Dietary fiber composition and a process for its preparation

Abstract

The present disclosure relates to a dietary fiber composition and a process for its preparation. The dietary fiber composition comprises fenugreek fiber, natural fiber, plant extract, and additives. The dietary fiber composition of the present disclosure has excellent water and oil holding capacities. The dietary fiber composition of the present disclosure helps in controlling appetite, weight management, reducing food intake, and maintaining appetite hormones.

Description

[0001] DIETARY FIBER COMPOSITION AND A PROCESS FOR ITS PREPARATION FIELD

[0002] The present disclosure relates to a dietary fiber composition and a process for its preparation. Particularly, the composition of the present disclosure comprises dietary fiber with herbal extract.

[0003] BACKGROUND

[0004] The background information herein below relates to the present disclosure but is not necessarily prior art.

[0005] Dietary fiber is a type of carbohydrate found in plant-based foods and plays a crucial role in maintaining overall health. It is required to maintain the balance of nutrients and promote healthy digestion. It is essential for digestive function, metabolism, heart health, blood sugar / lipids regulation, body weight management, and colon health.

[0006] It is generally recommended that an intake of 25 g to 30 g of dietary fiber is required for optimised health. The amount of fiber consumption typically ranges from 3 g to 20 g daily, depending on individual health needs and goals. While numerous clinical trials have highlighted various health benefits associated with supplementing plant-derived dietary fiber, such as managing body weight and regulating blood sugar and lipid levels, the required dosage is quite high to achieve these results.

[0007] Conventional dietary compositions comprise fiber obtained from fruits, vegetables, cereals, grains, and the like. To meet the dietary requirements, the person might be required to consume a large amount of fiber (~15 to 30 g / day) for health benefits, such as weight management by restricting food intake. However, consuming high amounts of fiber can lead to certain challenges, such as gastrointestinal discomfort, including bloating, gas, and cramps, nutrient malabsorption, and poor absorption of minerals like iron, zinc, and calcium. The taste and aroma associated with various dietary fiber compositions present a significant challenge to consumer acceptability and regular intake.

[0008] Therefore, there is a need to provide a dietary composition that mitigates the drawbacks mentioned herein above or at least provides an alternative solution. OBJECTS

[0009] Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:

[0010] An object of the present disclosure is to ameliorate one or more problems of the background or to at least provide a useful alternative.

[0011] Another object of the present disclosure is to provide a dietary fiber composition.

[0012] Still another object of the present disclosure is to provide a dietary fiber composition that helps in controlling appetite, reducing food intake, supporting body weight management, and enhancing GLP-1 secretion.

[0013] Still another object of the present disclosure is to provide a dietary fiber composition at a low dosage as low as which can have a positive effect on insulin sensitivity, blood glucose, and lipid profile.

[0014] Yet another object of the present disclosure is to provide a dietary fiber composition at a low dosage to provide a significant beneficial effect on anthropometric parameters. Yet another object of the present disclosure is to provide a dietary fiber composition when consumed at an effective dose, effective in modulating uncontrolled eating behaviour and emotional eating, thereby reducing food intake.

[0015] Yet another object of the present disclosure is to provide a dietary fiber composition at a low dosage that supports voluntary meal omission without inducing fatigue, thereby contributing to sustained energy and satiety.

[0016] Yet another object of the present disclosure is to provide a dietary fiber composition at a low dosage which can support loosening the stool.

[0017] Yet another object of the present disclosure is to provide a dietary fiber composition at a low dosage as low as 1 g / day, which can positively modulate the gut microbiome and overcome dysbiosis.

[0018] Another object of the present disclosure is to provide a dietary fiber composition that is safe and effective.

[0019] Yet another object of the present disclosure is to provide a dietary fiber composition that is highly soluble, stable, and with enhanced efficacy at low dosage as low as 1 g / per day. Yet another object is to deliver a dietary fiber-herbal extract complex without having the general issues of fiber supplementation such as bloating, postprandial fullness, suffocation, heartbum, nausea, diarrhoea, epigastric pain, and the like.

[0020] Still another object of the present disclosure is to provide a dietary fiber composition with high water-holding capacity.

[0021] Another object of the present disclosure is to provide a dietary fiber composition that modulates satiety hormones.

[0022] Yet another object of the present disclosure is to provide a dietary fiber composition that holds a high amount of oils and fats.

[0023] Yet another object of the present disclosure is to provide a process for the preparation of the dietary fiber composition that is safe, simple, easy to prepare, easy to scale up, and economical.

[0024] Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

[0025] BRIEF DESCRIPTION OF DRAWINGS

[0026] The present disclosure will now be described with the help of the accompanying drawing, in which:

[0027] Figure 1 A illustrates a graph showing the TFEQ-EE (Emotional eating) score of placebo and FSFW-0121 on day 0 (baseline) and day 56 (end of the study);

[0028] Figure IB illustrates a graph showing the TFEQ-CR (Cognitive restraint) score of placebo and FSFW-0121 on day 0 (baseline) and day 56 (end of the study);

[0029] Figure 1C illustrates a graph showing the TFEQ-UE (Uncontrolled eating) score of placebo and FSFW-0121 on day 0 (baseline) and day 56 (end of the study);

[0030] Figure ID illustrates a graph showing the changes in body weight (Kg) in placebo and FSFW-0121 on day 0 (baseline) and day 56 (end of the study);

[0031] Figure IE illustrates a graph showing the changes of BMI (Kg / m2) in placebo and FSFW-0121 on day 0 (baseline) and day 56 (end of the study);

[0032] Figure IF illustrates a graph showing the changes of GLP-1 (pmol / 1) in placebo and FSFW-0121 on day 0 (baseline) and day 56 (end of the study); Figure 2A illustrates a graph showing changes in mean VAS Satiety scores for BF-24 at different time points compared to placebo;

[0033] Figure 2B illustrates a graph showing changes in mean VAS Hunger scores for BF-24 at different a points compared to placebo;

[0034] Figure 3 A illustrates a graph showing changes in mean GLP-1 (pmol / L) for BF-24 at different time points compared to placebo;

[0035] Figure 3B illustrates a graph showing changes in mean Leptin (ng / mL) for BF-24 at different time points compared to placebo, where ns indicates non-significance;

[0036] Figure 3C illustrates a graph showing changes in mean Ghrelin (pg / mL) for BF-24 at different time points compared to placebo, where ns indicates non-significance;

[0037] Figure 3D illustrates a graph showing changes in mean Cholecystokinin (pg / mL) at different time points for BF-24 and placebo, where ns indicates non-significance;

[0038] Figure 4A illustrates the graph showing changes in body weight (kg) for BF-24 and placebo at baseline and end of the study;

[0039] Figure 4B illustrates the graph showing changes in BMI (Kg / m2) for BF-24 and placebo at baseline and end of the study; and

[0040] Figure 4C illustrates the graph showing changes in Waist Hip Ratio (WHR) for BF-24 and placebo at baseline and end of the study.

[0041] DETAILED DESCRIPTION

[0042] The present disclosure relates to a dietary fiber composition and a process for its preparation.

[0043] Embodiments, of the present disclosure, will now be described with reference to the accompanying drawing.

[0044] Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.

[0045] The terminology used in the present disclosure is only for the purpose of explaining a particular embodiment, and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising," “including,” and “having,” are open-ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units, and / or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed.

[0046] As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed elements.

[0047] The terms first, second, third, etc., should not be construed to limit the scope of the present disclosure, as the aforementioned terms may be only used to distinguish one element, component, region, layer, or section from another component, region, layer, or section. Terms such as first, second, third, etc., when used herein, do not imply a specific sequence or order unless suggested by the present disclosure.

[0048] Conventional dietary compositions comprise fiber obtained from fruits, vegetables, cereals, grains, and the like. To meet the dietary requirements, the person might require to consume a large amount of fiber (~15 to 30 g / day) for health benefits such as weight management by restricting food intake. But, consuming high amounts of fiber can lead to certain challenges such as gastrointestinal discomfort, including bloating, gas, and cramps, nutrient malabsorption, and poor absorption of minerals like iron, zinc, and calcium. The taste and aroma associated with various dietary fiber compositions present a significant challenge to consumer acceptability and regular intake.

[0049] The present disclosure provides a dietary fiber composition and a process for its preparation. The dietary fiber composition of the present disclosure has a synergistic effect of fibers, avoids adverse effects, and is made of GRAS (Generally Recognized as Safe) ingredients.

[0050] In an aspect of the present disclosure, the dietary fiber composition of the present disclosure comprises:

[0051] a. fenugreek fiber in an amount in the range of 60 mass% to 75 mass% with respect to the total mass of the composition;

[0052] b. at least one natural fiber in an amount in the range of 20 mass% to 40 mass% with respect to the total mass of the composition;

[0053] c. at least one plant extract in an amount in the range of 0 mass% to 10 mass% with respect to the total mass of the composition; and

[0054] d. at least one additive in an amount in the range of 0 mass% to 10 mass% with respect to the total mass of the composition.

[0055] In accordance with the embodiments of the present disclosure, the amount of fenugreek fiber is in the range of 60 mass% to 75 mass% with respect to the total mass of the composition.

[0056] In accordance with the embodiments of the present disclosure, the amount of fenugreek fiber is in the range of 60 mass% to 70 mass% with respect to the total mass of the composition.

[0057] In accordance with the embodiments of the present disclosure, the fenugreek fiber holds water in an amount in the range of 40 mL / g to 60 mL / g.

[0058] In accordance with the embodiments of the present disclosure, the fenugreek fiber holds water in an amount in the range of 20 mL / g to 30 mL / g.

[0059] In accordance with the embodiments of the present disclosure, the fenugreek fiber can hold half of its swelled weight of oil or fat.

[0060] In accordance with the embodiments of the present disclosure, the fenugreek fiber is obtained from fenugreek seeds rich in galactomannans.

[0061] In accordance with the embodiments of the present disclosure, the galactomannan-rich fenugreek fiber is isolated from dried fenugreek seeds by a mechanical process involving differential milling, sieving, gravity separation, grinding, and sieving. Fenugreek fiber is uniformly powdered in the range of 62 microns to 170 microns in size and is used in the composition of the present disclosure.

[0062] In accordance with the embodiments of the present disclosure, the galactomannan-rich fenugreek fiber comprises soluble dietary fiber in the range of 75% to 85% (w / w), insoluble fiber in the range of 3% to 10% (w / w), protein in the range of 0% to 5 % (w / w) and moisture content in the range of 5 % to 7 %.

[0063] In accordance with the embodiments of the present disclosure, the galactomannan in the fenugreek fiber is in the range of 70% w / w to 80% w / w.

[0064] In accordance with the embodiments of the present disclosure, the galactomannan-rich fenugreek is devoid / free from saponins, alkaloids, flavonoids, and polyphenols.

[0065] In accordance with the embodiments of the present disclosure, the natural fiber is at least one selected from Konjac fiber, Psyllium husk, Tara gum, or Xanthan gum.

[0066] In accordance with the embodiments of the present disclosure, the natural fiber is also referred to as the second fiber.

[0067] In accordance with the embodiments of the present disclosure, the water holding capacity and oil holding capacity of natural fibers are in the range of 15 ml / g to 35 ml / g and 5 ml / g to 20 ml / g, respectively.

[0068] In accordance with the embodiments of the present disclosure, the water holding capacity and oil holding capacity of natural fibers are in the range of 20 ml / g to 35 ml / g and 5 ml / g to 20 ml / g, respectively.

[0069] In accordance with the embodiments of the present disclosure, the water holding capacity and oil holding capacity of natural fibers are in the range of 20 ml / g to 35 ml / g and 8 ml / g to 16 ml / g, respectively.

[0070] In accordance with the embodiments of the present disclosure, the water holding capacity and oil holding capacity of natural fibers are in the range of 20 ml / g to 35 ml / g and 10 ml / g to 16 ml / g, respectively.

[0071] In accordance with the embodiments of the present disclosure, the natural fiber has significant swelling properties and is obtained from natural substances. In accordance with the embodiments of the present disclosure, the fenugreek fiber and natural fibers, combination in the specified amounts results in a synergistic interaction that substantially enhances water and oil holding capacity.

[0072] In accordance with the embodiments of the present disclosure, the natural fiber is in the range of 20 mass% to 40 mass% with respect to the total mass of the composition.

[0073] In accordance with the embodiments of the present disclosure, the natural fiber is in the range of 20 mass% to 35 mass% with respect to the total mass of the composition.

[0074] In accordance with the embodiments of the present disclosure, the natural fiber is in the range of 20 mass% to 30 mass% with respect to the total mass of the composition.

[0075] In accordance with the embodiments of the present disclosure, the Konjac fiber comprises soluble dietary fiber in the range of 80 w / w% to 95 w / w% and moisture content in the range of 5% to 7%.

[0076] In accordance with the embodiments of the present disclosure, the Konjac fibers further comprise carbohydrates.

[0077] In accordance with the embodiments of the present disclosure, the plant extract is at least one selected from berberine (berberis aristata), acacia catechu (Senegalia catechu), areca catechu, green tea extract, bitter orange extract (Citrus auraritiuni), chili extract (Capsicum annuum), and cinnamon extract (Cinnamomum cassia).

[0078] In accordance with the embodiments of the present disclosure, herbal extract demonstrating anti-obesity activity, appetite-regulating effects, or blood glucose and insulin management properties — such as inhibition of carbohydrate hydrolysis to monosaccharides (e.g., glucose), enhancement of cellular glucose uptake from systemic circulation, or facilitation of intracellular glucose-to-energy conversion — is suitable for incorporation within the compositions described in the present disclosure.

[0079] In accordance with the embodiments of the present disclosure, the plant extract is in the range of 0 mass% to 10 mass% with respect to the total mass of the composition.

[0080] In accordance with the embodiments of the present disclosure, the plant extract is in the range of 5 mass% to 10 mass% with respect to the total mass of the composition. In accordance with the embodiments of the present disclosure, the Berberis aristata extract contains berberine in the range of 50 mass% to 95 mass%.

[0081] In accordance with the embodiments of the present disclosure, the Berberis aristata extract contains berberine in the range of 85 mass% to 95 mass%.

[0082] In accordance with the embodiments of the present disclosure, the Berberis aristata extract contains berberine in the range of 50 mass% to 75 mass%.

[0083] In accordance with the embodiments of the present disclosure, the Acacia catechu extract contains catechins in the range of 20 mass% to 40 mass%.

[0084] In accordance with the embodiments of the present disclosure, the catechins in Acacia catechu extract is 40 mass%.

[0085] In accordance with the embodiments of the present disclosure, the Areca nut extract comprises alkaloids in the range of 0.5 mass% to 1 mass%.

[0086] In accordance with the embodiments of the present disclosure, the Bitter orange extract contains bitter content in the range of 1 mass% to 3 mass%.

[0087] In accordance with the embodiments of the present disclosure, the chilli extract contains capsaicin in the range of 4 mass% to 8 mass%.

[0088] In accordance with the embodiments of the present disclosure, the chilli extract in the dietary fiber composition provides 2 to 6 mg of Capsaicinoids per dosage.

[0089] In accordance with the embodiments of the present disclosure, the Green tea extract contains polyphenols in the range of 30 mass% to 50 mass%.

[0090] In accordance with the embodiments of the present disclosure, the additive is at least one selected from lecithin, cellulose, and edible fatty oils.

[0091] In accordance with the embodiments of the present disclosure, the edible fatty oil is at least one selected from fish oil, olive oil, prime rose oil, flaxseed oil, avocado oil, almond oil, and MCT (medium-chain triglycerides) oil.

[0092] In accordance with the embodiments of the present disclosure, the MCT (mediumchain triglycerides) oil is coconut oil.

[0093] In accordance with the embodiments of the present disclosure, the additive is in the range of 0 mass% to 10 mass% with respect to the total mass of the composition. In accordance with the embodiments of the present disclosure, the additive is in the range of 0 mass% to 5 mass% with respect to the total mass of the composition.

[0094] In accordance with the embodiments of the present disclosure, the additive is in the range of 5 mass% to 10 mass% with respect to the total mass of the composition.

[0095] In accordance with the embodiments of the present disclosure, the dietary fiber composition comprising a fenugreek fiber, a natural fiber, optionally a plant extract, and optionally at least one additive, provides a synergistic effect when combined and administered to a subject.

[0096] In accordance with the embodiments of the present disclosure, the dietary composition is in the form of a powder, granule, tablet, solution, gummies, gels, or capsules.

[0097] In accordance with the embodiment of the present disclosure, the dietary fiber composition of the present disclosure, when administered to humans at a therapeutically effective amount, provides the desired therapeutic effect.

[0098] In accordance with the embodiments of the present disclosure, the dietary fiber composition of the present disclosure can be suitably administered orally.

[0099] In accordance with the embodiments of the present disclosure, the dietary fiber composition of the present disclosure is administered at a dose in the range of 500 mg / day to 3000 mg / day.

[0100] In accordance with the embodiments of the present disclosure, the dosage of the disclosed dietary fiber composition of the present disclosure is comparatively lower than that of conventional fiber formulations designed to achieve similar health benefits. In accordance with the embodiments of the present disclosure, the dietary fiber composition helps in regulating appetite, reducing food intake, supporting body weight management, maintaining appetite-related biomarkers, and enhancing glucagon-like peptide-1 (GLP-1) levels after administration of a single dosage of 1g.

[0101] In accordance with the embodiments of the present disclosure, the dietary fiber composition has a significant effect on satiety hormones, CCK (cholecystokinin), Ghrelin, Leptin, and PYY (Peptide YY), that support healthy eating behaviour. In accordance with the embodiments of the present disclosure, the dietary fiber composition of the present disclosure was evaluated for its swelling capacity, oil holding capacity, total dietary fiber content, and soluble dietary fiber content.

[0102] Dietary fiber plays a vital role in appetite regulation and obesity management through its water-holding and oil-binding capacities, which modulate gastrointestinal physiology and energy intake. Fibers with high water-holding capacity absorb and retain large amounts of water, increasing gastric volume and meal viscosity. This distension activates gastric stretch receptors, promoting early satiation, delaying gastric emptying, and prolonging fullness. Additionally, fiber fermentation by gut microbiota in the colon produces short-chain fatty acids (SCFAs), notably propionate, which stimulate the secretion of appetite-regulating peptides such as peptide YY (PYY), glucagon-like peptide- 1 (GLP-1), and cholecystokinin (CCK), thereby enhancing satiety and reducing food intake (Salleh et al., 2019; Hervik & Svihus, 2 19). In parallel, the oil-binding capacity of fiber enables it to adsorb dietary lipids and bile acids, reducing fat absorption and increasing fecal fat excretion (Y He et al., 2022). This lowers the caloric density of meals and also enhances intestinal lipid sensing, further stimulating CCK release to suppress appetite and slow gastric emptying (Masoumeh 2024).

[0103] Collectively, dietary fiber exerts multifaceted effects on appetite control and energy balance through both physical and metabolic pathways. By altering gastric dynamics, modulating gut hormone secretion, and reducing lipid absorption, fiber effectively promotes satiety and decreases subsequent caloric intake. These combined actions contribute to improved weight management, metabolic regulation, and overall gastrointestinal health.

[0104] In another aspect, the present disclosure provides a method for the preparation of the dietary fiber composition. Particularly, the present disclosure provides a process for the dietary fiber composition comprising fenugreek fiber and natural fiber.

[0105] The process is described in detail.

[0106] In a first step, fenugreek powder is mixed with water at a temperature in the range of 40°C to 60°C under stirring to obtain a fenugreek fiber solution. In a second step, natural fiber is separately mixed with water at a temperature in the range of 40°C to 60°C under stirring to obtain a natural fiber solution.

[0107] In certain embodiments of the present disclosure, the natural fiber is at least one selected from Konjac fiber, Psyllium husk, Tara gum, or Xanthan gum.

[0108] In a third step, the natural fiber solution is added to the fenugreek fiber solution under stirring at a temperature in the range of 40°C to 60°C to obtain a first homogenized mixture.

[0109] In a fourth step, the plant extract and additives are optionally added to the first homogenized mixture under stirring to obtain a second homogenized mixture.

[0110] In a final step, the second homogenized mixture is evaporated under vacuum at a temperature in the range of 40°C to 60°C to obtain a mass with less than 6% moisture level. The mass was then powdered, agglomerated, and sieved to obtain the dietary fiber composition (pass through the 80 to 230 mesh size) in powder form.

[0111] In yet another aspect, the present disclosure provides a method for the preparation of the dietary fiber composition.

[0112] The process is described in detail.

[0113] In a first step, fenugreek powder is mixed with water at a temperature in the range of 40°C to 60°C under stirring to obtain a fenugreek fiber solution.

[0114] In a second step, natural fiber is separately mixed with water at a temperature in the range of 40°C to 60°C under stirring to obtain a natural fiber solution.

[0115] In certain embodiments of the present disclosure, the natural fiber is at least one selected from Konjac fiber, Psyllium husk, Tara gum, or Xanthan gum.

[0116] In a third step, the natural fiber solution is added to the fenugreek fiber solution under stirring at a temperature in the range of 40°C to 60°C to obtain a first homogenized mixture.

[0117] In a fourth step, the plant extract and additives are optionally added to the first homogenized mixture under stirring to obtain second homogenized mixture. In accordance with the embodiments of the present disclosure, the plant extract and additives are dissolved in a fluid medium, followed by adding to the first homogenized mixture.

[0118] In accordance with the embodiments of the present disclosure, the fluid medium is at least one selected from water, ethanol, or an ethanol / water mixture.

[0119] In a final step, the second homogenized mixture is cooled to room temperature, followed by drying and grinding to obtain the dietary fiber composition.

[0120] In accordance with the embodiments of the present disclosure, the mixture is dried under vacuum at <60°C.

[0121] In another aspect, the present disclosure provides a process for the preparation of dietary fiber composition in the form of tablets, capsules, gummies, gellies, and water-dispersible powder.

[0122] In accordance with the embodiments of the present disclosure, the process of preparing the dietary fiber composition is safe, simple, easy to prepare, easy to scale up, stable, and economical.

[0123] In another aspect, the present disclosure provides a method for regulating appetite, reducing food intake, supporting body weight management, maintaining appetite-related biomarkers, and enhancing glucagon-like peptide-1 (GLP-1) levels.

[0124] In accordance with the embodiments of the present disclosure, a method for regulating appetite, reducing food intake, supporting body weight management, maintaining appetite-related biomarkers, and enhancing glucagon-like peptide-1 (GLP-1) levels in a subject comprises administering to the subject, in need thereof, a therapeutically effective amount of dietary fiber composition of the present disclosure.

[0125] In accordance with the embodiments of the present disclosure, the appetite-related biomarker is at least one selected from leptin, ghrelin, PYY (Peptide YY), and cholecystokinin (CCK).

[0126] In accordance with the embodiments of the present disclosure, the body weight management includes body weight, body mass index (BMI), and waist-to-hip ratio (WHR). In another aspect, the present disclosure provides the use of dietary fiber composition for regulating appetite, reducing food intake, supporting body weight management, maintaining appetite-related biomarkers, and enhancing glucagon-like peptide-1 (GLP-1) levels.

[0127] In accordance with the embodiments of the present disclosure, the appetite-related biomarker is at least one selected from leptin, ghrelin, PYY (Peptide YY), and cholecystokinin (CCK).

[0128] In accordance with the embodiments of the present disclosure, the body weight management includes body weight, body mass index (BMI), and waist-to-hip ratio (WHR).

[0129] The foregoing description of the embodiments has been provided for purposes of illustration and is not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment but are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.

[0130] The present disclosure is further described in light of the following experiments, which are set forth for illustration purposes only, and not to be construed as limiting the scope of the disclosure. The following experiments can be tested to scale up to an industrial / commercial scale and the results obtained can be extrapolated to the industrial scale.

[0131] EXPERIMENTAL DETAILS

[0132] Example-1: Process for the preparation of dietary fiber composition

[0133] 65 kg of fenugreek fiber powder (pass 80 mesh) was mixed with 650 litres of water having a temperature in the range of 40°C to 60°C under stirring to obtain a fenugreek fiber solution. Separately, 25 kg of Konjac fiber was mixed with 250 litres of water having a temperature in the range of 40°C to 60°C under stirring to obtain the konjac fiber solution. The solution preparation allows the molecular chains of the fibers to assume an extended conformation for better interaction. The Konjac fiber solution was slowly added to the fenugreek fiber solution under stirring at 50°C to obtain a homogenized mixture. The homogenized mixture thus obtained was evaporated under vacuum, at <60°C, to less than 6% moisture level. It was then powdered, agglomerated, and sieved to obtain the dietary fiber composition (pass through the 80 to 230 mesh size) in powder form.

[0134] Bulk density: 0.71 g / mL; Swelling capacity in water: 48 mL / g; Oil holding capacity:45 mL / g; Total dietary fiber: 89 wt%; Soluble dietary fiber: 83 wt%.

[0135] Example 2: Process for the preparation of dietary fiber with berberine

[0136] 65 kg of fenugreek fiber powder (pass 80 mesh) was mixed with 500 to 700 Lit of water having a temperature in the range of 40°C to 60°C under stirring to obtain a fenugreek fiber solution. Separately, 25 kg of Konjac fiber was mixed with 200 to 300 Lit of water having a temperature in the range of 40°C to 60°C under stirring to obtain a konjac fiber solution. The solution preparation allows the molecular chains of the fibers to assume an extended conformation for better interaction. The Konjac fiber solution was slowly added to the fenugreek fiber solution under stirring at 50°C to obtain a first homogenized mixture. To the first homogenized mixture, 8.5 kg of berberine extract (75% berberine content) dissolved in 10 lit of water was added under stirring to obtain a second homogenized mixture. The second homogenized mixture was cooled to room temperature to obtain a gel. The so obtained gel was dried under vacuum at <60°C and powdered to obtain the dietary fiber composition (pass through the 80 to 230 mesh size).

[0137] Example-3: Process for the preparation of dietary fiber with berberine

[0138] 62 kg of fenugreek fiber powder (pass 80 mesh) was mixed with 500 to 700 Lit of water having a temperature in the range of 40°C to 60°C under stirring to obtain a fenugreek fiber solution. Separately, 25 kg of Konjac fiber was mixed with 200 to 300 Lit of water having a temperature in the range of 40°C to 60°C under stirring to obtain a konjac fiber solution. The konjac fiber solution was slowly added to the fenugreek fiber solution under stirring at 50±5°C to obtain a first homogenized mixture. Separately, 8.5 kg of berberine extract (71% berberine content) was mixed with 4.5 kg of Lecithin in ethanol / water (90 / 10 v / v) followed by heating to 50 to 70°C to obtain a second homogenized mixture. The second homogeneous mixture was heated at 50°C to 60°C under vacuum to remove the ethanol followed by dissolving the solution in water to obtain a third homogenized mixture. The third homogenized mixture was mixed with the first homogenized mixture, followed by cooling to room temperature to obtain a gel. The so obtained gel was dried under vacuum at <60°C and powdered to obtain the dietary fiber composition (pass through the 80 to 230 mesh size) in powder form.

[0139] Example 4: Process for the preparation of dietary fiber composition

[0140] 65 kg of fenugreek fiber powder (pass 80 mesh) was mixed with 650 litres of water having a temperature in the range of 40°C to 60°C under stirring to obtain a fenugreek fiber solution. Separately, 25 kg of Konjac fiber was mixed with 250 litres of water having a temperature in the range of 40°C to 60°C under stirring to obtain the konjac fiber solution. The Konjac fiber solution was slowly added to the fenugreek fiber solution under stirring at 50°C to obtain a first homogenized mixture. To the first homogenized mixture, 2.5 kg of lecithin and 2.5 kg of flaxseed oil were added and homogenized at >150 mm bar pressure to obtain the second homogenized mixture. The second homogenized mixture thus obtained was evaporated under vacuum, at <60 °C to less than 6% moisture level. It was then powdered, agglomerated, and sieved to obtain the dietary fiber composition (pass through the 80 to 230 mesh size) in powder form.

[0141] Bulk density: 0.70 g / mL; Swelling capacity in water: 51 mL / g; Oil holding capacity: 46 mL / g; Total dietary fiber 86 wt%; Soluble dietary fiber 77.2 wt%.

[0142] Example-5: Process for the preparation of dietary fiber composition with berberine 63 kg of fenugreek fiber powder (pass 80 mesh) was mixed with 570 litres of water having a temperature in the range of 40°C to 60°C under stirring to obtain a fenugreek fiber solution. Separately, 27 kg of Konjac fiber was mixed with 270 litres of water having a temperature in the range of 40°C to 60°C under stirring to obtain a konjac fiber solution. The konjac fiber solution was slowly added to the fenugreek fiber solution under stirring at 50°C to obtain a first homogenized mixture. To the first homogenized mixture, 8.5 kg of Berberis aristata extract (65% berberine) dissolved in 10 liters of water was added under stirring to obtain a second homogenized mixture. The second homogenized mixture was cooled to obtain a gel. The so obtained gel was dried under vacuum (< 60 °C) and powdered to obtain the dietary fiber composition (pass through the 80 to 230 mesh size) in powder form.

[0143] The powder was then agglomerated using a fluid bed drier, and coated with a mixture of the first homogenized mixture containing 2.7 % (w / w of the solid content) of cellulose powder to obtain the dietary fiber composition. Bulk density: 0.73 g / mL; Swelling capacity in water: 47 mL / g; Oil holding capacity: 41 mL / g; Berberine content: 5.8 wt%; Total dietary fiber:78.2 wt%; Soluble dietary fiber 75.7 wt%.

[0144] Example-6: Process for the preparation of dietary fiber composition with berberine 60 kg of fenugreek fiber powder (pass 80 mesh) was mixed with 600 litres of water having a temperature in the range of 40°C to 60°C under stirring to obtain a fenugreek fiber solution. Separately, 22 kg of Konjac fiber was mixed with 220 litres of water having a temperature in the range of 40°C to 60°C under stirring to obtain the konjac fiber solution. The Konjac fiber solution was slowly added to the fenugreek fiber solution under stirring at 50±5°C to obtain a first homogenized mixture. Separately, 8.5 kg of berberine extract (76% of berberine) was mixed with 3 kg of lecithin (>45% phosphatidylcholine) and 1.5 kg of olive oil in an ethanol / water mixture (90 / 10 v / v), followed by homogenization at 70°C to obtain a second homogenized mixture. The second homogenized mixture was heated at 50°C to 60°C under vacuum to remove the ethanol, followed by dissolving the solution in water to obtain a third homogenized mixture. The third homogenized mixture was mixed with the first homogenized mixture, followed by cooling to obtain a gel. The so obtained gel was dried under vacuum (<60°C) and powdered to obtain the dietary fiber composition (pass through the 80 to 230 mesh size) in powder form.

[0145] Bulk density: 0.72 g / mL; Swelling capacity in water: 53 mL / g; Oil holding capacity: 50 mL / g; Berberine content: 6.22 wt%; Total dietary fiber: 68.8 wt%; Soluble dietary fiber: 64.6 wt%.

[0146] Example-7: Process for the preparation of dietary fiber composition with berberine 62 kg of fenugreek fiber powder (pass 80 mesh) was mixed with 500 to 700 liters of water having a temperature in the range of 40°C to 60°C under stirring to obtain a fenugreek fiber solution. Separately, 20 kg of Konjac fiber was mixed with 200 to 300 liters of water having a temperature in the range of 40°C to 60°C under stirring to obtain a konjac fiber solution. The Konjac fiber solution was slowly added to the fenugreek fiber solution under stirring at 50±5°C to obtain a first homogenized mixture. The first homogenized mixture thus obtained was evaporated under vacuum, at <60°C to less than 6% moisture level. It was then powdered, agglomerated, and sieved to get the first free flowing granular powder. Separately, 6.3 kg of Berberine extract (95.1% of berberine) content was mixed with 3.5 kg of Lecithin containing >45% phosphatidylcholine in an ethanol / water mixture (90 / 10 v / v), followed by homogenization at 70°C to obtain a second homogenized mixture. The second mixture was heated at 50 to 60°C under vacuum to remove the ethanol, followed by dissolving the solution in water to obtain a third homogenized mixture. It was then dried under vacuum and powdered to get the second free-flowing powder (pass through the 80 to 230 mesh size).

[0147] The first and the second powders were uniformly blended and ground to get a homogeneous third powder. The third powder was subsequently agglomerated using a fluid bed drier and coated with a mixture of the first homogenized mixture containing 5 to 10% (w / w of the solid content) of cellulose powder to get free-flowing, taste-masked, granular fenugreek fiber - Konjac fiber - berberine fiber composition.

[0148] Bulk density: 0.69 g / mL; Swelling capacity in water: 42 mL / g; Oil holding capacity:38.2 mL / g; Berberine content: 7.7 wt%; Total dietary fiber: 71.4 wt%; Soluble dietary fiber: 63.8 wt%.

[0149] Example 8 to 12: Process for the preparation of dietary fiber composition with berberine

[0150] The dietary fiber compositions were prepared similarly using the process disclosed in Example 5 by varying the herbal extracts. The composition details are provided below in Table 1.

[0151] Table 1: Composition details of dietary fiber composition

[0152] Konjac Plant

[0153] Example Fenugreek Additive fiber Plant extract extract Additive

[0154] No. fiber (kg) (kg) (kg) (kg)

[0155] 8 57 27 Acacia catechu 9.5 Cellulose 1.5

[0156] extract (not less

[0157] than 20 %

[0158] catechins)

[0159]

[0160] 9 60 22 Areca nut (not less 8.5 Lecithin; 4.5

[0161] than 0.5%

[0162] Cellulose 5 Alkaloids)

[0163] 10 62 20 Bitter orange 8.5 Lecithin; 4.5;

[0164] extract (not less

[0165] Cellulose 5

[0166] than 2% bitter

[0167] content)

[0168] 11 57 27 Chilli extract (not 9.5 Cellulose 1.5

[0169] more than 6%

[0170] capsaicin content)

[0171] 12 57 27 Green tea extract 9.5 Cellulose 1.5

[0172] (not less than 40%

[0173] polyphenols)

[0174]

[0175] Examples 13 to 18: Process for the preparation of dietary fiber composition with berberine

[0176] The dietary fiber compositions were prepared similarly using the process disclosed in Example 5 by varying the natural fibers. The composition details are provided below in

[0177] 5 Table 2.

[0178] Table 2: Composition details of dietary fiber composition

[0179] Soln Water Total ble Oil

[0180] Natural holdin dietar diet Fenugre holding Example Natural fiber Additi g y ary ek fiber Additive capacit

[0181] No. fiber amount ve (kg) capacit fiber fibe (kg) y

[0182] (kg) y (wt% r (mL / g)

[0183] (mL / g) ) (wt

[0184] %)

[0185]

[0186] Psyllium

[0187] 3 65 25 38 25 75 67 fiber

[0188] Psyllium

[0189] 4 65 25 Lecithin 4.5 42 28 70 61 fiber

[0190] Xanthan

[0191] 5 65 25 42 30 87 79 gum

[0192] Xanthan

[0193] 6 65 25 Lecithin 4.5 47 36 80 73 gum

[0194] 7 65 Tara gum 25 40 28 76 69

[0195] 8 65 Tara gum 25 Lecithin 4.5 45 35 72 65

[0196]

[0197] Example 19: Water and oil holding capacity of fibers

[0198] The fiber components utilized in the present disclosure were assessed for their waterholding capacity and oil-holding capacity using the method described below.

[0199] Water holding capacity:

[0200] About 3 g of fiber is weighed accurately into a beaker and mixed with 50 mL of water, and quantitatively transferred into a weighed measuring cylinder with water. The water level in the cylinder is adjusted to about 2 cm above the swelled fiber level. It is then maintained for 30 min. If needed, water is again added to get a stable water level above the fiber. Once stabilised, the excess water was decanted, and the weight of the cylinder with the swelled fiber was taken. From this weight, swelling capacity or water holding capacity was estimated as ml / g.

[0201] Oil holding capacity:

[0202] Oil holding capacity was estimated by a trial-and-error method. The maximum swelled fiber (as mentioned above) was mixed with oil using a lab homogenizer and kept for standing for about 6 h. The amount of oil that can be imbibed within the swelled fiber without separation is mentioned as the oil holding capacity. The details are provided in Table 3.

[0203] Table 3:

[0204] Water holding Oil holding

[0205] S. No Dietary fiber capacity capacity (mL / g) (mL / g)

[0206] 1 Fenugreek fiber 23 10

[0207] 2 Konjac fiber 34 16

[0208] 3 Xanthan gum 26 10

[0209] 4 Tara gum 20 8

[0210] 5 Psyllium fiber 20 8

[0211]

[0212] Example 20: Influence of the dietary fiber composition of the present disclosure on TFWQ (Three Titre Eating Questionnaire), anthropometrical parameters (Body weight, BMI, W / H ratio), and appetite biomarker in overweight healthy adults Title: A Parallel-group study to evaluate the effect of FSFW0121 on TFWQ (Three Titre Eating Questionnaire), anthropometrical parameters (Body weight, BMI, W / H ratio), and appetite biomarker in overweight healthy adults

[0213] The efficacy of the dietary fiber composition of the present disclosure was evaluated in healthy subjects. A total of 24 healthy subjects, aged 18-45 years, with a BMI > 25.0 to < 35.0 kg / m2, were enrolled in the study. During the study period, the healthy subjects were required to maintain their habitual diet and physical activity throughout and refrain from starting any new weight-loss or exercise programs. The healthy volunteers were randomly assigned to two groups (n = 12 per group) as follows: Group 1: FSFW0121 (Dietary composition of Example 4) - Participants received a single capsule of 500 mg FSFW0121 administered orally, thrice daily for 56 days. Group 2: Placebo - Participants received a single capsule of 500 mg MCC as a placebo, administered orally, thrice daily for 56 days.

[0214] Clinical Evaluation Protocol

[0215] In accordance with the study design, all human subjects enrolled in the clinical trial were instructed to report to the designated study center at two specific time points: (i) baseline (designated as Day 0), and (ii) the conclusion of the study period (designated as Day 56). At each time point, subjects arrived following an overnight fasting period of no less than eight hours.

[0216] Upon arrival, subjects underwent a standardized evaluation protocol comprising anthropometric, behavioural, and biochemical assessments. All anthropometric measurements were performed by trained personnel utilizing calibrated equipment to ensure measurement accuracy and reproducibility.

[0217] The following parameters were assessed at both Day 0 and Day 56:

[0218] • Anthropometric Measurements: Body weight, Body Mass Index (BMI), and Waist-to-Hip Ratio (WHR);

[0219] • Behavioral Assessment: Conducted via the administration of the Three-Factor Eating Questionnaire (TFEQ), a validated instrument for evaluating eating behaviour traits;

[0220] • Biochemical Assessment: Quantification of circulating levels of Glucagon-like Peptide-1 (GLP-1) using standard biochemical assay techniques.

[0221] Statistical Analysis

[0222] Statistical evaluation of changes in measured parameters from baseline (Day 0) to the end of the study period (Day 56) was performed using established analytical methods. Intra-group comparisons were conducted utilizing a paired t-test to assess the significance of changes within each treatment group. Inter-group comparisons were performed using an independent t-test to evaluate differences between distinct treatment cohorts. The corresponding results of these analyses are presented below. Three-Factor Eating Questionnaire (TFEQ)

[0223] • Emotional eating (EE)

[0224] Subjects receiving FSFW0121 showed a statistically significant reduction in emotional eating scores (TFEQ-EE) over 56 days compared to placebo (p < 0.005), indicating improved emotional eating behavior and potential appetite regulation.

[0225] Within-group analysis revealed a significant decrease in the FSFW0121 group (-3.33; p < 0.0001), while the placebo group showed a non-significant change (-0.74; p = 0.165). These findings align with between-group comparisons, confirming the beneficial effect of FSFW0121. The results are shown in Figure 1A.

[0226] • Cognitive Restrain

[0227] Over the 56-day study period, both the placebo and FSFW0121 groups exhibited reductions in cognitive restraint scores. However, the magnitude of reduction was significantly greater in the FSFW0121 group, indicating a more pronounced effect. This outcome suggests a normalization of appetite or satiety mechanisms, resulting in reduced reliance on conscious dietary control. The results are shown in Figure IB.

[0228] • Uncontrolled eating

[0229] At the end of the study, i.e., Day 56, subjects receiving FSFW0121 exhibited a highly significant reduction in uncontrolled eating scores, whereas the placebo group showed no statistically meaningful change. These findings demonstrate that FSFW0121 supplementation effectively mitigates tendencies toward overeating and loss of control during food intake, indicating enhanced appetite regulation and satiety response. The results are shown in Figure 1C.

[0230] Anthropometrical parameters

[0231] • Body weight (Kg)

[0232] Over the 56-day study period, subjects in the placebo group exhibited a statistically significant increase in body weight, while subjects receiving FSFW0121 demonstrated a significant reduction. The difference in weight change between the two groups was statistically significant (p < 0.005), confirming the efficacy of FSFW0121 in reducing body weight relative to placebo. The results are shown in Figure ID. BMI (Kg / m2)

[0233] Over the 56-day study period, the placebo group exhibited a slight, non-significant increase in BMI (p ~ 0.051), while the FSFW0121 group showed a non-significant decrease (p = 0.285). However, between-group analysis revealed a statistically significant difference, indicating that FSFW0121 supplementation contributed to BMI maintenance in comparison to placebo. These findings suggest a potential role for FSFW0121 in supporting weight management and improving body composition. The results are shown in Figure IE.

[0234] • Appetite Biomarker - GLP-l(pmol / l)

[0235] Analysis of Glucagon-like Peptide-1 (GLP-1) concentrations over the 56-day study period revealed distinct differences between treatment groups. The placebo group exhibited no statistically significant change in GLP-1 levels, indicating a lack of measurable impact on this biomarker. In contrast, subjects receiving FSFW0121 supplementation demonstrated a highly significant increase in GLP-1 levels (p < 0.001), as determined by within-group analysis.

[0236] Furthermore, between-group comparison confirmed a statistically significant elevation in GLP-1 levels in the FSFW0121 group relative to placebo. These findings suggest that FSFW0121 actively promotes endogenous GLP-1 production, thereby supporting mechanisms associated with appetite regulation, satiety signalling, and metabolic homeostasis. The results are shown in Figure IF.

[0237] Example 21: Influence of dietary fiber composition of the present disclosure on appetite suppression using the Visual Analogue Scale (VAS) to measure hunger and satiety responses

[0238] Title: Acute cross-over study to evaluate the effect of BF-24 on appetite suppression and satiety hormone.

[0239] The efficacy of the dietary fiber composition of the present disclosure was evaluated in healthy subjects. A total of 12 healthy subjects, aged 18-65 years, with a BMI > 25.0 to < 35.0 kg / m2, were enrolled in the study. During the study period, the healthy subjects were required to maintain their habitual diet and physical activity throughout and refrain from starting any new weight-loss or exercise programs. The healthy volunteers were randomly assigned to two groups (n = 6 per group) as follows: Group 1: BF-24 (composition of Example 6-2 capsules containing 500 mg of fiber complex each with 200ml of water on an empty stomach)

[0240] Group 2: Rice flour as placebo (2 capsules containing 500 mg each with 200ml of water on an empty stomach)

[0241] The clinical study was an acute, single-dose, randomized, placebo-controlled, double-blind, crossover design. A washout period of five (5) days was implemented between each treatment phase to minimize carryover effects. Evaluation parameters included assessment of appetite suppression using the Visual Analogue Scale (VAS) for hunger and satiety.

[0242] Crossover Day Protocol and Analytical Methods

[0243] On the day before each crossover phase, participants were instructed to maintain consistent dietary and fluid intake, physical activity levels, and to abstain from alcohol consumption. An overnight fast commenced at 10:00 PM, during which only water was permitted until arrival at the study center at 8:00 AM the following morning.

[0244] Upon arrival, participants rested for approximately 10 minutes, underwent routine medical evaluations, and provided baseline blood samples. At 8:30 AM, the investigational product or placebo was administered with 200 mL of water. Subsequent assessments included repeated measurements of appetite using the Visual Analogue Scale (VAS) at 30-minute intervals for a duration of three (3) hours post-administration.

[0245] Following the final assessment (after 3 hours), participants were discharged without further dietary restrictions for the remainder of the test day. Statistical analysis of changes in measured parameters from baseline to each time point was performed using independent t-tests.

[0246] • VAS-Satiety score Analysis

[0247] At baseline (0 minutes), VAS-satiety scores were comparable between the BF-24 and placebo groups. Beginning at 30 minutes post-administration, BF-24 produced significantly higher satiety scores relative to placebo. Peak effects were observed between 60 and 120 minutes, with statistically significant differences maintained through 180 minutes. These results indicate that BF-24 enhances satiety compared to placebo, as measured by the Visual Analogue Scale. The results are shown in Figure 2A.

[0248] • VAS-Hunger score

[0249] At baseline (0 minutes), VAS-hunger scores were comparable between the BF-24 and placebo groups. From 30 minutes post-administration onward, BF-24 resulted in significantly lower hunger scores relative to placebo. The effect was most pronounced between 60 and 180 minutes and remained statistically significant through the 180-minute mark. These findings indicate that BF-24 effectively reduces hunger compared to a placebo. The results are shown in Figure 2B.

[0250] Example 22: Influence of dietary fiber composition of the present disclosure on appetite hormones

[0251] Title: Acute cross-over study to evaluate the effect of BF-24 on appetite hormones.

[0252] The efficacy of the dietary fiber composition of the present disclosure on appetite hormones was evaluated in healthy subjects. A total of 12 healthy subjects, aged 18-65 years, with a BMI > 25.0 to < 35.0 kg / m2, were enrolled in the study. During the study period, the healthy subjects were required to maintain their habitual diet and physical activity throughout and refrain from starting any new weight-loss or exercise programs. The healthy volunteers were randomly assigned to two groups (n = 6 per group) as follows:

[0253] Group 1: BF-24 (composition of Example 6-2 capsules containing 500 mg of fiber complex each with 200ml of water on an empty stomach)

[0254] Group 2: Rice flour as placebo (2 capsules containing 500 mg each with 200ml of water on an empty stomach)

[0255] The clinical study was an acute, single-dose, randomized, placebo-controlled, double-blind, crossover design. A washout period of five (5) days was implemented between each treatment phase to minimize carryover effects. Evaluation parameters included the quantitative assessment of key appetite-regulating hormones, specifically glucagon-like peptide-1 (GLP-1), leptin, ghrelin, and cholecystokinin (CCK). Crossover Day Protocol and Analytical Methods

[0256] On the day prior to each crossover phase, participants were instructed to maintain consistent dietary and fluid intake, physical activity levels, and to abstain from alcohol consumption. An overnight fast commenced at 10:00 PM, during which only water was permitted until arrival at the study center at 8:00 AM the following morning.

[0257] Upon arrival, participants rested for approximately 10 minutes, underwent routine medical evaluations, and provided baseline blood samples. At 8:30 AM, the investigational product or placebo was administered with 200 mL of water. Subsequent assessments included repeated measurements of appetite-regulating hormones from blood samples obtained at 30-minute intervals for a duration of three (3) hours postadministration.

[0258] Following the final assessment (after 3 hours), participants were discharged without further dietary restrictions for the remainder of the test day. Statistical analysis of changes in measured parameters from baseline to each time point was performed using independent t-tests.

[0259] • GLP-1 (pmol / L)

[0260] At baseline (0 minutes), GLP-1 concentrations were comparable between the BF-24 and placebo groups, with no statistically significant difference observed. Beginning at 60 minutes post-administration, the BF-24 group demonstrated a marked and statistically significant increase in GLP-1 levels relative to placebo, reaching peak concentrations at 90 minutes. Elevated GLP-1 levels in the BF-24 group remained statistically significant at 120 and 150 minutes. These findings indicate that BF-24 supplementation effectively enhances GLP-1 secretion compared to placebo. The results are shown in Figure 3 A.

[0261] • Leptin (ng / mL)

[0262] Leptin levels (ng / mL) were evaluated over a 180-minute postprandial period. Within-group analysis revealed a significant decline in leptin concentrations in the placebo group (p > 0.05), whereas the BF-24 group maintained stable leptin levels with no statistically significant change. Notably, between-group comparison at the 180-minute time point demonstrated significantly higher leptin concentrations in the BF-24 group relative to placebo (p < 0.05). These findings suggest that BF-24 supplementation effectively mitigates the postprandial decline in leptin and contributes to the maintenance of satiety-associated hormonal balance. The results are shown in 3B

[0263] • Ghrelin (pg / mL)

[0264] Within-group analysis revealed an increase in ghrelin levels in the placebo group from baseline to 180 minutes, consistent with the expected postprandial rise in hunger -associated hormone secretion. In contrast, the BF-24 group exhibited a progressive decline in ghrelin concentrations over the same period, resulting in a statistically significant within-group reduction (p < 0.05). Between-group comparison at 180 minutes confirmed a significantly lower ghrelin concentration in the BF-24 group relative to placebo (p < 0.05). These findings indicate that BF-24 supplementation effectively suppresses ghrelin secretion and contributes to the maintenance of satiety over time. The results are shown in Figure 3C.

[0265] • Cholecystokinin (pg / mL)

[0266] Cholecystokinin (pg / mL) levels remained relatively stable in the placebo group over the 180-minute postprandial period, with no statistically significant deviation from baseline. In contrast, the BF-24 group exhibited a gradual and statistically significant increase in cholecystokinin concentrations throughout the assessment period. Between-group analysis revealed significantly higher cholecystokinin levels in the BF-24 group compared to placebo beginning at 90 minutes, with the difference persisting through 180 minutes. These findings suggest that BF-24 supplementation enhances satiety signalling by stimulating cholecystokinin secretion, which contributes to delayed gastric emptying. The results are shown in Figure 3D.

[0267] Example 23: Influence of dietary fiber of the present disclosure on body weight, BMI, and waist-to-hip ratio

[0268] Title: Parallel-group study to evaluate the effect of BF-24 on body weight, BMI, and waist-to-hip ratio (WHR) in overweight volunteers.

[0269] The efficacy of the dietary fiber composition of the present disclosure was evaluated in subjects in overweight volunteers. A total of 24 subjects, aged 18-65 years, with a BMI > 25.0 to < 30.0 kg / m2, were enrolled in the study. During the study period, the healthy subjects were required to maintain their habitual diet and physical activity throughout and refrain from starting any new weight-loss or exercise programs. The healthy volunteers were randomly assigned to two groups (n = 12 per group) as follows: Group 1: BF-24 (composition of Example 6) (2 capsules containing 500 mg of fiber complex each, taken daily with 200 ml of water one hour before lunch for 56 days). Group 2: Placebo (2 capsules containing 500 mg of rice flour each, taken daily with 200 ml of water one hour before lunch for 56 days).

[0270] The study was a randomized, placebo-controlled, double-blinded, parallel-group design. Subjects reported to the study centre following an overnight fast at both baseline and at the conclusion of the intervention period for scheduled assessments. Standardized anthropometric measurements — including body weight, height, body mass index (BMI), and waist-to-hip ratio (WHR) — were performed using calibrated instruments. Measurements were obtained at baseline and post-intervention. Statistical analysis of changes in these parameters was conducted using paired t-tests for within-group comparisons and independent t-tests for between-group comparisons.

[0271] The subjects were required to report to the study centre after an overnight fast at baseline and end of the study for assessments. Standard anthropometric measurements were carried out by trained staff using calibrated instruments. Parameters evaluated were body weight, body mass index (BMI), and waist-to-hip ratio (WHR). Measurements were taken at baseline and post-intervention. Changes were statistically analysed within groups and between groups using paired t-test and independent t-test.

[0272] • Body weight (Kg)

[0273] At baseline (Day 0), the BF-24 group exhibited a significantly lower mean body weight compared to the placebo group. This difference became more pronounced following 56 days of intervention, with the BF-24 group maintaining a markedly lower mean body weight relative to placebo.

[0274] Within-group analysis showed no statistically significant change in body weight in the placebo group over the 56-day period (p = 0.978). In contrast, the BF-24 group demonstrated a statistically significant reduction in body weight from baseline to Day 56 (p = 1.63 * 104), indicating the efficacy of BF-24 in promoting weight reduction. The results are shown in Figure 4 A. • BMI (Kg / m2)

[0275] At baseline (Day 0), the mean BMI was 26.83 ± 1.63 in the placebo group and 26.96 ± 2.01 in the BF-24 group. After 56 days of intervention, the placebo group showed no appreciable change in BMI (26.83 ± 1.63; p = 0.994, within-group), whereas the BF-24 group exhibited a numerical reduction to 25.66 ± 2.12. The change between-group comparison revealed a significantly greater net reduction in BMI for the BF-24 group relative to placebo (AB MI: -1.30 vs +0.01; p = 0.00037). The results are shown in Figure 4B.

[0276] These results demonstrate that BF-24 supplementation produced a statistically significant improvement in BMI over the 56 days when compared to placebo.

[0277] • Waist Hip Ratio (WHR)

[0278] At baseline, waist-to-hip ratios (WHR) were comparable between the placebo group (0.911 ± 0.035) and the BF-24 group (0.906 ± 0.059). After 56 days of intervention, the placebo group exhibited no meaningful change in WHR (0.907 ± 0.034; p = 0.770, within-group), while the BF-24 group showed a numerical reduction to 0.882 ± 0.060. Although this within-group change did not reach statistical significance (p = 0.334), the between-group comparison revealed a statistically significant difference favoring BF-24 supplementation (p = 0.022).

[0279] These findings indicate that BF-24 produced a significant reduction in WHR relative to placebo over the 56 days, despite the within-group change not achieving statistical significance independently. The results are shown in Figure 4C.

[0280] TECHNICAL ADVANCEMENTS

[0281] The present disclosure described herein above has several technical advantages including, but not limited to, the realization of, a dietary fiber with herbal extract complex composition that:

[0282] • is stable, safe, and effective at low dosage;

[0283] • controls appetite;

[0284] • reduce food intake;

[0285] support in body weight management; • high water, fat, and oil holding capacity;

[0286] • elevate the GLP-1 levels, and favourably modulate satiety hormones;

[0287] • improves digestion and maintenance of microbiome;

[0288] • It is easy to administer through the oral route;

[0289] • contains only GRAS (Generally Recognized as Safe); and

[0290] • does not have any adverse effects;

[0291] a process for the preparation of the dietary fiber composition that is:

[0292] • easy to prepare, economical, and easy to scale up.

[0293] Throughout this specification, the word “comprise”, or variations such as “comprises” or “comprising, will be understood to imply the inclusion of a stated element, integer or step,” or group of elements, integers, or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

[0294] The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the invention to achieve one or more of the desired objects or results. While certain embodiments of the inventions have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions. Variations or modifications to the formulation of this invention, within the scope of the invention, may occur to those skilled in the art upon reviewing the disclosure herein. Such variations or modifications are well within the spirit of this invention. The numerical values given for various physical parameters, dimensions and quantities are only approximate values and it is envisaged that the values higher than the numerical value assigned to the physical parameters, dimensions and quantities fall within the scope of the invention unless there is a statement in the specification to the contrary.

[0295] While considerable emphasis has been placed herein on the specific features of the preferred embodiment, it will be appreciated that many additional features can be added and that many changes can be made in the preferred embodiment without departing from the principles of the disclosure. These and other changes in the preferred embodiment of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

Claims

1. Claims1. A dietary fiber composition comprising:3.a. fenugreek fiber in an amount in the range of 60 mass% to 75 mass% with respect to the total mass of the composition;4.b. at least one natural in an amount in the range of 20 mass% to 40 mass% with respect to the total mass of the composition;5.c. at least one plant extract in an amount in the range of 0 mass% to 10 mass% with respect to the total mass of the composition; and6.d. at least one additive in an amount in the range of 0 mass% to 10 mass% with respect to the total mass of the composition.

2. The composition of claim 1 , wherein the fenugreek fiber holds water in an amount in the range of 20 mL / g to 30 mL / g.

3. The composition of claim 1, wherein the fenugreek fiber comprises soluble dietary fiber in the range of 75% to 85% (w / w), insoluble fiber in the range of 3% to 10%, protein in the range of 0% to 5% (w / w), and moisture content in the range of 5% to 7%.

4. The composition of claim 1, wherein the galactomannan in the fenugreek fiber is in the range of 70% w / w to 80% w / w.

5. The composition of claim 1, wherein the natural fiber is at least one selected from Konjac fiber, Psyllium husk, Tara gum, or Xanthan gum.

6. The composition of claim 1, wherein the water holding capacity and oil holding capacity of natural fibers are in the range of 15 mL / g to 35 mL / g and 5 mL / g to 20 mL / g, respectively.

7. The composition of claim 5, wherein the konjac fiber comprises soluble dietary fiber, is in the range of 80 w / w% to 95 w / w% and moisture content in the range of 5 % to 7%.

8. The composition of claim 1, wherein the plant extract is at least one selected from berberis aristate, acacia catechu, areca catechu, green tea extract, bitter orange extract, chili extract, and cinnamon extract.

9. The composition of claim 8, the berberine extract comprises berberine in the range of 50 mass% to 95 mass%.

10. The composition of claim 1, the additive is at least one selected from lecithin, cellulose, and edible fatty oils.

11. The composition of claim 10, wherein the edible fatty oil is at least one selected from fish oil, olive oil, prime rose oil, flaxseed oil, avocado oil, almond oil, and MCT (medium-chain triglycerides) oil.

12. The composition of claim 1, wherein the dietary fiber composition is administered at a dose in the range of 500 mg / day to 3000 mg / day.

13. A method for the preparation of dietary fiber composition, said method comprises the following steps18.a. mixing fenugreek powder with water at a temperature in the range of 40°C to 60°C under stirring to obtain a fenugreek fiber solution;19.b. separately mixing natural fiber with water at a temperature in the range of 40°C to 60°C under stirring to obtain a natural fiber solution; c. adding the natural fiber solution to said fenugreek fiber solution under stirring at a temperature in the range of 40°C to 60°C to obtain a first homogenized mixture;20.d. optionally adding the plant extract and / or additive to said first homogenized mixture under stirring to obtain a second homogenized mixture;21.e. evaporating said second homogenized mixture, followed by agglomeration to obtain the dietary fiber composition.

14. The method as claimed in claim 13, wherein said evaporation is performed at a temperature in the range of 40°C to 60°C under vacuum.

15. A method for the preparation of dietary fiber composition, said method comprises the following steps24.a. mixing fenugreek powder composition with water at a temperature in the range of 40°C to 60°C under stirring to obtain a fenugreek fiber solution; b. separately mixing natural fiber with water at a temperature in the range of 40°C to 60°C under stirring to obtain a natural fiber solution; c. adding the natural fiber solution to the fenugreek fiber solution under stirring at a temperature in the range of 40°C to 60°C to obtain a first homogenized mixture;25.d. separately adding the plant extract and optionally an additive to said first homogenized mixture under stirring to obtain a second homogenized mixture;26.e. cooling the second homogenized mixture, followed by drying and grinding to obtain the dietary fiber composition.

16. The method as claimed in claim 15, wherein said second homogenized mixture is optionally heated at a temperature in the range of 50°C to 60°C under vacuum.

17. The method as claimed in claim 14, wherein step d) is performed at a temperature in the range of 60°C to 80°C.

18. A method for regulating appetite, reducing food intake, supporting body weight management, maintaining appetite-related biomarkers, and enhancing glucagon- like peptide-1 (GLP-1) levels in a subject comprising administering to the subject, in need thereof, a therapeutically effective amount of dietary fiber composition of claim 1.

19. The method of claim 18, wherein the appetite-related biomarker is at least one selected from leptin, ghrelin, PYY (Peptide YY), and cholecystokinin (CCK).

20. The method of claim 18, wherein body weight management includes body weight, body mass index (BMI), and waist-to-hip ratio (WHR).

21. The dietary fiber composition as claimed in claim 1, for use in regulating appetite, reducing food intake, supporting body weight management, maintaining appetite- related biomarkers, and enhancing glucagon-like peptide-1 (GLP-1) levels.

22. Use of dietary fiber composition as claimed in claim 1, for regulating appetite, reducing food intake, supporting body weight management, maintaining appetite- related biomarkers, and enhancing glucagon-like peptide-1 (GLP-1) levels.

23. The use of any one of claims 21 or 22, wherein the appetite-related biomarker is at least one selected from leptin, ghrelin, PYY (Peptide YY), and cholecystokinin (CCK).

24. The use of any one of claims 21 or 22, wherein body weight management includes body weight, body mass index (BMI), and waist-to-hip ratio (WHR).

25. The composition as claimed in claim 1, the dietary fiber composition in the form of tablets, capsules, gummies, gellies, and water-dispersible powder.

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