DESC:FORM 2

The Patents Act, 1970
(39 of 1970)
&
The Patent Rules, 2003
COMPLETE SPECIFICATION
(Section 10, Rule 13)
NUTRITIONAL COMPOSITION WITH LOW GLYCEMIC INDEX
Dr. Reddy's Laboratories Ltd.
An Indian Company having its registered office at 8-2-337, Road No. 3, Banjara Hills,
Hyderabad - 500034, Telangana, India

The following specification particularly describes the invention and the manner in which it is to be performed.

NUTRITIONAL COMPOSITION WITH LOW GLYCEMIC INDEX
FIELD OF THE APPLICATION
[001] The present application relates to a novel nutritional composition for oral administration. Particularly, the application relates to a baked nutritional composition which can be consumed as a healthy snack by humans of different age groups including people with pre-diabetic and diabetic conditions. More particularly, the application relates to a baked nutritional composition comprising macronutrients, fibers and prebiotics and the process of preparation for the same.
BACKGROUND
[002] Baked snacks or cookies are popular type of snacks around the globe. Cookies, biscuits and biscuit-like products have been prepared and regularly consumed by people around the world for a long time. Its origins date back to Roman times, when certain foods needed to be completely dried so that they could be stored for long periods of time. Thus, a cookie or a biscuit is a food item that is tasty, easy to store, carry and serve food item available in different forms and in different regions.
[003] Cookies or biscuits are found in a variety of categories attributing to their taste, aroma, textural properties, extent of hardness, nutritional value, energy value etc. which depend on the ingredients and methods of manufacturing used during their production.
[004] Process of manufacture of these baked snacks require curated amounts of ingredients to achieve desired texture, crunchiness and mouthfeel which becomes important for consumer acceptance. Conventional biscuits use refined flour (Maida) which is derived from wheat with no bran. Bran (dietary fiber) constitutes the outer fiber layers of plants, materials that human digestive enzymes cannot break down. Hence, Maida has no fiber, more calories and higher glycemic index than that of the wheat flour. As a result, conventional biscuits have low fiber content and consequently, the less nutritive value.
[005] As mentioned before, these cookies or biscuits are daily consumed by a large population of people of different age groups. Consumption of these low fiber snacks have very less nutritive value and can lead to various digestive and metabolic health issues. These health issues may become more exaggerated for people having sedentary lifestyle, obesity and metabolic diseases like diabetes mellitus.
[006] Hence, there is a need to develop a composition which can satisfy the hunger or food craving and at the same time provide nutritional benefits for a large and diverse pool of people irrespective of their age, gender, lifestyle or metabolic conditions.
[007] The present application aims to provide a nutritional composition that is suitable for oral administration by adults and kids and comprises essential macronutrients and fibers in adequate amounts. The nutritional composition disclosed by the present application is suitable for a wide range of people including people with pre-diabetic and diabetic conditions.
[008] The nutritional composition is rather well accepted, if it is provided in compact, consumer friendly form with acceptable organoleptic properties and provides positive nutritional effects and improves the health. Hence, present application attempts to provide the nutritional composition in the form of fiber rich cookies with low glycemic index (GI).
[009] The baked nutritional composition should also comply with the criteria for general physicochemical evaluation, have a good shelf stability, and should meet the desired standards for taste, texture, color, shape and brittleness. The ingredients of the composition, should be compatible with each other for arriving at a product with desired qualities as described in the above paragraphs.
[010] Hence, present application relates to a baked nutritional composition for oral administration which contains a unique combination of compatible ingredients to achieve a product with the desired properties. The composition aims to provide effective amounts of macronutrients, fiber and energy in order to contribute in maintaining daily health of people irrespective of their age and metabolic issues.
[011] The composition taught by the present application intends to provide nutritional benefits through a healthy snack which is suitable for daily consumption.
SUMMARY
[012] The primary object of the present application is to provide a nutritional composition having low glycemic index which comprises a macronutrient premix, fiber sources, prebiotics and nutraceutically acceptable excipients in order to improve overall digestive health of a subject.
[013] Another object of present application is to provide a nutritional composition in the form of a baked snack suitable for daily consumption by a large group of subjects including pediatric subjects, adults and individuals having diabetes and pre-diabetes condition.
[014] Another object of present application is to provide a baked nutritional composition with low glycemic index value comprising:
i. a macronutrient component; and
ii. a fiber component
wherein the ratio of fiber to macronutrient component is from 1:5 to 1:10

[015] Another object of present application is to provide a baked nutritional composition with low glycemic index value comprising:
i. a macronutrient component; and
ii. a fiber component
wherein the ratio of fiber to macronutrient component is from 1:5 to 1:10; and
wherein the composition is stable for a period of 6 months to 12 months.
[016] The various embodiments herein disclose oral nutritional composition in the form of baked cookies or biscuits and process of preparation of the same.
[017] 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.
DETAILED DESCRIPTION
[018] 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.
[019] 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.
[020] The present application teaches a novel nutritional composition comprising essential macronutrients and fiber suitable for oral administration by individuals of wide range of age groups from children to elderly people including normal, pre-diabetic and diabetic individuals.
[021] Definitions: The terms as used herein have the following meanings:
[022] 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.
[023] 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.
[024] 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.
[025] As used herein, the term “at least” refers to the presence of the recited substance in the composition in recited least amount.
[026] 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 nutritional compositions and does not 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 nutritional 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 excipient.
[027] 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 nutritional compositions in the present application are selected from, but are not limited to, biscuits, diskettes, cookies, crackers and baked snack compositions.
[028] The term, “effective amount” or “adequate 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.
[029] The term “dietary insufficiencies” refer to the deficit in the amount of recommended intake of a particular nutrient.
[030] 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 a human having or at risk for a medical condition that can benefit from or may need the nutritional composition as described herein in the present application.
[031] “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 are 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, flavorant, emulsifiers, mineral osmotic agents, pharmaceutically acceptable carriers, 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. As far as the present application is concerned the terms “Nutritional compositions” or “Nutraceutical preparation” or “Nutraceutical composition” or “Nutritional preparations” are used interchangeably.
[032] The term “cookies or biscuit(s)” means and includes a baked flour confectionery dried down to low moisture content. It is a chemically leavened cereal/millet/pulse flour product which may comprise additional optional ingredients, including, but are not limited to, leavening agents, conventional food additives, health benefit additives, one or more, acidity regulators, thickening/gelling agents, buffers or agents for pH adjustment, chelating agents, colorants, flavorant, emulsifiers, mineral osmotic agents, pharmaceutically acceptable carriers, preservatives, anti-oxidants, stabilizers, sweeteners, texturizers. As far as the present application is concerned, the term “biscuit(s)” means and includes biscuits, diskettes, cookies, crackers and baked snack compositions.
[033] Baked composition as mentioned in the present application may be sweet or savoury. Baked composition may be one or more of a wafer(s), cookies, cracker or biscuit(s). Wafers may be flat or shaped and cookies, crackers or biscuits may have many different shapes and sizes.
[034] The term “energy” or “energy density” of food refers to the amount of calories (energy) a food provides per unit of weight (calories per gram). Foods with high energy density pack more calories into a smaller volume, while low-energy-dense foods have fewer calories per gram.
[035] The term “protein”, as used herein, is understood to refer to any food component that includes two or more amino acids joined together by a peptide bond (dipeptide, tripeptide, or polypeptide), collagen, precursor, homolog, analog, mimetic, salt, prodrug, metabolite, or fragment thereof or combinations thereof. For the sake of clarity, the use of any of the above terms is interchangeable unless otherwise specified.
[036] Examples of proteins include, but are not limited to, dairy-based proteins, plant-based proteins, animal-based proteins, and artificial proteins. Dairy-based proteins include, for example, casein, caseinates (e.g., all forms including sodium, calcium, potassium caseinates), casein hydrolysates, whey (e.g., all forms including concentrate, isolate, demineralized), whey hydrolysates, milk protein concentrate, and milk protein isolate. Plant-based proteins include, for example, soy protein (e.g., all forms including concentrate and isolate), pea protein (e.g., all forms including concentrate and isolate), canola protein (e.g., all forms including concentrate and isolate), other plant proteins that commercially available, wheat and fractionated wheat proteins, corn and its fractions including zein, proteins from rice, oat, potato, peanut, green pea powder, green bean powder, and any proteins derived from beans, lentils, pulses and the like or combinations thereof.
[037] The terms “fats or lipids” are construed as per their general meaning and include but are not limited to, one or more short-chain fatty acid(s), medium-chain fatty acid(s), long-chain fatty acid(s), saturated fatty acid(s), unsaturated fatty acid(s), and/or combinations thereof.
[038] 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 and/or combinations thereof.
[039] The term “macronutrient premix” or “macronutrient component” denotes the mixture of one or more carbohydrates, fats, proteins and mixtures or combinations thereof.
[040] The term “fiber” is construed as per its general meaning and includes but are not limited to, a dietary fiber, or any mixture of dietary fibers; one or more of fructo-oligosaccharides, oligofructose, soluble non-starch polysaccharides, insoluble non-starch polysaccharides, non-digestible oligosaccharides, inulin, acacia fiber, arabic gum, soy polysaccharide, alpha-cellulose, resistant starch, and the like or combinations thereof. Fibers can be classified as soluble fibers (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 (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).
[041] 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.
[042] 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).
[043] The term “prebiotics” denotes the substrates for gut micro-organisms which ultimately confer several health benefits. Prebiotics are fermented by gut bacteria to produce short-chain fatty acids (SCFAs), hydrogen and carbon dioxide. Prebiotics affect gut health by altering the composition of the gut microbiome and by increasing the production of short chain fatty acids. They stimulate the growth of beneficial microbes in the gut, shifting the overall microbiome to a more positive composition. An increase in the number of friendly bacteria, further promotes the production of SCFAs which in turn reduce colonic luminal pH. A healthy microbiome is also associated with improved mucosal barrier integrity as the presence of friendly bacteria in the gut exert a ‘barrier effect’, protecting the gut lining from damage and increased permeability.
[044] The term “prebiotic” denotes the substances which are non-digestible food ingredients that beneficially affect the host by selectively stimulating the growth and/or activity of one or a limited number of bacteria in the colon, and thus improves host health. Examples of sources of prebiotics include, but are not limited to, various cereals, vegetables, and fruits like barley, oats, wheat, asparagus, chicory, sugar beet, soy bean, banana, flaxseeds etc. Prebiotics can be carbohydrates or non-carbohydrate compounds. Carbohydrate-prebiotics include compounds like fructans, fructo-oligosaccharides, oligofructose, galacto-oligosaccharides, trans-galacto-oligosaccharides, starch and glucose-derived oligosaccharides and pectic oligosaccharides etc. whereas non-carbohydrate prebiotics include cocoa-derived flavanols.
[045] The term “sweetener” denotes the additives which are used to give a sweet taste to the formulation. The term sweetener includes both natural and artificial sweeteners.
[046] Examples of natural sweeteners include, but are not limited to, raw sugar, agave nectar, brown rice syrup, date sugar, honey, maple syrup, molasses and blackstrap molasses, sorghum syrup, stevia and combination thereof.
[047] Examples of artificial sweeteners include, but are not limited to, saccharine, sucralose, aspartame, isomalt, maltitol, lactitol, mannitol, erythritol and combinations thereof.
[048] The term “vitamin” includes but is not limited to, 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, pro-vitamins, derivatives, analogs and the like or combinations thereof.
[049] Examples of vitamins include, but are not limited to, vitamin A, vitamin B1(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.
[050] The term “mineral” includes, but is not limited to, one or more minerals selected from sodium, boron, calcium, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, silicon, zinc, and the like or combinations thereof.
[051] The term “antioxidant” includes, but is not limited to, any one or more of various substances such as beta-carotene (a vitamin A precursor), vitamin C, vitamin E, and selenium that inhibit oxidation or reactions promoted by reactive oxygen species (“ROS”) and other radical and non-radical species. Additionally, antioxidants are molecules capable of slowing or preventing the oxidation of other molecules.
[052] Examples of antioxidants include, but are not limited to, carotenoids, ascorbyl palmitate, coenzyme Q10 (“CoQ10”), flavonoids, glutathione goji (wolfberry), hesperidin, lacto wolf berry, lignan, lutein, lycopene, polyphenols, selenium, vitamin A, vitamin B1, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, zeaxanthin, or combinations thereof.
[053] The term “acidity regulator” denotes the substances which are used to control and alter the acidity or alkalinity of the product; maintain desired pH which is necessary to maintain colour, flavour, taste and texture of the product and help in natural preservation of the product. These include, but are not limited to, acetic acid, citric acid, trisodium citrate, malic acid, fumaric acid, lactic acid, tartaric acid, succinic acid, phosphoric acid.
[054] The term “leavening agent(s)” or “leavener(s)” denotes the ingredients and techniques used in baking and cooking that cause the expansion of doughs and batters, leading to light and airy mixtures. Leavening agents are classified as chemical leaveners (e.g. baking soda and baking powder), organic leaveners (e.g. yeast)and mechanical leaveners (e.g. air or steam).
[055] Chemical leavening agents help in aerating the batter by releasing carbon dioxide. Carbon dioxide (CO2) is generated from the reaction of an acid with a base in the presence of heat and moisture. Examples of chemical leaveners includes ammonium bicarbonate, sodium bicarbonate, sodium bicarbonate in conjunction with acids like-acid calcium phosphate, potassium acid tartrate, tartaric acid, sodium acid pyrophosphate, glucono-delta lactone- or combinations thereof.
[056] The term “emulsifier(s)” denotes the surface-active ingredients that stabilize inhomogeneous mixtures, such as water and oil. Emulsifiers are used to assist in blending and emulsification of ingredients, enhance the properties of the shortening (i.e. fats used to “shorten” or tenderize baked foods), and interact with the components of the flour and other ingredients in the mix. Emulsifiers act as lubricants, emulsify oil or fat in batters, build structure, aerate, improve eating quality, extend shelf life, modify crystallization, prevent sticking, and retain moisture.
[057] Examples of emulsifiers include, but are not limited to, lecithin, glycerol mono stearate, mono- and diglycerides, lactylated monoglyceride, calcium stearoyl lactylate, sodium stearoyl lactylate, propylene glycol monoesters, diacetyl tartaric esters of monoglycerides, ethoxylated monoglycerides, sorbitan monostearate, polysorbate 60, polyglycerol esters, succinylated monoglycerides, sodium stearoyl fumarate, sucrose esters, stearoyl lactylate or combinations thereof.
[058] The term “diabetes” or “diabetes mellitus (DM)” denotes to a chronic metabolic disorder, characterized by inadequate control of blood glucose levels. 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 diabetes are the main subtypes, each with different pathophysiology, 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 due to obesity and aging. T1DM is present in children or adolescents, while T2DM is thought to affect middle-aged and older adults who have prolonged hyperglycemia due to poor lifestyle and dietary choices.
[059] The term “pre-diabetes” 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 pre-diabetes individuals are at high risk of developing diabetes and its complications.
[060] The term “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).
[061] 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 or supplement, the lesser and slower the tendency it has to affect your 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.
[062] GI of the food depends upon the contents of the food (carbohydrates, fat, protein, dietary fiber etc.), and the chemical structure of carbohydrates in it. Further, GI of a food varies when eaten alone and when consumed along with other foods. Fats, proteins and dietary fiber tend to lower the GI of a food.
[063] Experimentally, the GI is defined as the incremental area under the curve (IAUC) of blood glucose of an individual; elicited by 25g of available carbohydrate containing test food portion expressed as a percentage of the response of 25g of glucose taken by the individual.
[064] The terms “container, pack or packaging” as used herein means the combination of components necessary to contain, preserve, protect & deliver a safe, efficacious food composition or food product, such that at any time point before expiration date of the food composition or the product, it remains safe & stable.
[065] 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.
[066] The term “peroxide value” refers to the number of milli equivalents of active oxygen that expresses the amount of peroxide contained in 1000g of the substance. Peroxide value (PV) is an indicator of fat oxidative rancidity or degree of oxidation in food products. A higher PV indicates that more peroxide is produced and the oxidation level is also greater.
[067] Unless otherwise stated, this application uses following abbreviations:
Abbreviation Full Form
BMI Body Mass Index
CFU Colony Forming Units
FOS Fructo-oligosaccharides
GI Glycemic Index
GOS Galacto-oligosaccharides
IAUC Incremental area under the curve
MUFA Mono Unsaturated Fatty Acids
PUFA Poly Unsaturated Fatty Acids
SAFA Saturated Fatty Acids
SCFA Short-chain Fatty Acids
TOS Trans-galacto-oligosaccharides
[068] The present application relates to a nutritional composition for oral use which contains a blend of macronutrients, fibers and prebiotics along with nutraceutically acceptable excipients. More specifically it is a unique combination of essential macronutrients, fibers and prebiotics which is beneficial for a variety of population including pre-diabetic and diabetic individuals.
[069] The present application relates to a unit composition which is unique blend of nutraceutically effective macronutrients, fibers and prebiotics with no refined flour; having positive effects on subjects including individuals from pre-diabetic and diabetic populations. The combination of these ingredients has found to be useful for both adults and paediatric subjects.
[070] Because the nutritional composition taught by the present application is provided in the form of a baked snack, it can serve the dual purpose of addressing the hunger between the meals while also improving the digestive health of the subject.
[071] Accordingly, it would be beneficial to provide a nutritional composition comprising macronutrients, fibers and prebiotics; supporting digestive health in an easy-to-carry and easy-to-consume form that is extremely convenient in today’s fast pace of life.
[072] In some embodiments, the composition of the present disclosure comprises specific macronutrients, fibers and prebiotics wherein the combination of these ingredients provides a synergistic effect when incorporated in a nutritional composition.
[073] It is pertinent to note that the composition of the present disclosure is suitable for consumption by diabetic and pre-diabetic subjects owing to the meticulous choice of ingredients both qualitatively and quantitatively.
[074] In one embodiment, the nutritional composition comprising macronutrients together with fiber and prebiotics for a paediatric subject, will improve the subject’s digestive health. The composition being a healthy snack item in the form of crunchy biscuits, becomes more appealing for paediatric subjects.
[075] In one embodiment, the nutritional composition of the present disclosure attempts to address the dietary insufficiencies of fiber for individuals including diabetic and pre-diabetic subjects.
[076] Present application relates to a unique combination which attempts to combine the health benefits of necessary macronutrients, fibers and prebiotics in order to achieve improvements in overall digestive health of a subject irrespective of his age, gender, lifestyle and physiological conditions.
[077] The present application also describes a method for maintaining and enhancing the digestive health of a subject by administering effective amounts of a nutritional composition comprising of macronutrient sources (i.e. sources of carbohydrates, proteins and fats), fiber sources and prebiotic sources along with necessary ingredients imparting good palatability and better consumer acceptance.
[078] In an embodiment, the nutritional composition of the present application comprises the sources of carbohydrates that include, but are not limited to, cereals like rice, wheat, finger millet, maize, sorghum and combinations thereof.
[079] In an embodiment, the nutritional composition of the present application comprises the sources of proteins that include, but are not limited to, soy based ingredients, beans, lentils, pulses, millets, pulse flours, millet flours and combinations thereof.
[080] In an embodiment, the nutritional composition of the present application comprises the sources of fats that include, but are not limited to, fat based ingredients, nuts, oilseeds, vegetable oils and combinations thereof.
[081] In an aspect of above embodiment vegetable oils include, but are not limited to, olive oil, hazelnut oil, palm oil, sunflower oil, safflower oil, soybean oil, coconut oil, sesame oil, pumpkin seed oil, peanut oil, mustard oil, linseed oil, corn oil, rice bran oil and combinations thereof.
[082] In an embodiment, the nutritional composition of the present application comprises a macronutrient premix.
[083] In an aspect of above embodiment, the macronutrient component comprises one or more carbohydrates, proteins, fats or lipids and combinations thereof.
[084] In an embodiment, the nutritional composition comprises a macronutrient component in an amount from 60% to 90% w/w of the total composition.
[085] In an embodiment, the nutritional composition comprises a macronutrient component in an amount from 60% to 85% w/w of the total composition.
[086] In an embodiment, the nutritional composition comprises a macronutrient component in an amount from 70% to 80% w/w of the total composition.
[087] In an embodiment, the nutritional composition comprises a carbohydrate fraction present in an amount of about 35 % to about 55% w/w of the composition.
[088] In an embodiment, the nutritional composition comprises a carbohydrate fraction present in an amount of about 38 % to about 52% w/w of the composition.
[089] In an embodiment, the nutritional composition comprises a carbohydrate fraction present in an amount of about 40 % to about 50% w/w of the composition.
[090] In an embodiment, the nutritional composition comprises a protein fraction present in an amount of about 5% to about 20% w/w of the composition.
[091] In an embodiment, the nutritional composition comprises a protein fraction present in an amount of about 8% to about 18% w/w of the composition.
[092] In an embodiment, the nutritional composition comprises a protein fraction present in an amount of about 10% to about 15% w/w of the composition.
[093] In an embodiment, the nutritional composition comprises a fat fraction present in an amount of about 10% to about 30% w/w of the composition.
[094] In an embodiment, the nutritional composition comprises a fat fraction present in an amount of about 15% to about 25% w/w of the composition.
[095] In an embodiment, the nutritional composition comprises a fat fraction present in an amount of about 15% to about 20% w/w of the composition.
[096] In an embodiment, the nutritional composition further comprises one or more prebiotics.
[097] In an embodiment, the prebiotic component is selected from a group of compounds including, but are not limited to, compounds like fructans, fructo-oligosaccharides (FOS), oligofructose, galacto-oligosaccharides (GOS), trans-galacto-oligosaccharides (TOS), starch, glucose-derived oligosaccharides, pectic oligosaccharides and cocoa-derived flavanols.
[098] In an embodiment, the nutritional composition comprises a prebiotic component in an amount of about 1% to 15% w/w of the composition.
[099] In an embodiment, the nutritional composition comprises a prebiotic component in an amount of about 4% to 12% w/w of the composition.
[100] In an embodiment, the nutritional composition comprises a prebiotic component in an amount of about 5% to 12% w/w of the composition.
[101] In an embodiment, the nutritional composition further comprises one or more fibers.
[102] In an embodiment, the fiber component in the nutritional composition comprises one or more of a soluble fiber, insoluble fiber, prebiotic fiber, non-prebiotic fibers or combinations thereof. Edible fibers refer to any source of complex carbohydrate that can be ingested and processed without harm to humans. Fiber constitutes any plant, fungus, or yeast material that cannot be digested by the body. Fiber is usually referred to by its physical properties. Fibers that have high water-holding capacity are called soluble, whereas fibers with low ability to hold water are called insoluble. Each fiber has its own special properties and has multiple sources. Fiber product can have both soluble and insoluble fractions. The fibers may be selected from sources including, but are not limited to, apples, bananas, oats, guar, peas, black beans, lima beans, apples, citrus fruits, carrots, barley, psyllium, brussels sprouts, avocados, whole wheat flour, bran, nuts, seeds, and the skins of many fruits and vegetables, whereas prebiotic fiber may be selected from sources including, but are not limited to, fructans, fructo-oligosaccharides, galacto-oligosaccharides, trans-galacto-oligosaccharides, starch, glucose-derived oligosaccharides, pectic oligosaccharides or combinations thereof.
[103] In an embodiment, the nutritional composition comprises fiber component in an amount of about 5% to 25% w/w of the composition.
[104] In an embodiment, the nutritional composition comprises fiber component in an amount of about 8% to 22% w/w of the composition.
[105] In an embodiment, the nutritional composition comprises fiber component in an amount of about 12% to 18% w/w of the composition.
[106] In an embodiment, the nutritional composition comprises a prebiotic and macronutrient premix wherein prebiotic and macronutrient premix are present in the ratio of about 1:8 to about 1:25
[107] In an embodiment, the nutritional composition comprises a prebiotic and macronutrient premix wherein prebiotic and macronutrient premix are present in the ratio of about 1:10 to about 1:15
[108] In an embodiment, the nutritional composition comprises fiber and macronutrient premix wherein fiber and macronutrient premix are present in the ratio of about 1:5 to about 1:15
[109] In an embodiment, the nutritional composition comprises fiber and macronutrient premix components wherein fiber and macronutrient premix are present in the ratio of about 1:8 to about 1:10
[110] In an embodiment, the nutritional composition comprises total protein components and total carbohydrate components in the ratio of about 1:2 to about 1:8
[111] In an embodiment, the nutritional composition comprises total protein components and total carbohydrate components in the ratio of about 1:3 to about 1:7
[112] In an embodiment, the nutritional composition comprises total fat components and total carbohydrate components in the ratio of about 1:2 to about 1:6
[113] In an embodiment, the nutritional composition comprises total fat components and total carbohydrate components in the ratio of about 1:3 to about 1:4
[114] In an embodiment, the nutritional composition comprises a sweetener component.
[115] In an embodiment, the sweetener component is selected from a group of compounds including, but are not limited to, compounds like saccharine, sucralose, aspartame, isomalt, maltitol, lactitol, mannitol, erythritol and combinations thereof.
[116] In an embodiment, the sweetener component is a combination of one or more sweeteners mentioned in the above paragraph which is designed in a way that it can provide about half the calories of sugar.
[117] In an embodiment, the nutritional composition comprises two or more sweeteners.
[118] In an aspect of above embodiment, the nutritional composition comprises two sweeteners in the ratio of about 1:1 to about 1:4
[119] In an embodiment, the nutritional composition comprises a sweetener component and macronutrient premix component wherein the sweetener component and macronutrient premix are present in the ratio of about 1:5 to about 1:15
[120] In an embodiment, the nutritional composition comprises a sweetener component and macronutrient premix component wherein the sweetener component and macronutrient premix are present in the ratio of about 1:7 to about 1:12
[121] In an embodiment, the nutritional composition comprises one or more emulsifiers.
[122] In an embodiment emulsifiers are selected from, but are not limited to, lecithin, glycerol mono stearate, mono- and diglycerides, lactylated monoglyceride, calcium stearoyl lactylate, Sodium stearoyl lactylate, propylene glycol monoesters, diacetyl tartaric esters of monoglycerides, ethoxylated monoglycerides, sorbitan monostearate, polysorbate 60, polyglycerol esters, succinylated monoglycerides, sodium stearoyl fumarate, sucrose esters, stearoyl lactylate or mixtures/combinations thereof.
[123] In an embodiment, the nutritional composition comprises an emulsifier component and macronutrient premix component wherein emulsifier component and macronutrient premix are present in the ratio of about 1:200 to about 1:300
[124] In an embodiment, the nutritional composition comprises an emulsifier component and macronutrient premix components wherein emulsifier component and macronutrient premix are present in the ratio of about 1:225 to about 1:275
[125] In an embodiment, the nutritional composition comprises an emulsifier component and macronutrient premix components wherein emulsifier component and macronutrient premix are present in the ratio of about 1:240 to about 1:260
[126] In an embodiment, the nutritional composition comprises one or more vitamins selected from, but are not limited to, vitamin A (retinol), vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B8 (biotin), vitamin B9 (folic acid), vitamin B12 (cyanocobalamin), vitamin C (ascorbic acid), vitamin D2 (ergocalciferol), vitamin D3 (cholecalciferol), vitamin E (alpha-tocopherol), vitamin K and, and the like or mixtures thereof.
[127] In an embodiment, the nutritional composition comprises one or more minerals selected from, but are not limited to, boron, calcium, chromium, copper, iodine, iron, magnesium, manganese, molybdenum, phosphorus, potassium, selenium, silicon, , zinc, and the like or combinations thereof.
[128] In an embodiment, the nutritional composition further comprises antioxidants.
[129] In an embodiment, the nutritional composition comprises antioxidants which are selected from, but are not limited to, carotenoids, ascorbyl palmitate, coenzyme Q10 (“CoQ10”), flavonoids, glutathione goji (wolfberry), hesperidin, lacto wolf berry, lignan, lutein, lycopene, polyphenols, selenium, vitamin A, vitamin B1, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, zeaxanthin, or combinations thereof.
[130] In an embodiment, the nutritional composition further comprises acidity regulators.
[131] In an embodiment, the nutritional composition comprises one or more acidity regulators which are selected from, but are not limited to, acetic acid, citric acid, trisodium citrate, malic acid, fumaric acid, lactic acid, tartaric acid, succinic acid, phosphoric acid.
[132] In an embodiment the nutritional composition further comprises flavorants.
[133] In an embodiment the nutritional composition comprises one or more flavourants which can be natural flavours or permitted synthetic flavours.
[134] In an embodiment, the nutritional composition is used for oral administration.
[135] In another aspect of the present application, the oral nutritional composition is a biscuit, diskette, cookie, cracker and baked snack composition for direct oral consumption.
[136] In an aspect of above embodiment, the compositions have base material comprising of ingredients that can impart crunchiness.
[137] In an aspect of above embodiment, the ingredients imparting crunchiness act as a component providing good palatability and consequently better consumer acceptance.
[138] In an aspect of above embodiment, the ingredients imparting crunchiness are selected from, but are not limited to one or more emulsifiers, textured veg proteins or combinations thereof.
[139] In an embodiment, the nutritional composition provides an energy between 350kcal/100g to 550kcal/100g.
[140] In another embodiment, the nutritional composition provides an energy between 380kcal/100g to 500kcal/100g.
[141] In another embodiment, the nutritional composition provides an energy between 400kcal/100g to 460kcal/100g.
[142] An embodiment of the application relates to the process of preparation of the nutritional composition.
[143] In an embodiment, the application relates to the process for preparation of the nutritional composition comprising macronutrients, fibers and prebiotics.
[144] In an embodiment, the application relates to the process for preparation of the nutritional composition comprising macronutrients, fibers and prebiotics, which further comprises one or more vitamins and minerals.
[145] An embodiment further relates to a process of preparation of the nutritional composition comprising:
a) macronutrient premix (comprising of carbohydrates, proteins and fats);
b) fiber sources;
c) prebiotics; and
d) nutraceutically acceptable excipients.
[146] In an aspect of the above embodiments, the application further relates to a process of preparation of the oral baked nutritional composition, preferably cookies or biscuits.
[147] In a preferred embodiment of the present invention, the process comprises the following steps:
1. Preparation of dough: The ingredients are mixed in the required quantities and kneaded for desired time to obtain the dough.
2. Moulding: The dough obtained in step 1 is filled in the mould cavities or placed on a baking tray in desired shapes and sizes.
3. Baking: The baking tray with moulded dough is placed in the oven for baking.
4. Cooling: Once baked, the moulds or trays are cooled to set the baked composition.
5. Demoulding: The baked products are emptied from the moulds or the tray.
[148] According to one or more embodiments herein, the cookies or biscuits prepared by the teachings of the present application can be used in various products preparations including, but are not limited to, fitness supplements, smoothies, breakfast cereals, cereal bars, munching snacks, trail mixes, energy bars, snacks for hiking etc.
[149] In an embodiment of the present application, the compositions prepared can be further subjected to tests of shape, appearance, colour, odour, taste, friability, etc. in order to ensure the consumer acceptance. Also the compositions can be subjected to appropriate clinical studies to monitor their glycemic index (GI). Accordingly, modifications can be made to the compositions and process by the person skilled in the art to comply with the essential sensory and clinical parameters.
[150] In an aspect of above embodiment, the nutritional composition of the present application has a low glycemic index.
[151] In an embodiment, the nutritional composition of the present application has low glycemic index, wherein said glycemic index is 55 or less.
[152] In an embodiment, the nutritional composition of the present application has low glycemic index, wherein said glycemic index is 50 or less.
[153] In an embodiment, the nutritional composition of the present application has low glycemic index, wherein said glycemic index is between 25 to 55.
[154] In another embodiment, the nutritional composition of the present invention is packaged or contained in a primary packaging, and optionally, subsequently in a secondary packaging.
[155] For any of the 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.
[156] 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.
[157] 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 a thickness of between 5- 350 micron (µm), or within any range formed by any of these values, such as 10-300 µm, 15-250 µm, 20-200 µm, 25 -150 µm, 30-100 µm etc.
[158] 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.
[159] In an embodiment, the optical density of the packaging material is between 2.0 g/cc to 3.5 g/cc.
[160] In an embodiment, the optical density of the packaging material is between 2.2 g/cc to 3.2 g/cc.
[161] 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 multilayered 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.
[162] 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 acid copolymer, ethylene/methacrylic acid copolymer, ethylene/vinyl acetate copolymers or combinations thereof; polyacrylates, polymethacrylates, and/or their copolymers such as poly(methyl methacrylates).
[163] In another embodiment, the packaging material is selected from metalized or non-metalized 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.
[164] In another embodiment, the packaging material is selected from one or more of metalized or non-metalized polyesters or copolymers of polypropylene copolymer, polyethylene terephthalate, biaxially oriented polypropylene films and combinations thereof.
[165] In another embodiment, the nutritional composition of the present invention is stored at a relative humidity of less than 50%. This reduces softening, crumbling and loss of shape of the baked product. The nutritional composition is packaged in a package that keeps the relative humidity within the package at less than 50% for at least 4 weeks, more preferably for at least 6 months and even more desirably for up to 12 months.
[166] 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 ºC/60% RH
[167] 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 30ºC/65% RH.
[168] 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 40ºC/75% RH.
[169] In another embodiment, the biscuits of the present application are stable for the period of at least 9 months, when subjected to stability testing under 25 ºC/60% RH
[170] In another embodiment, the biscuits of the present application are stable for the period of at least 9 months, when subjected to stability testing under 30ºC/65% RH.
[171] In another embodiment, the biscuits of the present application are stable for the period of at least 9 months, when subjected to stability testing under 40ºC/75% RH.
[172] In another embodiment, the biscuits of the present application are stable for the period of at least 12 months, when subjected to stability testing under 30ºC/65% RH.
[173] In another embodiment, the biscuits of the present application are stable for the period of at least 12 months, when subjected to stability testing under 40ºC/75% RH.
[174] The final composition may have a defined shape, compact surface which is textured or smooth. Furthermore, the composition is not sticky when hand-held, thereby improving stability during handling, storage or transport. The product may exhibit a pronounced taste while avoiding excessive sweetness; presents a crunchy mouthfeel and further may avoid brittleness or excessive hardness.
[175] The present application is further illustrated by the examples provided merely to be exemplary of the pharmaceutical 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.
[176] 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.
Table 1: Examples 1-6: Biscuits Composition
Sr. No. Raw material/ Ingredients Composition (%w/w)

Example 1 Example 2 Example 3 Example
4 Example 5 Example 6
1. Macronutrient premix 74.0 78.0 80.0 72.0 - 76.0
2. Macronutrient premix with refined wheat flour - - - - 74.0 -
3. Fiber 5.0 2.0 1.0 3.0 2.0 1.0
4. Prebiotic FOS L95 3.0 6.0 10.0 - - -
5. Prebiotic FOS L65 - - - 12.0 10.0 8.0
6. Sweetener 14.0 10.0 6.0 12.00 10.00 14.00
7. Leavening agent 1.5 1.5 1.5 1.0 1.0 1.0
8. Emulsifier 0.25 0.35 0.45 0.25 0.35 0.45
9. Dough conditioner 0.05 0.05 0.05 0.05 0.05 0.05
10. Excipients q.s. q.s. q.s. q.s. q.s. q.s.
Table 2: Nutritional content for compositions as per Examples 1, 2 and 3
Sr. No. Nutrient component Nutrient composition (g/100g of the composition)
Example 1 Example 2 Example 3
1. Carbohydrates 40.0 44.0 48.0
2. Proteins 10.0 12.0 12.0
3. Fats 14.0 18.0 20.0
4. Total Fiber 10.0 15.0 16.00
5. Total sugars 4.0 5.0 12.0
6. Trans fatty acids 0.05 0.1 0.2
[177] Manufacturing Process for composition:
The process comprises of following steps:
Step I: Preparation of dough
The ingredients as per Table 1 were weighed and mixed in a mixer using appropriate quantity of water and as per the optimized process in order to get the dough of desired properties.
Step II: Kneading and foaming: Dough obtained in step I is subjected to kneading and foaming in a crusher unit.
Step III: Moulding: Kneaded dough from step II is moulded to desired shape and appearance.
Step IV: Baking: The moulded dough of Step III is subjected to baking in an oven for about 8 to 12 minutes at a temperature ranging between 200º to 280º Celcius.
Step V: Cooling and Packaging: The baked compositions are then allowed to cool and are subsequently packaged in suitable containers.
[178] EXPERIMENTAL DATA:
[179] The samples from the different batches were subjected to qualitative consumer testing. About 250 consumers were selected from the age group of 25 to 50 years out of which 50% were diabetic, 25% were pre-diabetic and 25% were healthy lifestyle seekers who wanted to manage their weight. They were asked to consume the randomly assigned test product and reference product (Example 5) for a month.
I. Organoleptic Evaluation:
Results of organoleptic evaluation are summarized in Table 3.
Table 3: Organoleptic evaluation of selected samples
Test Example 2 Example 3 Example 4 Example 6 Example 5
Colour Light brown on top and little darkish brown at bottom Light brown on top and darkish brown at bottom Brown on top and darkish brown at bottom Brown on top and little darkish brown at bottom Light brown
Aroma Baked cereal aroma Flavoured milk aroma Baked cereal aroma Baked cereal aroma Light flavoured aroma
Surface Texture Slight rough with the visible mould impression Slight rough with the visible mould impression Slight rough with the visible mould impression Slight rough with the visible mould impression Slight rough with the visible mould impression
Appearance and mouthfeel Very Crunchy Crunchy Soggy and chewy Soft and brittle Hard in the core, brittle outer surface
Flavor Slight vanilla flavour, very slight milky flavour Slight milky vanilla flavour Slight vanilla flavour Slight vanilla flavour Slight vanilla flavour
Taste Slightly sweet Slightly sweet mildly sweeter Strong sweet taste Strong sweet taste
Aftertaste Very slight aftertaste mild aftertaste mild aftertaste mild aftertaste mild aftertaste

II. Analytical Study Data:
Selected samples were subjected to analytical testing. The compositions were evaluated for certain analytical and microbiological parameters.
Results of the evaluation are summarized in the Table 4 and Table 5 below.

Table 4: Analytical evaluation of compositions of Example 2 and Example 3
Test Unit Specification Example 2 Example 3
Moisture g/100g NMT 3 0.9 1.5
Acid insoluble Ash g/100g NMT 0.1 <0.05 <0.05
Acidity of extracted Fat g/100g NMT 2 0.35 0.4
Energy kcal/100g NLT 450 450.2 450.5
Cholesterol mg/100g NMT 5 2.0 2.2
Total fiber g/100g NLT 15 18.0 19.0

Table 5: Microbiological Evaluation of compositions of Example 2 and Example 3
Test Unit Specification Example 2 Example 3
Enterobacteriaceae /g Absent Absent Absent
Salmonella /25g Absent Absent Absent
Coliforms /g Absent Absent Absent
Total plate count CFU/g NMT 5000 30 30
Yeast and Molds count CFU/g NMT 10 <10 <10
The results from Table 4 and Table 5 demonstrate that the formulations of Example 2 and 3 comply with all the required specifications for analytical and microbiological parameters.
[180] Stability Studies:
Formulations of Example 2 were packaged using a polypropylene laminate of optical density greater than 2.5 whereas formulations of Example 3 were packaged in polypropylene laminate of optical density lesser than 2.5. After packaging these two samples were subjected to real time stability study (30°C & 65% RH). Results of the stability studies are summarized in the Table 6 and Table 7 below.

Table 6: Results of real time stability study (30°C & 65% RH) for Example 2
Parameter Unit Initial 3 Months 6 Months 9 Months
Moisture g/100g 0.95 1.73 1.88 1.52
Acid insoluble ash g/100g <0.05 <0.05 <0.05 <0.05
Acidity of extracted fat g/100g 0.35 0.89 0.88 0.87
Ash g/100g 2.25 2.31 2.55 2.42
SAFA g/100g 7.87 8.75 8.81 8.65
MUFA g/100g 9.15 7.63 7.88 7.85
PUFA g/100g 2.45 2.13 2.51 2.32
Trans fatty acids g/100g <0.1 <0.1 <0.1 <0.1
Peroxide value meq/kg <0.2 <0.2 <0.2 <0.2
Water activity aw 0.1498 0.1803 0.2462 0.3074
Total plate count CFU/g 30 80 180 90
Yeast and mold CFU/g <10 <10 <10 <10
Salmonella per 25g Absent Not detected Not detected Not detected
Enterobacteriaceae per g Absent Absent Absent Absent
Coliforms per g Absent Not detected Not detected Not detected

Table 7: Results of real time stability study (30°C & 65% RH) for Example 3
Parameter Unit Initial 3 Months 6 Months 9 Months
Moisture g/100g 0.87 1.84 4.08 --
Peroxide value meq/kg <0.2 0.3 2.5 --
Water activity aw 0.2209 0.4 0.7 --

Formulations of Example 2 which were packaged using a polypropylene laminate of optical density greater than 2.5, were found to comply with all the specifications of stability parameters in real time stability study. Formulations of Example 3 packaged in polypropylene laminate of optical density lesser than 2.5, demonstrated higher moisture intake and therefore did not comply with the standards of stability studies. Thus, formulations of Example 3 were discontinued from further evaluation.

Formulations of Example 2 were further analyzed for their stability with respect to their nutrient content. Result of stability studies with respect to the nutrient content are summarized in Table 8 below.
Table 8: Results of real time stability study (30°C & 65% RH) for Example 2 for their nutrition content
Parameter Unit Initial 3 Months 6 Months 9 Months
Fat g/100g 19.89 18.58 19.24 18.83
Total fiber g/100g 18.19 18.68 15.67 15.3
Total carbohydrate g/100g 64.95 65.44 64.26 65.39
Protein g/100g 11.96 11.94 12.07 11.84
Energy kcal/100g 450.28 439.39 447.1 447.79

Formulations of Example 2 were found to comply with all the specifications of stability testing parameters and nutrient content in real time stability study.

Further, formulations of Example 2 were subjected to accelerated stability study (40°C & 75% RH). The results are summarized in the Table 9 and Table 10 below.
Table 9: Results of accelerated stability studies (40°C & 75% RH) for Example 2
Parameter Unit Initial 30 days 60 days 90 days
Moisture g/100g 0.95 1.77 1.04 1.24
Acid insoluble ash g/100g <0.05 <0.05 <0.05 <0.05
Acidity of extracted fat g/100g 0.35 0.64 0.6 0.8
Ash g/100g 2.25 2.48 2.25 2.25
SAFA g/100g 7.87 7.92 8.65 8.45
MUFA g/100g 9.15 9.18 8.39 8.04
PUFA g/100g 2.45 2.49 2.32 2.35
Trans fatty acids g/100g <0.1 <0.1 <0.1 <0.1
Peroxide value meq/kg <0.2 <0.2 <0.2 <0.2
Water activity aw 0.1498 0.2489 0.2266 0.2871
Total plate count CFU/g 30 350 300 130
Yeast and mold CFU/g <10 <10 <10 <10
Salmonella per 25g Absent Not detected Not detected Not detected
Enterobacteriaceae per g Absent Absent Absent Absent
Coliforms per g Absent Not detected Not detected Not detected
Table 10: Results of accelerated stability studies (40°C & 75% RH) for Example 2 tested for their nutrition content
Parameter Unit Initial 30 days 60 days 90 days
Fat g/100g 19.89 19.67 19.44 18.88
Total fiber g/100g 18.19 18.40 18.65 18.76
Total carbohydrate g/100g 64.95 65.28 65.31 65.51
Protein g/100g 11.96 11.97 11.97 12.12
Energy kcal/100g 450.28 448.12 446.77 442.93
Formulation as per the Example 2 was found to comply with all the specifications of stability testing parameters and nutrient content in accelerated stability study.

CLINICAL STUDY:
Formulation of Example 2 (test composition) was subjected to in-vivo clinical studies, with glucose used as a reference standard. The glycemic index of test composition was determined in healthy participants with age =18 to =45 and with BMI = 18.5 to = 22.9 kg/m2. The clinical study evaluated the GI of the test composition by calculating the incremental area under the curve (IAUC).
Study design and methodology:
Compositions of Example 2 were subjected to the clinical study as test composition (54g of the biscuits along with 125 mL of water, ~25g of carbohydrate equivalent) and was consumed by all the participants (n=10).
On three different occasions, each participant was tested with 25g of glucose (27.5g of glucose monohydrate drink-27.5g of glucose dissolved in 125 mL of water) as reference food.
Capillary blood glucose was measured at fasting (0 minute), 15, 30, 45, 60, 90, and 120 minutes for capillary blood glucose after consumption of test compositions and reference food for the study. (Participants who were not familiar with blood sampling via finger pricking i.e. capillary blood sampling performed a practice test to get acquainted with the procedure and to control the effects of anxiety on blood glucose response.) Fasting blood samples were taken at -5 minutes and 0 minutes by finger prick before consumption of the food and the baseline value is taken as a mean of these two values.
All participants underwent 3 days of reference food testing and 1 day of test composition in random order with 2-3 days’ washout between measurements to minimize carry over effects. Participants visited GI testing centre each test day in the morning after 10-12 hours of overnight fast. Brief questionnaire on previous day’s diet including last previous meal-dinner, physical activity, smoking, alcohol and caffeine containing drinks were obtained to ensure that the participants maintained similar diet and physical activity on pretest dates and refrained from smoking and alcohol during study period.
Results of clinical studies are summarized in table 11 below:
Table 11: Change in blood glucose between reference food and test composition over a period of 2 hours is as follows:
Time
(minutes) Change in blood glucose concentration
(mg/dL)
Reference food (Glucose) Test composition (Example 2)
0 0 0
15 28±3.0 6±1.2
30 55±3.3 22±2.9
45 60±4.2 33±2.4
60 46±5.4 27±2.1
90 5±4.3 12±2.7
120 -14±1.7 7±1.6

Calculation of GI of the test composition
Formula for GI value of test composition
GI value of test composition (%)
= Blood glucose IAUC value for test composition X 100
IAUC value for reference food

Table 12: Measurement of parameters to calculate the GI of the test composition
Participant No. BMI
kg/m2 IAUC for reference food
IAUC for test composition GI (%) for test composition
1. 19.8 4855 2283 47
2. 21.9 1430 745 52
3. 22.7 2662 1523 57
4. 20.3 3153 1561 50
5. 20.2 4361 2595 60
6. 21.6 3773 2033 54
7. 20.9 4004 2269 57
8. 19.3 3205 1324 41
9. 22.3 4162 1916 46
10. 22.2 3890 1913 49
Mean 21.1 3550 1816 51.3
Results: As evident from the results summarized in Table 12 on parameters to calculate the GI value of test composition, the mean glycemic index of the test composition is reported as 51.3 with mean IAUC of 1816, i.e. nearly half the value of mean IAUC of the reference composition. Thus with the above results, it is evident that the test composition exhibits low Glycemic Index as desired, and subsequently smoothens the glucose spike after food consumption, as evidenced by the lowered IAUC values for test product.

,CLAIMS:We claim,
1. A baked nutritional composition with low glycemic index value comprising:
i. a macronutrient component present in an amount of 60%w/w to 85%w/w of the composition; and
ii. a fiber component present in an amount of 5%w/w to 20 %w/w of the composition
wherein the ratio of fiber to macronutrient component is from 1:5 to 1:10
2. The composition as claimed in claim 1, wherein said macronutrient component comprises one or more sources of carbohydrates, proteins and fats.
3. The composition as claimed in and claim 2, wherein the ratio of fiber to carbohydrates is from of 1:2 to 1:7.
4. The composition as claimed in claim 1, wherein said fiber component comprises one or more of soluble, insoluble, prebiotic fibers, non-prebiotic fibers and combinations thereof.
5. The composition as claimed in claim 4, wherein said fiber is selected from one or more of fructo-oligosaccharides, oligofructose, soluble non-starch polysaccharides, insoluble non-starch polysaccharides, galacto-oligosaccharides, trans-galacto-oligosaccharides, glucose-derived oligosaccharides, pectic oligosaccharides, wheat fiber, inulin, acacia fiber, arabic gum, soy polysaccharide, alpha-cellulose, resistant starch and combinations thereof.
6. The composition as claimed in claim 5, wherein said prebiotic fiber is present in an amount of 1% w/w to 15 % w/w of the composition.
7. The composition as claimed in claim 1, wherein said composition provides energy in an amount of 350 to 550 kcal/100g of the composition.
8. The composition as claimed in claim 1, wherein said composition further comprises two or more sweeteners selected from saccharine, sucralose, aspartame, isomalt, maltitol, lactitol, mannitol, erythritol or combinations thereof.
9. The composition as claimed in claim 1, wherein said composition further comprises two or more emulsifiers selected from lecithin, glycerol mono stearate, mono- and diglycerides, lactylated monoglyceride, calcium stearoyl lactylate, sodium stearoyl lactylate, propylene glycol monoesters, diacetyl tartaric esters of monoglycerides, ethoxylated monoglycerides, sorbitan monostearate, polysorbate 60, polyglycerol esters, succinylated monoglycerides, sodium stearoyl fumarate, sucrose esters, stearoyl lactylate or combinations thereof.
10. The composition as claimed in claim 9, wherein said emulsifiers are present in an amount of 0.1% to 1% w/w of the composition.
11. The composition as claimed in claim 1, wherein upon consumption the said composition exhibits a reduced Incremental Area Under the Curve (IAUC), such that the mean IAUC of the test composition is decreased by nearly half of the mean IAUC for the reference composition.
12. The composition as claimed in claim 1, wherein said composition has glycemic index between 25 and 55.
13. A baked nutritional composition with low glycemic index value comprising:
i. a macronutrient component present in an amount of 60%w/w to 85%w/w by weight of the composition; and
ii. a fiber component present in an amount of 5%w/w to 20 %w/w by weight of the composition
wherein the ratio of fiber to macronutrient component is from 1:5 to 1:10; and
wherein the composition is stable for a period of 6 months to 12 months.
14. The composition as claimed in claim 13, wherein said composition is contained in a container, wherein the container material is selected from one or more of metalized or non-metalized polyesters or copolymers of 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 combinations thereof.
15. The composition as claimed in claim 14, wherein said composition is packaged in a container, wherein said container material is selected from one or more of metalized or non-metalized polyesters or copolymers of polypropylene copolymer, polyethylene terephthalate, biaxially oriented polypropylene films and combinations thereof.
16. The container as claimed in claim 15, wherein the container material has a thickness of between 5 to 350 microns and an optical density of 0.5- 5.0 g/cc.
17. The composition claimed in any of the preceding claims wherein the composition is formulated as biscuits, diskettes, cookies, crackers, snack bar and nutrition bar.

Dated this on 4th day of April 2025

For DR. REDDY’S LABORATORIES LIMITED

Dr. M Jayakumar Ph.D., LL.B
Associate Vice President-Intellectual Property Management,
Dr. Reddy’s Laboratories Ltd.,
Survey Nos. 42, 45, 46 & 54,
Bachupally Village, Medchal Malkajgiri District,
Hyderabad– 500 090, Telangana, India.
Telephone No.: +914044346861
Mobile No.: +918008555309
E-mail: ipm@drreddys.com,
jayakumarm@drreddys.com