FUNCTIONAL FOODS

FUNCTIONAL FOODS

A Seminar Report submitted in partial fulfillment of the requirements for Bachelor of Engineering (Biotechnology) in Semester VII

Submitted By

PANCHAL UMANG S.[05BT026]

Guided By

Prof. D.H.SUR

Department of Biotechnology V.V.P. Engineering College,Rajkot.

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V.V.P. ENGINEERING COLLEGE

RAJKOT

CERTIFICATE
This is to certify that Mr. PANCHAL UMANG S. Roll No. 05BT026 Branch Biotechnology Semester 7th has satisfactory completed the report on FUNCTINAL FOODS as part of syllabus in the subject SEMINAR within four walls of V.V.P. Engineering College, Rajkot.

DATE OF SUBMISSION:

STAFF IN CHARGE

HEAD OF DEPARTMENT
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ACKNOWLEDGEMENT
I would also like to thank my guide Prof. DHARMESH SUR H.O.D. Biotechnology Dept, V.V.P.Engineering College, Rajkot for guiding me on writing this project and helping me on certain issues.

I would like to thank my classmates for reviewing this report and for being an excellent critic throughout.

I would also thank Mr. SUMIT KUMAR TRIVEDI for kind support and help.

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INDEX
1. INTRODUCTION........6 1.1 DEFINITION 6 1.2 HISTORY6 1.3 TYPES OF FUNCTIONAL FOODS7 2. MAJOR INGREDIENTS9 2.1 ANTIOXIDANTS9 2.2 PHYTOCHEMICALS10 2.3 -3 FATTY ACIDS12 2.4 PROBIOTICS15 3. CASE STUDIES OF INGREDIENTS 18 3.1 CASE STUDY OF EFFICACY OF -3 FATTY ACIDS18 3.2 CASE STUDY OF EFFICACY OF SOY PROTEIN19 3.3 CASE STUDY OF EFFICCACY OF STANOL/STEROLS20 4. COMMERCIAL ASPECTS22 4.1 GLOBAL MARKET 22 4.2 INDIAN MARKET 23 4.3 FUNCTIONAL FOOD PRODUCTS24 4.4 CONSUMER ATTITUDE.25 5. OTHER ASPECTS.................................................................................27 5.1 HEALTH CLAIMS27 5.2 ETHICAL ISSUES 29 6. FUTURE 31 7. SUMMARY 32 REFERENCES 33

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LIST OF TABLES

1. DIFFERENT -3 FATTY ACIDS13 2. PROBIOTIC STRAINS..17 3. FUNCTIONAL FOOD PRODUCT24

LIST OF IMAGES
1.CHART OF GLOBAL MARKET23 2.AMUL PROBIOTIC ICE CREAM25

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CHAPTER 1 : INTRODUCTION
1.1 DEFINITION Plainly stated, functional foods are defined as foods that, in addition to supplying known nutrients, can provide other health benefits as well. Many common foods possess nutritional qualities that are not established as recommended nutrients, but are considered to have functional benefits such as reducing your risk of disease or promoting good health. A good example of a functional food would be the cranberry, known to promote healthy bacteria flora in the urinary tract which can lower the risk of urinary tract infections. Eggs contain the carotenoids lutein and zeaxanthin as well as choline which makes them a functional. A food is a functional food if it has clearly been documented that it has one or more properties beneficial to human health by improving the state of health or reducing health risks in addition to its nutritional value. Examples of functional foods include soy, oats, flaxseed, grape juice, broccoli and other cruciferous vegetables, phytosterol/stanol-enriched margarine, eggs enhanced with omega-3 fatty acids, foods fortified with herbal preparations, and psyllium. 1.2 HISTORY The concept of using foods to prevent disease and/or promote health is not new. In the early 1900s, the practice of fortifying table salt with iodine to prevent goiter was an early attempt at creating a functional food. Since that time, many foods that we are familiar with have become fortified, such as breakfast cereals, orange juice, milk and grain foods. Other foods that have lost some of their nutrient content due to processing are enriched with the lost nutrients. Classic examples of enriched foods are bread and bakery products. More recently, as technology has improved, scientists have come to recognize the advantages of a natural balance of wholesome foods. With the advancement of genetic engineering, crops can now be grown that optimize their beneficial nutritional qualities. Functional foods have been selected because of their qualities designed by nature to promote health and prevent disease beyond their basic nutrient content.

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The concept of functional food was developed in Japan in the mid 1980s. At that time, the Government of Japan decided that greater consumption of certain food types could help to limit or reduce the impact of a number of disease risk factors, and thereby assist in controlling the rising health costs associated with an ageing population. While a globally accepted definition has yet to be agreed, functional food is broadly regarded as generally consumed foodstuffs that may provide added health benefits following the addition/concentration of a beneficial ingredient, or the removal/substitution of an ineffective or harmful ingredient. Functional foods already available on the EU market include those with added cholesterol lowering plant sterols and stanols, as well as those containing live bacteria (probiotics) that allegedly enhance the quality of the human gut microflora.

1.3 TYPES OF FUNCTIONAL FOODS Thre are basically four types of functional foods as mention below: Fortified products (increasing the content of existing nutrients) Enriched products (adding new nutrients or components) Replacing existing components Enhanced commodities 1.3.1 FORTIFIED FOODS In such kind of functional foods , we increase the amount of the nutrients which are all ready existing in it. For example, increase in the concentration of iodine in the salt. 1.3.2 ENRICHED PRODUCTS In this particular type of functional foods , we add new nutrient component or

ingredients along with the existing nutrients. For example, addition of phytochemicals and antioxidants in conventional foods.

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1.3.3 REPLACED PRODUCTS In such type of functional food product , we add new component by replacing the other component which not so important or may be harmful. For example , replacement of saturated fatty acids by unsaturated fatty acids in foodstuffs.

1.3.4 ENHANCED COMMODITIES

In this type of functional food ,we add some other stuffs which are beneficial to health like bacteria such as probiotics.

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CHAPTER 2 : MAJOR INGREDIENTS

There are basically four types of ingredients are used as given below: Antioxidants Phytochemicals -3 fatty acids Probiotics

2.1 ANTIOXIDANTS: Antioxidants are present in foods as vitamins, minerals, carotenoids, and polyphenols, among others. Many antioxidants are often identified in food by their distinctive colorsthe deep red of cherries and of tomatoes; the orange of carrots; the yellow of corn, mangos, and saffron; and the blue-purple of blueberries, blackberries, and grapes. The most well-known components of food with antioxidant activities are vitamins A, C, and E; -carotene; the mineral selenium; and more recently, the compound lycopene A polyphenol antioxidents is a type of antioxidant containing a polyphenolic substructure. In human health these compounds, numbering over 4000 distinct species, are thought to be instrumental in combating oxidative stress, a syndrome causative of some neurodegenerative diseases and some cardiovascular diseases. Sources of polyphenol antioxidants The main source of polyphenol antioxidants is nutritional, since they are found in a wide array of phytonutrient-bearing foods. For example, most legumes; fruits such as apples, blackberries, blueberries, cantaloupe, cherries, cranberries, grapes, pears, plums, raspberries, and strawberries; and vegetables such as broccoli, cabbage, celery, onion and parsley are rich in polyphenol antioxidants. Red wine, chocolate, green tea, olive oil, bee pollen and many grains are alternative sources. The principal benefit of ingestion of antioxidants seems to stem from the
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consumption of a wide array of phytonutrients; correspondingly, the role of dietary supplements as a method of realizing these health benefits is the subject of considerable discussion. Health Effects The research continues to grow regarding the knowledge of antioxidants as healthful components of food. Oxidation, or the loss of an electron, can sometimes produce reactive substances known as free radicals that can cause oxidative stress or damage to the cells. Antioxidants, by their very nature, are capable of stabilizing free radicals before they can react and cause harm, in much the same way that a buffer stabilizes an acid to maintain a normal pH. Because oxidation is a naturally occurring process within the body, a balance with antioxidants must exist to maintain health. 2.2 PHYTOCHEMICALS: Phytochemicals are non-nutritive plant chemicals that have protective or disease preventive properties. There are more than thousand known phytochemicals. It is well-known that plant produce these chemicals to protect itself but recent research demonstrate that they can protect humans against diseases. Some of the well-known phytochemicals are lycopene in tomatoes, isoflavones in soy and flavanoids in fruits. They are not essential nutrients and are not required by the human body for sustaining life.

Health effects

There are many phytochemicals and each works differently. These are some possible actions: Antioxidant - Most phytochemicals have antioxidant activity and protect our cells against oxidative damage and reduce the risk of developing certain types of cancer.

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Phytochemicals with antioxidant activity: allyl sulfides (onions, leeks, garlic), carotenoids (fruits, carrots), flavonoids (fruits, vegetables), polyphenols (tea, grapes). Hormonal action - Isoflavones, found in soy, imitate human estrogens and help to reduce menopausal symptoms and osteoporosis. Stimulation of enzymes - Indoles, which are found in cabbages, stimulate enzymes that make the estrogen less effective and could reduce the risk for breast cancer. Other phytochemicals, which interfere with enzymes, are protease inhibitors (soy and beans), terpenes (citrus fruits and cherries). Interference with DNA replication - Saponins found in beans interfere with the replication of cell DNA, thereby preventing the multiplication of cancer cells. Capsaicin, found in hot peppers, protects DNA from carcinogens. Anti-bacterial effect - The phytochemical allicin from garlic has anti-bacterial properties. Physical action - Some phytochemicals bind physically to cell walls thereby preventing the adhesion of pathogens to human cell walls. Proanthocyanidins are responsible for the anti-adhesion properties of cranberry. Consumption of cranberries will reduce the risk of urinary tract infections and will improve dental health. Current research Recent studies have strongly indicated that certain daily-consumed dietary

phytochemicals could have cancer protective effects against transgenic mice cancer models and cancers mediated by carcinogens, irradiations and carcinogenic metabolites derived from exogenous or endogenous sources. The cancer-protective effects elicited by these dietary compounds are believed to be due at least in part to the induction of cellular defense systems including the detoxifying and antioxidant enzymes system, as well as the inhibition of anti-inflammatory and anti-cell growth signaling pathways culminating in cell cycle arrest and/or cell-death.

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2.3 -3 FATTY ACIDS : n3 fatty acids (popularly referred to as 3 fatty acids or omega-3 fatty acids) are a family of unsaturated fatty acids that have in common a carboncarbon double bond in the n3 position; that is, the third bond from the methyl end of the fatty acid. Important nutritionally essential n3 fatty acids are: -linolenic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). The human body cannot synthesize n3 fatty acids de novo, but it can form 20- and 22-carbon unsaturated n3 fatty acids from the eighteen-carbon n3 fatty acid, -linolenic acid. These conversions occur competitively with n6 fatty acids, which are essential closely related chemical analogues that are derived from linoleic acid. Both the n3 -linolenic acid and n6 linoleic acid are essential nutrients which must be obtained from food. Synthesis of the longer n3 fatty acids from linolenic acid within the body is competitively slowed by the n6 analogues. Thus accumulation of long-chain n3 fatty acids in tissues is more effective when they are obtained directly from food or when competing amounts of n6 analogs do not greatly exceed the amounts of n3. Chemical structure Chemical structure of alpha-linolenic acid (ALA), an essential n3 fatty acid, (18:39c,12c,15c, which means a chain of 18 carbons with 3 double bonds on carbons numbered 9, 12 and 15). Although chemists count from the carbonyl carbon (blue numbering), physiologists count from the n () carbon (red numbering). Note that from the n end (diagram right), the first double bond appears as the third carbon-carbon bond (line segment), hence the name "n3". This is explained by the fact that the n end is almost never changed during physiologic transformations in the human body, as it is more stable energetically, and other carbohydrates compounds can be synthetized from the other carbonyl end, for example in glycrids, or from double bonds in the middle of the chain. The term n3 (also called 3 or omega-3) signifies that the first double bond exists as the third carbon-carbon bond from the terminal methyl end (n) of the carbon chain.

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n3 fatty acids which are important in human nutrition are: -linolenic acid (18:3, n3; ALA), eicosapentaenoic acid (20:5, n3; EPA), and docosahexaenoic acid (22:6, n3; DHA). These three polyunsaturates have either 3, 5 or 6 double bonds in a carbon chain of 18, 20 or 22 carbon atoms, respectively. All double bonds are in the cis-configuration, i.e. the two hydrogen atoms are on the same side of the double bond.

List of 3 fatty acids This table lists several different names for the most common n3 fatty acids found in nature.

Common name

Lipid name

Chemical name

-Linolenic acid (ALA)

18:3 (n3)

all-cis-9,12,15-octadecatrienoic acid

Stearidonic acid (STD)

18:4 (n3)

all-cis-6,9,12,15-octadecatetraenoic acid

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Eicosatrienoic acid (ETE)

20:3 (n3)

all-cis-11,14,17-eicosatrienoic acid

Health benefits On September 8, 2004, the U.S. Food and Drug Administration gave "qualified health claim" status to eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) n3 fatty acids, stating that "supportive but not conclusive research shows that consumption of EPA and DHA [n3] fatty acids may reduce the risk of coronary heart disease."This updated and modified their health risk advice letter of 2001 (see below). People with certain circulatory problems, such as varicose veins, benefit from fish oil. Fish oil stimulates blood circulation, increases the breakdown of fibrin, a compound involved in clot and scar formation, and additionally has been shown to reduce blood pressure. There is strong scientific evidence that n3 fatty acids significantly reduce blood triglyceride levels and regular intake reduces the risk of secondary and primary heart attack. Some benefits have been reported in conditions such as rheumatoid arthritis and cardiac arrhythmias. Dietary sources Fish The most widely available source of EPA and DHA is cold water oily fish such as salmon, herring, mackerel, anchovies and sardines. Oils from these fish have a profile of around seven times as much n3 as n6. Other oily fish such as tuna also contain n3 in somewhat lesser amounts. Flax Flax seeds produce linseed oil, which has a very high n3 content ,six times richer than most fish oils in n3, Flax (aka linseed) (Linum usitatissimum) and its oil are perhaps the most

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widely available botanical source of n3. Flaxseed oil consists of approximately 55% ALA (alpha-linolenic acid). Flax, like chia, contains approximately three times as much n3 as n6.

2.4 PROBIOTICS: Probiotics are dietary supplements containing potentially beneficial bacteria or yeasts. According to the currently adopted definition by FAO/WHO, probiotics are: Live microorganisms which when administered in adequate amounts confer a health benefit on the host. Lactic acid bacteria (LAB) are the most common type of microbes used. LAB have been used in the food industry for many years, because they are able to convert sugars (including lactose) and other carbohydrates into lactic acid. This not only provides the characteristic sour taste of fermented dairy foods such as yogurt, but also by lowering the pH may create fewer opportunities for spoilage organisms to grow, hence creating possible health benefits on preventing gastrointestinal infections. Strains of the genera Lactobacillus and Bifidobacterium, are the most widely used probiotic bacteria.

Potential health benefits Managing Lactose Intolerance: As lactic acid bacteria actively convert lactose into lactic acid, ingestion of certain active strains may help lactose intolerant individuals tolerate more lactose than what they would have otherwise. In practice probiotics are not specifically targeted for this purpose, as most are relatively low in lactase activity as compared to the normal yogurt bacteria. Prevention of Colon Cancer: In laboratory investigations, some strains of LAB have demonstrated anti-mutagenic effects thought to be due to their ability to bind with heterocyclic amines; carcinogenic substances formed in cooked meat. Animal studies have demonstrated that some LAB can
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protect against colon cancer in rodents, though human data is limited and conflicting. Most human trials have found that the strains tested may exert anti-carcinogenic effects by decreasing the activity of an enzyme called -glucuronidase (which can generate carcinogens in the digestive system). Lower rates of colon cancer among higher consumers of fermented dairy products have been observed in some population studies. Cholesterol Lowering: Animal studies have demonstrated the efficacy of a range of LAB to be able to lower serum cholesterol levels, presumably by breaking down bile in the gut, thus inhibiting its reabsorption (which enters the blood as cholesterol). Some, but not all human trials have shown that dairy foods fermented with specific LAB can produce modest reductions in total and LDL cholesterol levels in those with normal levels to begin with, however trials in hyperlipidemic subjects are needed. Lowering Blood Pressure: Several small clinical trials have shown that consumption of milk fermented with various strains of LAB can result in modest reductions in blood pressure. It is thought that this is due to the ACE inhibitor-like peptides produced during fermentation. Improving Immune Function and Preventing Infections: LAB are thought to have several presumably beneficial effects on immune function. They may protect against pathogens by means of competitive inhibition (i.e., by competing for growth) and there is evidence to suggest that they may improve immune function by increasing the number of IgA-producing plasma cells, increasing or improving phagocytosis as well as increasing the proportion of T lymphocytes and Natural Killer cells. Clinical trials have demonstrated that probiotics may decrease the incidence of respiratory tract infections and dental caries in children. LAB foods and supplements have been shown to be effective in the treatment and prevention of acute diarrhea; decreasing the severity and duration of rotavirus infections in children as well as travelers diarrhea in adults.

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I have mention list of some bacterial strains, brand names, producers and their effects on human health on next page.

Strain

Brandname

Producer

Proven effect in humans

Bifidobacterium animalis DN 173 010

Activia

Danone

Stabilises intestinal passage

Bifidobacterium animalis subsp. lactis BB-12 Chr. Hansen

Immune stimulation, improves phagocytic activity, alleviates atopic eczema, prevents diarrhoea in children and traveller's diarrhoea

Bifidobacterium infantis 35624

Align

Procter & Gamble

Irritable Bowel Syndrome (IBS)

Bifidobacterium lactis HN019 (DR10)

Howaru Bifido

Danisco

Immune stimulation

Bifidobacterium longum BB536

Morinaga Milk Industry positive effects against allergies

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CHAPTER 3 : CASE STUDIES OF INGREDIENTS

Here I have given three case studies of efficacy of three ingredients. 3.1 CASE STUDY OF EFFICACY OF -3 FATTY ACIDS : The essentiality of omega-6 fatty acids was established in 1930. Although the physiological importance of the omega-3 fatty acids and their biochemical involvement in key pathways received scant attention until the 1990s, it is now well understood . Recently, research has focused on the role of omega-3 fatty acids in altering gene expression. A substantial body of literature demonstrates that the ingestion of omega-3 fatty acidstypically as the result of consuming fish or dietary supplementsprovides a variety of health benefits. Studies of omega-3 fatty acid supplementation during pregnancy support the important role of omega-3 fatty acids in fetal development and during early life . Numerous studies have documented the contribution of omega-3 fatty acid ingestion to improving cardiovascular health, apparently by reducing platelet aggregation, inhibiting inflammation in the intimal lining of blood vessels, and enhancing the HDL/ LDL ratio of circulating lipids. Other reports have suggested that omega-3 fatty acids reduce infectious diseases by enhancing the immune response (Anderson and Fritsche, 2002), improve mental function

(Edwards et al., 1998; Tanskanen et al., 2001), inhibit cancer (Simonsen et al., 1998; Terry et al., 2001), reduce arthritis pain (Cleland and James, 2000; Volker et al., 2000) and prevent cardiac arrhythmia (Nair et al., 1997).Multiple studies have demonstrated the necessary strength of association between consumption of omega-3 fatty acids and specific disease states, although the strength of the association varies by disease (Connor, 2000). The strength of association is determined largely by the consistency of results in available research reports. The known biochemical actions of omega-3 fatty acids provides a meaningful biological plausibility for their proposed health effects. The seminal work of Holman (1998) and Lands (2002) established that the two families of unsaturated fatty acids (i.e., omega-6 and omega-3 fatty acids) serve as substrates for enzymes that elongate and desaturate the commonly available precursors (e.g., linoleic acid [C18:2, omega-6] and alpha-linolenic acid [C18:3, omega-3]) to the longer chain and more highly unsaturated versions found predominantly in mammalian phospholipids. These longer chain analogs serve as precursors for formation of the eicosanoids, prostaglandins, and leukotrienes.
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Eicosanoids produced from omega-3 or omega-6 derivatives are similar in structure but often have opposing physiological effects. For example, eicosanoids derived from omega-6 fatty acids are inflammatory, whereas those derived from omega-3 fatty acids are either non-inflammatory or much less inflammatory (Shapiro et al., 1993). This understanding of the biological mechanisms provides coherence for evidence that suggests a wide array of physiological effects. Because omega-3 and omega-6 fatty acids serve as substrates for the same enzyme systems, it is not surprising that the two families of fatty acids compete for these enzymes. As a result, the dietary ratio of omega-6 fatty acids to omega-3 fatty acids influences which substrate and hence which eicosanoid will predominate. Compared to historical intake levels, the Western diet is relatively high in omega-6 fatty acids and low in omega-3 fatty acids. The omega-6:omega-3 fatty acid ratio of Paleolithic diets is estimated at 12:1 compared to 20-30:1 in the current Western diet (Simopoulos, 1999). This increased intake of omega-6 fatty acids has induced a relative deficiency of omega-3 fatty acids. In fact, it has been suggested that the ratio should be in the range of 1-4:1 for optimal health (Simopoulos, 2003).

3.2 CASE STUDY OF EFFICACY OF SOY PROTEIN:

Soy protein has been shown in numerous trials to reduce serum cholesterol in men and women with mild to moderate hypercholesterolemia. The active component(s) of soy protein foods have not been identified, despite extensive research. Prior to 1995, numerous human trials of very small group sizes had investigated the effects of various soy-based foods on serum cholesterol. Anderson and coworkers (1995) performed a meta-analysis on 38 studies and concluded that substituting soy protein (from isolated soy protein (ISP) or from textured vegetable protein) for animal protein significantly lowered total and LDL cholesterol and triglycerides, without affecting HDL cholesterol. Over the next few years, a number of larger, placebo-controlled, clinical trials verified these conclusions. In one study, mildly hypercholesterolemic men consumed up to 50 grams/day of soy protein, and a dose-response relationship was noted when comparing serum cholesterol reduction after 3 and 6 weeks of feeding (Teixeira et al., 2000). Although the exact mechanism is unknown, the primary bioactive components in soy are thought
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by many scientists to be the

isoflavones, which have mild estrogenic properties. Many

researchers have suggested that the isoflavones genistein, daidzein, and glycetein are responsible for lowering lipid levels. In a 9-week study of both men and women fed with 25 grams of ISP daily with varying amounts of isoflavones, Crouse et al. (1999) found that only ISP diets with higher amounts of isoflavones depressed serum cholesterol. However, removing isoflavones by alcohol washing the soy protein also removes other bioactives such as saponins that may affect lipid metabolism (Erdman, 2000), so the role of isoflavones is difficult to measure. The isoflavone-rich ethanol extract from soy has not been shown to significantly reduce serum cholesterol, although this fraction may have direct positive effects on the vascular system, such as improving systemic arterial compliance (Nestel et al., 1997). Therefore, some synergy among the components of intact soy protein appears to provide the maximum hypocholesterolemic properties (Erdman, 2000).

3.3 CASE STUDY OF EFFICACY OF STANOLS/STEROLS:

Phytosterols, widely distributed in the plant kingdom, significantly reduce serum LDL cholesterol and thus the risk of cardiovascular disease (Law, 2000). The efficacy of phytosterols has been demonstrated in scores of peerreviewed published studies (Jones and Raeini-Sarjaz, 2001; Ostlund, 2002). Structurally, phytosterols are closely related to cholesterol. The scientific plausibility for the benefits of phytosterols is well understood. Apparently, phytosterols compete with cholesterol for incorporation of sterols into micelles in the intestinal lumen, interfering with intestinal absorption of cholesterol, both dietary cholesterol and endogenous cholesterol secreted into the intestinal lumen (Jones et al., 2000; Normen et al., 2000; von Bergmann et al., 1999). Evidence also indicates that phytosterols influence the membrane proteins ABD-G5 and G8 (Berge et al., 2000; Chen, 2001; Hendriks et al., 1999). While the exact mechanism is not clear, the effect of phytosterols in reducing cholesterol absorption is well established (Miettinen et al., 2000; von Bergmann et al., 1999). This reduction in cholesterol influx then reduces cholesterol availability for incorporation into LDL particles (Blomquist et al., 1993; Hallikainen et al., 2000).

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The interference in cholesterol absorption has been demonstrated in animal studies and in human trials (Jones and Raeini- Sarjaz, 2001; Ostlund, 2002). Numerous well designed clinical studies have demonstrated the cholesterol lowering properties of sterols and their hydrogenated derivatives, the stanol family of compounds (Joneset al., 2000; Vanstone et al., 2002; Weststrate and Meijer, 1998). A recent study has established the parity of the two families of compounds (i.e., the stanols and the sterols) in lowering LDL cholesterol (Vanstone et al., 2002) as well as the equivalency of free unesterified stanols and sterols in reducing cholesterol. It is clear that sterols and stanols, free or esterified, are equivalent in lowering serum cholesterol levels and in interfereing with intestinal absorption of cholesterol (Normen et al., 2000).

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CHAPTER 4: COMMERCIAL ASPECTS

4.1 GLOBAL MARKET:

The International Functional Foods Market updates previous studies carried out in 2000 and 2004, and reports that sales of functional foods in the five major Western European markets, plus the USA, Australia and Japan, reached US$16.1 billion in 2005, of which Japan accounted for almost 36%. This uses a strict definition of products that make a specific health claim, whereas a broader definition results in a global market value of more than $36 billion. Using the strict definition, products marketed on a gut health platform represent the largest sector, with sales worth $6.8 billion in 2005. This represents over 42% of the overall market, compared with 36% for heart health products. Applying the broader definition, the share of the total market taking by the two categories falls to just over 40%. By product sector, dairy products account for almost 43% of the global market, ahead of other categories such as cereal products (19%), beverages (14%) and fats and oils (12%). Functional products are also apparent in the global confectionery industry, appearing in formats such as vitamin-enriched boiled sweets, breath-freshening mints and vapour-release chewing gum. Although it has reached maturity in many parts of the world, confectionery sales continue to grow, driven by rising demand from an increasingly affluent consumer base in developing countries such as Russia, China and India. In the developed world, much of the markets recent growth can be attributed to niche sectors, such as low-fat, low-sugar, organic and Fairtrade, as well as functional products.

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4.2 INDIAN MARKET:

The good growth in the Indian economy, coupled with a strong desire among the Indian consumers to maintain a healthy lifestyle and the growing awareness of functional ingredients such as herbs, minerals, vitamins, omega fatty acids and probiotics is driving the functional foods and beverages market, according to research and analyst firm Frost & Sullivan. Functional

foods are also likely to witness an expanding consumer base due to their specific health benefits, according to a report on 'Indian Functional Foods and Beverage markets'. The report also finds that the market earned revenues of over US$ 185 million in 2007 and estimates this to reach US$ 1,161 million in 2012.

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4.3 FUNCTINAL FOOD PRODUCTS: List of number of product launched by various countries across the globe.

JAPAN CHINA RUSSIA KOREA GERMANY FRANCE UK

4184 1555 1074 864 839 294 271

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PRODUCT LAUNCHED BY INDIA AMUL PROBIOTIC ICE CREAM

4.4 CONSUMER ATTITUDE :

Functional foods may play a role in managing risk of chronic diseases, such as the metabolic syndrome . However, for the potential of these foods to be maximised, they need to be consumed on a regular basis. Research to assess consumers views on functional foods, along with consumers attitudes to the use of new agro-food technologies and genetically modified foods, has been undertaken with consumers from six EU countries in association with the EU funded Lipgene project. Preliminary findings indicate that generally people are happy to purchase functional foods, such as foods with healthy fat. Many felt that if such foods could help tackle chronic health conditions, they could be a good option and this feeling was more prevalent amongst those who reported health conditions associated with the metabolic syndrome. However, consumers questioned had reservations about healthier foods that had been genetically modified (GM). More than one third of the Europeans in the six countries studied
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would not eat GM foods at all; indicating that there is still great concern about GM foods. The term metabolic syndrome describes a cluster of disorders (raised blood pressure, abdominal obesity, dyslipidaemia, insulin resistance and high blood glucose concentrations), which are associated with an increased risk of developing type 2 diabetes (2-3 fold) and cardiovascular disease (5-6 fold). It is estimated that between 10-35% of middle aged and elderly Europeans have metabolic syndrome. This figure is likely to rise as the prevalence of both obesity and type 2 diabetes increases across the continent, with a concurrent decrease in life expectancy. Only 31% of people who took part in the research were aware of the metabolic syndrome. Being a multi-factorial condition no single treatment for the metabolic syndrome exists as yet but we know that lifestyle changes, for example changes in diet and an increase in physical activity, form the underlying strategy for both prevention and treatment. There is a greater consumer awareness of the importance of physical activity in reducing the risk of chronic disease, than any other action. Consumers also commonly reported that eating more fruit and vegetables and cutting down on fatty foods were effective actions in reducing personal risk of becoming obese (~31% and ~30% respectively).

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CHAPTER 5 :
5.1 HEALTH CLAIMS:

OTHER ASPECTS

Functional foods are foods that claim to improve well being or health.1 The health claim may be implicit (rich in vitamin C), or vague (strengthens the bodys defence system), but invariably the product is presented with the suggestion of a benefit. Sales of such products are huge and growing. What ingredients do such foods containand who safeguards the truth of claims? Many functional foods contain added vitamins, minerals, and other essential nutrients. Some of these added nutrients indeed promote health: folic acid reduces the risk of neural tube defects, table salt with potassium reduces blood pressure, and polyunsaturated fatty acids reduce the risk of heart disease. But other claims are more dubiousfor example, that zinc lozenges protect against colds or that drinks rich in vitamin C protect against cardiovascular disease.Functional foods may also contain non-nutritive ingredients. Examples of effective non-nutritive ingredients are sugar alcohols in chewing gum, which reduce risk of dental caries; plant stanols and sterols, which lower low density lipoprotein cholesterol (although effects on heart disease remain to be shown); and probiotic bacteria, which may diminish rotavirus diarrhea in infants. But other effects of probiotics are insufficiently substantiated, as are effects of phytoestrogens against breast cancer,of oligosaccharides for gut health, of flavonoids against heart disease, and of conjugated linoleic acid for weight loss. Herbs such as Kava, St Johns wort, and echinacea can also be considered non-nutritive ingredients. They are sold as supplements and added to foods, but their efficacy is controversial and concern remains over potential harm.3 Functional foods are marketed directly to consumers, who are unable to assess the implied health claims. Consumers thus must rely on their governments to make sure that they are not misled. Unfortunately, current government regulations leave room for misleading claims. Deception is promoted by the fact that legislation of health claims for foods is layered: there are soft claims, which require soft evidence, and hard claims, which require harder evidence. For example, a draft regulation of the Codex Commission of the United Nations, which sets international food standards, recognises claims about nutrient content (rich in calcium) and disease reduction (prevents osteoporosis), as well as various intermediate categories. Manufacturers have

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therefore made the formulation of claims into a fine art, creating claims that imply health effects without actually naming a disease. Regulations differ between countries. Japan was the first country to recognise functional foods as a separate category when in 1991 it introduced the FOSHU (Foods for Specific Health Use) system to evaluate health claims. This system has valuable aspects: it regulates both safety and health, and it demands that the food be analysed for the amount of effective component.But it is voluntary, and even though the evidence required has been reduced in recent years and is minimal by pharmaceutical standards, most manufacturers opt for softer categories of claims, which require little evidence. An example is the unproved but lawful statement that extra vitamins help to maintain healthy skin and mucosa. Watering down of regulations has also occurred in the United States, which once had a solid system for disease reduction claims for foods, which were allowed only if there was significant scientific agreement that the claim was valid. However, the Food and Drug Administrations oversight over health claims has eroded, and the United States now allows qualified health claims for which there is hardly any evidence, as long as a disclaimer is included. In the European Union the safety of novel foods is thoroughly regulated but health claims are notEU legislation for nutrition claims is complex, fragmented, and poorly enforced. Paradoxically, current EU regulations prohibit claims that a food ingredient prevents a disease even when the claim is truefor example, that folic acid prevents neural tube defects. Finally, Canada, Australia, and New Zealand have introduced new systems to regulate health claims, but experience with these is still limited. The lack of proper regulatory oversight has led to some functional foods that are no more than quackery, while at the same time other functional foods do promote health and prevent disease. The potential for effective functional foods is certainly there. Foods and food components could prevent or ameliorate many diseases, but not enough research is being done to identify effective ingredients and substantiate their efficacy and safety. Whether such research will be done depends to a large extent on proper regulation. Major food companies are eager to expand into health promoting foods, but there is no incentive to underpin such health effects with solid research when products can be

successfully marketed on the basis of vague allusions alone. But there is hope. After more than 20 years of deliberations the European Commission recently agreed on new regulations that
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would prohibit vague claims and that would allow hard claims of disease reduction for foods if the evidence is solid.The commission even wants to grant companies seven years of exclusivity for truly novel claims backed up by solid data. If the European Parliament accepts these proposals it would be a step in the right direction.

5.2 ETHICAL ISSUES:

There is mainly two types ethical issues are concern as mention below:

Functional Food Effectiveness

The first concern about functional foods is practical, not philosophical. The fundamental practical problem with functional foods is that they do not work very well, and when they do work their health and nutritive affects are far less significant their advocates would have us believe. That is because the very reductivist premise of functional foods that food is the kind of thing that can be understood in terms of its component parts is mistaken. When food is understood in terms of parts rather than wholes it usually does not deliver its promised effect as well as conventional food. There is increasing evidence that food broken down into its component parts and then reassembling as processed food is less nutritious than conventional food. It has been shown that ingredients isolated in laboratories do not function in the same way they do in whole foods.The Center for Science in the Public Interest warns that too often manufacturer claims about functional ingredients are misleading and unsubstantiated by scientific evidence, and until governments establish adequate regulatory controls functional foods may merely amount to little more than 21 st Century quackery. Even the nutritionists and industry experts who contribute to Food Technology, the leading industry journal, caution that the single-nutrient approach is too simplistic. Food, it appears, is more than the sum of its chemical parts, therefore treating it as collections of ingle nutrients to be mixed and matched, rather than as the complex biological system it is, simply may not work.

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Functional foods as medicine

The regulatory oversight for these edible technologies is terrible: existing regulations do not provide clear guidance about much less enforceable laws on products ingredients, safety, and health claims. The most serious problem is the lack of regulation on medical foods. Although they are supposed to be used by patients under medical supervision, there is nothing stopping a food producer from calling any product a medical food and making it available to the public. Even when a medical food is used properly, there are no guarantees that the specific health claims made are supported by adequate scientific evidence. The FDA needs to change its current approach to the regulation of medical and functional foods to ensure safety and truthful labeling. It needs to clearly distinguish between medical and functional foods in unambiguous language, establishing standards and procedures for product composition, manufacturing practice and controls, and labeling requirements.

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CHAPTER 6: FUTURE
Extensive research is currently directed toward increasing our understanding of functional foods. Academic, government and private research institutes around the globe are devoting substantial efforts to identifying how functional foods and food ingredients might help prevent chronic disease or optimize health, thereby reducing healthcare costs and improving the quality of life for many consumers. An emerging discipline that will have a profound effect on future functional foods research and development efforts is nutrigenomics, which investigates the interaction between diet and development of diseases based on an individuals genetic profile. Interest in nutrigenomics was greatly augmented by the recent announcement that a rough draft of the complete sequence of the human genome had become available. In February 2001, the complete sequence of the human genome was announced by Ventor and colleagues. This technological breakthrough could eventually make it feasible to tailor a diet for an individuals specific genetic profile. Nutrigenomics will have a profound effect on future disease prevention efforts including the future of the functional foods industry. Another technology that will greatly influence the future of functional foods is biotechnology. Recent examples of biotechnology-derived crops which have tremendous potential to improve the health of millions worldwide include golden rice and iron-enriched rice. These grains are genetically engineered to provide enhanced levels of iron and -carotene which could, in turn, help prevent iron deficiency anemia and vitamin A deficiencyrelated blindness worldwide. In the future, other foods enhanced with other nutritive or nonnutritive substances may even help to prevent chronic diseases such as heart disease, osteoporosis or cancer. The acceptance of biotechnology by consumers (currently a major issue in Europe) will be important if the potential of this powerful methodology is to be realized.

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CHAPTER 7: SUMMARY
A functional food may be defined as a food having health promoting benefits and/or disease preventing properties over and above nutritional value. The term functional food was first used in Japan in the 1980 where it was approved by the Government and designated as foods for specified health use(FOSHU).Functional food is prepared by adding selected ingredients into some traditional foods to make it a functional food. For example, addition of n-3-poly unsaturated fatty acid which help in lowering the risk of heart attack and also by lowering the risk of some malignancy and by enhancing modulating immune system. Probiotics are diatery supplements containing potentially beneficial bacteria, yeast and fungi. Lactic acid bacteria(LAB) are widely used in this category. The functional food market is growing at a rate of 15-20% per year and the actual industry is claimed to be worth 33 billion $ US. There is tremendous growth in market value of functional foods and drinks in UK. Increase in sales is of 523% during 1998 to 2003. Indias launch of probiotic ice cream by AMUL. Nutrigenomics (the study of food and how it influences health through interactions with an individuals genetic make up) is a relatively new area of research but it is likely to be of significant importants in the future. The development of nutrigenomics might make it possible to present or treat disease by individualised diets in the absence of traditional medicines. This may provide the evidence based for the substantiation of health claims.

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Arendash G.W., Jensen M.T., Salem Jr. N., Hussein N., Cracchiolo J., Dickson A., Leighty R., Potter H. 2007. A diet high in omega-3 fatty acids does not improve or protect cognitive performance in Alzheimers transgenic mice. Neuroscience 149 (2): 286302

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Dimitrios B. 2006. Sources of natural phenolic antioxidants. Trends in Food Science & Technology 17(9):505-512;

Geelen A., Schouten J.M., Kamphuis C., Stam B.E., Burema J.,Renkema J. M. S, Bakker E-J, van't Veer P., Kampman E. 2007. Fish Consumption, n-3 Fatty Acids, and Colorectal Cancer: A Meta-Analysis of Prospective Cohort Studies. American Journal of Epidemiology. 166(10):1116-1125 ;

Institute of Food Technologists, Expert report, 2005: ``Functional Foods:Opportunities and Challenges''; (Available on line http://members.ift.org/IFT/Research/IFTExpertReports/functionalfoods_report.htm).

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