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​Foods for Specific Health Use (FOSHU): A Review

Priya Singla1,*, Piverjeet Kaur Dhillon2, Madhu3
1Indira Gandhi National Open University, LSC-2299, Nirman Campus of Education, Research and Training, Sunam, Sangrur-148 028, Punjab, India.
2Krishi Vigyan Kendra. Tarn Taran, Guru Angad Dev Veterinary and Animal Sciences University, Ludhiana-143 412, Punjab, India.
3Department of Home Science, Kashi Naresh Government PG College, Gyanpur-221 304, Uttar Pradesh, India.
Adequate nutrient intake (avoidance of excess or deficiency) is essential to ensure an optimum health status hence, no induction of risks related to lifestyle diseases. Even nutrients and functional ingredients in foods are chemical substances but we need to draw a line of demarcation between such substances, based on long history of dietary habits and novel substances and/or xenobiotics. FOSHU contains highly purified or concentrated functional ingredients, present in ordinary foods,however, it is to take safety issues into consideration. FOSHU is the only type of food product, with functional ingredients, can carry health claims and affect the structure and physiological functions of the body. These consumed for health promotion or to control specified health conditions such as gastrointestinal conditions Therefore, FOSHU products target both healthy individuals and diseased people. When the products are manufactured or distributed, the government approval is required with prior hand rigorous evaluation of safety and effectiveness of proposed product. In a nutshell, comprehensive knowledge on structure and function of human body, pathogenesis of diseases, nutrients and their metabolism etc., as well as the mechanisms of efficacy vis-à-vis FOSHU, which ranges over pharmacology, medicine and food and nutrition, is required.
Apart from ample health related disorders, reduced work capacity, growth retardation, poor mental and social development may develop due to inappropriate and unbalanced diet, inadequate nutrition and lack of physical activity (Hippocrates 2009). World Health Organization predicted that 17.9 million worldwide died due to cardiovascular diseases (an estimation of 31% each year). Globally, prevalence of diabetes had been increasing more speedily among population of low income and middle-income countries In the year 2019, total deaths were considered as 1.5 million due to diabetes and it is ninth leading cause of death (WHO, 2021). The figures quoted by International Diabetes Federation indicated that 1.1 million children and adolescents are living with type 1 diabetes, however, 4.2 million deaths were reported. In year 2019, prevalence of diabetes was 9.3 per cent and it is estimated to be rise by 10.2 and 10.9 per cent by 2030 and 2045, correspondingly. It was higher in urban areas than rural (10.8 vs 7.2 per cent) and also in high income countries than in nations with lower income (10.4 vs 4.0 per cent) (Saeedi et al., 2019). An eye-opening fact has come to force that one in ten adults suffered from diabetes and if untreated, can lead to blindness, cardiovascular diseases and kidney failure (WHO, 2012).

Japan introduced the term functional foods in the mid-1980s and formulated a specific regulatory approval process known as “Foods for Specified Health Use (FOSHU)by Japanese Ministry of Health and Welfare. By functioning in gastrointestinal tract to improve intestinal microflora and regulate nutrient absorption, thereby, more than 70 per cent of FOSHU products reduce the risk of metabolic syndrome. These are classified into eight categories according to their action on a particular part of body such as gut, tooth and gum health, bone strength, facilitation of mineral absorption and reduction in hypertension, blood cholesterol, blood sugar level and body fat accumulation to which these confer benefits (Hippocrates, 2009).

Soluble viscous properties of these products alter chyme present in the upper part of the gastrointestinal tract and affects the absorption of nutrients, gastric emptying and gut motility, prevents diabetes, lowers postprandial glucose and insulin responses. Flax fibers, oil and lignans have been found potent in reduction of atherosclerosis, arthritis, cancer, cardiovascular disease, diabetes, osteoporosis, autoimmune and neurological disorders. Therefore, various original research articles related to wheat, rice, oats and flax seed were studied to see the efficacy of FOSHU products overcome various health problems. Moreover, it tends to commensurate with some other risk factors such as high triglyceride level, hypertension, low high-density lipoprotein, cholesterol level and obesity (Simmons et al., 2010).

Plant foods constitute major part of human diet in developing nations but cannot be relied upon for providing a nutritionally adequate diet. Cereals generally contain poor quality protein and the bioavailability of micronutrients present in these such as iron, zinc, iodine and vitamin A is very low (Singla and Grover, 2017). Most commonly used cereal based functional foods and neutraceuticals, are the products made using wheat, rice, brown rice, corn, barley, millets, sorghum, oats, flaxseed and buckwheat (Otles and Cagindi, 2006). Nutritive and non-nutritive components of the cereals have been identified as prospective factors for reducing the risk of coronary heart disease, diabetes, tumor incidence, cancer risk, blood pressure, reduced levels of cholesterol and fat absorption and improved gastrointestinal health delayed gastrointestinal emptying. Thus, the regular consumption of right kind of cereals may lead to health endorsement and disease and escape avoidance. The current paper reviews the health benefits of different FOSHU products in terms of the prevention of diseases.
Role of FOSHU products in prevention of diseases
Some important FOSHU products are discussed below with regard to their health benefits.
Worldwide, most commonly cultivated cereal grain in temperate climatic conditions, is wheat, is rich in micronutrients. All plant tissues including grains and some vegetables and fruits, starch is present as a mixture of two polymers of glucose i.e. amylose and amylopectin. A linear chemical structure of amylose is relatively slowly digested in comparison to more rapidly digested amylopectin due to its branched structure. The fibre content ranges from 11.6 to 12.7 per cent dry weight basis in whole wheat grain. When whole-wheat based food products viz. baked, extrudates are eaten in recommended amounts, showed significant reductions in risks for type-2 diabetes, heart disease and associated with management of body weight (Brounes et al., 2013).

Plant based foods and their products are widely used in Indian diets to cure many body ailments and shoot belongs to family Graminea prepared from the cotyledons of Triticum aestivum is called wheat grass, an annual and biennial grasses. It is cultivated almost in all regions the world over and is available as fresh juice and dried powder, useful for human consumption. Intake of fresh juice and powder of wheat grass is beneficial to keep away some health problems such as skin problems, ulcerative colitis, high blood pressure, diabetes cancers, obesity etc. Along with therapeutic properties, wheat grass is a store house of many nutrients including proteins, essential amino acids, vitamins, minerals, bio flavonoids, chlorophyll and active enzymes. This way, for healthy and rejuvenating body, wheat grass is an efficient source and provides all necessary nutrients and medicinal benefits too. Alongside, due to presence of important constituents, wheat grass retains antioxidant, antibacterial, anti ulcer and anti cancer property. Three essential effects of wheat grass on human body are blood purification, liver detoxification and colon cleansing. It enhances immunity, chemically neutralizes environmental pollutants and restores energy and vitality (Mogra and Rathi, 2013).

Wheat bran is typically the richest source of fibre, is present in outer layers, pericarp and seed coat of the grain. About 46 per cent non starch polysaccharide is therein and most commonly available non starch polysaccharides are arabinoxylan (70 per cent), cellulose (24 per cent) and beta-glucan (6 per cent), respectively. In wheat, soluble fibre content is less than 1 per cent, whereas, in other cereals, such as barley and oats, it ranges from 3 to 11 percent and 3 to 7 per cent. Correspondingly, several studies reviewed (Table 1) beneficial effect of consumption of wheat bran in the diet. It may be helpful in the prevention of some cancers (colorectal cancer), cardiovascular diseases, some gastrointestinal diseases (diverticulitis disease, constipation and irritable bowel syndrome), obesity and also improved digestion. Wheat bran also has a positive impact on cholesterol reduction. A study reported that with consumption of wheat bran-based breakfast cereal containing approximately 13.5 g of fibre for 3 weeks, a significant reduction (5.576 to 4.385 mmol/l) in total serum cholesterol was found among the experimental subjects. On the other hand, no reduction was found in beneficial high-density lipoprotein (Costabile et al., 2008).

Table 1: Wheat products in disease prevention.

Worldwide, over 900 million poor people, living in underdeveloped and developing countries are at a higher risk of hunger and suffer from food insecurity, every year. In view of food insecurity and inadequate intake of nutrients, underdevelopment of infants’ and toddlers’ immune systems is there and making them more vulnerable to viral and bacterial diseases such as pneumonia and diarrhea (Guerrant et al., 2008). Similarly, growth and development of children depends entirely on nutrition and inadequate nutrition may results in malnutrition, reduced work capacity, growth retardation, poor mental and social development. As rice bran has incomparable protein and fat content, high digestibility and hypoallergenic effects, is a great opportunity to include this into complementary foods (Table 2) ; Watson et al., (2014).  In comparison to other cereal bran, rice bran is more appropriate because of its high-quality protein as it comprises a significant amount of lysine content which helps to meet the growth requirements of children. Lipids in rice bran can supply required energy depending upon the age (Khan et al., 2011). Being low in allergenicity, completely absorbable in the small bowel and low in fiber content; rice may work as the best carbohydrate source for people with functional bowel disorder. Many studies supported that complete absorption of rice in the small bowel lead to production of little intestinal gas and had low allergenicity. Thus, functional gastrointestinal disorders and irritable bowel syndrome patients should be advised to consume rice as a major source of carbohydrate (Gonlachanvit, 2010). About 77 per cent of the patients found with adequate relief from IBS symptoms (Austin et al., 2009). Kumari et al., 2018 nalyzed and compared the nutritional composition of full fat and defatted rice bran samples. The investigators revealed that defatted rice bran sample contained significantly higher content of crude protein, crude fiber, total dietary fiber, iron and calcium, when compared to full fat rice bran samples. Further, protein digestibility of full fat rice bran and defatted rice bran samples were found as 65.86 and 66.56 per cent, respectively. Thus, it was concluded that nutrient profile can be improved after removal of fat in rice bran, which can be further utilized as functional ingredients in treatment of many disorders.

Table 2: Rice bran in human health and disease.


Oats are good source of cholesterol lowering soluble dietary fiber β-glucan. Several whole oat feeding or supplementary studies have concluded that oats and oat bran may reduce serum cholesterol and may lower blood pressure in mild or borderline hypertension (Watson et al., 2014). The Quaker Oats Company (Chicago, Illinois) from 1980 to 1995, conducted 37 human clinical interventions to support their petition of health claim revealed a statistically significant (reduction in total and low density lipoprotein cholesterol in hypercholesterolemic subjects consuming oat bran or oatmeal with servings varied from 34 to 123 g per day. In addition, intake of 3 g β-glucan derived from oatmeal (60 g) or oat bran (40 g) based on its dry weight, lowered serum cholesterol level by 5 per cent in the human subjects. An oat product must comprise of 13 g oat bran or 20 g oatmeal and provide at least one g of β-glucan per portion without fortification, to qualify for a health claim. The first food-specific health claim was given by Food and Drug Administration (FDA), in January 1997 for oats and oat products (Jr and Steffen, 2003).

Oat β-glucan consists mainly of the linear polysaccharide (1®3), (1®4)-β-D-glucan and lowers total and low-density lipoprotein, attenuates blood postprandial glycemic and insulinemic responses and improves high-density lipoprotein cholesterol and blood lipid profile along with maintenance of body weight. Hence, its intake is beneficial in the prevention, treatment and management of diabetes and cardiovascular diseases. Moreover, stimulation of immune functions have been ameliorated by oats intake through activation of monocytes/macrophages and higher amounts of immunoglobulin, natural killer cells and killer T-cells, helps in prevention and resistance to cancer, viral and parasitic diseases (Hui et al., 2007).

A total of 268 men and women were studied with high cholesterol level from Chicago (Daou and Zhang, 2012) and were provided with the tall oil-based phytosterols and β-glucan derived from whole grain rolled oats. Reduction in low density lipoprotein as well as total cholesterol levels was observed in patients with medium to moderate hypercholesterolemia when compared to control group who fed corn flakes with whole grain rolled wheat and crisp rice. Similarly, the effect of oat â-glucan on serum lipoproteins in hypercholesterolemic subjects was studied by providing them oat β-glucan enriched bread, cookies and orange juice with the mean intake of oat β-glucan was 5.9 g per day (Maki et al., 2003). Enriched orange juice decreased significantly (P = 0.001) low density lipoprotein-cholesterol (0.26 mmol/L) whereas the lipid profile of the subjects consumed enriched bread and cookie did not show any significant change.  Formulation of bread with the addition of oat β-glucan (6 g) significantly increased plasma high density lipoprotein cholesterol from 39.4 to 49.5 mg/dL and significantly decreased total cholesterol from 231.8 to 194.2 mg/dL and low density lipoprotein cholesterol from 167.9 to 120.9 mg/dL when supplemented for a period of 8 weeks (Kerckhoffs et al., 2003). Furthermore, daily dose of oat β-glucan (3 g) increased high density lipoprotein cholesterol (0.03 mmol/L) and decreased the total cholesterol (0.60 mmol/L), low density lipoprotein cholesterol (0.66 mmol/L) and triglycerides/triacylglycerol (0.04 mmol/L) (Reyna et al., 2007).

Hypertension, a silent killer and there is an alarming increase in its incidence among the population of India and other developing countries. According to database from 1950 to 2013, overall prevalence of hypertension in India is 29.8%, about 33% urban and 25% rural Indian population. Africa has the highest prevalence, with over 40% adults affected by this disorder. It is also a leading cause of death in both men and women. A reduction in systolic (7.5 mm Hg) and diastolic (5.5 mm Hg) blood pressure was reported among subjects who had consumed standard American diet along with oats, whereas no change was observed in the control group who had consumed only the standard American diet (Tiwari and Cummins, 2011). When men suffering from type-2 diabetes consumed oat β-glucan (3 g in muesli) in breakfast for a period of 4 weeks, decreased in their cholesterol level and postprandial blood glucose levels peaks was observed while no effect was found on fasting plasma glucose and insulin levels (Chen and Huang, 2009). Similarly, studies summarized in Table 3, are in agreement with cholesterol lowering effect of above-mentioned investigations. 

Table 3: Oat products in disease prevention.

Oat β-glucan, comprises of soluble fiber, is beneficial for type-2 diabetics (Kabir et al., 2002). It helps to modify properties of chyme in the upper part of the gastrointestinal tract, lowers postprandial glucose and insulin responses, prevents diabetes and also affects gastric emptying, gut motility and nutrient absorption (Behall et al., 2006). In diverse preparations such as baked products, dairy products etc., oats can be added as functional ingredients. It is also documented that the total and LDL cholesterol was reduced by 5 to 10 per cent, on consumption of oat β-glucan at the rate of 3 g/day (Dhavalagi et al., 2021).

Due to the viscous characteristics of oats, reductions in glucose and insulin responses was reported. The area under the plasma glucose curve for the postprandial was larger after ingestion of the oat bran crisp as compared to the oat bran flour. They fed the subjects with type 2 diabetes in two series that is in series 1, oat bran flour, crisp and a glucose load provided 12.5 g glycemic carbohydrate whereas in series II, 25 g glucose load with 30 g oat bran flour and 25 g glucose load alone to control subjects. The results indicated that in both series, there was a reduction in postprandial glucose concentrations with the consumption of oat bran products during the 1st hour, but after 2 hours, it was greater than glucose load alone. Oat bran flour being high in β-glucan acting as an active ingredient had a low-glycemic response and decreasing the postprandial glycemic response in subjects with type2-diabetes (Tapola et al., 2005). Similar results were found by Juvonen et al., (2011) by performing experiment on healthy volunteers who were provided with four different types of meals such as without added cereal fibers and enriched with 10 g cereal fibers (wheat bran, oat bran and a combination of 5 g of each).
Flaxseed (Linum usitatissimum) is important as a functional food ingredient (Table 4; Moghaddasi, 2011). It is rich in a- linolenic acid (omega-3 fatty acid), fiber and lignans. Flaxseed oil, fibers and flax lignans have possible health benefits reduced of risk of arthritis, atherosclerosis, cancer, cardiovascular diseases, diabetes, osteoporosis, autoimmune and neurological disorders. Flax protein helps in prevention and treatment of heart diseases along with supporting the immune system. Flax or flaxseed oil could be incorporated into various food products such as baked foods, dry pasta products, juices, macaroni, meat, milk products (Goyal et al., 2014). Flaxseed meal contains 2.3 to 3.3 per cent phytic acid. Though phytic acid has been known in reducing bioavailability of micronutrients but some studies showed that it has antioxidant, anticancer, hypocholesterolemic and hypolipidemic effects too (Mazza, 2008).

Table 4: Flaxseed in management of various ailments.

Dietary fiber is a natural way to manage irritable bowel syndrome (IBS). Inclusion of flaxseed in diet, significantly increased plasma and adipose levels of alpha linoleic acid (McCullough et al., 2011). Multi branched hydrophilic substances such as soluble non starch dietary fibers of flaxseed mucilage, form viscous solutions that aid in nutrient absorption from small bowel and delay gastric emptying. Constipation is a major health problem mainly in Western societies, because of the refined diet, however, dietary fiber is a keystone in the management of constipation but only in recommended amount (Tarpila et al., 2005). Flaxseed consists of dietary fibers, lignans and omega-3 fatty acids which provide protection against diabetes. Supplementation of flaxseed powder (10 g) for a month, lowered fasting blood glucose level by 19.7 per cent, in persons with type-2 diabetes, could be due to higher content of dietary fibers and lower content glycemic carbohydrates (Mani et al., 2011). Besides, Kapoor et al., (2011) reported that postprandial blood glucose levels were decreased by 7.9 and 19.1 per cent among females with type 2 diabetes on supplementation of 15 and 20 g/day of flaxseed powder for two months.

Flaxseed intake showed a positive impact on suppressing the development of atherosclerosis. Flaxseed and its bioactive components revealed antidiabetic and positive hypocholesterolemic effects among postmenopausal women (Patade et al., 2008). Dietary flaxseed provides protection against ischemic heart disease by inhibiting the incidence of ventricular fibrillation and improving vascular relaxation responses (Jennifer et al., 2010). Inclusion of flaxseed oil in the diet for a period of 28 days posed the reduction in high density lipoprotein fraction levels in human serum (Gillingham et al., 2011). Simultaneously, when patients with type-2 diabetes were fed with defatted flaxseeds for a period of two months, a significant improvement in plasma lipid profile, reduction in plasma glucose and lipid peroxidation was observed (Mohamed et al., 2012). Similarly, administration of flaxseed amounting 15 g/d administered for three months, resulted in lowering serum triglycerides and low density lipoprotein cholesterol, without any change in high density lipoprotein cholesterol levels (Shim et al., 2014).

Further, it was reported that long-term supplementation of omega-3 fatty acids was linked with a significant reduction in both systolic and diastolic blood pressure (Cicero et al., 2010). Hypertension is also a risk factor for chronic kidney disease. The probable effect of long-chain n-3 polyunsaturated fatty acids mechanism on blood pressure by which it protects the kidneys. Nevertheless, a positive association between α- linolenic acid and moderate chronic kidney disease was found (Gopinath et al., 2011). Consumption of whole flaxseed based products such as bar, bun and muffin, comprising 30 g flaxseed, significantly lowered systolic and diastolic blood pressure (Rodriguez-Leyva et al., 2013).

Simultaneously, Kajla et al., 2017 investigated the nutritional and anti-nutritional composition of four different varieties of flaxseed (JL-27, JL-23, JLS-6 and JLS-9) in raw form and after their germination for 48 hours. Significant variations in raw and treated samples were observed with regard to their micro mineral content. Maximum increase in manganese, iron and zinc contents were noted in the germinated sample of JLS-9 among all other samples. Moreover, reduction of 82.37 and 52.27 per cent in cyanogenic glycosides and phytic acid contents was noted in JLS-9 and JL-23, respectively.
To recapitulate, several studies stated that consumption of FOSHU products i.e. whole grain and other plant foods, were useful in maintenance of health and prevention and treatment of dreadful complications of degenerative diseases. Nutritive and non-nutritive properties of these products reducing risk of total mortality by 40 per cent. It can be implicated for both normal and therapeutic conditions as per suggested intakes and intervals to attain maximum benefits to the host.

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