Description:FORM 2
THE PATENTS ACT 1970
(39 of 1970)
&
The Patent Rules 2003
COMPLETE SPECIFICATION
(See sections 10 & rule 13)
1. TITLE OF THE INVENTION
“PREBIOTIC AND DIETARY FIBER SUPPLEMENT AND PREPARATION METHOD THEREOF”
2. APPLICANT (S)
NAME NATIONALITY ADDRESS
Soulfuel India LLP Indian 13/14, 1301/1401, RNA Mirage, Sudam Kalu Ahire Marg, RNA Mirage, Worli, Mumbai 400018, Maharashtra, India.
3. PREAMBLE TO THE DESCRIPTION
COMPLETE SPECIFICATION
The following specification particularly describes the invention and the manner in which it is to be performed.

FIELD OF INVENTION
The present invention generally relates to dietary supplements, particularly a fiber supplement formulated to support and improve gut health, digestion, alleviate gut dysbiosis and associated symptoms while promoting overall well-being, with a specific focus on addressing gut health of overweight to obese individual and others with similar issues due to low consumption of dietary fiber.

BACKGROUND OF INVENTION
Gut health plays a crucial role in overall wellness, affecting not only digestive function but also immune system performance, metabolism, and waste elimination. A well-functioning digestive system is necessary for the efficient processing of food, nutrient absorption, and the maintenance of internal balance. However, modern diets and sedentary lifestyles have contributed to a rise in digestive disorders and metabolic conditions, such as obesity, with many individuals not consuming adequate amounts of dietary fiber.

Obesity is increasingly recognized as not only a result of caloric excess but also linked to gut health imbalances. The gut microbiota, which consists of trillions of microorganisms, plays an essential role in regulating metabolic processes, including the breakdown of food and the storage of fat. An imbalance in gut bacteria, or dysbiosis, has been associated with weight gain, insulin resistance, and chronic inflammation, all of which are hallmarks of obesity. Addressing gut health through dietary intervention has become a promising approach to managing and preventing obesity and its related complications.

Dietary fiber, a key nutrient for digestive health, is classified into two primary types: soluble and insoluble. Soluble fiber dissolves in water, forming a gel-like substance that slows digestion, helping to regulate blood sugar and lower cholesterol. It also prolongs the feeling of fullness, which can aid in weight management—a crucial factor for individuals dealing with obesity. Furthermore, soluble fiber nourishes beneficial gut bacteria, promoting a healthy gut microbiome, which is essential for balancing metabolism and preventing fat accumulation.

Insoluble fiber, on the other hand, does not dissolve in water but adds bulk to stool, promoting regular bowel movements and preventing constipation. Efficient waste elimination reduces bloating and other gastrointestinal discomforts commonly associated with obesity. A diet low in insoluble fiber can lead to irregular bowel habits, further complicating digestive and metabolic health.

Prebiotics, a specialized form of dietary fiber, have emerged as a significant element in maintaining gut health. Prebiotics act as a food source for probiotics—beneficial bacteria that help regulate digestion, synthesize vitamins, and support the immune system. Unlike probiotics, which are live bacteria, prebiotics selectively stimulate the growth and activity of the gut's healthy bacteria, creating a more balanced microbiota. A disrupted gut microbiome has been linked not only to digestive issues but also to obesity, type 2 diabetes, and other metabolic disorders. Therefore, integrating prebiotics into daily nutrition can help address obesity-related gut dysbiosis, contributing to weight regulation and improved metabolic health.

Despite the known benefits of dietary fiber, most individuals fail to meet the recommended daily intake. The World Health Organization (WHO) recommends 25–30 grams of fiber per day for adults, yet many fall short due to diets high in processed, fiber-poor foods. This fiber deficiency can exacerbate digestive problems, disrupt gut flora, and contribute to the onset of obesity and metabolic dysfunction.

Traditional fiber supplements often provide either soluble or insoluble fiber but rarely combine both in a balanced formulation. Additionally, most supplements lack prebiotics, which are crucial for fostering a healthy gut microbiome. Many fiber supplements are also unappealing in taste or texture, making them difficult to incorporate into a daily routine, further limiting their potential benefits.

In response to the growing need for a comprehensive solution, this invention presents a fiber supplement that combines soluble fiber, insoluble fiber, and prebiotics in a convenient, palatable form. This balanced formula supports weight management by enhancing satiety, regulating blood sugar, and improving gut health, particularly for individuals struggling with obesity and related metabolic conditions. The inclusion of prebiotics ensures the promotion of beneficial gut bacteria, helping to restore gut flora balance and reduce the risk of obesity-linked metabolic disorders.

In addition to addressing the current gaps in fiber supplementation, this fiber supplement addresses several critical areas of concern:
• Supports weight management by promoting prolonged satiety and reducing calorie intake.
• Enhances gut microbiota balance, reducing obesity-related dysbiosis and supporting metabolic health.
• Improves digestive function by promoting regular bowel movements and preventing constipation.
• Regulates blood sugar and cholesterol, contributing to overall metabolic health.

This invention offers an effective, science-backed solution for individuals looking to improve gut health, manage weight, and enhance overall well-being, addressing the growing need for multifunctional dietary supplements in today’s health-conscious market.

OBJECTS OF THE INVENTION
The main object of the present invention is to provide a prebiotic and dietary fiber supplement designed to support the unique digestive and nutritional needs of bariatric patients, aiding in digestion and enhancing gut health.

Another object of the present invention is to offer a multifunctional fiber supplement in powder form, ensuring ease of use and daily consumption.

Another object of the present invention is to provide a fiber supplement that combines the benefits of both soluble and insoluble fibers, along with prebiotics, in a convenient and palatable format.

Another object of the present invention is to provide a fiber supplement which will promote the growth of beneficial gut bacteria, enhancing gut microbiota balance and significantly reduce the ratio of firmicutes and bacteroidetes commonly seen in gut dysbiosis, facilitating regular bowel movements, and aiding in blood sugar regulation, which is particularly beneficial for weight management and metabolic health

Another objective of the present invention is to provide a fiber supplement which may reduce inflammation by modulating the gut microbiota and enhancing the production of SCFAs, which possess anti-inflammatory properties.

Yet another object of the present invention is to provide a process for preparation of dietary fiber supplement.

SUMMARY OF THE INVENTION
In an embodiment of the invention, the present invention relates to a prebiotic and dietary fiber supplement comprising;
a) Soluble fibers;
b) Insoluble fiber;
c) Prebiotic;
d) Enzyme; and
e) Inert excipients.

In an aspect of the embodiment, the inert excipients are texture enhancer, flavouring agent and sweetening agent.

In another aspect of the embodiment, the soluble fibers are fenugreek fiber and psyllium husk.

In another aspect of the embodiment, the insoluble fiber is rice bran.

In another aspect of the embodiment, the soluble fiber and insoluble fiber is present in weight ratio of 0.886:1.

In another aspect of the embodiment, the prebiotic is inulin and fructo-oligosaccharides (FOS).

In another aspect of the embodiment, the enzyme is protease.

In another embodiment, the present invention relates to a prebiotic and dietary fiber supplement comprising;
a) 4.86 % w/w of Fenugreek Fiber and 4 % w/w of Psyllium Husk as soluble fibers;
b) 10 % w/w of Rice bran, as an insoluble fiber;
c) 54.84 % w/w of Inulin and 14.63 % w/w of Fructo-Oligosaccharide (FOS), as prebiotic;
d) 0.38 % w/w of Protease, as an enzyme;
e) 8 % w/w of Lemon rods and 2.00 % w/w of Citric acid, as flavouring agents;
f) 0.10 % w/w of Xanthan gum, as a texture enhancer; and
g) 1.20 % w/w of Stevia, as a sweetening agent;
wherein the percentages are with respect to total weight of the formulation.

In another aspect of embodiment, the formulation is in powder form and is suitable for mixing with liquids or food.

In another embodiment, the process for preparation of a prebiotic and dietary fiber supplement comprising steps of,
a) Blending and mixing soluble fibers and insoluble fiber in a ratio of 0.886:1 to form a blend;
b) Adding prebiotics, enzyme, texture enhancer, flavouring agent and sweetening agent to above blend to form a mixture;
c) Sieving the above mixture to form a fine powder supplement.

DETAILED DESCRIPTION OF THE INVENTION:
The present invention relates to dietary supplements, particularly a fiber supplement formulated to support and improve gut health, digestion, alleviate gut dysbiosis and associated symptoms while promoting overall well-being, with a specific focus on addressing gut health of overweight to obese individual and others with similar issues due to low consumption of dietary fiber.
Unless defined otherwise, all technical and scientific terms used in this document have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains.

The term "comprising", which is synonymous with "including", "containing", or "characterized by" here is defined as being inclusive or open-ended and does not exclude additional, unrecited elements or method steps unless the context clearly requires otherwise.

The term "a" and "an" refers to one or more than one (i.e., to at least one) of the grammatical objects of the article. The information provided in this document, and particularly the specific details of the described exemplary aspects, provided primarily for clearness of understanding and no unnecessary limitations are to be understood from there.

As used herein, the term "about" means that the numerical value is approximate, and small variations would not significantly affect the practice of the disclosed embodiments. Where a numerical limitation is used, unless indicated otherwise by the context, "about" means the numerical value can vary by ±10% and remain within the scope of the disclosed embodiments.

As used herein, the terms "treat," or "treatment" mean both therapeutic treatment or prophylactic or preventative measures wherein the object is to prevent or slow down (lessen) undesired physiological condition, disorder, or disease, or obtain beneficial or desired clinical results. For purposes of this invention, beneficial or desired clinical results include, but are not limited to, alleviation of symptoms; diminishment of extent of condition, disorder or disease; stabilized (i.e., not worsening) state of condition, disorder or disease; delay in onset or slowing of condition, disorder or disease progression; amelioration of the condition, disorder or disease state or remission (whether partial or total), whether detectable or undetectable; an amelioration of at least one measurable physical parameter, not necessarily discernible by the patient; or enhancement or improvement of condition, disorder or disease.

The term “Supplement” refers to a product intended to add nutritional value to the diet or support specific physiological functions. Typically, it contains one or more ingredients such as vitamins, minerals, herbs, amino acids, enzymes, or dietary fibers. Supplements are often consumed to enhance health, fill dietary gaps, or address specific nutritional deficiencies. They come in various forms such as tablets, capsules, powders, or liquids.

For example, in the case of a dietary fiber supplement, the primary goal is to provide an additional source of dietary fiber, which may aid in digestion, support gut health, or promote regularity, depending on the type of fibers and other ingredients included.

The term “prebiotic and dietary fiber supplement” refers to a nutritional product designed to promote digestive health and overall well-being. It typically contains a combination of soluble and insoluble fibers, prebiotics, and digestive enzymes to support gut function, enhance nutrient absorption, and promote the growth of beneficial gut bacteria.

The benefits of prebiotic and dietary fiber supplement include;
• Digestive Health: Fiber and enzymes often work in tandem within the digestive system. Fiber helps regulate digestion by promoting gut motility, while protease enzymes assist in breaking down proteins, helping to prevent undigested food from fermenting in the gut, which can lead to discomfort, gas, or bloating. This creates a more balanced digestive environment.
• Gut Microbiome Support: Fiber supports a healthy gut microbiome by feeding beneficial bacteria. The prebiotic components foster the growth of beneficial bacteria in the gut, improving gut health and boosting immunity. This, in turn, enhances the overall effectiveness of fiber in maintaining digestive health, as prebiotics, selectively feeding beneficial gut bacteria like bifidobacteria and lactobacilli. This fosters a balanced microbiome, essential for overall gut health, immunity, and metabolism.
• Nutrient Absorption: Fiber can sometimes hinder the absorption of certain nutrients by trapping them within the digestive tract. By breaking down proteins more effectively, enzymes can help ensure that these nutrients are released from their fibrous matrix, making them more available for absorption.
• Soluble fiber aids in digestion by forming a gel-like substance that slows down the digestive process. This not only helps with nutrient absorption but also reduces digestive discomfort, bloating, and irregular bowel movements. Fenugreek Fiber and Psyllium Husk help moderate post-meal blood sugar spikes by slowing carbohydrate absorption, making the supplement helpful for individuals with insulin sensitivity or type 2 diabetes.
• Insoluble fiber promotes the smooth movement of food and waste through the intestines, preventing constipation and promoting regularity.
• Protease enzyme enhances protein digestion by breaking down complex proteins into smaller, more easily absorbed peptides and amino acids, improving nutrient utilization and digestive efficiency.

The term used herein “Inert excipients” refers to substances included in pharmaceutical formulations that do not have any direct therapeutic effect or active pharmacological action on the body. Their role is to support the formulation, manufacture, stability, or delivery of the active pharmaceutical ingredient (API). These substances are "inert" in the sense that they are not intended to alter the biological or therapeutic activity of the drug itself. They are carefully selected to ensure they are safe, non-toxic, and appropriate for their intended purpose in the drug formulation.

Although the invention has been described regarding specific embodiments, this description is not meant to be construed in a limiting sense. Various modifications of the disclosed embodiments, as well as alternate embodiments of the invention, will become apparent to persons skilled in the art upon reference to the description of the invention. It is therefore contemplated that such modifications can be made without departing from the spirit or scope of the present invention as defined.

The main embodiment of the present invention relates to a prebiotic and dietary fiber supplement comprising;
a) Soluble fibers;
b) Insoluble fiber;
c) Prebiotic;
d) Enzyme; and
e) Inert excipients.

In an aspect of the embodiment, the inert excipients are texture enhancer, flavouring agent and sweetening agent.

Soluble fiber is a type of dietary fiber that dissolves in water to form a gel-like substance in the digestive tract. It is typically found in plant-based foods such as oats, beans, fruits, and certain vegetables. Soluble fiber slows down digestion, helping to regulate blood sugar levels, lower cholesterol, and improve overall gut health. By absorbing water, soluble fiber can increase the bulk of stool and soften it, aiding in the prevention of constipation. Additionally, it serves as a prebiotic, providing nourishment for beneficial gut bacteria, which in turn support various bodily functions, including immune health and digestion. Examples of soluble fibers include inulin, pectin, beta-glucan, psyllium husk, and fenugreek fiber, etc.

In another aspect of the embodiment, the soluble fibers are fenugreek fiber and psyllium husk.

Fenugreek fiber is derived from the seeds of the fenugreek plant (Trigonella foenum-graecum), which are rich in galactomannan, a highly viscous soluble fiber. This fiber is known for its ability to form a thick gel in the digestive tract, slowing down the absorption of sugars and cholesterol. This makes fenugreek fiber effective in controlling blood sugar levels, particularly in individuals with diabetes, and reducing cholesterol, promoting heart health. Additionally, fenugreek fiber has been shown to support appetite control and weight management by increasing feelings of fullness, making it a valuable addition to dietary supplements aimed at improving metabolic health and digestive function.

Psyllium husk is the outer coating of the seeds of Plantago ovata. It is a highly absorbent soluble fiber that expands and forms a gel-like substance when mixed with water. This property helps psyllium husk to regulate bowel movements by increasing stool bulk and softness, making it a common remedy for constipation and promoting overall digestive health. Psyllium husk is also widely recognized for its role in lowering LDL cholesterol and improving heart health. Furthermore, its ability to slow down the digestion of carbohydrates helps maintain stable blood sugar levels, which is particularly beneficial for people with diabetes or those seeking to control weight.

Insoluble fiber is a type of dietary fiber that does not dissolve in water and remains largely intact as it passes through the digestive system. Its primary function is to add bulk to the stool, promoting regular bowel movements and preventing constipation. Unlike soluble fiber, which forms a gel, insoluble fiber helps to speed up the movement of food through the intestines, thereby improving digestive efficiency. It is often found in whole grains, vegetables, and the outer layers of seeds and legumes. Insoluble fiber also supports colon health and may reduce the risk of developing conditions such as diverticulosis. Examples of insoluble fibers are cellulose, hemicellulose, lignin, wheat bran, corn bran, rice bran, brown rice, fruit skins and vegetable skins.

In another aspect of the embodiment, the insoluble fiber is rice bran.

Rice bran, the outer layer of rice grains, is an excellent source of insoluble fiber. It is particularly rich in cellulose and hemicellulose, which contribute to its effectiveness in promoting bowel regularity. Rice bran helps increase stool bulk and accelerates the transit time of food through the intestines, making it beneficial for preventing constipation and maintaining digestive health. Additionally, rice bran is associated with potential health benefits like supporting weight management and promoting colon health due to its high fiber content. As a natural and cost-effective fiber source, rice bran is widely used in dietary supplements and functional foods aimed at enhancing digestive function.

In another aspect of the embodiment, the soluble fiber and insoluble fiber is present in weight ratio of 0.886:1.

A prebiotic is a non-digestible food ingredient that selectively stimulates the growth and activity of beneficial bacteria in the gut. Unlike probiotics, which are live microorganisms that confer health benefits, prebiotics serve as food for these beneficial bacteria, promoting a healthy balance of gut microbiota. Commonly found in high-fiber foods such as fruits, vegetables, and whole grains, prebiotics play a vital role in enhancing digestive health, improving nutrient absorption, and supporting immune function. By fostering the growth of beneficial bacteria, prebiotics can help alleviate digestive disorders, enhance gut barrier function, and may even contribute to improved mental health through the gut-brain axis.

In another aspect of the embodiment, the prebiotic is inulin and fructo-oligosaccharides (FOS).

Inulin is a type of soluble fiber that is classified as a prebiotic due to its ability to promote the growth of beneficial gut bacteria. It is naturally found in a variety of plants, including chicory root, garlic, onion, and asparagus. Inulin is not digested in the upper gastrointestinal tract; instead, it reaches the colon intact, where it is fermented by gut bacteria. This fermentation process produces short-chain fatty acids, which provide energy to colon cells and help regulate various metabolic processes. Inulin is recognized for its health benefits, including improving digestive health, enhancing calcium absorption, and aiding in blood sugar management. Its mild sweetness makes it a popular ingredient in many food products and dietary supplements aimed at improving gut health.

Fructo-oligosaccharides (FOS) are a type of prebiotic carbohydrate composed of short chains of fructose molecules. Naturally occurring in various fruits and vegetables, such as bananas, onions, and asparagus, FOS are recognized for their ability to stimulate the growth of beneficial gut bacteria, particularly Bifidobacteria. Like inulin, FOS are not digestible in the small intestine, allowing them to reach the colon, where they are fermented by gut bacteria. This fermentation process leads to the production of short-chain fatty acids, which provide numerous health benefits, including improved gut health, enhanced mineral absorption, and potential anti-inflammatory effects. FOS are often added to functional foods and dietary supplements due to their positive effects on gut microbiota and overall digestive health.

An enzyme is a biological catalyst that accelerates chemical reactions in living organisms without being consumed in the process. Enzymes are primarily composed of proteins and for various biochemical processes, including digestion, metabolism, and DNA replication. Each enzyme is specific to a particular substrate, meaning it can only catalyze a specific reaction or group of reactions. Enzymes function by lowering the activation energy required for a reaction to occur, thus increasing the rate of the reaction. They play essential roles in maintaining homeostasis and supporting cellular functions, making them vital for overall health and well-being. Examples of enzymes are amylase, lipase, protease, lactase, catalase, RNA polymerase, DNA polymerase, etc.

In another aspect of the embodiment, the enzyme is protease.

Protease, also known as proteolytic enzyme or proteinase, is a specific type of enzyme that catalyzes the breakdown of proteins into smaller peptides or amino acids through a process called proteolysis. Proteases are essential for numerous physiological processes, including digestion, immune response, and cell signaling. They are produced in various forms throughout the body, with different proteases targeting specific protein structures. In the digestive system, proteases, such as pepsin and trypsin, play a critical role in breaking down dietary proteins, facilitating their absorption and utilization by the body. Additionally, proteases are used in various industries, including food processing, biotechnology, and pharmaceuticals, due to their ability to modify proteins for specific applications.

A flavouring agent is a substance added to food, beverages, or dietary supplements to enhance or impart a specific taste and aroma. These agents can be natural or synthetic and are used to improve the overall sensory experience of a product, making it more appealing to consumers. Natural flavouring agents are derived from plant or animal sources and may include extracts, essential oils, or concentrates from fruits, herbs, and spices. Examples include vanilla extract, lemon juice, and peppermint oil. Synthetic flavouring agents, on the other hand, are chemically manufactured to replicate specific flavours and are often used for consistency and cost-effectiveness. Examples include artificial vanilla (vanillin) and ethyl maltol, which mimics the taste of caramel.

In another aspect of embodiment, the flavouring agents are lemon rods and citric acid.

Lemon rods are natural flavouring agents derived from the zest and juice of lemons, known for their bright, tangy flavour and refreshing aroma. They are often used in culinary applications and beverage formulations to enhance taste and provide a citrusy note. Lemon rods not only contribute to the flavour profile but also offer potential health benefits, as they are rich in vitamin C and antioxidants. Their natural acidity can help balance sweetness in recipes, making them a popular choice in the formulation of supplements and drinks. In addition to their flavor-enhancing properties, lemon rods can add visual appeal to products, making them more enticing to consumers.

Citric acid is a weak organic acid found naturally in citrus fruits and is widely used as a flavouring and preservative in food and beverages. It is known for its tart, sour taste, which can enhance the overall flavour profile of various products. In supplement formulations, citric acid serves as a flavouring agent that can help mask unpleasant tastes, making the product more palatable for consumers. Additionally, citric acid acts as a natural preservative, helping to prevent spoilage and maintain product stability by lowering the pH. Its multifunctional role in enhancing flavour and preserving freshness makes citric acid a popular ingredient in dietary supplements, beverages, and a wide range of food products.

A texture enhancer is an ingredient used in dietary supplements to improve the mouthfeel, viscosity, and overall sensory experience of a product. These enhancers can modify the physical properties of a formulation, contributing to a smoother, creamier, or thicker consistency that can make consumption more enjoyable. Texture enhancers are particularly important in dietary supplements, where they can help mask undesirable tastes or improve the palatability of powdered formulations.

In another aspect of embodiment, the texture enhancer is xanthan gum.

Xanthan gum is a widely used texture enhancer derived from the fermentation of glucose or sucrose by the bacterium Xanthomonas campestris. It is a highly effective thickening agent that forms a viscous gel when mixed with water, making it an ideal choice for dietary supplements in powder form. Xanthan gum not only improves the texture of products but also helps stabilize emulsions and suspensions, preventing ingredient separation. Its ability to create a smooth, creamy mouthfeel enhances the overall sensory experience, making it particularly beneficial in formulations designed to be mixed with liquids or foods.

A sweetening agent is a substance used to enhance the sweetness of product without significantly increasing caloric intake. These agents are commonly incorporated into dietary supplements to improve palatability, making them more enjoyable to consume. Sweetening agents can be natural, such as honey and agave syrup, or artificial, such as aspartame, stevia and sucralose.

In another aspect of embodiment, the sweetening agent is stevia.

Stevia is a natural sweetening agent derived from the leaves of the Stevia rebaudiana plant. It is known for its high sweetness potency, being up to 300 times sweeter than sugar, while containing virtually no calories. This makes stevia an ideal choice for dietary supplements targeting weight management or those suitable for individuals with diabetes, as it does not affect blood sugar levels.

In another embodiment, the present invention relates to a prebiotic and dietary fiber supplement comprising;
a) 4.86 % w/w of Fenugreek Fiber and 4 % w/w of Psyllium Husk as soluble fibers;
b) 10 % w/w of Rice bran, as an insoluble fiber;
c) 54.84 % w/w of Inulin and 14.63 % w/w of Fructo-Oligosaccharide (FOS), as prebiotic;
d) 0.38 % w/w of Protease, as an enzyme;
e) 8 % w/w of Lemon rods and 2.00 % w/w of Citric acid, as flavouring agents;
f) 0.10 % w/w of Xanthan gum, as a texture enhancer; and
g) 1.20 % w/w of Stevia, as a sweetening agent;
wherein the percentages are with respect to total weight of the formulation.

In another aspect of embodiment, the formulation is in powder form and is suitable for mixing with liquids or food.

The formulation is designed in powder form, making it convenient for mixing with liquids or food. This allows for flexible consumption, enabling users to incorporate the supplement easily into their daily diets. The powdered formulation can be mixed into beverages such as water, smoothies, or juices, as well as blended into various foods. This versatility not only enhances user compliance but also facilitates the seamless addition of essential nutrients and dietary fibers to meals, making it an effective option for those seeking to improve their overall health and nutritional intake. Additionally, the powder format ensures stability and ease of storage, allowing for extended shelf life without compromising efficacy.

In another embodiment, the process for preparation of a prebiotic and dietary fiber supplement comprising steps of,
a) Blending and mixing soluble fibers and insoluble fiber in a ratio of 0.886:1 to form a blend;
b) Adding prebiotics, enzyme, texture enhancer, flavouring agent and sweetening agent to above blend to form a mixture;
c) Sieving the above mixture to form a fine powder supplement.

The foregoing examples are illustrative embodiments and are merely exemplary. A person skilled in the art may make variations and modifications without deviating from the spirit and scope of the invention. All such modifications and variations are intended to be included within the scope of the claims.

EXAMPLES
Example 1 – Prebiotic and dietary fiber supplement according to the invention
SN Ingredients Quantity
(% w/w)
1. Fenugreek Fiber 4.86
2. Psyllium Husk 4.00
3. Rice Bran 10.00
4. Inulin 54.84
5. Fructo-Oligosaccharide (FOS) 14.63
6. Protease 0.38
7. Lemon rods 8.00
8. Xanthan gum 0.10
9. Citric acid 2.00
10. Stevia 1.20
Table 1 – Prebiotic and dietary fiber supplement

Manufacturing Process of Prebiotic and dietary fiber supplement -
1) Ingredients were accurately weighed according to the formulation.
2) Soluble fenugreek fiber and soluble psyllium husk were then blended to ensure uniformity.
3) Following this, the blended fibers were mixed with insoluble rice bran, prebiotic inulin, and fructo-oligosaccharides (FOS), protease, lemon rods, xanthan gum, citric acid, stevia to achieve a thorough and even distribution of all components.
4) The resulting mixture was sieved to obtain a fine, consistent powder.
5) The powder was filled into containers or sachets using filling machines, which were subsequently packaged to ensure protection of the product.
6) Each package was sealed to be airtight and tamper-proof.
7) Finally, the sealed packages were stored under controlled conditions to preserve the supplement's quality and stability.

Example 2 – Characterization of Prebiotic and dietary fiber supplement according to example 1
• Appearance:
The physical appearance of the supplement was described as an off-white powder with a free-flowing nature, indicating that the particles are not clumping together. This is important for the product's usability, as it suggests ease of mixing with liquids or food without forming lumps.

• Odour:
The powder supplement has a distinct lemon-like smell, which likely enhances the sensory experience for the user, masking any unpleasant odours from other ingredients.

• pH:
The pH of the supplement falls between 5 and 7, which indicates a slightly acidic to neutral range. A pH within this range is ideal for compatibility with both the supplement’s active ingredients and the human digestive system.

• Microbial Limit Test:
This test was used to ensure that the product is microbiologically safe for consumption by limiting the presence of harmful microorganisms and controlling the total microbial content. It consists of two parts:
a) Total Aerobic Microbial Count (TAMC): Measures the overall number of aerobic microorganisms (bacteria and fungi) in the product. The limit set was NMT (not more than) 100,000 cfu/g to ensure the product is not overloaded with microorganisms.
b) Total Yeast and Mold Count (TYMC): Quantifies the presence of yeasts and molds in the product, with a limit of NMT 1,000 cfu/g, ensuring the product remains safe from spoilage or potential contamination by these organisms.

Additionally, the Microbial Limit Test for Pathogens checks for the absence of specific harmful pathogens, including:
a) Escherichia coli (E. coli): was absent to avoid contamination from fecal matter.
b) Pseudomonas aeruginosa: was absent as it was a dangerous pathogen, especially for people with weakened immune systems.
c) Staphylococcus aureus: was absent to prevent foodborne illness, as this bacterium can produce toxins harmful to human health.
d) Salmonella abony: was absent to avoid salmonellosis, a potentially serious foodborne illness.

Microbial limit test by pour plate method
Total aerobic Microbial Count (TAMC) NMT 100000 cfu/g
Total Yeast and Mold Count (TYMC) NMT 1000 cfu/g
Microbial limit test for detection of pathogens
Escherichia coli Absent
Pseudomonas aeruginosa Absent
Staphylococcus aureus Absent
Salmonella abony Absent
Table 2 - Microbial Limit Test

 
We Claim:
1. A prebiotic and dietary fiber supplement comprising;
a) Soluble fibers;
b) Insoluble fiber;
c) Prebiotic;
d) Enzyme; and
e) Inert excipients.

2. The supplement as claimed in claim 1, wherein the inert excipients are texture enhancer, flavouring agent and sweetening agent.

3. The supplement as claimed in claim 1, wherein the soluble fibers are fenugreek fiber and psyllium husk.

4. The supplement as claimed in claim 1, wherein the insoluble fiber is rice bran.

5. The supplement as claimed in claim 1, wherein the soluble fiber and insoluble fiber is present in weight ratio of 0.886:1.

6. The supplement as claimed in claim 1, wherein the prebiotic is inulin and fructo-oligosaccharides (FOS).

7. The supplement as claimed in claim 1, wherein the enzyme is protease.

8. A prebiotic and dietary fiber supplement comprising
a) 4.86 % w/w of Fenugreek Fiber and 4 % w/w of Psyllium Husk as soluble fibers;
b) 10 % w/w of Rice bran, as an insoluble fiber;
c) 54.84 % w/w of Inulin and 14.63 % w/w of Fructo-Oligosaccharide (FOS), as prebiotic;
d) 0.38 % w/w of Protease, as an enzyme;
e) 8 % w/w of Lemon rods and 2.00 % w/w of Citric acid, as flavouring agents;
f) 0.10 % w/w of Xanthan gum, as a texture enhancer; and
g) 1.20 % w/w of Stevia, as a sweetening agent;
wherein the percentages are with respect to total weight of the formulation.

9. The supplement as claimed in claim 8 wherein the formulation is in powder form and is suitable for mixing with liquids or food.

10. A process for preparation of prebiotic and dietary fiber supplement comprising steps of,
a) Blending and mixing soluble fibers and insoluble fiber in a ratio of 0.886:1 to form a blend;
b) Adding prebiotics, enzyme, texture enhancer, flavouring agent and sweetening agent to above blend to form a mixture;
c) Sieving the above mixture to form a fine powder supplement.

Dated this: 10th October 2024

Vijaykumar Shivpuje
IN/PA-1096
Agent for the Applicants

To
The Controller of Patents
The Patent Office, Mumbai

ABSTRACT

“PREBIOTIC AND DIETARY FIBER SUPPLEMENT AND PREPARATION METHOD THEREOF”

The present invention relates to a dietary supplement, more specifically to a prebiotic and dietary fiber supplement formulated to enhance gut health, improve digestion, and support overall well-being. The supplement consists of soluble fiber, insoluble fiber, prebiotics, and enzymes, along with inert excipients. Each component has been meticulously chosen for its scientifically proven ability to support various aspects of digestive function, including promoting the growth of beneficial gut bacteria, ensuring regular bowel movements, optimizing nutrient absorption, and aiding in blood sugar regulation
, Claims:We Claim:
1. A prebiotic and dietary fiber supplement comprising;
a) Soluble fibers;
b) Insoluble fiber;
c) Prebiotic;
d) Enzyme; and
e) Inert excipients.

2. The supplement as claimed in claim 1, wherein the inert excipients are texture enhancer, flavouring agent and sweetening agent.

3. The supplement as claimed in claim 1, wherein the soluble fibers are fenugreek fiber and psyllium husk.

4. The supplement as claimed in claim 1, wherein the insoluble fiber is rice bran.

5. The supplement as claimed in claim 1, wherein the soluble fiber and insoluble fiber is present in weight ratio of 0.886:1.

6. The supplement as claimed in claim 1, wherein the prebiotic is inulin and fructo-oligosaccharides (FOS).

7. The supplement as claimed in claim 1, wherein the enzyme is protease.

8. A prebiotic and dietary fiber supplement comprising
a) 4.86 % w/w of Fenugreek Fiber and 4 % w/w of Psyllium Husk as soluble fibers;
b) 10 % w/w of Rice bran, as an insoluble fiber;
c) 54.84 % w/w of Inulin and 14.63 % w/w of Fructo-Oligosaccharide (FOS), as prebiotic;
d) 0.38 % w/w of Protease, as an enzyme;
e) 8 % w/w of Lemon rods and 2.00 % w/w of Citric acid, as flavouring agents;
f) 0.10 % w/w of Xanthan gum, as a texture enhancer; and
g) 1.20 % w/w of Stevia, as a sweetening agent;
wherein the percentages are with respect to total weight of the formulation.

9. The supplement as claimed in claim 8 wherein the formulation is in powder form and is suitable for mixing with liquids or food.

10. A process for preparation of prebiotic and dietary fiber supplement comprising steps of,
a) Blending and mixing soluble fibers and insoluble fiber in a ratio of 0.886:1 to form a blend;
b) Adding prebiotics, enzyme, texture enhancer, flavouring agent and sweetening agent to above blend to form a mixture;
c) Sieving the above mixture to form a fine powder supplement.