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Development of Nutraceuticals & functional foods

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“Nutraceuticals” & “Health food” shops has grown enormously, fostered by wide media coverage of their benefits. There has been a boom in their sales as patients rush to self-medicate, either in the hope that these products will be effective in treating diseases unsatisfactorily treated with pharmaceuticals, or that the adverse effects of some pharmaceuticals may be avoided.

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Development of Nutraceuticals & functional foods

  1. 1. Contents 1. Introduction 2. Relationship between Nutraceuticals and other health products 3. Nutraceuticals  Major Nutraceuticals: manufacture, source and use  Demographic trends for use of Nutraceutical supplements 4. Functional Foods  FF development  Probiotics  Prebiotics  Functional drinks  Functional cereals  Bakery products  Functional Eggs  Spreads  Consumer acceptance of FF 5. Conclusion
  2. 2. Introduction  Over the last 20 years the number of “Nutraceuticals” available for self-medication in pharmacies or for sale in supermarkets and “Health food” shops has grown enormously, fostered by wide media coverage of their benefits.  There has been a boom in their sales as patients rush to self-medicate, either in the hope that these products will be effective in treating diseases unsatisfactorily treated with pharmaceuticals, or that the adverse effects of some pharmaceuticals may be avoided.
  3. 3. Nutraceuticals  Dr Stephen De Felice, coined the term ‘Nutraceutical’ and defined it as a ‘food, or parts of a food, that provide medical or health benefits, including the prevention and treatment of disease’.  Another definition from the USA is ‘diet supplement that delivers a concentrated form of a presumed bioactive agent from a food, presented in a non-food matrix, and used to enhance health in dosages that exceed those that could be obtained from normal food’.
  4. 4. Relationship between Nutraceuticals and other health products
  5. 5.  Pharmaceuticals are usually classed as medicines by law, but some are freely available without legal constraints and some are legally classed as medicines. For example, in certain countries melatonin is classed as a medicine and is not freely available.  Herbal remedies may be classed as medicines because of their perceived risks with self-medication.  Functional foods are closely related to nutraceuticals as they often contain nutraceuticals in a food-based formulation, such as carotenoids, but others are novel biotechnological entities derived from foods, for instance, pre- and probiotics. A new term for these has recently been coined – ‘Phoods’ – which presumably aims to blur the distinction between pharmaceuticals and foods in the minds of consumers.  Vitamins can also be classed as medicines, but may be freely available. The distinction between certain vitamins and nutraceuticals is blurred (e.g. β-carotene, which is a vitamin A
  6. 6. Why consumers choose alternative over conventional remedies? o Many patients are not satisfied with the treatment they are given by their doctors due to adverse effects or because it has been ineffective. o Another reason for choosing alternative over conventional remedies is that patients may feel that conventional medicine is impersonal or technologically orientated. o Some patients prefer to have personal control over their healthcare and therefore are happier to self-select than be told what to take by their doctor.
  7. 7. NUTRACEUTICAL FORMULATIONS AVAILABLE • Manufacturers are increasingly marketing novel formulations. • Tablets, capsules and softgels are still the most widely available formulations, but new formulations such as soft chews, and fast dissolving tablets and strips are becoming available. • As with pharmaceuticals, nutraceutical manufacturers are extolling the virtues of controlled release formulations for release of precise levels of active entities over a particular time period, in order to achieve maximum therapeutic effects. An example of the use of this technology is the Novasoy soya isoflavone range.
  8. 8. S.N NUTRACEUTICAL SOURCE Therapeutic area Formulation Available 1 Glucosamine Bovine trachea, shellfish Joint, skin and animal health Tablet, capsule, patch, gel, effervescent tablet, sustained release tablet. 2 Chondroitin Bovine trachea/cartilage Joint and veterinary health Tablet, nasal drops 3 Methylsulfonyl-methane Meat, milk, capers, etc. Joint and veterinary health Tablet, capsule, cream, powder 4 Coenzyme Q10 Common foods Cardiovascular health, cancer prevention, respiratory, skin and animal health (antioxidant) Tablet, capsule, chewtab, drops, gel, gum, softgel 5 Melatonin Bovine pineal glands Cardiovascular health, cancer prevention, sport enhancement, sleep improvement & bone health (antioxidant) Tablet, patch, liquid 6 Carnitine Heart, skeletal muscle Sport enhancement, cardiovascular and bone health, weight optimisation, veterinary health Tablet 7 Acetyl-L-carnitine Brain, liver, kidney Mental health, sport enhancement, weight management Capsule 8 Octacosanol/ policosanol Sugarcane waste, wheatgerm, rice bran Cardiovascular health, sport enhancement Tablet, capsule MAJOR NUTRACEUTICALS
  9. 9. S.N NUTRACEUTICAL SOURCE Therapeutic area Formulation Available 9 S-Adenosyl methionine Meat, yeast, vegetable26 Joint and mental health Tablet 10 Docosahexaenoic acid/eicosapentaenoic acid (DHA/EPA) Fish, algae, plankton,29 seal blubber30 Joint, cardiovascular, eye and mental health, cancer prevention, bone, respiratory, skin and veterinary health Oil, soft capsule 11 ɣ-Linolenic acid Oenothera biennis, Borago officinalis Skin health, joint health Oil, soft capsule 12 α-Linolenic acid Linum usitatissimum Cancer prevention, respiratory health (antioxidant) Soft capsule 13 Conjugated linoleic acid Beef, dairy products37 Weight management, sport enhancement Soft capsule 14 Flax lignans Linum usitatissimum Cardiovascular health, cancer prevention, women’s health (antioxidant and weakly oestrogenic) Soft capsule 15 Pycnogenol Pinus pinaster Cardiovascular, eye, respiratory, and oral health (antioxidant) Capsule 16 Resveratrol Red wine, Polygonum capsidatum root, Veratrum sp., Vaccinium macrocarpon Cardiovascular health, cancer prevention, women’s health (antioxidant & weakly oestrogenic) Tablet, capsule
  10. 10. S.N NUTRACEUTICAL SOURCE Therapeutic area Formulation Available 17. Grape seed proanthocyanidin extract (GSPE) Vitis vinifera Cardiovascular and skin health (antioxidant) Tablet, capsule, patch, gel, effervescent tablet, sustained release tablet 18 Lycopene Foods, including tomato, green algae Cardiovascular and respiratory health, cancer prevention (antioxidant) Tablet, capsule, oral gel 19 Lutein Tomato, butternut squash Cardiovascular, eye and skin health (antioxidant) Capsule 20 Zeaxanthin Butternut squash Eye health (antioxidant) Capsule 21 Astaxanthin Fish, shellfish Eye and veterinary health (antioxidant) Tablet, capsule, liquid 22 Lipoic acid Meat, liver Cardiovascular and mental health, veterinary health Tablet 23 Dehydroepiandrosterone Wild yams Cardiovascular and mental health, veterinary health Tablet 24 Soy isoflavones Soy and fermented soy products Cardiovascular, mental, bone, women’s and skin health, cancer prevention (antioxidant and oestrogenic) Tablet, powder 25 Green tea extracts Camelia sinensis Cardiovascular, bone, skin and oral health, cancer prevention and weight management (antioxidant) Tablet, capsule, powder, tea 26 Creatine Skeletal muscle Mental health, sport enhancement Tablet, capsule, effervescent tablet, liquid
  11. 11. Predicted growth rate of nutraceutical usage Permission to use this data from Dr C Gaertner, Cognis, is gratefully acknowledged.
  12. 12. USE OF NUTRACEUTICALS FOR TREATING SPECIFIC DISEASES s.no. Medical condition Incidence of use (%) Nutraceuticals used 1 Prostate cancer 5.3 Lycopene, dehydroepiandrosterone 2 Enlarged prostate 16.9 Lycopene 3 Osteoarthritis 29.7 Glucosamine, chondroitin, methylsulfonylmethane 4 Neck, back, or joint pain 25.3 Glucosamine, chondroitin, methylsulfonylmethane 5 Degenerative eye conditions 9.9 Lutein 6 Memory loss 8.9 Fish oil, coenzyme Q10 7 Insomnia 20.0 Melatonin 8 Perimenopause 4.6 Soy products Data extracted from Gunther S, Patterson R E, Kristal A R, Stratton K L, White E. Demographic and health-related correlates of herbal and specialty supplement use, Journal of the American Dietetic Association 2004; 104: 27–34, with permission from the American Dietetic Association.
  13. 13. Manufacture and Analysis of major Nutraceuticals  Most nutraceuticals are natural products, being derived roughly equally from plants & animals. Some are endogenous human metabolites, while others are common dietary constituents that appear in human metabolism, for example lycopene. A number of entities exist in higher plants, and are commercially extracted from them, although some are present in insufficient levels for commercial exploitation, such as methylsulfonylmethane (MSM) and dehydroepiandrosterone (DHEA), and consequently are produced commercially by chemical synthesis.  Similarly, those of animal origin may be produced by chemical synthesis, (e.g.carnitine, creatine and the carotenoids,) but may also be produced by fermentation, e.g coenzyme Q10 (Co Q10) and S-adenosyl methionine (SAMe).  The n-3 fatty acids such as DHA)/EPA and ALA are usually available as complex mixtures, containing supradietary levels of the active constituents, and often partial purification from the other fatty acids is not carried out..
  14. 14.  In certain cases nutraceuticals exist in a number of isomeric forms, which may have varied activities or even be toxic; e.g carnitine, in which the D-form is toxic and thus chiral synthesis of the L-form is carried out.  A number of nutraceuticals have GRAS (Generally Recognized As Safe) status as defined by the US Food and Drug Administration (FDA), and increasingly manufacturers are gaining GRAS certification for products not normally ingested (in realistic levels) by consumption of foodstuffs, such as MSM and octacosanol/policosanol.  As with pharmaceuticals, the analytical procedures used for identification and quantification of nutraceuticals are becoming increasingly sophisticated, reflecting the analytical advances, and the desire by manufacturers to produce detailed information about levels of active constituents in the natural materials, formulated products & also in biological fluids in an attempt to determine the fate of ingested entities.
  15. 15. Use of Nutraceutical supplements: demographic trends • 57% of 979 adults agreed that they would like to use supplements more often, but were unsure of what to buy. This indicated a need for more information to be available. (Mintel Market Research in November 1998) • prime target users of supplements - middle-aged females with an above average income & above average education. There were also occasional users who used supplements at a time of illness or stress, rather like a medicine. These users were more varied in age and income and were less likely to take supplements on a long-term basis.(Mintel Market Research in March 1999 ) • Consumers use nutraceutical supplements for many varied reasons e.g., – supplementation of a poor diet, – to improve overall health, – to delay the onset of age-related diseases, – after illness, – for stress, – recommended by a health professional, – in pregnancy and slimming, – to improve sports performance and to treat symptoms (colds, coughs, arthritis, etc.).
  16. 16.  One survey from 1988 to 1990, of a cohort of 2152 middle to older age adults living in Wisconsin found that the use of nutraceutical supplements was more prevalent among women, people with more than 12 years of education, those with relatively low body mass index, people with active lifestyles, and people who had never smoked rather than current smokers.  Surveys concerning the use of specific nutraceuticals: notably creatine, cod liver oil and evening primrose oil. Creatine use amongst members of health clubs was found to be more likely in men using resistance training, and was associated with the consumption of dehydroepiandrosterone (DHEA) and other supplements used to increase strength.  The primary source of information guiding their use was found to be popular magazines, as opposed to qualified
  17. 17.  In most countries there is no legislative definition of the term and drawing a border line between conventional and functional foods is challenging even for nutrition and food experts.  A ‘functional food’ is a natural or formulated food that has enhanced physiological performance or prevents or treats a particular disease. This term was first used in Japan, and by 1998 it was the only country to legally define ‘Foods for specified health use’ (FOSHU).  Functional food is a ‘food that has a component incorporated into it to give it a specific medical or physiological benefit, other than purely nutritional benefit’. [Department for Environment, Food and Rural Affairs (Defra), UK] Functional Foods
  18. 18. Functional food development
  19. 19. 1. Concept testing: The process through which innovation in nutritional science occurs develops through intersecting alliances of various stakeholders as depicted in Fig. 1. Involved are research, industry, regulatory and consumer sector interests. 2. Product development: develop a real-world test product that embraces that concept. For instance, production of a probiotic enriched yogurt, a cheese enriched with omega 3 fats. 3. Efficacy/safety and evidence: Expression of a nutrition health concept through development of a product needs to be followed by verification that the product will mirror the original concept through the testing of biological efficacy. Efficacy assessment is an essential element of establishing the credibility of functional food entities , performed using in vitro or in vivo systems. Evidence also needs to be provided by parallel studies conducted across several jurisdictions and conducted in both academic and private sector institutional laboratories. 4. Publication: for dissemination of biological efficacy data is through publications in peer-reviewed journals. It is equally important that negative, as well as positive, efficacy and safety results be disseminated through peer-reviewed publication in order to provide a balanced evaluation of the true merits of that ingredient.
  20. 20. 5.Health claims and regulatory review: involves communication of the health messages generated through active research and regulatory review of a specific food product to the general public. Regulatory review is required in order to translate peer-reviewed published data supporting the efficacy and safety of a given bioactive product within a novel food matrix or capsule into policy changes consistent with approving products for sale of functional food products.  In the UK, the Joint Health Claims Initiative (JHCI) provides guidance on claims that are allowed for functional foods, such as fortified breakfast cereals and ‘bio’-yoghurts. In some cases although medical claims such as ‘helps prevent heart disease’ are not allowed, health promoting claims, such as ‘helps lower cholesterol’ can be made, if scientific evidence exists.  Companies marketing nutraceuticals cannot advertise specific medical claims for their products without a medicine licence. When launching a new product they have the option of either not doing any research at all or researching it thoroughly and possibly obtaining a patent.
  21. 21.  Unfortunately many companies tend towards the former route because of the expense, To bring a medicine to market can take about ten years and cost US$0.8–1.7 billion,9 but to market an unlicensed nutraceutical can take a fraction of this time and money. 6.Industry growth Securing specific messages on foods attesting to their health benefits represents a vital part of the cycle of moving a functional food from concept to a marketing success story. Given that consumers are both interested and informed about foods that confer health benefits beyond simply providing nutrients (Heller, 2006) the presence of an informative, authoritative claim on a food will stimulate the market share penetration of that product within its sector.
  22. 22. Functional food products  Most early developments of functional foods were those of fortified with vitamins and/or minerals such as vitamin C, vitamin E, folic acid, zinc, iron, and calcium.  Subsequently, the focus shifted to foods fortified with various micronutrients such as omega-3 fatty acid, phytosterol, and soluble fiber to promote good health or to prevent diseases such as cancers.  More recently, food companies have taken further steps to develop food products that offer multiple health benefits in a single food.  Functional food products are not homogeneously scattered over all segments of the food and drink market and consumer health concerns and product preferences may vary between markets. These products have been mainly launched in the dairy-, confectionery-, soft-drinks-, bakery- and baby-food market (Kotilainen et al., 2006; Menrad, 2003).
  23. 23. Probiotics  Probiotics are defined as ‘‘live microorganisms, as they are consumed in adequate numbers confer a health benefit on the host’’.  Lactic acid bacteria (LAB) and bifidobacteria, the most studied and widely employed bacteria within the probiotic field.  Dairy products are the key product sector. The sensitivity of probiotics to physical and chemical stress, heat and acidity makes the product development challenging for other type of food product. Recently encapsulation was assessed as possible technology for decreasing sensitivity of such probiotics (Clair, 2007; Mattila-Sandholm et al, 2002).  Extensive R&D activity resulted in a number of special new dairy products (e.g. Synbiofir drinking kefir, Synbioghurt drinking yoghurt, HunCult fermented drink, Milli Premium sour cream, Aktivit quark dessert, New Party butter cream, Probios cheese cream) (Szaka´ ly, 2007).  Fruit juice has also been suggested as a novel, appropriate medium for fortification with probiotic cultures because it is already positioned as a healthy food product, and it is consumed frequently and loyally by a large % of the consumer population (Tuorila & Cardello, 2002).
  24. 24.  Prebiotics are non-digestible food ingredients that beneficially affect the host by stimulating the growth and/or activity of one or a limited number of bacteria in the colon, thus improving host health. (Charalampopoulos et al., 2003; Stanton et al., 2005)  Fructo-oligosaccharide (FOS), inulin, isomalto-oligosaccharides (IMO), polydextrose, lactulose and resistant starch are considered as the main prebiotic components.  Primarily oligosaccharides, such as soy oligosaccharides (SOS), galacto-oligosaccharides (GOS) and xylo-oligosaccharides (XOS) are also marketed in Japan (Ouwehand, 2007).  Oligosaccharides play important role in obesity control through resulting increased satiety and reduced hunger (Bosscher, 2007; Bosscher, Van Loo, & Franck, 2006; Cani, Neyrinck, Maton, & Delzenne, 2005).  Inulin and oligofructose besides being prebiotics, have shown to increase calcium absorption, thus improve both bone mineral content and bone mineral density (BMD) (Bosscher et al, 2006). Furthermore, they influence the formation of blood glucose, and reduce the levels of cholesterol and serum lipids (Lo´ pez-Molina et al., 2005).  SYNBIOTICS: foods containing a combination of probiotics and prebiotics .
  25. 25.  Consists of non-alcoholic beverages fortified with vitamins A, C and E or other functional ingredients.  Although, there is a relatively high number of a product available in this segment, the market is still small and fragmented.  Other types of functional drinks are those of cholesterol lowering drinks (with combination of omega-3 and soy), ‘‘eye health’’ drinks (with lutein) or ‘‘bone health’’ drinks (with calcium and inulin) (Keller, 2006).  In Estonia, for example fortified juices are produced under the trade name of Largo containing inulin, L-carnitine, vitamins, Ca and Mg as functional ingredients.
  26. 26.  Cereals, in particular oat and barley.  The multiple beneficial effects of cereals can be exploited in different ways leading to the design of novel cereal foods or cereal ingredients that can target specific populations.  Cereals can be used as  fermentable substrates for the growth of probiotic microorganisms  as sources of non-digestible carbohydrates that besides promoting several beneficial physiological effects can act as prebiotics.  cereal constituents, such as starch, can be used as encapsulation materials for probiotics in order to improve their stability during storage and enhance their viability during their passage through the adverse conditions of the gastrointestinal tract (Brennan & Cleary, 2005; Charalampopoulos et al., 2002).  functional cereal components e.g., beta-glucan, are also applied in the dairy and bakery industries for the manufacture of low-fat ice creams and yogurts. It makes their mouthfeel, scoopability and sensory properties resemble those of full-fat products (Brennan & Cleary, 2005).
  27. 27.  In relation to Functional foods bakery is still relatively underdeveloped. Bakery products however provide ideal matrix by which functionality can be delivered to the consumer in an acceptable food.  It is important to realize that achieving functional food quality does not simply involve delivering the active principle at the appropriate level for physiological effectiveness, but also supplying a product which meets the consumer’s requirements in terms of appearance, taste and texture (Alldrick, 2007).  In late 2003, Unilever innovated the bakery sector by introducing a white bread called Blue Band Goede Start, which was the first white bread containing the nutritional elements normally available in brown bread including fibers, vitamins B1, B3 and B6; iron; zinc; inulin, a starch that comes from wheat (Benkouider, 2005a).
  28. 28.  It can be assumed that cholesterol-lowering spreads will gain increasing relevance in the coming years due to the market introduction of e.g. a functional variety of Becel1 margarine of Unilever (named ‘‘Becel pro-activ’’), containing phytostanol esters which are supposed to lower the cholesterol level.  Low-cholesterol butter under the trade name of BaladeTM has been produced and marketed in Belgium since 1992. In this case more than 90% of the cholesterol in milk fat has been removed by the addition of crystalline betacyclodextrin to the molten butter.  Other low-cholesterol milk products, like cheese, cream, or even low-cholesterol egg, are produced by this technology .
  29. 29. Functional eggs  Eggs are of particular interest from a functionality point of view, because they are relatively rich in fatty acids and the associated fat-soluble compounds.  The idea of egg enrichment with omega-3 FAs simultaneously with antioxidants & other vitamins has recently been used to produce VITA eggs by Freshlay Foods (Devon, UK). They state that their eggs were enriched with omega-3 fatty acids, Se, vitamins D, E, B12 and folic acid.  Eggs enriched in omega-3 and vitamin E produced by Belovo under the trade name of Columbus first appeared in Belgium in 1997, and since then they have been sold in the UK (from 1998), The Netherlands (from 1999), India, Japan and South Africa (from 2000). Currently, production of Columbus egg exceeds 50 millions/year in Europe.  Similar eggs are produced by Pilgrim’s Pride Company, Gold Circle Farms and OmegaTech in the USA (Surai & Sparks, 2001).
  30. 30. CONSUMER ACCEPTANCE OF FUNCTIONAL FOODS  socio-demographic characteristics, cognitive and attitudinal factors emerged as potential determinants  studies showed that consumer acceptance of functional foods is far from being unconditional, with one of the main conditions for acceptance pertaining to taste, besides trustworthiness of health claims. Although increasing the functionality of the food should not necessarily change its sensory quality (Urala & La¨hteenma¨ ki, 2004), bitter, acrid, astringent or salty off-flavours often inherently result from enhancing food functionality with bioactive compounds or plant-based phytonutrients.  most of these studies identified typical functional food consumer as being female, well educated, higher income class and older than 55.  Given the fact that prevention is a major motivation of use of functional food (Verbeke, 2006; Wrick, 1995), it can logically be hypothesized that experience with illnesses increases probabilities of functional food acceptance  Relatively high price can be regarded as one reason for the limited market success of several functional food products.
  31. 31. Conclusion • Nutraceuticals & functional foods generate one of the most promising and dynamically developing segments of food industry. • Increasing consumer awareness in combination with new advances in various scientific domains is supporting the inflow of functional product. • In the case of a successful product development attention should be paid both to consumer demands and technical conditions, furthermore, the legislation background should not be neglected. Consumer acceptance is key success factor. • Consumer Acceptance, is determined by factors like primary health concerns, consumers’ familiarity with the ‘‘functional food’’ concepts and with the functional ingredients, the nature of the carrier product, the manner of health effect communication, etc. • Main conditions for acceptance of functional foods is pertaining to taste, besides, product quality, price, convenience and trustworthiness of health claims. • By purchasing functional foods in general consumers may achieve a modern and positive impression of themselves. These products provide consumers a modern way to follow a healthy lifestyle, which differs from the conventionally healthy diet defined by nutrition experts.

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