DESC:FIELD OF THE INVENTION

The present disclosure relates to a high protein nutritional supplement composition. More particularly, the present disclosure relates to a nutritional supplement for supplementing the nutritional value of a food or beverage. The invention also provides the process for the preparation of such compositions.

BACKGROUND OF THE INVENTION
Proper nutrition is generally regarded as one of the key factors for achieving and maintaining good health. All over the world people are looking for products with nutritional values at the same time products which are convenient and holistic without compromising original traditional taste.
WO 2015/148384 discloses a nutritional supplement powder and method of supplementing the nutritional value of a food or beverage and includes a protein system, vitamins, minerals, and fiber. The protein system has a water solubility of at least about 70% at room temperature. The nutritional supplement powder is essentially free of divalent ions of copper, iron, and zinc, and is also essentially free of vitamin C.
Similarly,WO2007026245 discloses a palatable baked nutritional composition comprising fructose which has a low glycaemic index and low glycemic load and improved sensory characteristics such as crispiness mouthfeel and suitable as a snack for people who are seeking options without added sucrose and for those with diabetes.
IN212549 discloses process for the preparation of protein rich cereal grits comprising Maltodextrin, soyabean flour and other ingredients. The process and product disclosed does not offer any undesirable flavour or taste which is a common problem with almost all the soy-based products.
IN201717012676 discloses nutritional compositions comprising an oxidizable component and a water-soluble plant extract, and methods of reducing off-flavors and aromas in a nutritional composition comprising an oxidizable component.
WO2015187817 discloses nutritional compositions comprising vegetable proteins like potato protein, soy protein, rice protein, wheat protein, legume protein, hydrolyzed soy protein, hydrolyzed rice protein, hydrolyzed wheat protein, and hydrolyzed legume protein. The composition also includes dairy proteins like milk protein isolate, milk protein concentrate, sodium caseinate, calcium caseinate, micellar casein, whey protein, hydrolyzed milk protein isolate, hydrolyzed milk protein concentrate, hydrolyzed sodium caseinate, hydrolyzed calcium caseinate, and hydrolyzed whey protein.
There are many nutritional products available in market with high protein claims, but most of the products are not having low glycemic index or are not enrich with fibers or are of unpleasant taste. Moreover the products are also not cost-effective. There still remains a need to provide a high-protein nutritional supplement, enrich in fibers and low-cost. The nutritional supplement composition should be able to manufactured using simple systems and commonly available ingredients without sacrificing the attractive taste and which will not result in the abnormal elevation of blood glucose levels providing a healthy nutrition. Retention of nutritional values as compared to the fresh ingredients is also required. The present discloser provides an advantage of the available products with low cost complete plant protein source ingredients, traditional Indian taste and suitable for diabetic population. Compositions of the present invention is a ready to use nutritional supplement for people who are seeking options without added sugar and for those with diabetes.
SUMMARY OF THE INVENTION

The present disclosure relate to nutritional supplement composition. More particularly, the general inventive concepts relate to nutritional compositions with high protein and rich in fiber content for supplementing the nutritional value of a food or beverage. The composition of the present disclosure has a low glycemic index and comprising low cost water-soluble plant-based protein components. The invention also provides the process for the preparation of such compositions.

In one aspect, the present invention relates to a high protein nutritional supplement composition comprising;
a) One or more plant based proteins, and
b) millets.

In another aspect, the present invention relates to a high protein nutritional supplement composition comprising;
a) One or more plant based proteins comprises defatted soy flour, gram flour and combinations thereof, and
b) millets.

In yet another aspect, the present invention relates to a high protein nutritional supplement composition comprising;
a) One or more plant based proteins, and
b) millets,
wherein the said composition is having glycemic index value of less than 55.
In one aspect, the present invention relates to a high protein nutritional supplement composition comprising;
a) One or more plant based proteins, and
b) finger millets.

In another aspect, the present invention relates to a high fiber and high protein nutritional supplement composition comprising;
a) One or more plant based proteins, wherein the protein content of the said composition is more than about 25%.
b) millets,
c) fibers, wherein the fibers content of the said composition is more than about 10%.

In another aspect of the present invention relates to a process of preparing a high protein nutritional supplement composition comprising one or more plant based proteins, millets and one or more edible additives.

DESCRIPTION OF THE INVENTION

The present disclosure relate to nutritional supplement composition. More particularly, the general inventive concepts relate to nutritional compositions with high protein and rich in fiber content for supplementing the nutritional value of a food or beverage. The composition of the present disclosure has a low glycemic index and comprising low cost water-soluble plant-based protein components. The invention also provides the process for the preparation of such compositions.

In one aspect, the present invention relates to a high protein nutritional supplement composition comprising;
c) One or more plant based proteins, and
d) millets.

In another aspect, the present invention relates to a high protein nutritional supplement composition comprising;
c) One or more plant based proteins comprises defatted soy flour, gram flour and combinations thereof, and
d) millets.

In yet another aspect, the present invention relates to a high protein nutritional supplement composition comprising;
c) One or more plant based proteins, and
d) millets,
wherein the said composition is having glycemic index of less than 55.

In one aspect, the present invention relates to a high protein nutritional supplement composition comprising;
c) One or more plant based proteins, and
d) finger millets.

In another aspect, the present invention relates to a high fiber and high protein nutritional supplement composition comprising;
d) One or more plant based proteins, wherein the protein content of the said composition is more than about 25%.
e) millets,
f) fibers, wherein the fibers content of the said composition is more than about 10%.

The term "high protein nutritional supplement composition" as used herein, means that the composition is having some nutritional value and high protein content and may be used as nutritional supplement in infants, children, adults or diabetic patients. The term “high protein” as used herein means that the composition is having total protein content preferably more than 25% by weight.

As per the Food Safety and standard Authority of India (FSSAI) regulations and CODEX Nutrition and Health Claims for a claim of high protein, the product must contain 20% recommended dietary allowance (RDA) of protein per 100g. The RDA for protein is 60g. Accordingly, the product should contain minimum 12g of protein per 100g. The nutritional supplement composition of the current invention contain total protein preferably more than 25% by weight, more preferably more than 28% by weight.

The “composition” could be in the form any conventional nutritional products like dry flakes, dry powder, protein bar, protein biscuits or similar kind which may be consumed orally or may be reconstituted with an aqueous liquid/milk and which are suitable for oral administration to a human. In one exemplary embodiment nutritional supplement composition in the form of powder is provided.

The term "Plant protein” or “Plant based protein” as used herein, refers to plant based proteins present in the composition comprising preferably more than 80% vegetable or plant originated proteins, more preferably more than 90% vegetable or plant originated proteins, and most preferably more than 95% vegetable or plant originated proteins for use in the nutritional supplement composition. Suitable plant based proteins include but not limited to gram flour protein, soy protein, pea proteins combinations thereof, and the like.

In an embodiments, the nutritional supplement composition comprises gram flour. Gram flour or chickpea flour or besan is a pulse flour made from a variety of ground chickpea known as Bengal gram. It is a staple ingredient in the cuisine of the Indian subcontinent. Gram flour can be made from either raw or roasted gram beans. Gram flour, is a highly nutritions food which provides us with lots of health benefits. Owing to its high protein content it can be easily be consumed by vegetarians to fulfil their protein needs. Gram flour is rich in fiber, iron, potassium, manganese, copper, zinc, phosphorus, magnesium, folate, vitamin B-6 and thiamine. Gram flour has lesser calories than whole wheat flour. Gram flour naturally contains nearly twice the folate as an equal amount of fortified wheat flour. Folate vitamin plays an important role in preventing spinal cord defects during pregnancy.

Table 1. ONE CUP (92 GRAMS) OF GRAM FLOUR CONTAINS:
Calories 356
Protein 20 grams
Fat 6 grams
Carbs 53 grams
Fiber 10 grams
Thiamine 30% of the RDI
Folate 101% of the RDI
Iron 25% of the RDI
Phosphorus 29% of the RDI
Magnesium 38% of the RDI
Copper 42% of the RDI
Manganese 74% of the RDI
* RDI = Reference Daily Intake

Gram flour being nutritionally dense promote weight loss as they contain lower levels of fat as compared to their non-vegetarian protein counterparts. In spite of huge nutritional value of gram flour as, it is neglected for use in nutritional supplement compositions available in market. Compositions of the present invention comprise Gram flour in an amount of 10.0 to 70.0 % w/w, suitably 15.0 to 60.0 % w/w and more suitably 20.0 to 40.0 % w/w.

“Soybean” or “soyabean” or “Soy flour” is a commodity known for its high-protein plant source ingredient and many health benefits. Soybean protein is a plant protein that contains most essential amino acids in a relatively high proportion. Soy flour is a great source of high quality soy protein, dietary fiber and important bio-active components, such as isoflavones. Soybean flour is a versatile ingredient which provides a good source of iron, B vitamins and potassium. Soybean flour are a good source of essential fatty acids and contain no cholesterol and little or no saturated fat. This comparison of the protein content of several flours indicates the high protein content of soy flours in relation to wheat flours:
Full-fat soy flour : 40 % protein
Low-fat soy flour : 52 % protein
Defatted soy flour : 55 % protein
Whole wheat flour : 16 % protein
Enriched white flour : 12 % protein

USDA National Nutrient Database for Standard Reference, has published the following data in Release 17 (2004).
Table 2. 1/4-CUP (30 GRAMS) SERVING OF SOY FLOUR PROVIDES
Defatted % Daily Value Full Fat % Daily Value
Calories 82 92
Total Fat 0g 0% 4g 2%
Saturated Fat 0g 0% 0.5g 0%
Total Carbohydrates 10g 3% 7g 3%
Protein 12g 24% 7g 20%
Cholesterol 0mg 0% 0mg 0%
Sodium 5mg 0% 3mg 0%
Dietary Fiber 5g 18% 2g 8%
Calcium 60mg 6% 43mg 4%
Potassium 596mg 17% 528mg 16%
Phosphorus 168mg 17% 104mg 13%
Folate 76mcg 19% 72mcg 23%

In an exemplary embodiments, the nutritional supplement composition comprises defatted soybean flour. “Defatted soybean flour” obtained after the extraction of oil, have high protein and fiber content. On the other hand, defatted soybean flour is an under-utilized low cost raw material though its protein content is nearly half of the ingredient itself. In the present composition the use of defatted soybean flour helps to increasing the nutritional value and decrease the cost of product.

One or more plant based proteins comprises defatted soy protein in an amount of 10 to 70 % by weight of the total protein. In certain exemplary embodiments, one or more plant based proteins comprises defatted soy protein in an amount of about 50 % by weight of the total protein.

It has been found that the plant protein in nutritional compositions can be used up to 100% based on total weight of the protein, without adversely affecting the nutritional value. This is accomplished through the use of gram flour protein, and in certain embodiments, the use of gram flour protein in combination with other proteins, including soya protein, millets and other vegetable proteins.

In some embodiments, the nutritional supplement composition comprises millet. The term “Millets” refers to group of highly variable small-seeded grasses, widely grown around the world as cereal crops or grains for fodder and human food. The millet contains about 5-8% protein, 1-2% ether extractives, 65-75% carbohydrates, 15-20% dietary fibre and 2.5-3.5% minerals. It is also a very good source of micronutrients and phytochemicals such as dietary fibre, polyphenols, pigments and phytate. Millets are a rich source of magnesium, which help in stimulating the level of insulin, thereby increasing the efficiency of glucose receptors in the body, which further helps in maintaining a healthy balance of sugar level in the body. This helps in reducing the chance of diabetes type 2. Non-limiting examples of millets include Jowar (Sorghum), Ragi (Finger Millet), Foxtail millet, Bajra (Pearl millet), Barnyard millet, Proso millet, Little millet and combinations thereof.

In another embodiments, the nutritional supplement composition comprises Finger millet. Finger millet grains or Ragi (Eleusina coracana L) are rich in important vitamins viz. thiamine, riboflavin and niacin. The millet protein has a well-balanced amino acid profile and is a good source of methionine, cystine and lysine. These essential amino acids benefit those who depend on plant food for their nourishment. The millet grain contains a high proportion of carbohydrates, which are the form of non-starchy polysaccharides and dietary fibers, which helps in prevention of constipation, lowering of cholesterol and slow release of glucose to blood stream during digestion. Finger millet grains provides added advantage of consumption for population suffering from Diabetes. Finger millet contains 0.3-3% polyphenols. Health benefits associated with the millet, such as its hypoglycemic, hypocholestrolemic characteristics and anti-ulcerative properties and also the excellent storage quality of the mille could be attributed to a large extent to its polyphenol contents. Compositions of the present invention comprise Finger millets in an amount of 1.0 to 20.0 % w/w, suitably 3.0 to 15.0 % w/w and more suitably 5.0 to 10.0 % w/w.

The composition of the nutritional supplement may contains “high fiber”. The term "fiber" as used herein, unless otherwise specified, refers to soluble dietary fiber. A non-limiting list of fiber includes fructooligosaccharide, inulin, modified corn dextrin, and modified wheat dextrin. Various health benefits are associated with the fibers, such as protection against heart disease, promotes regular bowel movements and prevents constipation, helps control blood sugar levels and aids in achieving healthy weight. The term “high fiber” as used herein means that the composition is having total protein content preferably more than 8% by weight, more preferably more than 10% be weight.

As per the Food Safety and standard Authority of India (FSSAI) regulations and CODEX Nutrition and Health for a claim of high fibre, the product must contain 6g per 100g or 20% recommended dietary allowance (RDA) of fibre per 100g. The RDA for fibre is 30g. Accordingly, the product should contain minimum 6g of fibre per 100g. The composition is having total protein content preferably more than 8% by weight, more preferably more than 10% be weight.

Fiber rich diet stimulates the important colon mechanisms to increase levels of satiation (the process that terminates eating) and satiety (the process that inhibits further eating after a meal has been finished) to help promote energy balance and weight stability (along with physical activity). Lower energy dense fiber-rich diets, as a replacement for higher energy dense diets, help to promote energy balance to prevent weight gain. This is because: (1) fiber is generally considered to be 2kcals/g or less as compared to 4kcals/g for digestible carbohydrates such as sugar and starch because fiber is not digested in the small bowel and (2) lower energy dense fiber-rich foods displace higher density food. Fiber-rich meals are more mouth filling and harder to swallow because of their higher bulk, physical density, volume, or viscosity compared with energy-matched, low-fiber meals, and more rapidly reduce hunger after ingestion. Fiber-rich foods or clinically proven fiber supplements, especially bulky, viscous soluble fibers, increase intraluminal concentration or viscosity, slow gastric emptying, and create a mechanical barrier to enzymatic digestion of macronutrients such as starch in the small intestine. There are a number of hormonal satiety inducing activities associated with increased fiber intake. Due to the reasons stated the composition of the preset invention “Supports weight management”.

The nutritional supplement composition may further comprise vitamins or related nutrients, non-limiting examples of which include vitamin A, vitamin E, vitamin K, vitamin B1, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B12, carotenoids, vitamin B9, biotin, vitamin C, choline, inositol, salts, and derivatives thereof, and combinations thereof.

The nutritional supplement composition may further comprises minerals suitably in the form of salts of elements such as sodium, potassium, magnesium, zinc, iron, manganese, copper, iodine, chromium, calcium, phosphorus, selenium, chloride, molybdenum, and combinations thereof.

In an embodiments, the nutritional composition comprises vitamins and minerals as spray dried premix forms. The term “spray dried premix” as used herein, unless otherwise specified refers to a Vitamins and/or Minerals are premixed and has been subjected to spray-drying process. The process of preparation of spray died premix Vitamins and Minerals was briefed in patented literature US3869539A, US4892889A, US4395422A.

The nutritional supplement composition of the present disclosure does not substantially change the organoleptic properties of the food or beverage. The term "organoleptic" as used herein, unless otherwise specified, refers to a sensory property of a food or beverage such as taste, color, odor, and mouth feel.

In an embodiments, the nutritional supplement composition may further comprises carbohydrates. Non-limiting examples of suitable carbohydrates or sources thereof for use in the nutritional supplement composition described herein may include maltodextrin, hydrolyzed or modified starch or cornstarch, glucose polymers, corn syrup, corn syrup solids, rice-derived carbohydrates, glucose, fructose, lactose, high fructose corn syrup, honey, sugar alcohols (e.g.,maltitol, erythritol, sorbitol), and combinations thereof.

In an embodiments, the nutritional supplement compositions of the present invention further comprise fat. Suitable sources of fat include hydrogenated vegetable fat, unhydrogenated vegetable fat and interesterified fat. Non-limiting examples of suitable fats or sources thereof for use in the nutritional supplement composition described herein include coconut oil, fractionated coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm and palm kernel oils, palm olein, canola oil, marine oils, cottonseed oils, and combinations thereof.

In an embodiments, the nutritional supplement compositions of the present invention further comprise other additives. The term "other additives" includes but not limited to one or more of coloring and flavoring agents, sweetening agents, masking agents, emulsifiers, leavening agents and stabilizers. Such other additives are well known in the art. Typically the other additives employed in the nutritional supplement composition are in the range of 0-10% w/w.

The composition of the present disclosure is essentially free of artificial coloring and flavoring agents. The term "essentially free" as used herein, unless otherwise specified, means that the nutritional supplement composition may include a trace amount, typically less than about 0.1 wt%, of a particular component. Such trace amounts of the component typically result from the component being inherently present in a required ingredient. In addition, the term "essentially free" should be understood to mean that the nutritional supplement composition is not manufactured utilizing a particular component. For example, a nutritional supplement composition that is essentially free of artificial colors and/or flavors would not be manufactured using any of synthetic colors and/or flavors. Non-limiting examples of natural coloring and flavoring agents include turmeric powder, saffron, ginger dry powder, garlic powder and combinations thereof.

The nutritional supplement composition may also include one or more masking agents to reduce or otherwise obscure bitter flavors and after taste in the reconstituted powders. Suitable masking agents include sweeteners, sodium sources such as sodium chloride, and hydrocolloids, such as xanthan gum, guar gum, carrageenan, gellan gum, and combinations thereof.

Suitable example of the sweetening agent includes sugar alcohol such as maltitol, erythritol, sorbitol, xylitol, mannitol, isolmalt, and lactitol, or artificial or high potency sweetener such as sucralose, acesulfame K, aspartame, saccharin, stevia, tagatose, and combinations thereof. These sweetener combinations can effectively mask undesirable flavors, for example, as sometimes associated with the addition of plant proteins to a nutritional composition.

In the present disclosure the sweetening agent used in the nutritional composition facilitate to provide low Glycemic index. Compositions of the present invention comprise sucralose and/or fructose from 3.0 to 12.0 % w/w, suitably from 4.0 to 10.0 % w/w and more suitably from 6.0 to 8.0 % w/w. Sucralose and fructose provides sweetness whilst avoiding the negative effects of elevated blood glucose levels.

The term “Glycemic index” (GI) refers to the increase in blood glucose (over the fasting level) that is observed in the two-hours following the ingestion of a set amount of carbohydrate in an individual food. The Glycemic index (GI) is useful for quantifying the relative rapidity with which the body breaks down carbohydrates. It takes into account only the available carbohydrate in a food. Foods with carbohydrates that break down quickly during digestion and release glucose rapidly into the bloodstream tend to have a high GI; foods with carbohydrates that break down more slowly, releasing glucose more gradually into the bloodstream, tend to have a low GI. A lower glycemic index suggests slower rates of digestion and absorption of the foods' carbohydrates and can also indicate greater extraction from the liver and periphery of the products of carbohydrate digestion. The concept of Glycemic Index (GI) has clinically important benefits for preventing, managing, and treating a number of chronic diseases such as diabetes, cardiovascular disease (CVD), and obesity. The GI is defined as the incremental area under the blood glucose response elicited by 25 or 50 g of available carbohydrate containing test food portion expressed as a percentage of the response to 25 or 50 g of glucose taken by the same participant. As per international guidelines, a high GI value is 70 or more, a medium GI value is in the range 56-69 inclusive and low GI value is 55 or less.

The term “Glycemic response” (GR) refers to the changes in blood glucose after consuming a carbohydrate-containing food. Glycemic response term is used for foods containing more than one source of carbohydrates (example: Mixed meals, breakfast cereals with milk, beverages mixed with milk).

The term “Glycemic load” (GL) refers to the product of the glycaemic index of the food and the amount of carbohydrate in a serving (Sheard, N. F. et al, Dietary Carbohydrate [Amount and Type] in the Prevention and Management of Diabetes).
Both the quality and quantity of carbohydrate determines an individual’s glycemic response to a food or meal. Glycemic load estimates the impact of carbohydrate consumption using the glycemic index while taking into account the amount of carbohydrates that are consumed in a serving. GL is a GI-weighted measure of carbohydrate content. Glycemic load is based on the glycemic index (GI), and is calculated by multiplying the grams of available carbohydrate in the food by the food's glycemic index, and then dividing by 100. As per international guidelines, a high GL is 20 or more, a medium GL value is in the range of 11-19 inclusive and low GL value is in the range of 10 or less.

The term “Satiety” as used herein, is post-ingestive or inter-meal satiety. The skilled person will understand the scope of the term. For example, satiety may be defined as the suppression of further intake of food after eating has ended, and may be assessed in terms of intensity, i.e., the amount of food consumed at a subsequent eating event, and in terms of strength, i.e., the duration of the suppression of hunger (see Blundell J E: Hunger, Appetite and satiety—constructs in search of identities. In: Turner M (ed) Nutrition and Lifestyles. Applied Science Publishers, London 1979; 21-42, incorporated herein by reference). Human appetite is controlled by central and peripheral mechanisms that interact with the environment. The nutrient composition of foods is especially important. Foods varying in their nutrient content engage differently with the mediating processes to exert different physiologic effects. Some of these effects are signals that induce satiety, which is the inhibition of hunger after a meal is eaten. Foods that increase satiety, such as fiber-rich foods, have been an area of active investigation. Epidemiological studies have highlighted the inverse association of dietary fibre and body weight and the reasons attributed were higher satiety and lower energy intake of high fibre foods. The mechanism could be related to many factors including changes in glucose, insulin, gut hormone concentrations, the gut microbiota, and enhanced production of short chain fatty acids (SCFA). Studies have shown an inverse association between the GI of the food and satiety. Foods with high GI may stimulate and increase the intake of subsequent meal. Foods with high satiety value would be helpful in reducing consequent meal intake and thereby reduce energy intake compared to foods with low satiety value.

The term “Diabetes” refers to a metabolic disorder wherein the main problem is that the glucose in the blood does not get cleared at a normal rate leading to elevated blood glucose levels. This has been linked to the hormone insulin. There are two main types of diabetes. In type 1, the body is unable to produce insulin. Onset of type 1 diabetes usually starts in childhood or young adulthood. In type 2 diabetes, not enough insulin is produced or the insulin that is produced doesn't effect the appropriate response. Type 2 diabetes tends to affect people as they get older. In both types the result is an inability to control blood glucose levels, leading to hyperglycaemia. Hyperglycaemia is the cause of symptoms associated with diabetes, such as polydypsia, polyuria and polyphagia and may contribute to the development of macrovascular disease, which is associated with the development of coronary artery disease. Since the body is unable to control the level of blood glucose, a major aspect of life for a person with diabetes is to manage blood glucose levels as close to normal as possible. Control of diet, in particular distribution of carbohydrate and sugar, in meals throughout the day is therefore of importance.

In an embodiments, the nutritional supplement compositions of the present invention further comprise emulsifier. Suitable emulsifiers include soy lecithin and glycerol monosterate and mixtures thereof.

Suitably, leavening agents are added during processing at from 0.5 to 1.5 % w/w of the total ingredients. Suitable leavening agents include sodium chloride, cumin dry powder, asofoetida and calcium caseinate and mixtures thereof.
The nutritional supplement composition may also comprises a stabilizer. Any stabilizer that is known or otherwise suitable for use in a nutritional composition may be suitable for use herein include gums such as xanthan and carrageenan gum.

All percentages, parts and ratios as used herein, are by weight of the total formulation, unless otherwise specified. All such weights as they pertain to listed ingredients are based on the active level and, therefore, do not include solvents or by-products that may be included in commercially available materials, unless otherwise specified.

Nutritional supplement composition of the present disclosure can be prepared by dry blending all of the ingredients together to form a dry blended base powder into which Spray-dried mineral and vitamin premix are added and dry blended using ribbon blender.

Alternatively, the nutritional supplement composition of the present disclosure can be prepared using conventional wet processes which generally include utilizing two or more slurries that are ultimately mixed together, treated, and dried.

The term "serving" as used herein, unless otherwise specified, refers to an amount of a nutritional composition administered, or intended to be administered, in a single administration event. In certain exemplary embodiments, the nutritional composition is packaged as a single serving. In certain exemplary embodiments, the nutritional supplement composition is packaged in a container containing multiple servings, wherein the container bears instructions on how to separate a single serving of the nutritional composition from the bulk nutritional composition.

The following examples illustrate specific embodiments and/or features of the dry blended nutritional supplement composition. All exemplified amounts are weight percentages based upon the total weight of the composition, unless otherwise specified. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the present disclosure, as many variations thereof are possible without departing from the spirit and scope of the disclosure.

The example clearly indicate that amount of nutritional supplement present in the present invention is higher even though part of it consume along with the daily food, so it helps to overcome from disease condition occur due to deficiency of nutrients. The Nutritional supplement helps to overcome disease condition like osteomalacia, beriberi, scurvy, muscular distrophy, anemia, nocturnal muscle cramps, intermittent claudication, fibrocystic breast disease, atherosclerosis, pellagra and other disease condition which occur due to deficiency of nutrients.

The Nutritional supplement is prepared by using spray drying process that adds novelty in the invention. The process aids in improving the solubility and gets it easily dispersed in water or milk without forming lumps in dispersion.

EXAMPLES
Example 1 illustrates an exemplary embodiment of a nutritional composition comprising one or more plant based proteins. All ingredient amounts are listed as total amount included in a 1000 kg total batch. Appropriate overages of vitamins added to compensate loss of potency during storage.
Table 3. COMPOSITION DETAILS
Ingredient kg/1,000 g
Defatted soybean flour 475
Gram flour 240
High Oleic Sunflower Oil 140
Ragi flour 50
Soy oil 24
Soy lecithin 6
Mineral Premix 0.12
Vitamin Premix 0.13
Sucralose/Fructose 30
Other additives* q.s.
*Other additive mixtures contains xanthan gum powder, carboxy methyl cellulose powder, sodium chloride, cumin dry powder, turmeric powder, ginger dry powder, garlic powder, asofoetida and calcium caseinate.

Table 4. NUTRITIONAL INFORMATION (Approximate values)
Nutrients Unit Per 100g Per Serving 25g % RDA*
Energy kcal 318.00 79.50 2.91%
Protein g 30.00 7.50 12.50%
Carbohydrates g 27.00 6.75 **
Added Sugar g 0.00 0.00 **
Dietary Fibre g 12.00 3.00 **
Fat g 10.00 2.50 8.33%
Saturated Fatty Acids g 1.30 0.33 **
Monounsaturated Fatty Acids g 4.40 1.10 **
Polyunsaturated Fatty Acids g 4.20 1.05 **
Cholesterol mg <1 <1 **
VITAMINS
Vitamin C mg 54.05 13.51 33.77%
Vitamin B5 mg 4.45 1.11 **
Vitamin E mg 4.05 1.01 10.10%
Biotin mcg 13.34 3.33 **
Vitamin B6 mg 1.08 0.27 13.50%
Vitamin B2 mg 0.98 0.25 15.62%
Vitamin B1 mg 0.76 0.19 13.57%
Folic Acid mcg 124.52 31.13 15.56%
Vitamin A mcg 243.24 60.81 10.13%
Vitamin K mcg 21.62 5.41 9.83%
Vitamin D mcg 7.12 1.78 17.80%
Vitamin B12 mcg 1.35 0.34 34.00%
MINERALS
Potassium mg 889.43 222.35 5.92%
Magnesium mg 71.15 17.78 5.22%
Zinc mg 4.45 1.11 9.25%
Iron mg 5.34 1.33 7.82%
Manganese mg 1.25 0.31 6.20%
Copper mcg 548.65 137.16 10.16%
Iodine mcg 102.70 25.68 17.12%
Chromium mcg 45.95 11.49 34.81%
* % RDA value Established as per ICMR Guidelines.
** % RDA value Not Established.

Brief Manufacturing Process
Nutritional supplement composition of the present invention is made by the following process:
a) Premix of defatted soybean flour, gram flour, high oleic sunflower oil, ragi flour, soy oil and soy lecithin was prepared by dry blending.
b) Premix of Vitamins and Minerals was prepared separately and spray-dried.
c) The half the quantity of premix spray-dried powder of step b and maltodextrin was transferred into a blender containing Premix powder of step a.
d) Subsequently the other additives were added into the step c.
e) The remaining half the quantity of premix spray-dried powder of step b and maltodextrin were added into step d and blended for 10 minutes.
f) Blend of step e was lubricated with colloidal silicon dioxide and blended.
g) Weighted quantities of powder was collected in IPC/HDPE container and labelled.
Study summary
The objective of this study was to assess the Glycemic index (GI) without milk and Glycemic response (GR) with milk of two different flavours of a plant-based supplement which is high in protein and fibre, along with a subjective assessment of satiety.
a) Glycemic Index (GI) and Glycemic response (GR)
The GI and GR of test foods were determined in fifteen overweight/ obese volunteers with mean age of 31.7 ± 2.0 years and mean body mass index (BMI) of 26.5 ± 0.8 kg/m2.
The amounts of test food for dietary GI study (each containing 25 g available carbohydrates) were as follows:
1) 134 g of nutritional supplement (flavor 1) mixed in 670 mL of water
2) 153 g of nutritional supplement (flavor 2) mixed in 765 mL of water
The test foods for glycemic response (GR) study (each containing 25 g available carbohydrates) were as follows:
1) 46 g of nutritional supplement (flavor 1) mixed in 300 mL of milk
2) 38 g of nutritional supplement (flavor 2) mixed in 345 mL of milk
Reference food was 27.5 g of monohydrate glucose dissolved in 100 mL of water for both GI and GR.

Participants underwent 3 days of reference food testing and 1 day of test food in random order with 2 days of wash-out period. The GI was assessed using a validated protocol recognized by FAO/WHO, as well as the guidelines by the International Dietary Carbohydrate Task Force for GI Methodology.
Capillary blood glucose was measured at fasting (0 minute), 15, 30, 45, 60, 90 and 120 minutes after consuming reference and test food for both GI and GR study. Incremental area under the blood glucose response curve (IAUC) was calculated. Individuals with GI > mean ± 2 SD (unrepresentative response) were considered as outliners. Each subject’s IAUC after consumption of the test food was expressed as a percentage of the mean IAUC after standard glucose taken by the same subject to calculate individual GI and GR. The mean value of the test foods is declared as GI of ‘Test foods’ and GR of ‘Test foods’.

Results:
Table 5. Glycemic Index (GI) [Mean ± *SEM] of ‘Test foods’ (n=15)
Test and Reference Food Glycemic Index GI category
Composition favor-1 with water 27.3 ± 4.8 Low
Composition favor-2 with water 36.7 ± 4.4 Low
Glucose (Reference food) 100 -
*SEM: Standard Error of Mean
Table 6. Glycemic Response (GR) [Mean ± *SEM] of ‘Test foods’
Test and Reference Food Glycemic Response
Composition favor-1 with milk 3% fat (n=14) 16.4 ± 2.6
Composition favor-2 with milk 3% fat (n=13) 25.7 ± 2.3
Glucose (Reference food) 100
*SEM: Standard Error of Mean
The Glycemic Index for both the flavours is below 55 and therefore has a low GI. The product is scientifically designed to have high fibre and high protein. The protein and fibre content of the product contributes to the low GI.

In healthy individuals, stepwise increases in glycemic load (GL) have been shown to predict stepwise elevations in postprandial blood glucose and/or insulin levels. The GL of Composition favor-1 is 1.84 while that of Composition favor-2 is 2.01. Thus the GL of both the flavours is low. The glycemic response of the product is also low when consumed with milk, as is its glycemic load.

b) Satiety
The test foods were provided to participants between 4.00pm-5.00pm in random order with at least 2 days gap as a washout period between each test food. Satiety index rating using the visual analogue scale (VAS) was performed soon after the complete ingestion of the test food and also when a participant reported ‘feeling hungry’ after the consumption of each test food.
Table 7. ATTRIBUTES AND RATING SCALE
Attributes Rating scale
Extremely hungry (-3)
Hungry (-2)
Semi hungry (-1)
No particular feeling (0)
Semi satisfied (1)
Satisfied (2)
Extremely satisfied (3)

The dietary intake on the day prior to the test and on the day of the test was assessed using 24-hour dietary recall. During the entire study period, all the participants were advised not to alter any other aspects of their lifestyle. Satiety ratings of the products tested are given in Table 9. Overall, all the 4 test foods showed similar satiety related ratings (response). After consumption of flavour 2 of drink with either water or milk, 60% of subjects felt “Semi hungry”. For flavour 1 with water, 47% of the subjects felt “semi hungry” and with milk, 53% felt “semi hungry”. This “semi hungry” response was reported 3.1 hours post-ingestion of nutritional supplement flavour-1 with water before the next meal/drink, whereas for nutritional supplement flavour-1 with milk, the duration was reduced to 2 hours. However, flavour 2 with either milk or water provided satiation for just 1.6 to 1.9 hours among those who reported “semi hungry”.

Table 8. SATIETY RATING FOR THE TEST PRODUCTS.
Test Foods Overall Hungry n (%) (semi hungry and hungry) Hungry n (%) Semi Hungry n (%) No Particular Feeling n (%) Satisfied n (%)
Composition favor-1 with water 9 (60.0%) 2 (13.3%) 7 (46.7%) 5 (33.3%) 1 (6.7%)
Composition favor-1 with milk 10 (66.7%) 2 (13.3%) 8 (53.3%) 4 (26.7%) 1 (6.7%)
Composition favor-2 with water 11 (73.3%) 2 (13.3%) 9 (60.0%) 3 (20.0%) 1 (6.7%)
Composition favor-2 with milk 11 (73.3%) 2 (13.3%) 9 (60.0%) 3 (20.0%) 1 (6.7%)

The “overall hungry” satiety rating was derived from the average of “hungry” and “semi hungry” responses reported in the VAS. Almost two-thirds of the study subjects (60%) reported an “overall hungry” rating after 3 hours of ingestion of flavour 1 with milk, while 66.7% reported this rating after 2.3 hours. Although almost three-fourths of the study subjects (73%) reported feeling “overall hungry” for flavour 2 with water and milk, the average duration being 1.7 hours for flavour 2 with milk and 2.3 hours for flavour 2 with water. There was only 1 subject who reported “satisfied” (feeling full) for almost 5 hours for flavour 2 with milk whereas another subject reported feeling “satisfied” [but only for 1.3 hours], as the subjects used to take evening beverage of soup at this hour. Soon after the ingestion of test foods, 75% of the subjects reported feeling “semi satisfied”.

Clinically, the data suggest that the test product was having low Glycemic Index values. Based on the acute glycemic profile, in its recommended serve size, the nutritional supplement composition of the present application is suitable for consumption by people with type 2 diabetes and Supports weight management.
,CLAIMS:We Claim
1. A high protein nutritional supplement composition comprising one or more plant based proteins, and millets.

2. The composition as claimed in claim 1, wherein the plant based proteins comprises defatted soy flour, gram flour and combinations thereof.

3. The composition as claimed in claim 1, wherein the millets is selected from group consisting of jowar, finger millets, foxtail millet, bajra, barnyard millet, proso millet, little millet and combinations thereof.

4. The composition as claimed in claim 1, wherein the composition is having glycemic index value of less than 55.

5. The composition as claimed in claim 1, wherein the composition is having glycemic load value of less than 10.

6. The composition as claimed in claims 1, wherein the composition further comprises one or more of vitamins are selected from the group consisting of vitamin A, Vitamin C, vitamin D, vitamin E, vitamin K, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B12, and combinations thereof.

7. The composition as claimed in claims 1, wherein the composition further comprises one or more of minerals are selected from the group consisting of sodium, potassium, magnesium, zinc, iron, manganese, copper, iodine, chromium, calcium, phosphorus, selenium, chloride, molybdenum, and combinations thereof.

8. The composition as claimed in claim 1, wherein the protein content of the said composition is more than about 25%.

9. The composition as claimed in claim 1, wherein the composition further comprising fibers, wherein the fibers content is more than about 10%.

10. The composition as claimed in claim 9, wherein fibers are selected form fructooligosaccharide, modified corn dextrin, modified wheat dextrin, inulin, and combinations thereof.