A food composition comprising a coloured marker for estimating whole gut transit time and gut health

Abstract

The present invention provides a food composition for estimating the whole gut transit time and gut health of an individual, comprising a dye ingredient, which allows for a non-invasive, scalable, and economical method to assess or monitor the gut health of a person based on whole gut transit time. Particularly, the food composition has been formulated such that the appearance of the colored dye in the stool from time of ingestion is indicative of gut transit time correlated with gut health.

Description

[0001] A FOOD COMPOSITION COMPRISING A COLOURED MARKER FOR ESTIMATING WHOLE GUT TRANSIT TIME AND GUT HEALTH FIELD OF INVENTION

[0002] The present invention generally relates to gut health. In particular, the present invention relates to a colored dye-based food composition for estimating the whole gut transit time and gut health. BACKGROUND OF THE INVENTION

[0003] In India, gut health issues are prevalent among the urban population. A survey conducted by Country Delight in partnership with the Indian Dietetic Association in Mumbai revealed that 7 out of 10 urban Indians experience digestive problems, with 59% reporting issues weekly and 12% daily. These issues manifest through symptoms such as bloating, upset stomach, diarrhoea, and vomiting, which serve as indicators of the condition of the digestive system.

[0004] According to various studies, functional gastrointestinal disorders such as irritable bowel syndrome (IBS) and gastroesophageal reflux disease (GERD) are prevalent, affecting approximately 15-20% of the Indian population. GERD alone affects about 8-20% of Indians, with variations across different regions.

[0005] Furthermore, a community-based survey indicated that constipation is a common problem, affecting around 22% of Indian adults. The prevalence is higher in metropolitan areas, with Kolkata reporting the highest at 28%, followed by Chennai at 26% (22% of Indian adults suffer from constipation: abbott 'gut health survey' Smritee et al). Factors contributing to constipation include dietary habits, low fiber intake, sedentary lifestyles, and metabolic disorders such as diabetes and hypothyroidism (Uday, 2017). The survey also noted that irregular eating habits, consumption of junk food, and inadequate water intake are significant contributors to this condition.

[0006] Given the high prevalence of these gastrointestinal issues and the impact on quality of life, there is a pressing need for effective interventions. This invention aims to address gut health through a functional food product that can aid in the measurement and management of gut transit time, ultimately improving digestive health for urban Indians.

[0007] A critical metric in assessing digestive health is the Whole Gut Transit Time (WGTT), which measures how long food takes to travel from the mouth to the anus. This metric provides valuable insights into the efficiency of digestion and absorption processes. Importantly, WGTT is closely intertwined with the gut microbiome, the diverse community of microorganisms residing in thedigestive tract. The gut microbiome and WGTT have a bidirectional relationship: gut bacteria produce metabolites that influence gut motility, affecting how quickly or slowly food moves through the digestive system. Conversely, WGTT impacts microbial composition and metabolism, highlighting the interconnected nature of digestive health and the gut microbiome in the context of urban Indian lifestyles.

[0008] Understanding how gut bacteria affect transit time is crucial. Gut bacteria primarily derive their energy from carbohydrates, producing beneficial byproducts that support the gut barrier and bolster the immune system. However, when transit time is slow, these bacteria may shift to consuming protein. This shift can result in the production of harmful by-products, potentially leading to mucosal damage and inflammation.

[0009] Conversely, a fast transit time can impede nutrient absorption, leading to problems such as dehydration. Various conditions can contribute to faster-than average transit times, including food allergies, anxiety, celiac disease, and inflammatory bowel disease. These conditions highlight the delicate balance required for optimal digestive health.

[0010] The connection between diet and gut health significantly influences digestion, immunity, and mental well-being. In urban populations experiencing gut health issues, there is a notable link to mental health challenges.

[0011] Several validated methods exist to measure gut transit time, including scintigraphy, wireless motility capsules, radio-opaque markers, and breath testing. Among these, radio-opaque marker techniques are widely used in clinical and research settings. However, these methods require specialized equipment, trained staff, and at least one in-person visit, making them laborious, inconvenient, and expensive. These limitations hinder their widespread use in studies.

[0012] This situation underscores the need for easily accessible and inexpensive techniques to assess gut transit time. The dye method through functional food offers a practical solution to efficiently and cost-effectively measure gut transit time, thereby advancing understanding of the relationship between diet, the microbiome, and overall health.

[0013] The present method is simple, cost-effective, and scalable, making it suitable for widespread application in both research and clinical settings.

[0014] OBJECTIVES OF THE INVENTION

[0015] An objective of the present invention is to provide a ready-to-eat food composition comprising a colored dye component to estimate the whole gut transit time of an individual in an accurate and effective manner.Another objective of the present invention is to provide a method to estimate the whole gut transit time of an individual in an accurate and effective manner using a ready-to-eat food composition comprising a colored dye component to estimate the whole gut transit time of an individual in an accurate and effective manner.

[0016] SUMMARY OF THE INVENTION

[0017] In an aspect of the present invention, there is provided a food composition for estimating the whole gut transit time and gut health of an individual, said food composition comprising at least a colored dye, wherein the colored dye is a natural dye in an amount in the range of 14-20wt% of the food composition; or wherein the colored dye is a synthetic food grade dye in an amount of 0.5-0.7wt% of the food composition.

[0018] In an aspect of the present invention, the weight of the food composition is in the range of 25-30g per serving.

[0019] In an aspect of the present invention, the natural dye is a vegetable dye.

[0020] In an aspect of the present invention, the vegetable dye is beetroot extract.

[0021] In an aspect of the present invention, the synthetic food grade dye is brilliant blue.

[0022] In an aspect of the present invention, the food composition comprises: at least a dietary fiber selected from fructooligosaccharides, cereal-derived fibers, or combinations thereof, in an amount of 20-50 wt%; at least a carbohydrate source selected from date syrup, dried fruits, or combinations thereof, in an amount of 15-35 wt%; at least a nut or seed component in an amount of 5-20 wt%; a colored dye in an amount of 0.5-20wt%; and at least a botanical or antioxidant component in an amount of 0.01-10 wt%.

[0023] In an aspect of the present invention, the food composition comprises fructooligosaccharide in an amount of 11 ,8wt%; oats in an amount of 12wt%; date syrup in an amount of 20wt%; peanut in an amount of 9.36wt%; dried cranberry in an amount of 10wt%; raisins in an amount of 7wt%; blueberry powder in an amount of 4wt%; almond powder in an amount of 5wt%; wheat bran in an amount of 10.06wt%; antioxidant in an amount of 0.1wt%; colored dye in an amount of 0.68wt%; amla powder in an amount of 6wt%; and mulethi in an amount of 4wt%.

[0024] In another aspect of the present invention, the food composition comprises rolled oats in an amount of 19.35 wt%; sattu in an amount of 19.35 wt%; wheat bran in an amount of 9.68 wt%; almond in an amount of 4.52 wt%; date paste in an amount of 4.84 wt%; fructooligosaccharide in an amountof 19.04 wt%; coconut oil in an amount of 3.76 wt%; colored dye in an amount of 19.35 wt%; and rosemary extract in an amount of 0.10 wt%.

[0025] In yet another aspect of the present invention, there is provided a method of monitoring gut health of an individual, comprising: obtaining a food composition comprising at least a colored dye, wherein the colored dye is a natural dye in an amount in the range of 14-20wt% of the food composition; or wherein the colored dye is a synthetic food grade dye in an amount of 0.5-0.7wt% of the food product; ingesting one serving of the food composition by the individual; and estimating the time elapsed between ingestion of the food composition and first appearance of color corresponding to the colored dye present in the food composition in stool, wherein the elapsed time represents the whole gut transit time and is indicative of gut health of the individual. In an aspect, a transit time of less than 14 hours or more than 48 hours is indicative of sub-optimal gut health.

[0026] In another aspect, a transit time of 14-48 hours is indicative of normal gut health.

[0027] In an aspect, there is provided a food composition comprising at least a colored dye, wherein the colored dye is a natural dye in an amount in the range of 14-20wt% of the food composition; or wherein the colored dye is a synthetic food grade dye in an amount of 0.5-0.7wt% of the food composition for use in estimating the whole gut transit time and gut heath of an individual based on whole gut transit time.

[0028] DETAILED DESCRIPTION OF THE INVENTION

[0029] The following description includes the preferred best mode of one embodiment of the present invention. It will be clear from this description of the invention that the invention is not limited to these illustrated embodiments but that the invention also includes a variety of modifications and embodiments thereto. Therefore, the present description should be seen as illustrative and not limiting. While the invention is susceptible to various modifications and alternative constructions, it should be understood, that there is no intention to limit the invention to the specific form disclosed but, on the contrary, the invention is to cover all modifications, alternative constructions, and equivalents falling within the scope of the invention as defined in the claims.

[0030] The present invention provides an innovative, cost-effective, and scalable solution for measuring whole gut transit time (WGTT) using a colored dye infused food composition. A user can consume the formulated food composition containing a food grade dye and monitor their stool for appearance of the dye color, where the dye “transit” time is indicative of gut health. The present invention allows for reliable, repeatable, and accurate measurement of WGTT. The presentinvention provides a “simplified” solution to assessment of WGTT, which can be used in both clinical and personal health setting.

[0031] Unlike conventional methods, which primarily focuses on stool consistency and frequency, the present invention is non-invasive, hygienic and cost-effective. It assesses gut transit time, which is an important indicator of gut microbiome health. By providing a simple yet effective way to evaluate digestive health, the present invention is a practical, cheaper, user friendly, and superior alternative to conventional methods.

[0032] The present invention provides a food composition for monitoring gut health of an individual, comprising at least a colored dye, wherein the colored dye is a natural dye in an amount in the range of 14-20wt% of the food composition; or wherein the colored dye is a synthetic food grade dye in an amount of 0.5-0.7wt% of the food composition.

[0033] In an embodiment, the colored dye a natural dye. In an embodiment, the natural dye is a vegetable extract. In a preferred embodiment, the vegetable extract is beetroot extract. In an embodiment, the food composition comprises at least a vegetable extract in an amount in the range of 14-20wt% of the food product. In a preferred embodiment, the food composition comprises beetroot extract in an amount in the range of 14-20wt%. In a more preferred embodiment, the food composition comprises beetroot extract in an amount of about 19wt%.

[0034] In an embodiment, the colored dye is a synthetic dye. In a preferred embodiment, the synthetic dye is a food grade synthetic dye. In a more preferred embodiment, the food grade synthetic dye is brilliant blue. In an embodiment, the food composition comprises at least a food grade synthetic dye in an amount in the range of 0.5-0.7wt% of the food product. In an embodiment, the food composition comprises brilliant blue in an amount in the range of 0.5-0.7wt%. In a more preferred embodiment, the food composition comprises brilliant blue in an amount of about 0.56wt%. In still another preferred embodiment, the food composition comprises brilliant blue in an amount of about 0.68wt%.

[0035] In an embodiment, the natural dye is obtained from at least a vegetable. In an embodiment, the natural dye is obtained from at least an alga. In an embodiment, the natural dye is obtained from the group consisting of beetroot, blue pea flower, spirulina, marine blue, elderberry, and combinations thereof.

[0036] In an embodiment, the synthetic food-grade dye is selected from the group consisting of brilliant blue, patent blue, ponceau 4R, carmoisine, erythrosine, and combinations thereof.In an embodiment, the color of the dye is selected from the group consisting of red, pink, blue, purple, and combinations thereof. In a preferred embodiment, the color of the dye is blue. In another preferred embodiment, the color of the dye is beetroot red.

[0037] The colored dye is stable during processing and gastrointestinal transit so as to allow reliable visual identification in stool without inducing pharmacological or laxative effects.

[0038] In an embodiment, the weight of the food composition is in the range of 25-30g. In an embodiment, the weight of the food composition is 25g. In an embodiment, the weight of the food composition is 30g. In an embodiment, a single serve / one serving of the food composition is in the range of 25-30g. In an embodiment, a single serve / one serving of the food composition is 25g. In an embodiment, a single serve / one serving of the food composition is 30g.

[0039] In an embodiment, the food composition is in a form selected from the group consisting of a bar, brownie, muffin, cookie, fiber ball, capsule, and the like. In a preferred embodiment, the food composition is a bar, such as a health bar.

[0040] In an embodiment, the food composition comprises fructooligosaccharide in an amount of 11.8wt%; oats in an amount of 12wt%; date syrup in an amount of 20wt%; peanuts / peanut butter in an amount of 9.36wt%; dried cranberry in an amount of 10wt%; raisins in an amount of 7wt%; blueberry powder in an amount of 4wt%; almond powder in an amount of 5wt%; wheat bran in an amount of 10.06wt%; antioxidant in an amount of 0.1 wt%; colored dye in an amount of 0.68wt%; amla powder in an amount of 6wt%; and mulethi in an amount of 4wt%.

[0041] In an embodiment, the food composition comprises fructooligosaccharide in an amount of 11.8wt%; oats in an amount of 12wt%; date syrup in an amount of 20wt%; peanuts / peanut butter in an amount of 9.36wt%; dried cranberry in an amount of 10wt%; raisins in an amount of 7wt%; blueberry powder in an amount of 4wt%; almond powder in an amount of 5wt%; wheat bran in an amount of 10.06wt%; antioxidant in an amount of 0.1 wt%; brilliant blue dye in an amount of 0.68wt%; amla powder in an amount of 6wt%; and mulethi in an amount of 4wt%.

[0042] In an embodiment, the food composition comprises rolled oats in an amount of about 19.36 wt%, sattu in an amount of about 19.36 wt%, wheat bran in an amount of about 9.68 wt%, almond in an amount of about 4.52 wt%, date paste in an amount of about 4.84 wt%, fructooligosaccharide in an amount of about 19.04 wt%, coconut oil in an amount of about 3.76 wt%, colored dye in an amount of about 19.36 wt%, and rosemary extract in an amount of about 0.12 wt%.

[0043] In an embodiment, the food composition comprises rolled oats in an amount of about 19.36 wt%, sattu in an amount of about 19.36 wt%, wheat bran in an amount of about 9.68 wt%, almond in anamount of about 4.52 wt%, date paste in an amount of about 4.84 wt%, fructooligosaccharide in an amount of about 19.04 wt%, coconut oil in an amount of about 3.76 wt%, beetroot extract in an amount of about 19.36 wt%, and rosemary extract in an amount of about 0.12 wt%.

[0044] The fiber content of the food composition facilitates the physiological gastrointestinal transit of the food composition and enable consistent measurement of gut transit time.

[0045] The various constituents of the food composition of the present invention and their relative amounts have been identified and combined after meticulous experimentation so as to provide a food composition that consistently and reliably transits the whole gut in a time frame consistent with established standards so as to be able to give an accurate indication of gut health.

[0046] The dietary fiber components include both soluble and insoluble fiber fractions that contribute to stool bulk formation, water retention, and regulated intestinal motility, thereby supporting uniform progression of the coloured dye through the gastrointestinal tract without inducing abnormal bowel patterns.

[0047] The fibre-containing edible matrix of the coloured food bar enables the coloured dye to traverse the gastrointestinal tract in a manner reflective of normal gut motility, without exerting a pharmacological, stimulant, or laxative effect. The coloured food bar therefore functions as a non-invasive, food-based motility tracer capable of generating an observable gastrointestinal transit endpoint that is directionally comparable to established radiological methods.

[0048] The present invention provides a method of estimating the whole gut transit time and gut health of an individual, the method comprising: (a) obtaining a food composition comprising at least a colored dye in an amount of 14-20wt% of the food composition, wherein the colored dye is a vegetable dye; or comprising at least a colored dye in an amount of 0.5-0.7wt% of the food composition, wherein the colored dye is a synthetic food grade dye; (b) ingesting one serving of the food composition; and (c) estimating the time taken since ingestion of the one serving of the food composition for stool passed by the individual to be colored of the same color as the colored dye in the food product, wherein the time taken since ingestion of the one serving of the food composition to appearance of colored dye in stool passed by the person (transit time) is indicative of whole gut transit time and gut health of the individual based on the whole gut transit time. In an embodiment, one serving of the food composition is ingested generally in the evening prior to dinner. In another embodiment, one serving of the food composition is ingested approximately 3 hours after breakfast or lunch.In an embodiment, a transit time of less than 14 hours is indicative of sub-optimal gut health. In an embodiment, a transit time of less than 14 hours is designated as “fast” transit time. A transit time of less than 14 hours, or fast transit time may be symptomatic of food passing through the gut too quickly, resulting in nutrients not being fully absorbed, suboptimal nutrient uptake, nutritional deficiency, reduced time for gut bacteria to metabolize food, thereby impacting gut microbiome and overall digestive health.

[0049] In an embodiment, a transit time of more than 48 hours is indicative of poor gut health. In an embodiment, a transit time of more than 48 hours is designed as “slow” transit time. A transit time of more than 48 hours, or slow transit time may be symptomatic of shift in gut bacteria’s metabolic activity from carbohydrates to protein, production of protein breakdown by-products such as ammonia and sulfur compounds, and constipation.

[0050] In an embodiment, a transit time of 14-48 hours is indicative of normal gut health. A transit time of 14-48 hours is indicative of optimal absorption of water and nutrients, thereby facilitating bacterial metabolism and nourishment of beneficial gut flora.

[0051] EXAMPLES

[0052] Food composition

[0053] In an exemplary example, the food composition is in the form of a functional food bar formulated to pass through the digestive system in 14-48 hours, which is representative of “normal” whole gut transition time (WGTT). The normal WGTT is also standardized as per known / conventional methods such as using radio-opaque markers, scintigraphy, wireless motility capsules, and the like. Table 1 below provides a formulation of a 25g single serve functional food bar as per the present invention.

[0054] Table 1

[0055]

[0056]

[0057] In another exemplary example, the food composition is in the form of a coloured functional food bar comprising a vegetable-based dye (beetroot extract). The coloured food bar was formulated to traverse the gastrointestinal tract within a physiologically representative range of approximately 14-48 hours, consistent with normal WGTT as defined by conventional clinical methodologies. Table 2 below provides a formulation of a 25 g single-serve functional food bar as per the present invention.

[0058] Table 2

[0059]

[0060] Standardization of Food Composition

[0061] In an exemplary embodiment, the functional food bar formulation was standardized to ensure that ingestion of the food product does not itself induce accelerated or delayed gastrointestinal transit, thereby enabling accurate assessment of an individual’s inherent whole gut transit time.The formulation was designed to be nutritionally balanced and non-laxative, with controlled levels of dietary fibre, fat, carbohydrates, moisture content, and binding agents. In particular, the type and quantity of dietary fibre were selected to avoid excessive bulking or osmotic effects, while fat content and sweetening agents were maintained within ranges commonly consumed as part of a regular diet.

[0062] During development, multiple alternative formulations and recipe variations were evaluated, including variations in fibre type, fibre load, fat composition, and binding matrices. Certain formulations were observed to alter bowel habits, produce inconsistent stool coloration, or result in accelerated or delayed gastrointestinal transit. Such formulations were excluded from further evaluation.

[0063] The standardized formulation disclosed herein demonstrated reproducible gastrointestinal washout times, maintained normal stool consistency, and did not induce laxative or constipating effects, thereby allowing reliable visualization and estimation of gastrointestinal transit time using the coloured dye-based approach described in the present invention.

[0064] Weight Concentration and Colour Selection of Coloured Dye in Food Composition

[0065] In order to determine a suitable coloured dye and an effective amount thereof for use in measuring whole gut transit time, one or more food-grade-coloured dyes were evaluated at varying weight concentrations in a single serving of a food composition. In the present examples, the food composition was a functional food bar having a single-serve weight of approximately 25 g.

[0066] Weight Concentration of Synthetic Food-Grade Dye

[0067] Synthetic food-grade dye, specifically brilliant blue, was incorporated into single servings of the food composition at various weight concentrations ranging from approximately 0.0004 g to 0.2 g per serving. Representative concentrations evaluated included 0.0004 g, 0.0006 g, 0.01 g, 0.03 g, 0.08 g, 0.1 g, and 0.17 g of brilliant blue per 25 g serving of the food composition.

[0068] The efficacy of each dye concentration was assessed by visually observing the presence, intensity, and consistency of stool coloration following ingestion of the food composition. Based on these evaluations, it was observed that incorporation of approximately 0.17 g of brilliant blue in a 25 g serving of the food composition produced the most consistent and visually detectable stool coloration. A similar level of visual detectability was observed when approximately 0.17 g of brilliant blue was incorporated into a 30 g single-serve food composition.

[0069] At lower dye concentrations, stool coloration was inconsistent or insufficiently visible, while at higher concentrations the colour persisted in stool beyond a single bowel cycle. These observationshighlight the importance of optimizing dye concentration to achieve reliable visual detection without prolonged colour retention.

[0070] Fiber Content

[0071] In an example, the natural dye-based food bar comprising beetroot-derived coloring exhibited a dietary fiber content of approximately 4.72 g per 25 g serving, as determined by laboratory analysis. In a comparative example, the synthetic dye-based food bar comprising brilliant blue exhibited a dietary fiber content of approximately 3.94 g per 25 g serving. Despite differences in fiber composition and dye source, both food bars demonstrated consistent visual dye detection in stool and comparable gut transit time measurement performance.

[0072] Nutritional information of food product comprising brilliant blue (per 25 g serving), based on formulation calculations

[0073] Table 3

[0074]

[0075] Nutritional information food product comprising beetroot extract (per 25 g serving), as determined by laboratory analysis

[0076] Table 4

[0077]

[0078]

[0079] The nutritional values of the synthetic dye-based food bar were estimated based on formulation calculations, while the nutritional values of the natural dye-based food bar were determined through laboratory analysis. Both representations are provided for illustrative purposes and do not limit the scope of the invention.

[0080] Gut transition time measurement (Synthetic Dye)

[0081] The functional food bar as per Table 1 was tested in 20 individuals, each adhering to a standardized diet and lifestyle regimen. Each individual was directed to consume one serving of the bar in the evening. The individual participants were instructed to log the first occurrence of “colored stool”. The transit time was measured from the bar ingestion time to first sighting of color in stool. The time was recorded in hours to document transit time and color transition.

[0082] <

[0083]

[0084] Slow transit time: 5% of the test subjects experienced prolonged / delayed transit of food through the digestive tract. Delayed transit of food can shift the gut bacteria’s metabolic activity from carbohydrates towards proteins, which can lead to production of ammonia and sulfur compounds as by-products, which can negatively affect gut health. The slow passage can lead to constipation. Normal transit time: 45% of the test subject showed normal gut transit time, where digested food material spends adequate time in the GI tract, which facilitates optimal absorption of water and nutrients., facilitating good gut microbiome health, and a harmonious balance between nutrient absorption and waste elimination.

[0085] Fast transit time: 50% of the test subjects exhibited fast transit time, which is indicative of less than desirable digestive efficiency. When food passes through the GI tract too quickly, nutrients may not be fully absorbed, which may lead to suboptimal nutrient uptake, leading to nutritional deficiency over time despite optimal food intake amount. It can also impact the gut microbiome and cause disbalance to the gut microbial population.

[0086] While the blue bar experiment did not include direct comparison with a conventional gastrointestinal transit measurement method, subsequent validation using a natural dye-based foodbar and a radio-opaque marker technique demonstrated comparable physiological transit categorisation, supporting the reliability of the coloured food bar approach.

[0087] Gut Transit Time Measurement (Natural Dye-Based Food Bar with Radio-Opaque Marker Comparison)

[0088] A coloured food bar comprising a vegetable-derived dye as described herein (red bar embodiment) was evaluated in a clinical setting using a comparative radio-opaque marker (ROM) method. The study was conducted as an open-label, cross-over, exploratory pilot study in ten (10) healthy adult volunteers in accordance with predefined inclusion and exclusion criteria. All participants adhered to a standardised diet and lifestyle regimen during the assessment period.

[0089] Each participant consumed one serving of the coloured food bar approximately three hours after breakfast or lunch, in accordance with the study protocol. Participants were instructed to observe and record the appearance of coloured stool. Total washout time was defined as the interval between ingestion of the food bar and the last reported occurrence of coloured stool.

[0090] In parallel, gastrointestinal transit was assessed using a radio-opaque marker method, wherein participants ingested radio-opaque markers and abdominal radiographic assessments were conducted at 36 hours and 60 hours in accordance with standard clinical practice. Marker retention and percentage passage were recorded.

[0091] The coloured food bar produced measurable and reproducible gastrointestinal washout times, with a median total washout time of approximately 38.5 hours. Nine of ten participants (90%) demonstrated complete washout within 60 hours following ingestion of the coloured food bar, while one participant (10%) exhibited a prolonged washout time of approximately 66 hours, indicative of slower gastrointestinal transit.

[0092] At an individual participant level, comparison of outcomes from the coloured food bar and radioopaque marker methods showed broadly comparable physiological transit patterns in the majority of participants. Eight of ten participants demonstrated similar overall transit categorisation using both approaches, while two participants showed non-comparable outcomes. Notably, one participant classified as having delayed transit based on radio-opaque marker retention demonstrated coloured food bar washout within approximately 40 hours, highlighting the complementary nature of the two measurement approaches.

[0093] The food product of the present invention demonstrates gastrointestinal washout times that fall within physiologically expected ranges for healthy adults and exhibit directional similarity to radio-opaque marker clearance patterns observed at corresponding time points. The coloured foodbar does not induce abnormal stool consistency, persistent diarrhoea, or constipation, as assessed using standardized stool form classifications.

[0094] Slow Transit Time: A subset of participants exhibited prolonged washout times exceeding 48 hours. Delayed gastrointestinal transit may be associated with a shift in gut microbial metabolism from carbohydrates toward proteins, leading to the production of metabolic by-products such as ammonia and sulfur-containing compounds, and may be associated with constipation-like symptoms.

[0095] Normal Transit Time: The majority of participants demonstrated washout times within the range of approximately 14 to 48 hours, consistent with normal gastrointestinal transit. Within this range, digested food material spends adequate time in the gastrointestinal tract to support optimal absorption of water and nutrients, maintenance of stool consistency, and balanced gut microbiome activity.

[0096] Fast Transit Time: No participants in this cohort demonstrated washout times below 14 hours. This indicates that the natural dye-based food bar did not induce accelerated gastrointestinal transit or laxative-like effects.

[0097] Comparative assessment of coloured food bar washout times and radio-opaque marker outcomes at 60 hours demonstrated broadly comparable physiological transit characteristics in the majority of participants, supporting the feasibility of the coloured food bar as a non-invasive, food-based approach for estimating gastrointestinal transit characteristics.

[0098] Stool form assessment using the Bristol Stool Chart showed that stool consistency remained predominantly within the normal range (Types 3-5) across sequential bowel movements following ingestion of the coloured food bar, indicating that the food bar did not induce abnormal bowel patterns or pharmacological laxative effects.

[0099] ADVANTAGES OF THE PRESENT INVENTION

[0100] The present invention provides a cost-effective, non-invasive, scalable, and user-friendly solution for estimating gastrointestinal transit characteristics and monitoring gut health status. The invention utilizes readily available, ingestible food-based materials and does not require specialized equipment, trained personnel, imaging facilities, or laboratory infrastructure.

[0101] An advantage of the present invention is that it can be readily used at an individual level to estimate gut transit time at a desired frequency, or implemented in larger population-based studies, observational studies, or clinical research settings for monitoring gastrointestinal transit patterns.Another advantage of the present invention is that the food composition is consumed as a single serving to obtain the desired measurement, thereby minimizing disruption to an individual’s daily routine and improving ease of use, compliance, and participant acceptability.

[0102] The present invention further provides a nutritional food matrix, allowing gut transit estimation to be integrated into routine dietary intake without the use of pharmaceuticals, laxatives, or invasive procedures.

[0103] The present invention may also support increased awareness of gastrointestinal health by enabling individuals to observe and understand their gut transit patterns, thereby encouraging informed lifestyle and dietary choices related to digestive well-being.

[0104] Additionally, the present invention enables proactive self-monitoring of gastrointestinal transit characteristics, which may assist individuals in recognizing deviations from their usual transit patterns and seeking appropriate professional advice when needed, without constituting a diagnostic or therapeutic tool.

Claims

I / We claim:

1. A food composition for estimating whole gut transit time and gut health of an individual, said food composition comprising at least a colored dye, wherein the colored dye is a natural dye in an amount in the range of 14-20wt% of the food composition; or wherein the colored dye is a synthetic food grade dye in an amount of 0.5-0.7wt% of the food composition.

2. The food composition as claimed in claim 1, wherein the weight of the food composition is in the range of 25-30g per serving.

3. The food composition as claimed in claim 1, wherein the natural dye is a vegetable dye.

4. The food composition as claimed in claim 3, wherein the vegetable dye is beetroot extract.

5. The food composition as claimed in claim 1, wherein the synthetic food-grade dye is brilliant blue.

6. The food composition as claimed in claim 1, comprising:a. at least a dietary fiber selected from fructooligosaccharides, cereal -derived fibers, or combinations thereof, in an amount of 20-50 wt%;b. at least a carbohydrate source selected from date syrup, dried fruits, or combinations thereof, in an amount of 15-35 wt%;c. at least a nut or seed component in an amount of 5-20 wt%;d. a colored dye in an amount of 0.5-20wt%; ande. at least a botanical or antioxidant component in an amount of 0.01-10 wt%.

7. The food composition as claimed in claim 6, comprising:a. Fructooligosaccharide in an amount of 11 ,8wt%;b. Oats in an amount of 12wt%;c. Date syrup in an amount of 20wt%;d. Peanut in an amount of 9.36wt%;e. Dried cranberry in an amount of 10wt%;f. Raisins in an amount of 7wt%;g. Blueberry powder in an amount of 4wt%;h. Almond powder in an amount of 5wt%;i. Wheat bran in an amount of 10.06wt%;j . Antioxidant in an amount of 0.1 wt%;k. Colored dye in an amount of 0.68wt%;l. Amla powder in an amount of 6wt%; andMulethi in an amount of 4wt%.

8. The food composition as claimed in claim 6, comprising:a. Rolled oats in an amount of 19.35 wt%;b. Sattu in an amount of 19.35 wt%;c. Wheat bran in an amount of 9.68 wt%;d. Almond in an amount of 4.52 wt%;e. Date paste in an amount of 4.84 wt%;f. Fructooligosaccharide in an amount of 19.04 wt%;g. Coconut oil in an amount of 3.76 wt%;h. colored dye in an amount of 19.35 wt%; andi. Rosemary extract in an amount of 0.10 wt%.

9. A method of estimating whole gut transit time and gut health of an individual, comprising:a. obtaining a food composition as claimed in claim 1;b. ingesting one serving of the food composition by the individual; andc. eestimating the time elapsed between ingestion of the food composition and first appearance of color corresponding to the colored dye present in the food composition in stool,wherein the elapsed time represents the whole gut transit time and is indicative of gut health of the individual.

10. The method as claimed in claim 9, wherein a transit time of less than 14 hours or more than 48 hours is indicative of sub-optimal gut health.

11. The method as claimed in claim 9, wherein a transit time of 14-48 hours is indicative of normal gut health.

12. The food composition as claimed in claim 1, for use in estimating the whole gut transit time and gut heath of an individual based on the whole gut transit time.

Images