Composition for lowering the glycemic index of the food

Abstract

The present application relates to a nutraceutical composition for oral administration. Particularly, the application relates to a nutraceutical composition comprising one or more fiber source(s) and micronutrients, which is useful to manage postprandial sugar spikes. More particularly, the application relates to a nutraceutical composition comprising one or more fiber source(s) and micronutrients which can be consumed directly or as an adjunct to the food items in order to lower the glycemic index of the food, which in turn may help to manage or reduce the sugar spikes in the subject.

Description

COMPOSITION FOR LOWERING THE GLYCEMIC INDEX OF THE FOODFIELD OF THE APPLICATION

[0001] The present application relates to a nutraceutical composition for oral administration. Particularly, the application relates to a ready-to-consume nutraceutical composition for subjects including prediabetic and diabetic conditions. More particularly, the application relates to a nutraceutical composition comprising one or more fiber source(s) and micronutrients which can be consumed directly or added / mixed to any of the food items in order to lower the glycemic index of the food, which in turn may help to manage or reduce the sugar spikes in the subject.BACKGROUND

[0002] Glucose is human body’s main and preferred source of energy. It is also the most important substrate of energy metabolism of cells. The nervous system, blood cells and several other parts of the human body are strictly dependent on glucose for energy gain.

[0003] Insulin is a polypeptide hormone that regulates glucose levels in the bloodstream. Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Hyperglycaemia, also called raised blood glucose or raised blood sugar, is a common effect of uncontrolled diabetes and over time leads to serious damage to many of the body's systems, including the nerves system and the blood vessels.

[0004] The normal fasting blood glucose concentration are between 70 mg / dL (3.9 mmol / L) and 100 mg / dL (5.6 mmol / L). Thus, a fasting blood sugar level of 99 mg / dL or lower indicates that individual has normal blood sugar levels, 100 to 125 mg / dL indicates that the individual may be prediabetic, and 126 mg / dL or higher indicates that the individual may be a diabetic, that needs medical attention.

[0005] A blood sugar spike occurs when body’s blood glucose level rises sharply right after eating food. When people eat a meal, especially when it contains carbohydrates, there is spike in their sugar level, often known as a postprandial sugar spike. Postprandial glucose level in people with normal glucose tolerance is less than 7.8 mmol / L (140 mg / dL) in response to meals and typically returns to premeal levels within two to three hours. Thecondition when plasma glucose level is abnormally increased in the postprandial state is termed as postprandial hyperglycaemia. In case of postprandial hyperglycaemia, plasma glucose level is greater than 7.8 mmol / L (140 mg / dL) 1-2 hours after ingestion of food.

[0006] Postprandial hyperglycaemia has been identified as an independent risk factor for cardiovascular diseases (CVDs) in both diabetic and non-diabetic individuals and has been proposed as an important predictor of diabetes-related complications as compared with other glycemic markers. It is considered as a key prevention and treatment target for individuals with and without diabetes.

[0007] Intake of dietary fiber can affect stomach function, by promoting satiety and slowing down the nutrient absorption. Further intake of dietary fiber can favourably influence the change in gut hormone levels that act locally and, in the brain, to affect eating behaviour. However, directly consuming the high fiber components is not feasible because of its dry rough texture, non-palatable taste and bulky volumes that needs to be consumed, in order to meet the daily dietary requirement.

[0008] Hence, there is a need to develop a composition comprising effective amount of fiber, wherein the composition is tasteless, odourless and palatable with or without any adjuvant food items. The composition may be further useful in managing the postprandial hyperglycemia and or blood sugar spikes in prediabetic, diabetic or non-diabetic people; irrespective of their age, gender, lifestyle or metabolic conditions.

[0009] The present application aims to provide a nutraceutical composition comprising effective amounts of fiber and capable of managing postprandial blood sugar spikes.

[0010] The nutraceutical composition should also comply with the criteria for general physicochemical characteristics, have a good shelf stability, and should meet the desired standards for taste, texture and other organoleptic properties. The ingredients of the composition, should be compatible with each other which can provide desired benefits ultimately leading to overall health improvement.

[0011] Hence, present application relates to a blend of one or more fiber source(s) and micronutrients, which is useful to manage postprandial sugar spikes in people irrespective of their age and metabolic conditions. More specifically, present application relates to a composition comprising of one or more fibers and micronutrients which either can beconsumed directly or as an adjunct to the foods to lower the glycemic index (GI) of the food to which it has been added or consumed with.SUMMARY OF THE APPLICATION

[0012] The primary object of the present application is to provide a nutraceutical composition comprising one or more fiber source(s) and micronutrients, which is intended to lower the glycemic index (GI) of the food to which it is added or consumed with; without altering the taste and flavour of the food.

[0013] Another object of the present application is to provide a nutraceutical composition comprising specifically curated combination of resistant fibers, digestible carbohydrate and micronutrients which is intended to lower the glycemic index (GI) of the food to which it is added or consumed with.

[0014] Another object of the present application is to provide a nutraceutical composition comprising a combination of resistant maltodextrin, digestible maltodextrin and micronutrients, which may be useful in managing the postprandial glucose or sugar spikes.

[0015] Another object of the present application is to provide a nutraceutical composition comprising a combination of resistant maltodextrin, digestible maltodextrin, and micronutrients designed for daily consumption by subjects, including individuals having diabetes and prediabetes conditions.

[0016] Another object of present application is to provide a nutraceutical composition in the form of a powder to be consumed directly or as an adjunct to the food items, and which may lower the GI of the food to which it has been added. The composition further helps to manage blood glucose or sugar spikes in the subject.

[0017] Yet another object of the present application is to provide a nutraceutical composition comprising a combination of resistant maltodextrin, digestible maltodextrin, and micronutrients designed for daily consumption with food to increase the satiety level of the subject, as compared to the consumption of food without the said composition as add-on.

[0018] Other objects and advantages of the present application will become apparent to those skilled in the art upon reading the following detailed description of the preferred embodiments.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The compositions of the present application were subjected to in-vivo clinical studies, with glucose used as a reference standard. The accompanying drawings, which are incorporated herein and constitute a part of this invention, illustrate exemplary results and different outcomes of the clinical studies. These drawings comprise the graphical representation of the outcomes of clinical studies. Components in the drawings are not necessarily to scale; emphasis is instead placed upon clearly illustrating the results of clinical studies in order to underscore the clinical effect of the compositions of the present invention. It will be appreciated by those skilled in the art that the results of clinical studies are often represented graphically for clear understanding of clinical efficacy of a formulation as represented herein.

[0020] Figure 1 depicts the graph showing mean change in blood glucose concentration after consuming ‘Test Food A’, in comparison with ‘Reference Food’; over a period of 2 hours.

[0021] Figure 2 depicts the graph showing mean change in blood glucose concentration after consuming ‘Test Food B’ in comparison with ‘Reference Food’; over a period of 2 hours.

[0022] Figure 3 depicts the graph indicating the mean change in levels of plasma GLP-1 (in terms of incremental Area under the curve i.e. IAUC) in case of test meals.DETAILED DESCRIPTION OF THE APPLICATION

[0023] The details of one or more embodiments of the present invention are set forth in this document. Modifications to embodiments described in this document and other embodiments will be evident to those of ordinary skill in the art after studying the information provided in this document. The information provided in this document, particularly the specific details of the described exemplary embodiments, is provided primarily for clear understanding, and no unnecessary limitations are to be understood therefrom.

[0024] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by a person having an ordinary skill in the art.

[0025] The present application teaches a nutraceutical composition comprising one or more fibers and micronutrients which is useful to manage postprandial sugar spikes and suitablefor oral administration by individuals of wide range of age groups including prediabetic and diabetic people.

[0026] Definitions: The terms as used herein have the following meanings:

[0027] The term “comprising” is “open-ended” and means the elements recited, or their equivalent in structure or function, plus any other element or elements which are not recited. The terms “having” and “including” are also to be construed as open-ended unless the context suggests otherwise. These terms are not in the exclusive sense of “consisting only of’. All ranges recited herein include the endpoints, including those that recite a range “between” two values.

[0028] The terms “a” and “the” as used herein are understood to encompass the plural as well as the singular or otherwise clearly mentioned wherever needed. For example, “an excipient” includes one or more of such excipients.

[0029] As used herein, “about”, “up to” is understood to refer to numbers in a range of numerals. Moreover, all numerical ranges herein should be understood to include all integers, whole or fractions, within the range.

[0030] As used herein, the term “at least” refers to the presence of the recited substance in the composition in recited least amount.

[0031] The term, “effective amount” is an amount that prevents a deficiency, treats a disease or medical condition in an individual, or, more generally, reduces symptoms, manages progression of the diseases, or provides a nutritional, physiological, or medical benefit to the individual. Treatment can be patient- or doctor-related.

[0032] While the terms “subjects,” “individual,” and “patient” are used herein to refer to a human, the application is not so limited. Accordingly, the terms “individual” and “patient” refer to any human, healthy or having risk or at a risk for a medical condition that can benefit from or may need the nutraceutical composition as described herein in the present application.

[0033] The terms “excipient(s)” or “additive(s)” are used interchangeably to mention any safe food acceptable material or a component of the composition that is not having any pharmacological effect, which is acceptable for use in nutraceutical compositions and doesnot provide any therapeutic effect, and may contribute to physicochemical properties or any relevant nontherapeutic function of the composition. The excipients that are useful in preparing a nutraceutical composition are generally safe, non-toxic, do not interact with other components of a composition in a deleterious manner, and are acceptable for human or veterinary use. As used in the specification, the term “excipient” includes both one and more than one such excipients.

[0034] The terms “composition” and “formulation” are used interchangeably and refer to a mixture of two or more components, elements, or fractions. Also, the terms “composition” and “formulation” may be used to refer to a mixture of the components with or without excipients or other carriers. The nutraceutical compositions in the present application are selected from, but are not limited to, powders, granules, pellets, minitablets, sachets, or capsules. As used in the specification, the term “composition” and “formulation” includes both one and more than one such compositions / formulations.

[0035] “Nutritional compositions” or “Nutraceutical preparation” or “Nutraceutical composition” or “Nutritional preparation” as used herein, are understood to include one or more of the dietary nutrients as components and any number of additional optional ingredients, including, but not limited to, conventional food additives, health benefit additives, one or more, acidity regulators, thickening / gelling agents, buffers or agents for pH adjustment, chelating agents, colorants, flavorants, emulsifiers, mineral osmotic agents, pharmaceutically acceptable carrier, preservatives, anti-oxidants, stabilizers, sweeteners, texturizers. The optional ingredients can be added in any suitable amount. “Nutritional composition” further means a substance or composition that satisfies at least a portion of a subject’s nutrient requirements. In the present application, the terms “Nutritional compositions”, “Nutritional preparations”, “Nutraceutical preparations” and “Nutraceutical compositions” or are used interchangeably.

[0036] The term “food(s)” or “food item(s)” include, but are not limited to, the raw and cooked / fried / roasted / boiled / ready to eat edible items, salads, dressings, cereals, meals, snacks, bakery products, dairy products, confectionary items, fluids and beverages for human consumption that provide one or more of macronutrients, micronutrients (including carbohydrates, proteins, fats, vitamins, minerals and water) and energy to the subject. The food can be solid, semi-solid or liquid.

[0037] The terms “supplement”, “adjunct” and “add-on” mean and include, but are not limited to, the compositions that are added to or sprinkled over or consumed with the foods in order to improve or alter their nutritive value, alter their GI, make up for a deficiency or to bring in desired change etc. In the present application the terms “supplement”, “adjunct” and “add-on” are used interchangeably.

[0038] The term “carbohydrate” is construed as per its general meaning and includes, but is not limited to, sorbitol, xylitol, or maltitol, trehalose, maltodextrin, processed starch, amylose starch, tapioca starch, fructose, lactose, and the like or combinations thereof.

[0039] The term “maltodextrin” denotes nutritive saccharide polymers which are partially hydrolyzed starches, composed of longer chains than glucose. Maltodextrins are water soluble compounds which are produced from starches from various plant sources like com, potato, wheat, rice, tapioca, sago palm, barley, sorghum and any other similar sources. Maltodextrins as described in the present application can be digestible maltodextrins or indigestible or resistant maltodextrins.

[0040] The term “digestible maltodextrins” denotes saccharide polymers consisting of D- glucose units linked primarily linearly with alpha- 1,4 bonds, but can also have a branched structure through alpha- 1,6 bonds. Digestible maltodextrins are glucose polymers derived from plant starches and they are rapidly digested and provide glucose as food energy. Often, maltodextrins are classified by the amount of reducing sugars present relative to the total carbohydrate content; between 3 and 20 percent in the case of digestible maltodextrins. Glucose from digested maltodextrins is rapidly absorbed in the small intestine. These relatively small polymers are used as food ingredients derived by hydrolysis from crops naturally rich in starch. Some examples of digestible maltodextrins include, but are not limited to, com-based maltodextrin, rice-based maltodextrin, potato-based maltodextrin, wheat-based maltodextrin etc.

[0041] The term “resistant maltodextrin” or “indigestible maltodextrin” denotes the maltodextrin resistant to human digestive enzymes which is not absorbed in the small intestine and thus passes to the large intestine where it is fermented by the colonic bacteria producing short-chain fatty acids, which lower colon pH and promote the growth of gutfriendly microbes. Resistant maltodextrins or digestion-resistant maltodextrins are specially processed starch-derived fibers that resist digestion in the small intestine and areinstead fermented by gut bacteria. Examples include, but are not limited to, Fibersol® which is commercially available resistant maltodextrin derived from corn starch.

[0042] The degree of polymerization (DP) is defined as the number of repeating monomeric (glucose) units that are linked together in a polymer chain. In simple terms, DP is a measure of the chain length of the polymer. For carbohydrates like maltodextrins, it is calculated as the ratio of the polymer's molecular weight to that of the repeating glucose unit. This parameter plays a crucial role in determining the solubility, viscosity, and fermentability of the product. In the case of resistant maltodextrins, such as Fibersol, the DP is intentionally engineered to achieve a balance between resistance to digestion and desired functional properties. The DP value for specific maltodextrins may vary depending on processing and formulation goals. For examples, DP values around 1-4 may yield a more soluble product with lower viscosity. Higher DP values around 8-15 generally produce a polymer that offers increased viscosity, and higher prebiotic effects and modified fermentation profiles. Manufacturers adjust processing conditions such as the enzyme treatment and hydrolysis steps etc. to fine-tune the DP distribution, ensuring these resistant maltodextrins meets the specific functionality required for its intended nutritional or food application.

[0043] In an embodiment, the resistant maltodextrin may exhibit a degree of polymerization from about 4 to about 20, imparting prebiotic properties while resisting digestive enzyme activity in the small intestine. In a further embodiment, the resistant maltodextrin may exhibit a degree of polymerization from about 6 to about 18.

[0044] Starch hydrolysis products are commonly characterized by their degree of hydrolysis, expressed as the dextrose equivalent (DE), which is the percentage of reducing sugar calculated as dextrose on dry-weight basis. The DE value is inversely related to molecular weight, i.e., the degree of polymerization (DP), and is an indicator of the degree of hydrolysis. Thus, glucose has a DE value of 100, while intact starch may have an effective DE of O.

[0045] The term “fiber” is construed as per its general meaning and includes, but is not limited to, dietary fibers, both digestible and non-digestible, or any mixture of dietary fibers; more preferably one or more of fructo-oligosaccharides (FOS), soluble non-starch polysaccharides, insoluble non-starch polysaccharides, non-digestible oligosaccharides, inulin, acacia fiber, arabic gum, soy polysaccharide, alpha-cellulose, resistant starch,resistant maltodextrins and the like or combinations thereof. Fibers can be classified as soluble fibers i.e. those which dissolve in water and forms a gel-like substance in the stomach, slowing down digestion; they help to control your blood sugar and cholesterol and non-soluble fibers i.e. those which do not dissolve in water and remain whole as they pass through the stomach; they support insulin sensitivity and help to keep the bowels healthy.

[0046] The sources of soluble fibers include, but are not limited to, apples, bananas, oats, peas, black beans, lima beans, apples, citrus fruits, carrots, barley, psyllium, brussels sprouts, and avocados.

[0047] The sources of insoluble fibers include, but are not limited to, whole wheat flour, bran, nuts, seeds, and the skins of many fruits and vegetables (such as cauliflower, green beans and potatoes).

[0048] The term “micronutrient premix” denotes the mixture of one or more of vitamins, minerals and mixtures or combinations thereof.

[0049] The term “vitamin” includes, but is not limited to, any of various fat-soluble or water- soluble organic substances essential in minute amounts for normal growth and activity of the body and obtained naturally from plant and animal foods or synthetically made, provitamins, derivatives, analogs and the like or combinations thereof.

[0050] The examples of vitamins include, but are not limited to, vitamin A, vitamin Bl (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin or niacinamide), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine, pyridoxal, or pyridoxamine, or pyridoxine hydrochloride), vitamin B7 (biotin), vitamin B9 (folic acid), and vitamin B12 (various cobalamins; commonly cyanocobalamin in vitamin supplements), vitamin C, vitamin D, vitamin E, vitamin K and combinations thereof.

[0051] The term “diabetes” or “diabetes mellitus (DM)” denotes a disease of inadequate control of blood levels of glucose. It is a heterogeneous metabolic disorder characterized by the presence of hyperglycemia due to impairment of insulin secretion, defective insulin action or both. It has many sub classifications, including type 1, type 2, maturity-onset diabetes of the young (MODY), gestational diabetes, neonatal diabetes, and steroid- induced diabetes. Type 1 and 2 DM are the main subtypes, each with differentpathophysiology, presentation, and management, but both have a potential for hyperglycemia. Type 1 diabetes mellitus (T1DM) is characterized by the destruction of beta cells in the pancreas, typically secondary to an autoimmune process. The result is the absolute destruction of beta cells, and consequentially, insulin is absent or extremely low. Type 2 diabetes mellitus (T2DM) involves a more insidious onset where an imbalance between insulin levels and insulin sensitivity causes a functional deficit of insulin. Insulin resistance is multifactorial but commonly develops from obesity and aging. T1DM largely affects children or adolescents, while T2DM is thought to affect middle-aged and older adults who have prolonged hyperglycemia due to poor lifestyle and unhealthy dietary choices.

[0052] The term “prediabetes” refers to blood glucose levels that are higher than normal, but not yet high enough to be diagnosed as type 2 diabetes. In the condition of prediabetes, individuals at high risk of developing diabetes and its complications.

[0053] The “glycemic index (GI)” defined as a rating system for foods containing carbohydrates that shows how quickly each food affects your blood sugar (glucose) level when that food is consumed. The glycemic index compares the potential of foods containing the same amount of carbohydrate to raise blood glucose. According to the GI, foods are ranked according to how fast they are digested into glucose and how much each food causes blood glucose to rise. Glucose is used as the standard at GI = 100. Pure sugar creates the greatest rise, and then cereals (about 60-75 GI), fruits (about 40-65 GI), dairy products (about 30-40 GI), and finally legumes with the least potential rise in blood glucose (about 15-35 GI). The GI of foods is influenced by many factors like fat, protein, dietary fibre, cooking method, chewing time and carbohydrate’s chemical structure. Further, the GI of a food varies when eaten alone and when consumed along with other foods. Fat, protein and dietary fiber can tend to lower the GI of a food.

[0054] In the present application, experimentally, the GI is defined as the incremental area under the blood glucose elicited by 50g of available carbohydrate containing test meal portion expressed as a percentage of the response of 50g of glucose (55g of glucose monohydrate) taken by the same participant.

[0055] Food and nutritional supplements are classified as low, medium, or high glycemic foods or supplements and ranked on a scale of 0-100. The lower the GI of a specific food orsupplement, the lesser and slower the tendency it has to affect the blood sugar levels. The general GI ratings followed in the nutritional and medical context are Low GI: 55 or less, Medium GI: 56-69, and High GI: 70 or above.

[0056] The term “fasting plasma glucose (FPG)” denotes the glucose levels in the blood sample of a subject who have fasted for at least 8 hours.

[0057] The term “postprandial glucose (PPG)” denotes the glucose levels in the blood sample of a subject 1-2 hours after ingestion of food.

[0058] The term “postprandial hyperglycemia” denotes the blood glucose level above a desirable level 1 or 2 hours after a person has consumed food. Postprandial hyperglycemia is characterized by abnormally increased levels of glucose in the postprandial state, and contributes to development of type 2 diabetes mellitus (T2D) which is often a comorbid condition along with cardiovascular diseases (CVDs).

[0059] In this application, the terms “blood glucose” and “plasma glucose” are used interchangeably.

[0060] The term “total sugar” in a composition denotes complete sugar content of the composition. The term “total sugar” includes both “added sugar” and “natural sugar”.

[0061] The term “added sugar” as used herein, denotes one or more of natural or artificial sweeteners added to the composition during formulation or manufacturing or processing of the composition. The term “added sugar” includes, but is not limited to, glucose, fructose, sucrose, dextrose, lactose, maltose, sucralose, invert sugar, malt sugar, honey, maple syrup, corn syrup, brown sugar, fruit juice concentrate etc.

[0062] The term “natural sugar” as used herein, denotes the sugar components that are found naturally in any of the ingredients of the composition other than the sweeteners.

[0063] In this application, the terms “sugar spikes” and “glucose spikes” are used interchangeably.

[0064] The terms “container, pack or packaging” as used herein means the combination of components necessary to contain, preserve, protect and deliver a safe, efficaciouscomposition, such that at any time point before expiry date of the composition, it remains safe and stable.

[0065] The term “water activity” (a w) of a food refers to the ratio between the vapour pressure of the food itself, when in a completely undisturbed balance with the surrounding air media, and the vapour pressure of distilled water under identical conditions. Moisture content defines the amount of water in food and ingredients, whereas water activity explains how the water in your food will react with microorganisms. Foods having a water activity above 0.95 will provide sufficient moisture to support the growth of bacteria, yeasts, and mold. Some yeasts and molds can grow at water activities as low as 0.60. Foods with water activity below 0.60 are generally considered microbiologically stable. The parameters moisture content and water activity as measured herein, help to determine the efficacy of packaging used for the formulations.

[0066] As per the present application, the terms “to manage” or “managing” means and include, but not limited to, “to alter”, or “to reduce” or “to improve” or, to bring in desired change etc.

[0067] Unless otherwise stated, this application uses following abbreviations:

[0068] Present application relates to a nutraceutical composition for oral use comprising of a blend of one or more fiber source(s) and micronutrients along with nutraceutically acceptable excipients, meant to manage the postprandial sugar spikes. More specifically, it is a combination of resistant maltodextrin, digestible maltodextrin and essential micronutrients, designed to benefit a variety of population including prediabetic and diabetic individuals.

[0069] Present application relates to a unit composition which is a blend of one or more fiber source(s) and micronutrients which can either be consumed alone or as an adjunct to the foods, to lower the GI of the food to which it has been added.

[0070] Present application relates to a unit composition which is a blend of one or more fiber source(s) and micronutrients which can either be consumed alone or as an adjunct to the foods, to increase the satiety level of the subject as compared to the food without the said composition as add-on.

[0071] Accordingly, it would be beneficial to provide a nutritional composition comprising one or more fiber source(s) and micronutrients; supporting digestive health in an easy-to- carry and easy-to-consume form that is extremely convenient to manage blood sugar spikes in daily hectic routines of different individuals.

[0072] It is pertinent to note that the composition of the present disclosure is suitable for consumption of a variety of individuals including diabetic and prediabetic subjects owing to the meticulous choice of ingredients both qualitatively and quantitatively.

[0073] Present application relates to a composition which attempts to combine the health benefits of fibers and necessary micronutrients in order to achieve improvements in overall digestive health of a subject irrespective of age, gender, lifestyle and physiological conditions.

[0074] The present application also describes a method for managing blood sugar spikes and also maintaining and enhancing the overall digestive health of a subject by administering the composition comprising of fibers and micronutrient along with necessary excipients imparting good palatability and better consumer acceptance.

[0075] In an embodiment, the nutraceutical composition comprises one or more fibers.

[0076] In an embodiment, the nutraceutical composition comprises one or more fibers selected from a group of compounds including, but not limited to, fructo-oligosaccharides (FOS), soluble non-starch polysaccharides, insoluble non-starch polysaccharides, non-digestible oligosaccharides, inulin, acacia fiber, arabic gum, soy polysaccharide, alpha-cellulose, resistant starch, resistant maltodextrins and the like and combinations thereof.

[0077] In an embodiment, the nutraceutical composition comprises dietary fiber in an amount of about 50% to 95% w / w of the composition.

[0078] In an embodiment, the nutraceutical composition comprises dietary fiber in an amount of about 60% to 85% w / w of the composition.

[0079] In an embodiment, the nutraceutical composition comprises dietary fiber in an amount of about 70% to 75% w / w of the composition.

[0080] In an embodiment, the nutraceutical composition of the present application comprises of a micronutrient premix.

[0081] In an aspect of above embodiment, the micronutrient premix comprises of one or more of vitamins and minerals and combinations thereof.

[0082] In an embodiment, the nutraceutical composition comprises one or more vitamins selected from vitamin A (retinol), vitamin Bl (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B8 (biotin), vitamin B9 (folic acid), vitamin B 12 (cyanocobalamin), vitamin C (ascorbic acid), vitamin D2 (ergocalciferol), vitamin D3 (cholecalciferol), vitamin E (alpha-tocopherol), vitamin K and, and the like and combinations thereof.

[0083] In an embodiment, the nutraceutical composition comprises micronutrient premix in an amount of about 0.01% to 1% w / w of the composition.

[0084] In an embodiment, the nutraceutical composition comprises micronutrient premix in an amount of about 0.01% to 2% w / w of the composition.

[0085] In an embodiment, the nutraceutical composition comprises micronutrient premix in an amount of about 0.05% to 1.5% w / w of the composition.

[0086] In an embodiment, the nutraceutical composition comprises micronutrient premix in an amount of about 0.1% to 1% w / w of the composition.

[0087] In an embodiment, the nutraceutical composition comprises vitamin D3.

[0088] In an embodiment, the nutraceutical composition comprises vitamin D3 in an amount of about 25 pg to 75 pg per 100 g of the composition.

[0089] In an embodiment, the nutraceutical composition comprises vitamin D3 in an amount of about 35 pg to 65 pg per 100 g of the composition.

[0090] In an embodiment, the nutraceutical composition comprises one or more carbohydrates selected from a group of compounds including, but not limited to, sorbitol, xylitol, maltitol, trehalose, maltodextrin, processed starch, amylose starch, tapioca starch, fructose, lactose, and the like and combinations thereof.

[0091] In an embodiment, the nutraceutical composition comprises maltodextrins.

[0092] In an aspect of above embodiment, the nutraceutical composition comprises one or more of resistant maltodextrins, digestible maltodextrins and combinations thereof.

[0093] In an embodiment, maltodextrins have a DE (dextrose equivalent) value between 3 and 20.

[0094] In an embodiment, resistant maltodextrin has a DE value in the range of 8 to 12.

[0095] In an embodiment, digestible maltodextrin has DE value in the range of 15 to 19.

[0096] In an embodiment, the nutraceutical composition comprises resistant maltodextrin and digestible maltodextrin in the ratio of 5 : 1 to 15: 1.

[0097] In an embodiment, the nutraceutical composition comprises resistant maltodextrin and digestible maltodextrin in the ratio of 7 : 1 to 13: 1.

[0098] In an embodiment, the nutraceutical composition comprises resistant maltodextrin and digestible maltodextrin in the ratio of 9: 1 to 11 : 1.

[0099] In an embodiment, the nutraceutical composition comprises resistant maltodextrin in an amount of about 50% to 95% w / w of the composition.

[0100] In an embodiment, the nutraceutical composition comprises resistant maltodextrin in an amount of about 60% to 85% w / w of the composition.

[0101] In an embodiment, the nutraceutical composition comprises resistant maltodextrin in an amount of about 70% to 75% w / w of the composition.

[0102] In an embodiment, the nutraceutical composition comprises digestible maltodextrin in an amount of about 5% to 40% w / w of the composition.

[0103] In an embodiment, the nutraceutical composition comprises digestible maltodextrin in an amount of about 10% to 30% w / w of the composition.

[0104] In an embodiment, the nutraceutical composition comprises digestible maltodextrin in an amount of about 15% to 20% w / w of the composition.

[0105] In an embodiment, the nutraceutical composition of the present application contains no added sugar. The total sugar content of the final composition is attributed to the one or more maltodextrins present in the composition.

[0106] In an embodiment, the nutraceutical composition of the present application has total sugar content less than 10% w / w of the composition.

[0107] In an embodiment, the nutraceutical composition of the present application has total sugar content of about 1% to 10% w / w of the composition.

[0108] In an embodiment, the nutraceutical composition of the present application has total sugar content of about 3% to 7% w / w of the composition.

[0109] In an embodiment, the nutraceutical composition of the present application has total fat content of about 0.01% to 0.5% w / w of the composition.

[0110] In an embodiment, the nutraceutical composition of the present application has total fat content of about 0.01% to 0.3% w / w of the composition.

[0111] In an embodiment, the nutraceutical composition of the present application has total fat content of about 0.01% to 0.1% w / w of the composition.

[0112] In an embodiment, the nutraceutical composition of the present application when consumed as an adjunct to the food, reduces the GI of the food by 5% to 30% as compared to the food, without the said composition as add-on.

[0113] In an embodiment, the nutraceutical composition of the present application when consumed as an adjunct to the food, reduces the GI of the food by 10% to 25% as compared to the food, without the said composition as add-on.

[0114] In an embodiment, the nutraceutical composition of the present application when consumed as an adjunct to the food, reduces the GI of the food by 15% to 20% as compared to the food, without the said composition as add-on.

[0115] In an embodiment, the nutraceutical composition of the present application when consumed as an adjunct to the food shows reduction in PPG of the subject by 5% to 20% as compared to the food, without the said composition as add-on.

[0116] In an embodiment, the nutraceutical composition of the present application when consumed as adjunct to the food shows reduction in PPG of the subject by 10% to 15% as compared to the food, without the said composition as add-on.

[0117] In an embodiment, the nutraceutical composition of the present application when consumed as an adjunct to the food increases GLP-1 levels in the subject which in turn increases insulin secretion and sensitivity and inhibits gastric acid secretion and emptying, thus increasing satiety signals in the brain.

[0118] In an embodiment, the nutraceutical composition of the present application when consumed as an adjunct to the food increases the satiety level of the subject by 5% to 30% as compared to the food without the said composition as add-on.

[0119] In an embodiment, the nutraceutical composition of the present application when consumed as an adjunct to the food increases the satiety level of the subject by 10% to 25% as compared to the food without the said composition as add-on.

[0120] In an embodiment, the nutraceutical composition of the present application when consumed as an adjunct to the food increases the satiety level of the subject by 15% to 20% as compared to the food without the said composition as add-on.

[0121] In an embodiment, the compositions of the present application when added as a supplement to the foods; do not affect the original colour or flavour or the taste of the food to which they are added.

[0122] In an embodiment, the nutraceutical composition of the present application provides energy in an amount of about 150 to 450 kcal / 100g of the composition.

[0123] In an embodiment, the nutraceutical composition of the present application provides energy in an amount of about 200 to 400 kcal / 100g of the composition.

[0124] In an embodiment, the nutraceutical composition of the present application provides energy in an amount of about 10 kcal to 30 kcal per unit of the composition.

[0125] In an embodiment, the nutraceutical composition of the present application is used for oral administration.

[0126] In another aspect of the present application, the oral nutraceutical composition is a powder, granules, pellets, minitablets, sachet, capsules for suitable oral consumption.

[0127] In an embodiment, the application relates to the process for preparation of the nutraceutical composition comprising of one or more fiber source(s) and micronutrients.

[0128] In an embodiment, the application relates to the process for preparation of the nutraceutical composition comprising of one or more fiber source(s) and micronutrients, wherein micronutrients comprise one or more vitamins.

[0129] An embodiment further relates to a process of preparation of the nutraceutical composition comprising: a) one or more fiber source(s); b) micronutrient premix; and c) nutraceutically acceptable excipients.

[0130] In an aspect of the above embodiments, the application further relates to a process of preparation of the oral nutraceutical composition, preferably powder or granules.

[0131] In a preferred embodiment of the present invention, the process comprises the following steps:1. Preparation of mixture: The ingredients are mixed in the required quantities.2. Unit doses of mixtures are packed in suitable pouch / container which are convenient to store and carry.

[0132] In an embodiment, per unit of the composition of the present application is in the range of 10g to 20g. The daily intake of the composition may involve a single or multiple units in order to achieve the desired effect.

[0133] According to one or more embodiments herein, the powder or granules prepared by the process known in the art including the teachings of the present application can be used in various food products / preparations including, but not limited to, cooked and raw food items including daily meals (for e.g. dough for roti, salads, cooked vegetables, curries, chutrieys, pickles, fruit juices, beverages etc.), fitness supplements, smoothies, breakfast cereals, cereal bars, munching snacks, trail mixes, energy bars, snacks for hiking etc.

[0134] In an embodiment of the present application, the compositions prepared can be further subjected to tests of colour, odour, taste etc. in order to ensure the consumer acceptance. They can be further evaluated using established tests and methods for the determination of various parameters including, but not limited to, particle size, particle shape, surface area, density (bulk density, true density, and granular density), granule strength, flow properties (angle of repose, Hausner ratio, % compressibility index), moisture content, % fines, and dissolution etc. in order to ensure their physicochemical properties and bioavailability. Further, necessary modifications can be made to the compositions and process by the person skilled in the art in order to comply with the necessary standards with respect to the sensory parameters and pharmacokinetic parameters. Also the compositions can be subjected to appropriate clinical studies to monitor change in the GI of the foods to which they are added.

[0135] In an embodiment, the composition of the present application prepared in the powder form.

[0136] In an embodiment, the composition of the present application has untapped bulk density in the range of 0.1 to 1.0 g / mL.

[0137] In an embodiment, the composition of the present application has untapped bulk density in the range of 0.3 to 0.9 g / mL.

[0138] In an embodiment, the composition of the present application has tapped bulk density in the range of 0.1 to 1.0 g / mL.

[0139] In an embodiment, the composition of the present application has tapped bulk density in the range of 0.3 to 0.9 g / mL.

[0140] In an embodiment, the composition of the present application has moisture content in the range of 1% to 10%.

[0141] In an embodiment, the composition of the present application has moisture content in the range of 2% to 7%.

[0142] In an embodiment, the composition of the present application has moisture content in the range of 3% to 5%.

[0143] In an embodiment, the composition of the present application has particle size (d90) in the range of 200 microns to 700 microns.

[0144] In an embodiment, the composition of the present application has particle size (d90) in the range of 300 microns to 650 microns.

[0145] In an embodiment, the composition of the present application has particle size (d90) in the range of 400 microns to 600 microns.

[0146] In another embodiment, the nutraceutical compositions of the present invention are packaged in an appropriate container and may undergo a secondary packaging.

[0147] For any of the above embodiments, the packaging or containers, disclosed herein, can include one or more of flexible containers, laminates, film wraps, cartons, card board box, jars, pouches and combinations thereof.

[0148] As used herein, when referring to a flexible container, the term “flexible material” refers to a thin, easily deformable, sheet-like material, having a flexibility factor within the range of 1,000-2,500,000 N / m.

[0149] As used herein, when referring to a sheet of packaging material, the term “thickness or overall thickness” refers to a linear dimension measured perpendicular to the outer major surfaces of the sheet, when the sheet is lying flat. For any of the embodiments of containers, disclosed herein, any of the packaging materials can be configured to have an thickness of between 5- 350 micron (pm), or any value for micrometers from 5-350, or within any range formed by any of these values, such as 10-300 pm, 15-250 pm, 20-200 pm, 25 -150 pm, 30-100 pm etc.

[0150] As used herein, when referring to a sheet of packaging material, the term “Optical Density or OD” refers to a value that indicates light transmittance of the material and is measured using an optical densitometer. For any of the embodiments of containers, disclosed herein, any of the packaging materials can be configured to have an optical density of 0.5- 5.0 g / cc or within any range formed by any of these values, such as 0.8- 4.5 g / cc, 1.0 - 4.0 g / cc, 1.5 - 3.8 g / cc, 2.0- 3.6 g / cc, 2.5- 3.5 g / cc etc.

[0151] As examples, the packaging materials such as films, card boards, boxes and nonwovens, can be made from one or more papers, corrugated sheets, thermoplastic polymers, as described herein and / or as known in the art. Thermoplastic polymers can include polyolefins such as polyethylene and / or copolymers thereof, including low density, high density, linear low density, or ultra-low density polyethylenes. Thermoplastic polymers, and their variations, as disclosed herein can be formed into a film and can comprise many different configurations, depending on the film properties desired. The properties of the film can be manipulated by varying, for example, the thickness, or in the case of multi-layered films, the number of layers, the chemistry of the layers, i.e., hydrophobic or hydrophilic, and the types of polymers used to form the polymeric layers. The films disclosed herein can be multi-layer films.

[0152] Other suitable polymers include polyamides or copolymers thereof, such as Nylon 6, Nylon 11, Nylon 12, Nylon 46, Nylon 66; polyesters and / or copolymers thereof, such as maleic anhydride polypropylene copolymer, polyethylene terephthalate; olefin carboxylic acid copolymers such as ethylene / acrylic acid copolymer, ethylene / maleic acidcopolymer, ethylene / methacrylic acid copolymer, ethylene / vinyl acetate copolymers or combinations thereof; polyacrylates, polymethacrylates, and / or their copolymers such as poly(methyl methacrylates).

[0153] In another embodiment, the packaging material is selected from polyesters and / or copolymers thereof, such as maleic anhydride polypropylene copolymer, polyethylene terephthalate; olefin carboxylic acid copolymers, Polypropylene and / or polypropylene copolymers, including atactic polypropylene; isotactic polypropylene, syndiotactic polypropylene, biaxially oriented polypropylene films and / or combinations thereof can also be used. The containers or packaging materials can further be metallized, heat stable, resealable and or reusable or combinations thereof.

[0154] In another embodiment, the compositions of the present application are stable for the period of at least 6 months, when subjected to stability testing under 25 °C / 60% RH.

[0155] In another embodiment, the compositions of the present application are stable for the period of at least 6 months, when subjected to stability testing under 30°C / 65% RH.

[0156] In another embodiment, the compositions of the present application are stable for the period of at least 6 months, when subjected to stability testing under 40°C / 75% RH.

[0157] In another embodiment, the compositions of the present application are stable for the period of at least 9 months, when subjected to stability testing under 25 °C / 60% RH.

[0158] In another embodiment, the compositions of the present application are stable for the period of at least 9 months, when subjected to stability testing under 30°C / 65% RH.

[0159] In another embodiment, the compositions of the present application are stable for the period of at least 9 months, when subjected to stability testing under 40°C / 75% RH.

[0160] In another embodiment, the compositions of the present application are stable for the period of at least 12 months, when subjected to stability testing under 25°C / 60% RH.

[0161] In another embodiment, the compositions of the present application are stable for the period of at least 12 months, when subjected to stability testing under 30°C / 65% RH.

[0162] In another embodiment, the compositions of the present application are stable for the period of at least 12 months, when subjected to stability testing under 40°C / 75% RH.

[0163] In an embodiment the composition of the present application is manufactured by a process, wherein the process comprises of following steps: i. weighing and dispensing the resistant fiber and digestible maltodextrin in a suitable container, ii. weighing, dispensing and mixing desired quantities of one or more micronutrients to prepare micronutrient premix, iii. sifting the resistant fiber and digestible maltodextrin, iv preblending half amount of digestible maltodextrin with one or more micronutrients by trituration process to obtain a pre-blend, v. blending together of all components obtained in Step i to Step iv. vi. packaging the blend in suitable unit dose packs / container.

[0164] The present application is further illustrated by the examples provided merely to be exemplary of the nutraceutical composition described above and do not limit the scope of the application. Certain modifications and equivalents will be apparent to those skilled in the art and are intended to be included within the scope of the present application.

[0165] The present invention is illustrated below by reference to the following examples. However, the one skilled in the art will appreciate that the specific methods and results discussed are merely illustrative of the present invention and not to be construed as limiting the application. The following examples may include compilations of data that are representative of data gathered at various times during development and experimentation related to the present invention.

[0166] Table 1: Examples 1-6: Composition of Powder:

[0167] Manufacturing process:The process comprises of following steps:Weighing, dispensing and manufacturing is carried out in area where temperature is NMT 25°C & RH is NMT 45%. Step I: Weighing and dispensing of resistant maltodextrin (Fibersol®), FOS, and digestible maltodextrin in a suitable container.Step II: Weighing, dispensing and mixing desired quantities of required one or more micronutrients to prepare micronutrient premix.Step III: Sifting the Fibersol®, FOS, and digestible maltodextrin through an appropriate sieve. Sifted materials are used for further blending steps.Step IV: Pre-blending: Blending approx. one tenth quantity of digestible maltodextrin with micronutrient premix by trituration process to obtain a pre-blend.Step V: Blending together of all components obtained in Step I to Step IV in appropriate blender for optimized rotations and time for blending. Step VI: Packaging the blend in suitable unit dose packs / containers.EXPERIMENTAL DATA:I. Organoleptic EvaluationPertaining to higher amounts of fiber sources, compositions of Examples 2, 4, and 5 were subjected to organoleptic evaluation. Results of organoleptic evaluation are summarized in the table below.Table 2: Organoleptic evaluation of compositions of Example 2, Example 4 and Example 5Conclusion: Examples 4 and 5 had no odour and taste, hence were considered suitable for further analytical evaluation.II. Analytical Evaluation:The compositions of examples 4 and 5 were subjected to analytical evaluation and results of the evaluation are summarized in the table below. Table 3: Analytical and microbiological evaluation of compositions of Example 4 andExample 5Conclusion: The results from Table 3 demonstrate that the composition of Example 5 complied with all the required specifications for analytical and microbiological parameters; hence composition of Example 5 was considered suitable for further evaluation.III. Sensorial profile evaluation In this evaluation, composition of Example 5 was added to different kind of base foods (viz. water, orange juice, rasam and curd etc.) The base foods were evaluated after addition of composition of Example 5 for the parameters like colour intensity, viscosity, overall aroma, off aroma, overall flavor and taste.Conclusion: Apart from insignificant variation in colour and viscosity there were no changes in other parameters of the base foods after addition of compositions of Example 5. Hence, compositions of Example 5 were considered suitable for further evaluations.IV. Stability StudyCompositions of Example 5 were packaged in suitable laminates and were subjected to real time stability study (30°C & 65% RH) and accelerated stability study (40°C & 75% RH). Results of the stability studies are summarized in the tables below.Table 4: Results of real time stability study (30±2°C / 65±5%RH) for composition of Example 5Table 5: Results of accelerated stability studies (40±2°C / 75±5%RH) for composition ofExample 5Conclusion: Composition of Example 5 was found to comply with all the specifications of stability testing parameters and nutrient content in real-time and accelerated stability studies.V. Clinical Study:Composition of Example 5 was subjected to in-vivo clinical studies, with glucose used as a reference standard. The aim of the clinical study was as follows:A. to assess the impact of composition of Example 5 on the GI of carbohydrate-rich foods when carbohydrate rich foods are consumed along with composition of Example 5.B. to assess the change in the levels of gut hormone (GLP-1) of the participants.Study design and methodology: The composition of Example 5 was subjected to the clinical study. For the purpose of the clinical study, composition of Example 5 is referred to as “test composition” whereas the food to which composition of Example 5 was added was referred to as “test food”. The term “control food” as used herein refers to the food without adding the composition of Example 5. Descriptions of test foods and control foods are given in the table 6a and 6b. ‘Test Food A’, ‘Control Food A’, ‘Test Food B’ and ‘Control Food B’ are collectively referred to as ‘Test meal(s)’ in this section. The two carbohydrate-rich foods chosen for study were: A. Aloo Paratha >. Idly white rice. Arms for the study were as follows:Table 6a: Arm A for clinical studyTable 6b: Arm B for clinical studyAssessment of Glycemic index (GI)The GI is defined as the incremental area under the blood glucose elicited by 50g of available carbohydrate containing test meal portion expressed as a percentage of the response of 50g of glucose (55g of glucose monohydrate) taken by the same participant. The clinical study evaluated the GI of the test composition (Example 5) by calculating the incremental area under the curve (IAUC).The GI of each test meal i.e. ‘Test Food A’, ‘Control Food A’, ‘Test Food B’ and ‘Control Food B’- was determined in normal healthy subjects (n=10) with age >18 to <45 and with BMI > 18.5 to < 22.9 kg / m2. The test meals containing 50g of available carbohydrates were fed to all the participants. In addition, on three different occasions, each participant was tested with 55g of glucose (glucose monohydrate) drink as ‘Reference Food’.Participants who were not familiar with blood sampling via finger-pricking (capillary blood sampling) performed a practice test to acquaint them with the procedure and to control the effects of anxiety on blood glucose response. All participants underwent 3 days of ‘Reference Food’ testing and 2 days for test meal in random order with 2-3 days washout between measurements to minimize carry over effects. Participants visited the GI testing Centre each test day in the morning after a 10-12 hr. overnight fast. Brief questionnaire on previous day’s diet (24hr recall) including last previous meal - dinner, physical activity, smoking, alcohol and caffeine containing drinks were obtained to ensure that the participants maintained the similar diet and physical activity on pretest dates and refrained from smoking and alcohol during the study period.For assessment of GI of foods, fasting blood samples were taken at -5 mins and 0 min by fingerprick, using an automatic lancet device before consumption of the food and the baseline value taken as a mean of these two values. The participants then consumed respective test food &control food in random order and on separate occasions. The first bite / sip in the mouth is set as time 0 and the first blood sample is taken conventionally at exactly 15 mins afterwards and further capillary blood samples were obtained at 30, 45, 60, 90 and 120 minutes after the start of the test meal. Participants were given 250 mL of water during the subsequent 2h of GI testing. Incremental area under the blood glucose curve (IAUC) over these time points was calculated. Each participant’s IAUC after consumption of the test meal was expressed as a percentage of the mean IAUC after standard glucose (Reference Food) taken by the same participant to calculate individual GI. The mean value of the test meals is declared as GI of the test foods.Results of GI assessment are summarized in the tables below.Assessment of GIGI value of test meal (%) = Blood glucose IAUC value for the test meal X 100IAUC value of the Reference Food♦♦♦ Assessment of GI for ‘Test Food A’ and ‘Control Food A’Figure 1 depicts the graph showing mean change in blood glucose concentration after consuming ‘Test Food A’, in comparison with ‘Reference Food’; over a period of 2 hours.Measurement of IAUC and calculation of GI for ‘Test Food A’ and ‘Control Food A’ are shown in Table 7a and Table 7b below.Table 7a: Individual Mean IAUC of ‘Reference food’ and ‘Test Food A’, GI of the ‘Test Food A’Table 7b: Individual Mean IAUC of ‘Reference Food’ (Glucose) & ‘Control Food A’, GI of the ‘Control Food A’♦♦♦ Assessment of GI for ‘Test Food B’ and ‘Control Food B’Figure 2 depicts the graph showing mean change in blood glucose concentration after consuming ‘Test Food B’ in comparison with ‘Reference Food’; over a period of 2 hours.Measurement of IAUC and calculation of GI for ‘Test Food B’ and ‘Control Food B’ are shown in Table 8a and Table 8b below.Table 8a: Individual Mean IAUC of ‘Reference Food’ and ‘Test Food B’, GI of the ‘Test Food B’Table 8b: Individual Mean IAUC of ‘Reference Food’ & ‘Control Food B’, GI of ‘ControlFood B’Glycemic Indices of all the test meals assessed, are summarized in the table 9 below.Table 9: Glycemic Indices of all the test meals assessedResult:GI of ‘Test Food A’ was lower than that of ‘Control Food A’ .GI of ‘Test Food B’ was lower than that of ‘Control Food B’.Hence, it was concluded that test composition was capable of lowering GI of a food to which the test composition was added or which the test composition was consumed with.B. Assessment of changes in gut hormoneThe change in level of gut hormone GLP-1 after consumption of each test meal i.e. ‘Test Food A’, ‘Control Food A’, ‘Test Food B’ and ‘Control Food B’ was determined in normal healthy participants (n=20) with age >18 to <45 and with BMI > 18.5 to < 22.9 kg / m2All participants underwent 2 days of reference food testing and 4 days for test meals (Test Food A’, ‘Control Food A’, ‘Test Food B’ and ‘Control Food B’) in random order with 2 days washout between measurements to minimize carry over effects. Participants visited the Centre each test day in the morning after a 10-12 hr overnight fast during which fasting (-5 minutes) venous blood sample was collected. The participants consumed 50g available carbohydrate portion of the test meals, the first bite / sip in the mouth is set as time 0 minutes and venous blood samples were taken conventionally at exactly 60, 120 and 240 minutes after the start of the test meal using BD P800 tubes for all the participants. Participants were given 250 mL of water during the subsequent 4 hrs period of GI testing.Brief questionnaire on previous day’s diet (24hr recall) including last previous meal - dinner, physical activity, smoking, alcohol and caffeine containing drinks were obtained to ensure that the participants maintained the usual diet and physical activity on pretest dates and refrained from smoking and alcohol during the study period.Blood samples were assessed for selected gut hormone- GLP-1 as per standard protocol using the ELISA kit.Results of gut hormone assessment are summarized in Figure 3. Figure 3 depicts the graph indicating the mean change in levels of plasma GLP-1 (in terms of incremental Area under the curve i.e. IAUC) in case of Test meals.Result Consumption of food with composition of Example 5 (test food) led to increase in gut hormone-glucagon-like peptide- 1 (GLP-1) in the subjects.Conclusion Comparison of the graphs in Figure 1 and Figure 2 shows that there is reduction in change in blood glucose concentration after consuming the food along with test composition when compared to blood glucose levels after consuming the reference food.Also, the data from the clinical studies showcases that the GI of food consumed with test composition was lower than the GI of food consumed without test composition. Results of clinical studies described by above mentioned figures and tables underscore the ability of test composition to lower the GI of the food by 10% to 20% to which it is added. Hence it was concluded, that the test composition was able to lower the glucose spikes in the subjects when it was added to carbohydrate-rich foods in the diet of the subjects.Also, the test composition when combined with the food, has shown to increase glucagon-like peptide-1 (GLP-1) levels in the subject. Increase in GLP-1 levels increases insulin secretion and sensitivity and inhibits gastric acid secretion and emptying, thus increasing satiety signals in the brain. Hence, test composition seems to contribute to the increase in satiety levels of the subject.Therefore, the overall assessment and data points signal towards improved efficiency of the test composition, in order to lower the GI of variety of food products and thereby help in managing postprandial blood sugar spikes.

Claims

We claim,1. An oral nutritional composition comprising: a. a resistant maltodextrin in an amount of from about 50% to about 95% by weight of the composition; b. a digestible maltodextrin component in an amount of from about 5% to about 40 % by weight of the composition; and c. a micronutrient premix in an amount of from about 0.01% to 1.0% by weight of the composition, wherein the micronutrient premix comprises one or more vitamins, minerals or combinations thereof.

2. The composition as claimed in claim 1, wherein the said resistant maltodextrin is composed of one or more of 1-2, 1-3, 1-4, 1-6 glucosidic linkages and combinations thereof.

3. The composition as claimed in claim 1, wherein the said resistant maltodextrin is comprised of a soluble starch-derived fibers obtained from plant sources selected from one or more of com, wheat, potato or combinations thereof.

4. The composition as claimed in claim 1, wherein the said resistant maltodextrin has a degree of polymerization from about 4 to about 20.

5. The composition as claimed in claim 1, wherein the dextrose equivalent value of said resistant maltodextrin is in the range of 8 to 12, and for the digestible maltodextrin is in the range of 15 to 19.

6. The composition as claimed in claim 1, wherein the said digestible maltodextrin is obtained from plant based starches and is selected from one or more of corn-based maltodextrin, rice-based maltodextrin, potato-based maltodextrin, wheat-based maltodextrin or combinations thereof.

7. The composition as claimed in claim 1, wherein the said micronutrient premix comprises one or more vitamins and minerals selected from the group of vitamin A, vitamin Bl, vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B8, folic acid, vitamin B12,vitamin C, vitamin D2, vitamin D3 (cholecalciferol), vitamin E, vitamin K, sodium, calcium, magnesium, potassium and combinations thereof.

8. The composition as claimed in claim 1, wherein the said resistant maltodextrin and the said digestible maltodextrin are present in a ratio of 5: 1 to 15: 1.

9. The composition as claimed in claim 1, wherein the said composition is consumed along with a food or can be added as a supplement, an adjunct or an add-on to the food.

10. The composition as claimed in claim 9, wherein the said composition upon consumption with food product reduces the glycemic index (GI) of the said food product.

11. The composition as claimed in claim 10, wherein the said composition reduces the glycemic index (GI) of the food by 5% to 30% without altering the taste or flavour of the food.

12. The composition as claimed in claim 1, wherein the said composition provides fiber in an amount from 65% to 95% w / w of the composition.

13. The composition as claimed in claim 1, wherein the said composition provides energy in an amount of from 150 to 450 kCal / 100g of the composition.

14. The composition as claimed in claim 1, wherein after subjecting the composition to a 6-month stability testing at 25°C ±2°C / 60% ±5% relative humidity and 40°C ±2°C and 75% ±5% relative humidity conditions, the composition exhibits moisture content of less than or equal to about 5 percent by weight of the composition and water activity (aw) of less than or equal to about 0.50.

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