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Recently, "nutraceuticals" and functional foods have drawn a lot of attention due to their claimed safety and potential therapeutic and nutritional benefits. Dr. Stephen DeFelice, the chairman of the Foundation for Innovation in Medicine, combined the words "nutrition" and "pharmaceutical" to create the phrase "nutraceutical" in 1989. The word "nutraceutical" was created for marketing purposes and refers to dietary supplements sold with the goal of curing or preventing disease. Therefore, a "nutraceutical" is any substance that might be categorised as food or a component of food that has medical or health advantages, including the prevention and treatment of diseases. These goods could include everything from isolated nutrients, dietary supplements, and diets to GM or "designer" foods, herbal remedies, and processed foods . Currently, there are around 500 nutraceutical and functional food items with proven health benefits available in the market . When compared to other medicinal agents, the usage of nutraceuticals has proven to be a very profitable method of achieving desired therapeutic goals with fewer adverse effects. The pharmaceutical and biotechnology industries are aware of the preference for the development and manufacture of nutraceuticals over medications.

The nutraceutical business in India offers promising futures. A wide variety of items have been offered throughout the past ten years, providing insight into the enormous expansion. On the one hand, a strong economy has increased the population's overall disposable income, along with that, unhealthy eating habits coupled with sedentary lifestyle have led to increase incidence of diet and its related health issues. On the other hand, there is a growing awareness on the importance of nutrition and diet for long term good health. All these factors have contributed towards nutraceutical industry in India. India has a lot of advantages like qualified human resources, world class R & D facilities and varied raw material-aspects that give our country a leading edge. The Indian Nutritional market growth is showing a promising upward trend. While the global market is growing at a CAGR of 7%, the Indian market has been growing much faster at a CAGR of 18% during recent years . This growth is driven by Functional food and beverages categories. However the latent market in India is two to four times the current market size.The Indian nutraceutical market is dominated primarily by pharmaceuticals and FMCG companies with very few pure nutraceutical companies. Some major companies Marketing Nutraceuticals in India are GlaxoSmithKline consumer healthcare, Dabur India, Cadila Health care, EID Parry’s, Zandu Pharmaceuticals, Himalaya herbal Healthcare, Amway, Sami labs, Elder pharmaceuticals and Ranbaxy. The functional foods, nutraceuticals, novel foods etc are dealt in chapter IV of the New food Safety and Standards Act, 2006. These products are examined by the Scientific Panel of Food Safety and Standard Authority of India (FSSAI).

Nutraceutical scenario in India

Need for the nutraceuticals

Consumer interest in how certain nutraceuticals that are physiologically active can improve health has skyrocketed. These goods include value-added processed foods, nutritional supplements, food supplements, and non-food supplements including tablets, soft gels, capsules, etc. The bioactive flavonoids, carotenoids, anthocyanins, vitamins, and other polyphenolics found in these materials are abundant. By acting as antioxidants, they lower the risks of contracting diseases and aid in disease prevention. The following disorders have been claimed to be protected against by nutraceuticals, or they have been found to act as:

a. Cardiovascular agents

b. Anti-obesity agents

c. Anti-diabetics

d. Anticancer agents

e. Immune boosters

f. Chronic inflammatory disorders

g. Degenerative diseases 

Health scenario of Indian population:

Along with a growth in lifestyle disorders like obesity, diabetes, hypertension, cancer, and cardiovascular diseases, life expectancy is also continuing to rise (CVD). By 2030, it is predicted that India will have 215 million hypertensives, 40 million diabetics, and 23.6 million people with CVD.

Benefits of Functional Foods and Nutraceuticals:

Functional foods of plant origin

Numerous plant diets or physiologically active substances derived from plants have been studied for their potential contribution to health and disease prevention. However, only a small fraction of these have had their health advantages supported by thorough clinical documentation. Currently, plant foods such as oat soluble (-glucan) fibre, soluble fibre from psyllium seed husk, soy protein, and margarine supplemented with sterols and stanol esters are permitted to carry an FDA-approved health claim (FDA 2000).

Although several plant-based foods or dietary components do not currently have authorised health claims, accumulating clinical data is in favour of their prospective health advantages; as a result, they would be considered to have reasonably good evidence. Cranberries, garlic, almonds, grapes, and chocolate are a few of these.

Oats (Avena sativa)

Oats include a lot of fibre and the active ingredient avenanthramides. Oat fibre aids in the removal of dietary cholesterol that would otherwise enter the bloodstream from the digestive tract. Avenanthramides, which are antioxidants found only in oats, work to stop free radicals from harming LDL-C, lowering the risk of cardiovascular disease. A study was done to see how drinking beverages containing B glucans from oats and barley would affect the levels of blood lipids, post-meal glucose, and insulin. For 8 weeks, 89 hypercholesterolemic participants received a beverage supplemented with 5 grammes of oat-derived B glucan. The results of the intervention showed that total cholesterol levels had decreased by 7.4%. (Biorkland et al ,2005)

In hypercholesterolemic adults, Queenam et al., 2007 investigated the impact of concentrated oat B-glucan on blood cholesterol. For six weeks, the subjects received a daily supplement of 6 g of oat B glucan. It was discovered that TC (-0.3 0.1 mmol/L) and LDL cholesterol (-0.3 0.1 mmol/L) had significantly decreased.

Flax seeds

Flax seeds have numerous cardioprotective properties. Its mucilaginous, gelatinous nature bulks up the stool and helps the body remove waste, toxins, and cholesterol. Flax seed lignans function as antioxidants and lower plasma cholesterol. Omega-3 fatty acids are found in flax seeds and help lower bad cholesterol as well as battle stress, anxiety, and tension in the body and brain, which can help prevent heart disease Bloedan et al. (2008).

In 199 healthy menopausal women, Dodin et al. examined the impact of flaxseed on cardiovascular disease in 2008. For 12 months of the experiment, 40 g of flaxseed or wheat germ placebo was administered everyday. Alpha-linolenic, Docosa-pentaenoic, and total omega-3 fatty acid levels in the blood were said to be elevated by flaxseed. Apolipoproteins A-1 and B were enhanced by flaxseed by 4.4% and 3% and by wheat germ by 11.6% and 7%, respectively, from baseline levels. Both therapies raised lipoprotein(a) levels while lowering LDL.

Soy bean

Proteins, isoflavones, and fibre found in soy are all favorable for the health. The amount of isoflavones in soy protein has a significant impact on the reduction of hypertension. After adjusting for age, body mass index, lifestyle, and other dietary characteristics, Yang et al. (2005) found that soy protein intake was inversely linked with both systolic BP (P for trend = 0.01) and diastolic BP (P for trend = 0.009). Women who consumed 25 g soy protein/d compared to women who consumed 2.5 g/d had adjusted mean systolic blood pressure that was 1.9 mm Hg lower (95% CI: 3.0, 0.8 mm Hg) and diastolic blood pressure that was 0.9 mm Hg lower (1.6, 0.2 mm Hg). Age-related increases in the inverse relationships were stronger (P for interaction 0.05 for both BPs).

Patients with prehypertension and stage 1 hypertension who consume soy and milk proteins have lower systolic blood pressure than those who consume refined carbohydrates with a high glycemic index. Protein from soy or milk may be a key ingredient in dietary intervention methods for the prevention and treatment of hypertension in place of some carbohydrates (Pal and Ellis 2009).

Patients with hypertension experienced a moderate reduction in blood pressure thanks to milk and soy protein supplements. Soy or milk protein "may be an important component of nutrition intervention programmes for the prevention and treatment of hypertension," replacing some refined carbs like white rice and bread in the diet (Jiang 2011).

Cranberries

Since the 1920s, cranberries have been used successfully to treat urinary tract infections. This therapeutic benefit was verified in a well-controlled study comprising 153 elderly women by a seminal clinical trial (Avorn et al 1994). Condensed tannins (proanthocyanins), which are found in cranberries, are the physiologically active substance and prevent E. coli from sticking to the epithelial cells lining the urinary tract, according to more recent studies (Howell et al 1998). According to recent early studies, the cranberry's antiadhesion characteristics may have other health benefits, including those for the mouth (Leahy et al 2001).

Garlic

Since garlic (Allium sativum) contains a number of physiologically active organosulfur components, it has been utilised for thousands of years for a range of medical uses (e.g., allicin, allylic sulfides). The immunologically active ingredient, allicin, has been shown to influence immune response and oxidative stress. It works to prevent heart disease, as well as artery hardening or atherosclerosis (plaque buildup that can obstruct blood flow and cause a heart attack or stroke), high cholesterol, excessive blood pressure, and immune system stimulation.

While a growing body of epidemiologic data indicates an inverse relationship between garlic consumption and certain types of cancer, particularly stomach cancer (Fleischauer et al., 2000), garlic has been shown to have a modest blood pressure-lowering effect in clinical studies (Silagy et al., 1994).

Garlic (Allium sativum) supplementation with traditional anti-diabetic medications improved diabetic control in type 2 diabetes patients, according to a 2011 study by Ashraf et al. 60 participants with type 2 diabetes were selected for the study. Two groups were formed out of them. Garlic 300 mg tablets were given to Group 1 along with Metformin 500 mg tablets twice day. For 24 weeks, Group 2 received Placebo plus Metformin 500 mg twice daily. It was discovered that Group 1 had much lower TC (-2.82%), LDL-C (-2.18%), and TGs (3.12%), compared to Group 2, while having significantly higher HDL-C (6.72%). Thus, it was determined that adding garlic to the treatment of individuals with diabetes and hyperlipidemia would be a smart option.

In 2011, Mahmoodi et al. conducted a study to examine the effects of raw garlic consumption on blood sugar, serum lipid levels, and a variety of important hormones that regulate lipid and sugar metabolism in hyperglycemic and/or hyperlipidemic people. In the second and third groups, it was found that eating 10 grams of garlic daily reduced TC and TGs and improved HDL-C.

Green Tea (Camellia sinensis)

Catechins and polyphenolic compounds are the active ingredients in green tea. Epicatechin (EC), epigallocatechin (EGC), epicatechin-3-gallate (ECG), and epigallocatechin-3-gallate are the four main catechins found in tea (EGCG). According to the level of fermentation, tea can be divided into three primary categories: fully fermented black tea, semi-fermented oolong tea, and unfermented green tea. Catechins decrease lipid levels, lessen oxidative stress, prevent platelet aggregation, enhance the ratio of ApoA-1/ApoB, decrease apolipoprotein B levels, and inhibit platelet aggregation. A galloyl group in the 3' position on green tea catechins prevents tissue factor-induced thrombin production.

Kuriyama and colleagues conducted a study in 2006 on the relationship between green tea drinking and death from cancer and cardiovascular disease in Japan. It was discovered that green tea drinkers who consumed more than five cups per day had a decreased risk of all-cause and CVD mortality than those who only drank one cup per day. Thus, it can be said that drinking green tea is linked to a lower risk of dying from cardiovascular disease.

Green tea use has been shown by Yang et al. (2011) to prevent cancer and cardiovascular disease. It was discovered that drinking more than 10 cups of green tea per day reduced the relative chance of dying from a CVD.

Systolic blood pressure, total cholesterol, and LDL cholesterol all decrease significantly when green tea is consumed. Systolic blood pressure is only marginally affected, although total and LDL cholesterol appear to be moderately affected. Independent clinical trials that last longer and examine the effects of green tea are necessary (Onakpoya and co. 2014).

Nuts

Unsaturated fats, plant fibre, and arginine, which may all contribute to the decrease of LDL, are the active components of nuts. Nitric acid, which is a chemical formed in the walls of blood vessels and relaxes the blood vessels and inhibits clotting, is a precursor of arginine. Alpha-linolenic acid, a precursor to omega-3 fatty acids that help prevent heart disease, is present in some nuts, particularly walnuts.

The impact of nuts on human blood lipid profiles was thoroughly reviewed. Approximately five times each week, almonds (50-100 g/d), peanuts (35-68 g/d), and walnuts (40-84 g/d) were provided. In comparison to participants following control diets, it was observed that there were decreases in TC between 2-16% and LDL-C between 2- 19% (Petersen et al 2005).

Walnuts and fatty fish were tested by Rajaram et al. in 2009 to see how they affected various serum lipid fractions in people with normal to mild hyperlipidemia. The patients followed one of three isoenergetic diets for four weeks—control diet (no nuts or fish), walnut diet (42.5 g walnuts/d), or fish diet (113 g salmon, twice/wk)—all of which contained about 30% total fat and 10% saturated fat. According to the results, participants on the walnut diet had lower TC and LDL-C concentrations than those on the control diet and the fish diet. Thus, it was determined that incorporating walnuts and fatty fish in a healthy diet reduced serum cholesterol and TG levels, respectively, which favourably lowers the risk of CHD.

In adults with prediabetes, Wien et al. (2010) examined the relationship between almond consumption and cardiovascular risk variables. 65 adults with prediabetes were chosen at random. For 16 weeks, the respondents received 56g of almonds per day. When compared to the control group, it was shown that there had been a considerable decrease in LDL-C (-12.4 mg/dl vs. -0.4 mg/dl).

Tomatoes

Tomatoes and tomato products are also being investigated for their role in cancer chemoprevention and are unique because they are the most significant dietary source of lycopene, a non-provitamin A carotenoid that is also a potent antioxidant (Clinton,1998). A comprehensive review of 72 epidemiologic studies (Giovannucci,1999) found an inverse association between tomato intake or plasma lycopene concentration and the risk of cancer.

Citrus fruits

Citrus fruits have been demonstrated to be protective against a number of human malignancies in epidemiological investigations. While vitamin C, folate, and fibre are mostly found in citrus fruits including oranges, lemons, limes, and grapefruits, Elegbede et al. (1993) hypothesised that there may be another ingredient that is responsible for the anticancer effect. An especially high concentration of limonoids, a group of phytochemicals, can be found in citrus fruits (Hasegawa and Miyake, 1996).

Evidence for limonene's ability to prevent cancer has been growing over the past ten years (Gould, 1997). This substance has been demonstrated by Crowell (1997) to be effective against a range of spontaneous and chemically induced rodent cancers. These findings have led to the suggestion that limonene may be an excellent candidate for assessment in human clinical chemoprevention trials because of its low or nonexistent toxicity in people. Patients with advanced malignancies are currently participating in Phase I clinical trials for the limonene metabolite perrillyl alcohol (Ripple et al., 1998).

Functional foods of animal origin

The (n-3) fatty acids, which are mostly present in fatty fish like salmon, tuna, mackerel, sardines, and herring, are perhaps the class of physiologically active components originating from animal products that has been the subject of the most extensive research (Kris-Etherton et al, 2000). Eicosatetraenoic acid (EPA; 20:5) and docosahexaenoic acid are the two main (n-3) fatty acids (DHA; 22:6). Particularly in the brain and retina of the eye, DHA is a vital part of the phospholipids that make up cellular membranes and is required for their healthy operation. Crawford (2000) noted that DHA plays a crucial role in the growth of these two organs in infants, and that the FDA has approved the use of DHA and arachidonic acid in formula for full-term babies (FDA 2002). The best-documented health benefit of (n-3) fatty acids is their role in heart health, which has been the subject of hundreds of clinical studies examining their physiological effects in such chronic conditions as cancer, rheumatoid arthritis, psoriasis, Crohn's disease, cognitive dysfunction, and cardiovascular disease (Rice, 1999). Intake of (n-3) fatty acids may lower overall mortality, mortality from myocardial infarction, and sudden death in individuals with CHD, according to a recent meta-analysis of 11 randomised control trials (Bucher et al 2002 ).

Probiotics are a different category of biologically active animal-derived substances that have drawn more attention recently. The scientific basis for the therapeutic and/or preventive use of these functional ingredients for a variety of health concerns, including cancer, intestinal tract function, immune function, allergy, stomach health, urogenital health, cholesterol lowering, and hypertension, was recently summarised in a Scientific Status Summary on probiotics from the Institute of Food Technologists (Sanders, 1999).

The future of functional foods

Around the world, academic, governmental, and private research institutions are putting a lot of effort into figuring out how functional foods and food ingredients might help prevent chronic disease or maximise health, lowering healthcare costs and raising the quality of life for many consumers. Nutrigenomics, an emerging field that examines the relationship between diet and illness development depending on an individual's genetic profile, will have a significant impact on future functional food research and development initiatives. The recent announcement that a preliminary version of the entire sequence of the human genome was now available substantially increased interest in nutrigenomics. Future efforts to prevent disease, as well as the future of the functional food sector, will be significantly impacted by nutrigenomics.

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