the methodology used. Often it is the case that the study in question has a number of methodological flaws which will not be highlighted. In particular 2013 produced a raft of studies seemingly contradicting the apparent benefits of EPA and DHA for good health, leading to a number of negative press articles. Sometimes these articles are well founded and based on studies utilising sound methodology which genuinely aid in furthering our current understanding of the topic. However in some instances this is not the case and the studies behind the headlines are poorly conducted while the conclusions do not accurately reflect the obtained results. This review looks in more detail at a selection of studies published during 2013 which have received negative attention from the media. 30

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Figure 2

Figure 3 Figure 3. Total number of human randomised controlled trials for a range of nutraceuticals and pharmaceuticals (source: Pubmed, cited by GOED)

Atrial Fibrillation

One of the most recognised benefits of omega-3 is for the prevention of cardiovascular disease (CVD), especially in the

Unfortunately not all of the studies behind the headlines are well-designed and reach objective conclusions as the previously discussed studies have done. The best example of this was the study by Brasky et al looking into the benefits of EPA and DHA in reducing the risk of prostate cancer, receiving significant media attention around the world4. The authors concluded that the “study confirms previous reports of increased prostate cancer risk among men with high blood concentrations of long-chain omega-3 PUFA. The consistency of these findings suggests that these fatty acids are involved in prostate tumorigenesis. Recommendations to increase long-chain omega-3 PUFA intake should consider its potential risks.” However the study was subject to a variety of methodological flaws and the conclusions the researchers drew from the study in no way reflected the actual results. A number of trade organisations and scientists produced documents debunking the results from this trial, pointing out its numerous failings. First and foremost the study was not designed to measure the risk of omega-3 blood levels on prostate cancer, but was instead designed to measure the effect of selenium and vitamin E on prostate cancer; no data on dietary intakes of oily fish or fish oil was collected from this study. Secondly this is a prospective cohort study which is unable to establish a cause and effect relationship and thus it cannot be concluded that fish oils are directly responsible for the increased cancer risk seen in this study. A closer inspection of the actual results produced from the study reveal that the differences between the DHA and EPA blood levels of cases in comparison to controls is minimal,

with only a ca. 0.2% difference in omega-3 levels which is expected within the normal variation. Lastly the omega-3 blood markers used in this study were plasma phospholipid fatty acids, which are highly susceptible to recent dietary patterns and do not accurately reflect long term intake. A more appropriate measure would have been red blood cell fatty acid concentrations. Considering all of these major flaws it is difficult to see how the authors came to such firm conclusions on the role of EPA and DHA in prostate cancer.

Blood Pressure

One of the worst examples in 2013 of studies using poor methodology and coming to unsubstantiated conclusions was a paper by Hoshi et al which aimed to assess the effects of different forms of EPA and DHA on their ability to lower blood pressure4. This study received considerable media attention, with a number of articles claiming that the most common form of concentrated fish oil, ethyl esters, were not effective at lowering blood pressure whereas the free fatty acid variant was. The authors in their conclusion even went as far as to say that “this finding has practical implications for the use of omega-3 fatty acids as nutraceuticals for the general public”. However the study was fundamentally flawed in the fact that the EPA and DHA was administered as a bolus directly into the arteries, hence skipping out the hydrolysis of the ethyl ester to free fatty acid that occurs in the digestive system. Ethyl esters would never normally occur within the circulation, so these results are only really applicable to clinical nutrition administered parentally and not nutraceuticals.

Conclusion

EPA and DHA are one of the most scientifically substantiated nutraceuticals available on the market and this science has been recognised by regulatory bodies around the world, permitting health claims in a number of different areas, including heart health, eye health and pregnancy. However omega-3 fatty acids are not a panacea and well-conducted trials allow us to understand both the possibilities and the limitations of where EPA and DHA supplementation can benefit our health. Nevertheless, studies that utilise unsuitable methodology and come to unsubstantiated conclusions only serve to increase both scientific and consumer confusion around the true benefits associated with these nutrients.

References

1. GISSI-Prevenzione Investigators. Dietary supplementation with n-3 fatty acids and Vitamin E after myocardial infarction: results of the GISSI-Prevenzione gruppo italiano per lo studio della sopravvienza nell’infarto miocardico. Lancet(1999);354(9177):447-55. 2. Macchia A Grancelli H Varini S et al on behalf of the GESICA Investigators (Epub ahead of print 2012 Dec 13). Omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: Results of the FORWARD (randomized trial to assess efficacy of PUFA for the maintenance of sinus rhythm in persistent atrial fibrillation) trial. J Am Coll Cardiol. doi: 10.1016/j.jacc.2012.11.021. 3. Mozaffarian D Wu JH de Oliveira Otto MC Sandesara CM, et al(2013). Fish Oil and Post-Operative Atrial Fibrillation - A Meta-Analysis of Randomized Controlled Trials. J Am Coll Cardiol doi: 10.1016/j.jacc.2013.02.045. 4. Brasky TM, Darke AK, Song X, et al. Plasma phospholipid fatty acids and prostate cancer risk in the SELECT trial. J atl Cancer Inst(2013);105(15):1132-41. 5. Hoshi T, Wissuwa B, Tian Y, et al. Omega 3 fatty acids lower blood pressure by directly activating large conductance Ca dependent K channels. Proc Natl Acad Sci USA(2013);110(12):4816-12. nutraceuticals now

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Vitamin K2, the “missing vitamin”

Consumer protection from misleading marketing

. . . now clinically-proven vital for bone and cardiovascular health

By Vladimir Badmaev MD, PhD, Head R&D NattoPharma ASA The history of vitamin K illustrates a never-ending discovery of the use of the seemingly known nutritional compound. The importance of vitamin K, especially menaquinone-7 (vitamin MK-7) as a multitasking vitamin has been illuminated in the last five years, despite the fact that vitamin K has more than an 80-year-old history since its discovery. Vitamin K denotes a fat-soluble vitamin that occurs in two biologically active forms, phylloquinone (vitamin K1) and menaquinone (vitamin K2). Vitamin K1 is produced by plants and algae, and vitamin K2 is predominantly of microbial origin and comprises a family of molecules distinguished from K1 by unsaturated side chains of isoprenoid units varying in length from 1 to 14 repeats (hence, menaquinone-4, menaquinone-7 etc. or MK-4, MK-7).

The commonly recognized function of vitamin K is as a cofactor for γ-glutamylcarboxylase, an endoplasmic enzyme involved in the posttranslational carboxylation (activation) of proteins with glutamic acid (Glu) residues into γ-carboxyglutamate (Gla). With the carboxylation of glutamic acid residues on the protein substrate, a negative chemical group is formed that attracts and binds positively charged calcium. Calcium is a central element in the physiological role played by the Gla proteins; on the other hand calcium cannot be properly utilized by the body without Gla proteins and vitamin K. Vitamin K2 in particular is responsible for carboxylation and activation of osteocalcin, which is essential for bone building cells, osteoblats. K2 helps in carboxylation and activation of another protein besides osteocalcin, matrix GLAprotein (MGP), for elasticity and prevention of calcification of blood vessels. Despite the strong epidemiological evidence showing that dietary intake of vitamin K2 may improve overall health status, it was not until the three-year ‘breakthrough’ study of MenaQ7® brand – a natural supplement of K2 as MK-7 – that showed a significant health benefits with supplemental vitamin K (Osteoporosis Int. 2013). The study was a double-blind randomized clinical trial evaluating the results of a three-year regular intake of natural MK-7 in a 180 mcg daily dose by a group of 244 healthy post-menopausal Dutch women, 55 to 65 years old. The outcome showed significant protection of the vertebrae and the hip (femoral neck) against osteoporosis and fractures due to osteoporosis and, for the first time, substantial benefits of nutritional vitamin K2, as compared to the placebo group, in preventing age-related stiffening of arteries manifested by a significant increase of the pulse wave velocity – a sign of aging and hardening of arterial walls (age-related calcification of arteries). Enter the paradox of calcium: supplemental calcium is crucial for the maintenance of strong bones and cardiovascular system. On the other hand, several recent epidemiological studies – including the results of a 2013 JAMA-published study – indicate that supplemental calcium and vitamin D (which increases absorption of calcium) may be detrimental to cardiovascular health, presumably by increasing arterial calcification. In view of the role of vitamin K as one of the most important biological compounds regulating calcium in the body, and the above cited three-year clinical study the new paradigm for supplemental calcium emerges, i.e. the guidelines for calcium supplements may have to be revised, and calcium and vitamin D supplements may need to be complemented with vitamin K2 due to vitamin K2’s increasingly recognized role as a calcium chaperone. 32

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This emerging trend in vitamin K (K2’s MK-7 variety in particular) supplemental use has been further supported by the most recent clinical study in patients with chronic renal disease, evaluated for the cardiovascular effects of oral administration of vitamin K2 (MenaQ7 brand) plus vitamin D or vitamin D alone (Kurnatowska & Nowicki et al. 2013; 50th ERA-EDTA Congress). In this six-month study the progression of coronary artery calcification index (CAC) and common carotid intima media thickness (CCA-IMT) – both markers of calcium deposits in arteries detected with computerized tomography -- showed a slower progression of the calcification in the vitamin K2/vitamin D group than detected in the vitamin D-alone group of patients. Historically, calcium and vitamin D supplementation are one of the most researched and sound nutritional combinations to strengthen the bone structure in infants, children, women, men and diverse racial or ethnic groups. Therefore, calcium and vitamin D supplements should not be avoided, but complemented with vitamin K2 supplementation; especially that recent epidemiological studies suggest that most healthy adults may be subclinically K2 insufficient – which results in K2-dependent proteins being biologically inactive in regulating calcium placement and utilization in the body. In a recently published clinical study (Food&Function, 2013) the response to vitamin K2 supplementation was evaluated in populations of healthy children and middle aged and aging adults by measuring the levels of active and inactive K dependent proteins, osteocalcin and MGP respectively. The eight week supplementation with vitamin K2 improved status of active osteocalcin and MGP with outcome more pronounced in individuals with the initial higher levels of inactive K-dependent proteins. The authors of the study concluded that both children as well as adults above 40 years old may benefit from MK-7 supplementation to improve K-dependent proteins responsible for bone and cardiovascular health. The current state of modern nutrition depletes sources of food-derived vitamin K2 and dietary supplementation of this vitamin is increasingly favored by the medical community. An effective supplemental vitamin K2 obtained in the fermentation process requires standardization for content, quality and stability. Through a significant innovation and multi-step purification process, the fermentation vitamin K2 up to 98,4% menaquinone-7, 100% trans- form, has been obtained in a crystal form (MenaQ7® Crystals). This natural MK-7 is backed by the above discussed three-year study demonstrating for the first time statistically significant improvements in bone and cardiovascular health status in a cohort of 244 healthy postmenopausal women.

Since December 2012, any health claims on food packaging or used in advertising have to be authorised by the European Food Safety Authority (EFSA), to protect consumers from misleading, marketing. These claims have to backed up by a large dossier of scientific evidence, but this has posed a problem to SMEs and other organisations without the resources or expertise to put together these evidence dossiers. Yet it is these SMEs who have been at the leading edge of nutraceutical innovation, raising concerns that the regulations are stifling new product development just at the time when healthier ingredients and diets are most needed. To address this problem, the BACCHUS consortium formed, bringing together SMEs with leading food and health research organisations. Funded by the European Commission BACCHUS will help develop tools and techniques specifically aimed at helping SMEs generate dossiers of evidence for new foods or ingredients with demonstrable benefits for cardiovascular health. Cardiovascular disease is responsible for almost half of all deaths in the EU, so there is a need for any new nutraceuticals that could help reduce this. This also presents a significant business opportunity for innovation, depending on the quality of the evidence. So what evidence is needed for health claims? A growing body of evidence is showing that diets rich in polyphenols benefit cardiovascular health. But that’s not enough for a health claim. Claims must refer to a specific food or food component. The dossier must address three general areas: is characterisation of the food or food component sufficient? Is the claimed effect beneficial to human health? And, is there a cause-effect relationship between consumption and the claimed effect? It is over the third of these where most polyphenol health claims have been rejected. Randomised, placebocontrolled studies in humans provide the best evidence, but these sorts of trials are hard and expensive to carry out. This is where BACCHUS will help. The expertise in the BACCHUS is helping to design experiments that align with EFSA’s requirements, for example in developing appropriate placebos and using relevant population groups. BACCHUS is also helping ensure potential nutraceutical foods are properly characterised. Foods aren’t like drugs, they consist of many different compounds with different potentially bioactivities. BACCHUS is ensuring the characterisation of polyphenols in these complex foods is sufficiently rigorous. Polyphenols are often modified as they are taken up by the body, if they are indeed absorbed at all. The members of the BACCHUS consortium have expertise in understanding this bioavailability – is the compound taken up in sufficient quantities and in a metabolised form to have a genuine effect in the body? Without knowing this,

there is little chance of getting a mechanistic understanding of potential health benefits. Identifying the bioavailable, bioactive form of a food ingredient is key to working out how these compounds interact with our bodies and bring about potential health benefits. A mechanism describing how an ingredient affects health in humans is essential for health claim approval. BACCHUS will identify these mechanisms for a number of bioactive peptides and polyphenols linking together, scientifically, the consumption of food ingredients with health benefits. BACCHUS is looking at a number of polyphenols that have already been identified as having possible beneficial benefits to cardiovascular health. The focus is on just a handful of these, in effect using them as case studies. Flavanols from apples are an example. Studies have shown already that apple flavanols are bioavailable. The BACCHUS project will look at whether they can reduce blood pressure, and whether they can be delivered in effective dosages. If so there is good potential for the development of apple flavanol based nutraceuticals. The longer term aim of BACCHUS is learn from case studies like this to develop best practice in evidence gathering for gold-standard health claims. This will be made available more widely through training sessions and advice targeted to the food industry. At the same time this will boost the scientific understanding of the links between food and human health, and give us all the best chance of seeing new products on supermarket shelves that benefit us all.

BACCHUS is a four-year FP7-KBBE-funded Collaborative (Research) Project, targeted at a special group, with 28 beneficiaries including 16 Small and Medium Enterprises (SME) from 11 countries, led by the Institute of Food Research (IFR, UK). To find out more please see: http://www.bacchus-fp7.eu/

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New bright and stable colored film-coating . . . based on coloring foodstuffs Nowadays it is more and more difficult to give a bright and deep coloration to food supplement tablets while complying with the European Union food regulation and meeting consumers’ expectations. The well-know aluminum lakes and azoic based pigments are confronted to huge restrictions in terms of dosage in the final forms. Recently, Regulation 232/2012/EU of 16 March 2012 (amending Annex II to Regulation 1333/2008/EC) has drastically reduced the maximum levels of use of E104 (Quinoline yellow), E110 (Sunset yellow) and E124 (Ponceau red) in dietary supplements and Regulation 380/2012/EU of 3 May 2012 (amending Annex II to Regulation 1333/2008/EC) has set a maximum limit for aluminum that greatly limits the possible use of aluminum lakes in dietary supplements. In the meantime, a large number of consumers is more and more concerned about the origin of food ingredients and additives and tends to search for more natural options.

To face this issue, SEPPIC has developed a new version of SEPIFILMTM: SEPIFILMTM NATurally COLored in which classical pigments have been replaced by “coloring foodstuffs”. SEPIFILMTM NATurally COLored is based on HPMC. The coloring foods are obtained from comestible algae and plants which are normally consumed as food within the EU and which don’t undergo selective physical and/or chemical extraction processes. Therefore, they are considered as food ingredients instead of additives. They have no E-number and consequently no specific labelling is required. Effective from January 1st, 2014 EU Guidance Notes have been published by the EU to clarify the distinction between color food additives and coloring foods. SEPIFILMTM NATurally COLored is an instant release film-coating in powder form. It is easy to handle as it does not create any lumps in the dispersion which is ready in 45 minutes mixing. Solid content in water is 15 % (w/w) and the applied weight gain ranges from 4 % to 5 % according to the aspect of the substrate to coat. Besides, viscosity in water is low resulting in very comfortable spraying. Film-coating parameters are classical parameters for aqueous coating. As many food supplement tablets are hygroscopic, SEPIFILMTM NATurally COLored can be a cosmetic layer on top of a functional film-coating layer such as SEPIFILMTM LP. The final aspect of tablets is bright (similar to aluminium lakes) and smooth and the film-coating is stable in time.

In line with its natural composition, SEPIFILMTM NATurally COLored does not contain titanium dioxide. Therefore, a higher weight gain is required to get opacity. The SEPIFILMTM NATurally COLored range is specifically designed for the food supplements market. It is produced under HACCP conditions. All components are authorized for food applications in Europe. For the US market, each reference is to be verified individually. For any other countries, SEPPIC’s team is available to help you to obtain the specific status.

SEPPIC: 35 years of film-coating

SEPPIC is an expert in the field of film-wrapping and coating for pharmaceutical and nutraceutical applications, and was the first manufacturer in the world to offer a film-coating solution that both protected against humidity and allowed immediate release, namely the SEPIFILM LP range. The SEPPIC film-coating solutions (SEPIFILM, SEPISPERSE and SEPICOAT) are ready-to-use granular or powder products. They have always responded to the needs of customers, and in particular regarding ease of use, safety and ease of cleaning. SEPPIC also develops tailor-made solutions for its clients, and offers a complete service, from product development to industrial production. Contact: nutrition.seppic@airliquide.com + 33 1 42 91 42 29 www.seppic.com 34 nutraceuticals now

nutraceuticals now

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The Original Krill Oil

neptunebiotech.com


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