A formulation for weight and metabolic regulation

Abstract

The present invention provides a formulation comprising a blend of probiotics and fibers for weight management, digestive health management, and health parameter management in a subject The formulation aids in weight loss particularly in overweight subjects, while concurrently improving health parameters. Also provided are dosage forms, dosages, and kits comprising said formulation and methods and modes of administration of the formulation.

Description

A FORMULATION FOR WEIGHT AND METABOLIC REGULATION CROSS-REFERENCED PATENT REFERENCES

[0001] The present application is a cognate application claiming priority from Indian Provisional Patent Application No.202421048039 filed on 22ndJune 2024, and Indian Provisional Patent Application No.202521021999 filed on 11thMarch 2025. FIELD OF INVENTION

[0002] The present invention generally relates to the field of weight, and metabolic regulation. In particular, the present invention relates to formulations and methods suitable for weight loss, and metabolic improvement. BACKGROUND OF THE INVENTION

[0003] Over the last few decades, the incidence of obesity has risen to pandemic levels in many nations. In 2024, NCD-RisC reported about 880 million adults and 159 million children and adolescents aged 5–19 globally have obesity, with nearly 3 billion individuals experiencing overweight or obesity according to the World Obesity Federation. [World Obesity Federation. (n.d.). About obesity: Prevalence of obesity. Retrieved March 11, 2025, from https: / / www.worldobesity.org / about / about-obesity / prevalence-of-obesity] According to the World Obesity Atlas 2022, by 2030, obesity will impact about 1 in 5 women and 1 in 7 men globally. (World Obesity Federation. (n.d.). World Obesity Atlas 2024. Retrieved March 11, 2025, from https: / / www.worldobesity.org / resources / resource-library / world-obesity-atlas- 2024). It also raises the risk of many cardiovascular risk factors, such as dyslipidemia, type 2 diabetes, hypertension, and sleep problems. Obesity also increases the risk of non-alcoholic fatty liver disease, osteoarthritis, dementia, depression, and cancer including but not limited to colon, kidney, oesophagus, endometrium and postmenopausal breast cancer. Given that obesity shortens lifespan and deteriorates health, this tendency is concerning. While dietary interventions can help with obesity management, however, long-term patient compliance and success is challenging.

[0004] Metabolic syndrome is defined by a combination of interconnected physiological, biochemical, clinical and metabolic factors, linked to an increased risk of cardiovascular diseases and type 2 diabetes mellitus. Raised blood pressure, dyslipidemia (defined byincreased triglycerides and reduced high-density lipoproteins), raised fasting glucose and central obesity are the main features of metabolic syndrome.

[0005] There are several weight loss products available, either as prescription medications or over- the-counter (OTC) weight loss products. Those are categorized as appetite suppressants, metabolic rate enhancers, fat absorption inhibitors, and fat blockers. These medications, include semaglutide, liraglutide, tirzepatide, phentermine-topiramate, orlistat, and naltrexone- bupropion, among others, are intended for long-term weight control in individuals with varying degrees of weight-related concerns. However, long-term use of prescription medications and OTC weight loss products can lead to a variety of disadvantages. Prescription medications, such as appetite suppressants, fat blockers, and GLP-1 agonists, may cause serious side effects like cardiovascular issues, gastrointestinal problems, liver or kidney damage, and even dependency or tolerance. Prolonged use of fat blockers can also result in nutrient deficiencies, while GLP-1 agonists carry risks of pancreatitis and potential thyroid problems. OTC products, including fat burners and appetite suppressants, often lead to increased heart rate, anxiety, insomnia, and dehydration. Chronic use of some of these products can cause liver damage, digestive issues, or nutrient absorption problems. Additionally, long-term usage of these products may lead to reduced efficacy, resulting in requiring higher dosage for effectiveness, and can also potentially exacerbate side effects. Therefore, there is a need for looking at alternative approaches have become necessary.

[0006] In this context, it has become relevant to explore the correlation between the gut health and obesity. Understanding the intricate connection between gut health and obesity reveals a complex ecosystem within the gut microbiota, comprising billions of bacteria, fungi, viruses, archaea, and protozoa. This collective genetic material, known as the gut microbiome, surpasses the human genome by over 100 times in terms of gene count (Dixon et. al, 2020; Davis et. al 2016). Among the dominant phyla in the gut microbiota are Firmicutes and Bacteroidetes. Various factors, including genetics, diet, lifestyle, and medications, influence the composition of the gut microbiota. Alterations in the gut microbiota, termed gut dysbiosis, can directly or indirectly impact the host's metabolism. This dysbiosis has been associated with a range of health conditions, including allergies, atopic dermatitis, irritable bowel syndrome, colorectal cancer, metabolic syndrome, and obesity (Davis et al 2016). Research conducted on obese human subjects have confirmed specific changes on gut microbiota composition, such as a reduction of Bacteroidetes phylum and a proportional increase of Firmicutes (Ley et al., 2006; Santacruz A et al.,2010).

[0007] Moreover, a reduction of Bifidobacterium and Bacteroides and an increase of Staphylococcus, Enterobacteriaceae and Escherichia coli were detected in overweightcompared to normal-weight pregnant women (Santacruz A et al.,2010). It is therefore tempting to define the bacterial species that can lead to weight loss.

[0008] For example, AU 2019204843 discloses a composition containing species selected from Lactobacillus, Bifidobacterium or Leuconostoc and a prebiotic agent.

[0009] Similarly, AU 2015100928 discloses a probiotic composition for the treatment or prevention of fatigue wherein the bacterial strains are selected from species of Lactobacillus and Bifidobacterium.

[0010] CN 115804454 discloses a probiotic composition wherein the composition comprises species selected from Lactobacillus and Bifidobacterium.

[0011] However, other studies showed conflicting results. For example, Duncan et al., 2008 reported no significant differences of the Bacteroidetes / Firmicutes ratio between obese and lean subjects, as well as no significant changes of fecal Bacteroidetes count during diet induced weight loss. Schwiertz et al., 2010 reported a significant increase of Bacteroidetes in obese and overweight subjects. Indeed, research indicates that low bacterial diversity in the faecal microbiota of overweight / obese individuals correlates with heightened low-grade inflammation, impaired glucose regulation, and more pronounced obesity-related issues such as dyslipidemia.

[0012] Research studies indicate these conflicting observations reflect the adaptation of gut microbiota to host’s diet, with consequent enrichment of bacterial species hydrolyzing complex polysaccharides. The results of this adaptation are the maximization of energy extraction from dietary fibers, but also an enrichment of microbial diversity and the potential protection from inflammation and non-infectious colonic disease, observed in populations consuming high-fibre diet (De Fillipo C et al., 2010). SUMMARY OF THE INVENTION

[0013] In an aspect of the present invention, there is provided a formulation, said formulation comprising: (a) a probiotic blend comprising at least a microorganism selected from the group consisting of Bifidobacterium spp., Lactobacillus spp., Lactococcus spp., Streptococcus spp., Bacillus spp., Saccharomyces spp., Akkermansia spp., Anaerobutyricum spp., Faecalibacterium spp., Roseburia spp., Christensenella spp., Clostridium spp., and combinations thereof; and (b) a fiber blend comprising at least a fiber selected from the group consisting of prebiotic fibers, soluble fibers, insoluble fibers, and combinations thereof.

[0014] In an aspect of the present invention, there is provided a dosage form of a formulation, said formulation comprising: (a) a probiotic blend comprising at least a microorganism selected from the group consisting of Bifidobacterium spp., Lactobacillus spp., Lactococcusspp., Streptococcus spp., Bacillus spp., Saccharomyces spp., Akkermansia spp., Anaerobutyricum spp., Faecalibacterium spp., Roseburia spp., Christensenella spp., Clostridium spp., and combinations thereof; and (b) a fiber blend comprising at least a fiber selected from the group consisting of prebiotic fibers, soluble fibers, insoluble fibers, and combinations thereof; wherein said dosage form is selected from the group consisting of powder, tablet, and capsule, preferably powder form.

[0015] In another aspect of the present invention, there is provided a single dosage form of a formulation comprising Bifidobacterium animalis subsp. Lactis BL-04 in an amount of about 5 billion CFU; Lactobacillus gasseri Lg-36 in an amount of about 1 billion CFU; Bifidobacterium longum Bl-05 in an amount of about 1 billion CFU; Bifidobacterium bifidum Bb-06 in an amount of about 3 billion CFU; Bifidobacterium breve Bb-03 in an amount of about 5 billion CFU; Limosilactobacillus reuteri 1E1 in an amount of about 1 billion CFU; L carnitine in an amount of about 500mg; Chromium picolinate in an amount of about 400mcg; Fructooligosaccharides (FOS) in an amount of about 2.450g; Inulin in an amount of about 275mg; Glucomannan in an amount of about 1g; and Wheat Dextrin in an amount of about 5g.

[0016] In another aspect of the present invention, there is provided a kit comprising one or more of a single dosage form for a formulation comprising Bifidobacterium animalis subsp. Lactis BL-04 in an amount of 5 billion CFU; Lactobacillus gasseri Lg-36 in an amount of 1 billion CFU; Bifidobacterium longum Bl-05 in an amount of 1 billion CFU; Bifidobacterium bifidum Bb-06 in an amount of 3 billion CFU; Bifidobacterium breve Bb-03 in an amount of 5 billion CFU; Limosilactobacillus reuteri 1E1 in an amount of 1 billion CFU; L carnitine in an amount of 500mg; Chromium picolinate in an amount of 400mcg; Fructooligosaccharides (FOS) in an amount of 2.450g; Inulin in an amount of 275mg; Glucomannan in an amount of 1g; and Wheat Dextrin in an amount of 5g.

[0017] In yet another aspect of the present invention, there is provided a method of weight management in a subject, comprising orally administering to the subject in need to weight management, one or more of a dosage form selected from the group consisting of powder, tablet, and capsule, preferably powder form, said formulation comprising (a) a probiotic blend comprising at least a microorganism selected from the group consisting of Bifidobacterium spp., Lactobacillus spp., Lactococcus spp., Streptococcus spp., Bacillus spp., Saccharomyces spp., Akkermansia spp., Anaerobutyricum spp., Faecalibacterium spp., Roseburia spp., Christensenella spp., Clostridium spp., and combinations thereof; and (b) a fiber blend comprising at least a fiber selected from the group consisting of prebiotic fibers, soluble fibers, insoluble fibers, and combinations thereof; or a single dosage form of a formulationcomprising Bifidobacterium animalis subsp. Lactis BL-04 in an amount of 5 billion CFU; Lactobacillus gasseri Lg-36 in an amount of 1 billion CFU; Bifidobacterium longum Bl-05 in an amount of 1 billion CFU; Bifidobacterium bifidum Bb-06 in an amount of 3 billion CFU; Bifidobacterium breve Bb-03 in an amount of 5 billion CFU; Limosilactobacillus reuteri 1E1 in an amount of 1 billion CFU; L carnitine in an amount of 500mg; Chromium picolinate in an amount of 400mcg; Fructooligosaccharides (FOS) in an amount of 2.450g; Inulin in an amount of 275mg; Glucomannan in an amount of 1g; and Wheat Dextrin in an amount of 5g.

[0018] In yet another aspect of the present invention, there is provided a method of managing digestive health of a subject, comprising orally administering to the subject in need to digestive health management, one or more of a dosage form selected from the group consisting of powder, tablet, and capsule, preferably powder form, said formulation comprising (a) a probiotic blend comprising at least a microorganism selected from the group consisting of Bifidobacterium spp., Lactobacillus spp., Lactococcus spp., Streptococcus spp., Bacillus spp., Saccharomyces spp., Akkermansia spp., Anaerobutyricum spp., Faecalibacterium spp., Roseburia spp., Christensenella spp., Clostridium spp., and combinations thereof; and (b) a fiber blend comprising at least a fiber selected from the group consisting of prebiotic fibers, soluble fibers, insoluble fibers, and combinations thereof; or a single dosage form of a formulation comprising Bifidobacterium animalis subsp. Lactis BL-04 in an amount of 5 billion CFU; Lactobacillus gasseri Lg-36 in an amount of 1 billion CFU; Bifidobacterium longum Bl-05 in an amount of 1 billion CFU; Bifidobacterium bifidum Bb-06 in an amount of 3 billion CFU; Bifidobacterium breve Bb-03 in an amount of 5 billion CFU; Limosilactobacillus reuteri 1E1 in an amount of 1 billion CFU; L carnitine in an amount of 500mg; Chromium picolinate in an amount of 400mcg; Fructooligosaccharides (FOS) in an amount of 2.450g; Inulin in an amount of 275mg; Glucomannan in an amount of 1g; and Wheat Dextrin in an amount of 5g.

[0019] In still another aspect of the present invention, there is provide a method of managing at least a health parameter of a subject, comprising orally administering to the subject in need to health parameter management, one or more of a dosage form selected from the group consisting of powder, tablet, and capsule, preferably powder form, said formulation comprising (a) a probiotic blend comprising at least a microorganism selected from the group consisting of Bifidobacterium spp., Lactobacillus spp., Lactococcus spp., Streptococcus spp., Bacillus spp., Saccharomyces spp., Akkermansia spp., Anaerobutyricum spp., Faecalibacterium spp., Roseburia spp., Christensenella spp., Clostridium spp., and combinations thereof; and (b) a fiber blend comprising at least a fiber selected from the group consisting of prebiotic fibers, soluble fibers, insoluble fibers, and combinations thereof; or asingle dosage form of a formulation comprising Bifidobacterium animalis subsp. Lactis BL- 04 in an amount of 5 billion CFU; Lactobacillus gasseri Lg-36 in an amount of 1 billion CFU; Bifidobacterium longum Bl-05 in an amount of 1 billion CFU; Bifidobacterium bifidum Bb- 06 in an amount of 3 billion CFU; Bifidobacterium breve Bb-03 in an amount of 5 billion CFU; Limosilactobacillus reuteri 1E1 in an amount of 1 billion CFU; L carnitine in an amount of 500mg; Chromium picolinate in an amount of 400mcg; Fructooligosaccharides (FOS) in an amount of 2.450g; Inulin in an amount of 275mg; Glucomannan in an amount of 1g; and Wheat Dextrin in an amount of 5g.

[0020] In an aspect of the present invention, there is provide a formulation, a dosage form, a single dosage powder form, or a kit, for use in any one or more of weight management in a subject, digestive health management in subject, and health parameters management in a subject. DETAILED DESCRIPTION OF THE INVENTION

[0021] The present invention provides a formulation comprising one or more probiotics and one or more fibers that aids in management and / or loss of weight in a human subject. The said formulation also provides for aid in management of one or more metabolic parameters indicated in metabolic syndrome.

[0022] The present invention provides a formulation, said formulation comprising: (a) a probiotic blend comprising at least a microorganism selected from the group consisting of Bifidobacterium spp., Lactobacillus spp., Lactococcus spp., Streptococcus spp., Bacillus spp., Saccharomyces spp., Akkermansia spp., Anaerobutyricum spp., Faecalibacterium spp., Roseburia spp., Christensenella spp., Clostridium spp., and combinations thereof; and (b) a fiber blend comprising at least a fiber selected from the group consisting of prebiotic fibers, soluble fibers, insoluble fibers, and combinations thereof.

[0023] In an embodiment, the probiotic blend comprises at least a microorganism selected from the group consisting of Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Lactobacillus gasseri, and Limosilactobacillus reuteri, and combinations thereof.

[0024] In an embodiment, the Bifidobacterium spp. is selected from the group consisting of Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium animalis, Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Bifidobacterium infantis, Bifidobacterium angulatum, Bifidobacterium thermophilum, Bifidobacterium scardovii, Bifidobacterium pseudocatenulatum, and combinations thereof.

[0025] In an embodiment, the Lactobacillus spp, is selected from the group consisting of Lactobacillus gasseri, Lactobacillus reuteri, Limosilactobacillus reuteri Lactobacillus fermentum, Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus bulgaricus, Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus sakei, Lactobacillus caucasicus, Lactobacillus curvatus, Lactobacillus salivarius, Lactobacillus amylovorus, Lactobacillus gallinarum, Lactobacillus helveticus, Lactobacillus brevis, Lactobacillus johnsonii, Lactobacillus delbrueckii, and combinations thereof.

[0026] In a preferred embodiment, the one or more probiotics is a combination of Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Lactobacillus gasseri, and Limosilactobacillus reuteri.

[0027] In an embodiment, the Bifidobacterium spp. strain is selected from the group consisting of Bifidobacterium lactis Bl-04, Bifidobacterium breve Bb-03, Bifidobacterium breve B-3 (MCC1274), Bifidobacterium bifidum Bb-06, Bifidobacterium longum Bl-05, Bifidobacterium animalis subsp. lactis 420, Bifidobacterium lactis CECT 8145, Bifidobacterium animalis subsp. lactis CP-9, Bifidobacterium animalis subsp. lactis BB-12® Bifidobacterium lactis HN019, Bifidobacterium bifidum W23, Bifidobacterium lactis W51, B. lactis W52, Bifidobacterium animalisssp. lactis 420 (B420), Bifidobacterium infantis 35624, and combinations thereof.

[0028] In an embodiment, the Lactobacillus spp. strain is selected from the group consisting of Lactobacillus gasseri Lg-36, Lactobacillus gasseri, SBT2055 (LG2055), Limosilactobacillus reuteri 1E1, Lactobacillus fermentum K7-Lb, Lactobacillus fermentum K8-Lb1, Lactobacillus fermentum K11-Lb3, Lactobacillus rhamnosus bv-77, Lactobacillus gasseri BNR17, Lactobacillus acidophilus LA-5, Lactobacillus acidophilus W37, Lactobacillus casei W56, Lactobacillus brevis W63, Lactobacillus salivarius W24, . Lactobacillus lactis W58 and Lactobacillus lactis W19, Lactobacillusrhamnosus GG (LGG®), Lactobacillus rhamnosus CGMCC1.372, Lactobacillus rhamnosus HN001, Lactobacillus casei Shirota, Lactobacillus delbrueckii subsp. Bulgaricus, Lactobacillus plantarum LMT1-48, Lactobacillus salivarius Ls-33, Lactobacillus reuteri DSM 17938, Lactobacillus reuteri NCIMB 30242 (Cardioviva™), Lactobacillus plantarum KY1032, Lactobacillus curvatus Lactobacillus amylovorus CP1563, HY7601, Lactobacillus plantarum 299v, Lactobacillus acidophilus NCFM®, and combinations thereof.

[0029] In an embodiment, the probiotic blend comprises at least a microorganism selected from the group consisting of Bifidobacterium lactis Bl-04, Bifidobacterium breve Bb-03, Bifidobacterium bifidum Bb-06, Bifidobacterium longum Bl-05, Lactobacillus gasseri Lg-36, and Limosilactobacillus reuteri 1E1, and combinations thereof.

[0030] In a preferred embodiment, the one or more probiotics is combination of Bifidobacterium lactis Bl-04, Bifidobacterium breve Bb-03, Bifidobacterium bifidum Bb-06, Bifidobacterium longum Bl-05, Lactobacillus gasseri Lg-36, and Limosilactobacillus reuteri 1E1.

[0031] In an embodiment, the prebiotic fiber is selected from the group consisting of Inulin, Fructooligosaccharides (FOS), Galactooligosaccharides (GOS), Galactomannans-based standardized fenugreek seeds extract (LMWGAL-TF), Wheat Dextrin, Maize Dextrin, Polydextrose, Isomalto-oligosaccharides (IMO), Gluco-oligosaccharides, Xylo- oligosaccharides (XOS), Gentio-oligosaccharides, Lactulose, Partially Hydrolyzed Guar Gum (PHGG), Resistant Dextrin, Acacia Fiber (Gum Arabic), and combinations thereof.

[0032] In an embodiment, the soluble fiber is selected from the group consisting of Psyllium Husk, Inulin, Beta-Glucan, Glucomannan, Flaxseed mucilage, Apple Fiber (pectin), Citrus Fiber (pectin), Chia Fiber (soluble component), Wheat Dextrin, Maize Dextrin, Polydextrose, Isomalto-oligosaccharides (IMO), Galactooligosaccharides (GOS), Gluco-oligosaccharides, Xylo-oligosaccharides (XOS), Gentio-oligosaccharides, Lactulose, Partially Hydrolyzed Guar Gum (PHGG), Pectin, Resistant Dextrin, Acacia Fiber (Gum Arabic), and combinations thereof.

[0033] In an embodiment, the insoluble fiber is selected from the group consisting of Chia Fiber (insoluble component), Citrus Fiber (insoluble component), Apple Fiber (insoluble component), Carrot Fiber, Cellulose, Lignin, Soya polysaccharides, Resistant Starch, and combinations thereof.

[0034] In an embodiment, the formulation further comprises at least one or more micronutrients. In an embodiment, the micronutrient is selected from the group consisting of chromium picolinate, L-carnitine-L-tartrate, Lactoferrin, Vitamin-D, Omega 3-fat, B-Complex Vitamins, Choline Bitartarate, Conjugated Linoleic Acid (CLA), Alpha-Lipoic Acid (ALA) and combinations thereof.

[0035] In an embodiment, the composition further comprises one or more botanicals selected from the group consisting of L-Carnitine, Curcumin, Capsaicin, Green Tea Extract, Meratrim®, Merastin, Green Coffee Extract, Garcinia Cambogia, Berberine, Coleus forskohlii Root Extract, Caffeine, Phaseolus vulgaris Extract, Apple Cider Vinegar Extract, Japanese Matcha Extract, Ginger Extract, Cinnamon Extract, Saffron Extract, Piperine, and combinations thereof.

[0036] In an embodiment, the formulation further comprises at least an acidity regulator and / or at least a flavor enhancer. In an embodiment, the at least one acidity regulator is selected from the group consisting of citric acid, and sodium citrate. In an embodiment, the at least oneflavor enhancer is selected from the group consisting of lemon flavor, orange, berry, and the like.

[0037] In a preferred embodiment, the formulation comprises (a) a probiotic blend comprising Bifidobacterium lactis Bl-04, Bifidobacterium breve Bb-03, Bifidobacterium bifidum Bb-06, Lactobacillus gasseri Lg-36, Bifidobacterium longum Bl-05, and Limosilactobacillus reuteri 1E1; (b) a prebiotic blend comprising glucomannan, resistant wheat dextrin, and fructooligosaccharides (FOS), inulin, and (c) micronutrients comprising chromium picolinate, and L-carnitine L-tartrate.

[0038] The present invention provides a dosage form of the formulation as substantially described in this description, wherein the dosage form is selected from the group consisting of powder, tablet, and capsule. In a preferred embodiment, the dosage form of the formulation is powder form.

[0039] In an embodiment, where the dosage form of the formulation is powder form, the one or more probiotics component is separate from the one or more prebiotics component.

[0040] In an embodiment, where the dosage form of the formulation is powder form, the one or more probiotics component is provided in one or more sachets. In a preferred embodiment, the one or more probiotics component of a single dosage of the formulation is provided in a single sachet. In an embodiment, the sachet comprising the one or more probiotics component further comprises at least a micronutrient.

[0041] In an embodiment, where the dosage form of the formulation is powder form, the one or more prebiotics component is provided in one or more sachets. In a preferred embodiment, the one or more prebiotics component of a single dosage of the formulation is provided in a single sachet. In an embodiment, the sachet comprising the one or more prebiotics component further comprises at least a micronutrient.

[0042] In a preferred embodiment, the powder dosage form comprises Bifidobacterium animalis subsp. Lactis BL-04; Lactobacillus gasseri Lg-36; Bifidobacterium longum Bl-05; Bifidobacterium bifidum Bb-06; Bifidobacterium breve Bb-03; Limosilactobacillus reuteri 1E1; L carnitine; Chromium picolinate; Fructooligosaccharides (FOS); Inulin; Glucomannan; and Wheat Dextrin.

[0043] The present invention provides a single dosage powder form of the formulation as substantially described in this specification. In an embodiment, a single dosage powder form of the formulation comprises 1-500 billion CFU of probiotics. in a preferred embodiment, a single dosage powder form of the formulation comprises 1-16 billion CFU of probiotics. In an embodiment, the ratio of CFU of a first probiotic to at least a second probiotic in a single dosage powder form of the formulation is in the range of 1:99 to 99:1.

[0044] In an embodiment, the one or more fibers in the single dosage powder form of the formulation is in the range of 0.5 gm to 10 gm. In a preferred embodiment, the range is 7- 8gm. In an embodiment, where the fiber component of the single dosage powder form of the formulation comprises glucomannan, glucomannan is present in an amount in the range of 1 gram to 2 gram. In an embodiment, where the fiber component of the single dosage powder form of the formulation comprises resistant wheat dextrin, resistant wheat dextrin is present in an amount in the range of 5 gram to 7 gram. In an embodiment, where the fiber component of the single dosage powder form of the formulation comprises fructooligosaccharide, fructooligosaccharide is present in an amount in the range of 0.3 gram to 2.5 gram. In an embodiment, where the fiber component of the single dosage powder form of the formulation comprises inulin, inulin is present in an amount in the range of 0.3 gram to 1 gram.

[0045] In an embodiment, the at least one or more micronutrients in the single dosage powder form of the formulation is present in an amount in the range of 50µg - 5000 mg. In an embodiment, the single dosage powder form of the formulation comprises chromium picolinate in an amount in the range of 200-500µg. In an embodiment, the single dosage powder form of the formulation comprises L-carnitine L-tartarate in an amount in the range of 500-1000mg.

[0046] In a preferred embodiment, the single dosage powder form of the formulation comprises Bifidobacterium animalis subsp. Lactis BL-04 in an amount of about 5 billion CFU; Lactobacillus gasseri Lg-36 in an amount of about 1 billion CFU; Bifidobacterium longum Bl-05 in an amount of about 1 billion CFU; Bifidobacterium bifidum Bb-06 in an amount of about 3 billion CFU; Bifidobacterium breve Bb-03 in an amount of about 5 billion CFU; Limosilactobacillus reuteri 1E1 in an amount of about 1 billion CFU; L carnitine in an amount of about 500mg; Chromium picolinate in an amount of about 400mcg; Fructooligosaccharides (FOS) in an amount of about 2.450g; Inulin in an amount of about 275mg; Glucomannan in an amount of 1g; and Wheat Dextrin in an amount of about 5g.

[0047] In an embodiment, the single dosage powder form of the formulation is comprised in a first sachet and a second sachet. The first sachet comprises Bifidobacterium animalis subsp. Lactis BL-04 in an amount of about 5 billion CFU; Lactobacillus gasseri Lg-36 in an amount of about 1 billion CFU; Bifidobacterium longum Bl-05 in an amount of about 1 billion CFU; Bifidobacterium bifidum Bb-06 in an amount of about 3 billion CFU; Bifidobacterium breve Bb-03 in an amount of about 5 billion CFU; Limosilactobacillus reuteri 1E1 in an amount of about 1 billion CFU; L carnitine in an amount of about 500mg; Chromium picolinate in an amount of about 200mcg; Fructooligosaccharides (FOS) in an amount of about 450mg; and Inulin in an amount of about 275mg. The second sachet comprises Glucomannan in an amountof about 1g; Chromium picolinate in an amount of about 200mcg; Wheat Dextrin in an amount of about 5g; and Fructooligosaccharides (FOS) in an amount of about 2g.

[0048] The present invention provides a kit comprising one or more of a single dosage powder form of a formulation as substantially described herein. In a preferred embodiment, the kit comprises a plurality of first sachets and a plurality of second sachets.

[0049] The present invention provides a method of weight management in a subject, said method comprising orally administering per day to the subject in need of weight management, one or more of a single dosage powder form of a formulation as substantially described herein. In a preferred embodiment, the subject is a human. In an embodiment, the subject is overweight. In an embodiment, the Body Mass Index of the subject is in the range of 25-29.9. In an embodiment, the Body Mass Index of the subject is in the range of 30-39.9. In an embodiment, the Body Mass Index of the subject is equal to or more than 40. In an embodiment, the subject is orally administered a single dose of the single dosage powder form of the formulation per day. In an embodiment, the subject is orally administered a plurality of the single dosage powder form of the formulation per day. In an embodiment, the single dosage powder form is mixed with water or any other liquid prior to administration. In an embodiment, the first and second sachet of the single dosage powder form of the formulation is administered preferably concurrently or in temporal proximity to each other. In an embodiment, the single dosage powder form of the formulation is orally administered prior to a meal, preferably before breakfast. In an embodiment, the single dosage powder form of the formulation can be orally administered any time during the day.

[0050] In an embodiment, weight management can be weight loss. In an embodiment, weight management can be inhibiting weight gain. In an embodiment, the said method of weight management effectuates weight loss of about 4-15% over a period of 1-3 months.

[0051] In an embodiment, weight loss is effectuated without calorie restriction. In an embodiment, weight loss is enhanced by calorie restriction.

[0052] The present invention provides a method of managing digestive health in a subject, said method comprising orally administering per day to the subject in need of digestive health management, one or more of a single dosage powder form of a formulation as substantially described herein. In an embodiment, managing digestive health is improving digestive health, which can be gut health.

[0053] The present invention provides a method of managing at least a health parameter in a subject, said method comprising orally administering per day to the subject in need of managing at least a health parameter, one or more of a single dosage powder form of a formulation as substantially described herein. In an embodiment, the health parametermanagement is reduction in triglyceride levels. In an embodiment, the health parameter management is reduction in cholesterol levels. In an embodiment, the health parameter management is reduction in blood glucose levels. In an embodiment, health parameter management is reduction in blood pressure levels. In an embodiment, the health parameter management is reduction in one or more of triglyceride levels, cholesterol levels, and blood glucose levels.

[0054] The present invention also provides use of the formulation, single dosage powder form, or kit as substantially described herein, for any one or more of, weight management in a subject, digestive health management in subject, and health parameters management in a subject.

[0055] Reference will be made to various embodiments of the invention, examples of which are illustrated. These examples are intended to be illustrative, not limiting. Although the invention is generally described in the context of these embodiments, it is understood that it is not intended to limit the scope of the invention to these embodiments. EXAMPLES Example 1

[0056] Table 1 below provides an exemplary example of the formulation of the present invention. A single dosage of the formulation is provided as 2 sachets, which are to be taken concurrently. Table 1 S. No. Ingredient Amount per single dosage Sachet 1 1 Bifidobacterium animalis subsp. Lactis BL-04 5 Billion CFU 2 Lactobacillus gasseri Lg-36 1 Billion CFU 3 Bifidobacterium longum Bl-05 1 Billion CFU 4 Bifidobacterium bifidum Bb-06 3 Billion CFU 5 Bifidobacterium breve Bb-03 5 Billion CFU 6 Limosilactobacillus reuteri 1E1 1 Billion CFU 7 L carnitine 500mg 8 Chromium picolinate 200mcg 9 Fructooligosaccharides (FOS) 450mg 10 Inulin 275mg 11 Citric acid 30 mg 12 Magnesium Stearate 5 mg 13 Lemon flavour 100 mg 14 Steviol glycosides 5 mg Sachet 2 15 Glucomannan 1g 16 Chromium picolinate 200mcgS. No. Ingredient Amount per single dosage 17 Wheat Dextrin 5g 18 Fructooligosaccharides (FOS) 2g Source of probiotics and prebiotics

[0057] The probiotics were obtained from DuPont Nutrition Biosciences ApS (DuPont™ Danisco®) DSMZ Deposit; DuPont Nutrition & Health, Edwin Rahrs Vej 38, DK-8220 Braband, Denmark.

[0058] L carnitine L tartate chemical grade was obtained from Aditya Chemicals, President Plaza, Nr. Thaltej Cross Road, S.G. Highway, Ahmedabad, India.

[0059] FOS was obtained from Tata Chemicals Ltd., Mambattu, Andhra Pradesh, India.

[0060] Inulin was obtained from Rue Louis Marechal 1 Oreye, WLG B-4360, Belgium.

[0061] Glucomannan was obtained from Shaanxi Belen Biotechnology Co., Ltd., Qujiang, New District, Xi’an, Shaanxi, China.

[0062] Resistant Dextrin was obtained from Route de Rhin CS 20004, 67930 Beinheim, France.

[0063] Chromium picolinate was obtained from Salvi Chemicals, Western Urban Rd., H.W. Borivali East, Mumbai Maharashtra, India. Example 2

[0064] The following table 2 shows a comparative study of efficacy of the formulation of the present invention as regards to weight loss compared to pharmaceutical interventions. Table 2 Formulation Comparator 1 Comparator of present (Wegovy® / Ozempic® 2 invention (Semaglutide) (Mounjaro® (Tirzepatide) % Weight loss 12% ~15% ~17% Regimen no calorie 500kcal daily calorie 500kcal daily deficit deficit calorie deficit Duration 12 weeks 68 weeks 72 weeks Dosage form Oral Injectable Injectable

[0065] It can be appreciated from the table 2 above that the formulation of the present invention is clearly superior than pharmaceutical alternatives known in the art. As seen above, the formulation of the present invention can achieve 12% weight loss in 12 weeks, which issignificantly less time than semaglutide (Phillips, Anna, and Jennifer N. Clements. "Clinical review of subcutaneous semaglutide for obesity." Journal of clinical pharmacy and therapeutics 47.2 (2022): 184-193) or tirzepatide (Chavda, Vivek P., et al. "Tirzepatide, a new era of dual-targeted treatment for diabetes and obesity: a mini-review." Molecules 27.13 (2022): 4315). Example 3: Clinical Trials Study

[0066] Briefly, the efficacy of the formulation of the present invention was conducted by designing a randomized, double-blind, placebo-controlled, parallel-arm, comparative, multicentric clinical study. The study was conducted over a period of 90 days.

[0067] Male and female participants of 30-45 years of age, with class I obesity (BMI between ≥30 and <35) and class II obesity (BMI between ≥35 and <40) were included. The participants also had at least three of the following indications of metabolic syndrome, namely: Serum triglycerides: ≥ 150 mg / dL HDL cholesterol: ≤ 40 mg / dL in men, ≤ 50 mg / dL in women Blood pressure: ≥ 130 mmHg systolic or ≥ 85 mmHg diastolic Fasting plasma glucose ≥ 100 mg / dL Abdominal obesity, waist circumference: Men >90 cm; Women > 80 cm.

[0068] The primary efficacy assessment involved evaluating changes in anthropometric parameters including body weight(kg), basal metabolic rate (BMR), BMI, waist and hip circumference, along with skeletal muscle mass and body fat percentage using bioelectric impedance analysis (BIA) at screening, and at day 30, 60, and end of the study.

[0069] The secondary efficacy assessment was done by evaluating changes in biochemical parameters such as HbA1c, fasting plasma glucose, post-prandial plasma glucose and lipid profile (total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol) assessed at screening and the end of the study.

[0070] Assessment of changes in digestive health symptoms such as acidity, bloating, bowel movements, cravings, hunger and satiety as per self-assessment questionnaire score using a 4-point ordinal scale and 11-point numerical rating scale at screening, day 30, 60, and end of the study.

[0071] Assessment of change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite) score at screening and end of the study.

[0072] Assessment of change in Perceived stress scale-10 (PSS-10) score, Metabolic Syndrome Severity Z Score (MetS-Z score) and Thyroid stimulating hormone (TSH) at screening, and end of the study.

[0073] Assessment of Clinical global impression-improvement scale score at the end of the study. Body Weight

[0074] The change in body weight over time showed a significant reduction in both groups (test and placebo). At baseline, the mean body weights were comparable. By Day 30, the test group had lost an average of 4.15 kg, significantly more than Placebo group’s 0.90 kg. The trend persisted at Day 60, with Test group losing 6.86 kg versus 1.78 kg in Placebo group. By Day 90, Test group had achieved a substantial 10.31 kg reduction, far exceeding Placebo group’s 3.01 kg loss. Within-group comparisons at each time point confirmed highly significant weight reductions (Table 3 below). Table 3: Assessment of reduction in weight between groups Weight (Kg) Visits Test Group Placebo Group(BePtweveanlguroeups) Baseline 85.85 ± 10.77 85.32 ± 9.42 0.792 Day 30 81.69 ±10.45 84.43±9.21 (4.84%) 4.15kg (1.05%) 0.90kg <0.001 P value <0.001 <0.001 Day 60 78.99 ±10.47 83.55±8.93 (7.99%) 6.86kg (2.08%) 1.78kg <0.001 P value <0.001 <0.001 Day 90 75.54 ± 11.12 82.32 ± 9.40 (12.01%) 10.31kg (3.52%) 3.01kg <0.001 P value <0.001 <0.001

[0075] Data is represented as Mean ± S.D (percent change). The data was analysed within a group using Student t test-dependent and between groups by using student t independent. Significant at p-value <0.05. Body Mass Index

[0076] The BMI analysis revealed significant reductions in Test group compared to Placebo group across all visits. At baseline, both groups had comparable BMI values. By Day 30, Test group showed a 4.85% reduction, while Placebo group experienced a modest 1.03% reduction. On Day 60, BMI reductions reached 8.04% in Test group compared to 2.05% in Placebo group. By Day 90, Test group achieved a 12.14% reduction, markedly higher than the 3.53% reduction observed in Placebo group. The mean BMI differences from baseline wereconsistently and significantly greater in Test group at all-time points, demonstrating the superior efficacy of Test group in reducing BMI compared to Placebo group (Table 4 below). Table 4 BMI (kg / m2) Visits Test Group Placebo GroupP valueBaseline 33.21 ± 2.85 33.31 ± 2.84(Betw0ee.n8g5r7oups)Day 30 31.60 ± 2.73 32.97 ± 2.85 (4.85%)1.61 (1.03%) 0.34 <0.001 P value <0.001 <0.001 Day 60 30.54 ± 2.68 32.63 ± 2.76 (8.04%) 2.67 (2.05%) 0.68 <0.001 P value <0.001 <0.001 Day 90 29.18 ± 3.08 32.13± 2.88 (12.14%) 4.03 (3.53%) 1.18 <0.001 P value <0.001 <0.001

[0077] Data is represented as Mean ± S.D (percent change) Difference. The data was analysed for within group by using Student T dependent test and Wilcoxon Signed-Rank Test and between group by using Mann-Whitney U Test and Student T independent test significant at <0.05. Waist Circumference

[0078] Waist circumference reductions were gradual and significantly greater in Test group than in Placebo group across all time points. At baseline, both groups had comparable mean waist circumferences. By Day 30, Test group showed a 3.69% (3.89 cm) reduction, while Placebo group experienced a minimal 0.32% (0.33 cm) decrease. The trend continued at Day 60, with Test group achieving a 6.92% (7.29 cm) reduction compared to 1.59% (1.62 cm) in Placebo group. By Day 90, Test group demonstrated a substantial 9.64% (10.16 cm) reduction, significantly exceeding the 2.74% (2.79 cm) decrease in Placebo group. The mean differences from baseline were consistently significant, highlighting the superior effectiveness of Test group in reducing waist circumference over time (Table 5 below). Table 5 Waist Circumference (cm) Visits Test Group Placebo Group P value (Between groups) Baseline 105.40 ± 11.14 102.02 ± 9.05 0.093 Day 30 101.52±10.89 101.69±8.89 (3.69%) 3.89cm (0.32%) 0.33cm <0.001 P value <0.001 0.033 Day 60 98.11 ± 10.87 100.40±8.99 <0.001(6.92%) 7.29cm (1.59%) 1.62cm P value <0.001 <0.001 Day 90 95.25 ± 10.75 99.22±8.59 (9.64%) 10.16cm (2.74%) 2.79cm <0.001 P value <0.001 <0.001

[0079] Data is represented as Mean ± S.D (percent change). The data was analysed within groups by using Student t test-dependent means and between groups by using the student t independent test. Significant at p-value <0.05. Hip Circumference

[0080] Hip circumference reductions were gradual and significantly greater in Test group than in Placebo group at all time points. Both groups had comparable baseline values. By Day 30, Test group showed a 4.10% reduction, while Placebo group had a minimal 0.19% decrease. The trend persisted at Day 60, with reductions of 7.24% in Test group and 1.09% in Placebo group. By Day 90, Test group achieved a substantial 9.63% reduction, significantly exceeding the 2.86% decrease in Placebo group. The mean differences from baseline were consistently significant, demonstrating the superior efficacy of Test group in reducing hip circumference over time (Table 6 below). Table 6 Hip Circumference (cm) Visits Test Group Placebo Group P value (Between groups) Baseline 108.80 ± 12.93 106.58 ± 9.42 0.509 Day 30 104.34 ± 12.49 (4.10%) 106.38 ± 9.49 (0.19%) 4.47 cm 0.20 cm <0.001 P value <0.001 0.079 Day 60 100.93 ± 12.58 (7.24%) 105.42 ± 9.59 (1.09%) 7.88 cm 1.16 cm <0.001 P value <0.001 <0.001 Day 90 98.32 ± 12.57 (9.63%) 103.54 ± 9.67 (2.86%) 10.48 cm 3.04 cm P value <0.001 <0.001 <0.001

[0081] Data is represented as Mean ± S.D (percent change) Difference. The data was analysed for within group by using Student T dependent test and Wilcoxon Signed-Rank Test and between group by using Mann-Whitney U Test significant at <0.05. Basal metabolic rate

[0082] Basal metabolic rate represents the energy expenditure required to maintain basic physiological functions at rest and is typically calculated using predictive equations based on age, sex, weight, and height. In the context of this weight management trial, a reduction in BMR reflects a decline in energy expenditure, which may be a physiological adaptation to weight loss. While a gradual decrease in BMR is expected with weight reduction.

[0083] Males: Among males, the test and placebo groups had comparable BMR values at baseline. By Day 30, the test group exhibited a 2.14% reduction, while the placebo group showed a minimal 0.63% decrease. The trend continued at Day 60, with the test group demonstrating a 3.51% reduction compared to 1.25% in the placebo group. By Day 90, the test group achieved a significant 5.23% decrease in BMR, whereas the placebo group showed a modest 1.65% decline. The between-group differences were statistically significant at all time points, indicating a greater reduction in BMR in the test group.

[0084] Females: A similar pattern was observed among females, with both groups showing comparable BMR values at baseline. By Day 30, the test group exhibited a 2.01% reduction, while the placebo group showed a marginal 0.29% decrease. By Day 60, the test group experienced a 3.34% decline in BMR, significantly greater than the 0.57% reduction in the placebo group. The trend persisted through Day 90, with the test group demonstrating a 5.02% decrease compared to a 1.38% reduction in the placebo group. The between-group differences were statistically significant at all time points, reinforcing the greater decline in BMR observed in the test group.

[0085] Overall, the test group exhibited a more pronounced and statistically significant reduction in BMR over time in both males and females compared to the placebo group. While a gradual decrease in BMR is expected with weight loss and are still within expected physiological ranges for weight loss (Table 7 below). Table 7 Basal Metabolic Rate (kcal / day) Visits Test Group Placebo Group P value (Between groups) Male Baseline 1891.68±134.61 1857.81 ± 107.51 0.339 Day 30 1851.11±135.30 1846.11±108.91 (2.14%) (0.63%) <0.001 P value <0.001 <0.001 - Day 60 1825.31±138.92 1834.65±109.19 (3.51%) (1.25%) <0.001 P value <0.001 <0.001 - Day 90 1792.75±135.37 1827.20±106.43 (5.23%) (1.65%) <0.001P value <0.001 <0.001 - Female Baseline 1513.14±104.46 1518.74±98.10 0.838 Day 30 1482.76 ± 99.85 1514.34±94.85 (2.01%) (0.29%) <0.001 P value <0.001 0.003 Day 60 1462.63 ± 97.99 1510.03±92.60 (3.34%) (0.57%) <0.001 P value <0.001 <0.001 Day 90 1437.20±108.22 1497.73±99.07 (5.02%) (1.38%) <0.001 P value <0.001 <0.001

[0086] Data is represented as Mean ± S.D (percent change). The data was analysed within a group using the Student t-test dependent means and between groups using the Student t-independent test. Significant at p-value <0.05. Skeletal muscle mass

[0087] Skeletal muscle mass percentage, assessed using bioelectrical impedance analysis, increased significantly over time in both groups, with a more pronounced gain in the test group. At baseline, skeletal muscle mass percentages were comparable between groups. By Day 30, the test group showed a 0.85% increase, while the placebo group experienced a 1.83% gain. By Day 60, skeletal muscle mass increased by 5.31% in the test group compared to 2.73% in the placebo group. The trend continued through Day 90, with the test group achieving an 8.27% increase, significantly surpassing the 5.10% gain in the placebo group. The mean differences from baseline were statistically significant at all time points, demonstrating the superior efficacy of the test intervention in enhancing skeletal muscle mass compared to the placebo (Table 8 below). Table 8 Visits TestSgkreoleutpal MPulsaccleeb(%o g)roup(BePtwveeanlguroeup)Baseline 33.99 ± 8.74 33.61 ± 3.81 0.430 Day 30 34.28 ± 8.12 34.22 ± 4.67 0.009 (0.85%) (1.83%) P value 0.447 0.298 Day 60 35.80 ± 7.68 34.53 ± 4.73 0.002 (5.31%) (2.73%) P value 0.038 0.009 Day 90 36.81 ± 7.73 35.33 ± 4.88 0.009 (8.27%) (5.10%) P value 0.013 <0.001

[0088] Data is represented as Mean ± S.D (percent change). The data was analysed for within group by using Wilcoxon Signed-Rank Test and between group by using Mann-Whitney U Test significant at <0.05. Body Fat (%)

[0089] The assessment of body fat percentage evaluated using bioelectrical impedance analysis, revealed a gradual and pronounced reduction in Test group compared to Placebo group across all visits. At baseline, the body fat percentages was comparable between the groups. By Day 30, Test group demonstrated an 11.13% reduction, while Placebo group exhibited a modest 2.88% decrease. On Day 60, the reduction in Test group reached 20.64%, significantly surpassing the 5.04% reduction in Placebo group. By Day 90, Test group achieved a 26.73% reduction, compared to a 7.50% decrease in Placebo group. The mean differences in body fat percentage from baseline were statistically significant and consistently more pronounced in Test group across all time points, underscoring the superior efficacy of the test intervention in reducing body fat (Table 9 below). Table 9 VisitsBody Fat (%)P vroup(BetwalueTest group Placebo geen group)Baseline 41.57 ± 6.00 40.88 ± 4.71 0.520 Day 30 36.94 ± 5.83 39.71 ± 4.59 <0.001 (11.13%) (2.88%) P value <0.001 0.002 Day 60 32.99 ± 5.45 38.82 ± 4.73 <0.001 (20.64%) (5.04%) P value <0.001 <0.001 Day 90 30.46 ± 5.15 37.82 ± 4.82 <0.001 (26.73%) (7.50%) P value <0.001 <0.001

[0090] Data is represented as Mean ± S.D (percent change). The data was analysed within groups using Student t test-dependent means and between groups by using student t independent test. Significant at p-value <0.05. Assessment of MetS-Zscore

[0091] The Metabolic Syndrome (MetS-Z) score is a composite measure of key metabolic parameters (waist circumference, triglycerides, HDL cholesterol, systolic blood pressure, and fasting plasma glucose), where a lower score indicates improved metabolic health.

[0092] At screening, the Test group had a significantly higher MetZ score (1.60 ± 0.42) than the Placebo group (1.35 ± 0.38). By Day 90, the Test group showed a substantial 54.02% reduction, while the Placebo group exhibited a modest 18.88% decrease. The between-group analysis at Day 90 confirmed a significantly greater improvement in the Test group, highlighting the intervention’s efficacy in enhancing metabolic health compared to the Placebo (Table 14). Table 14 Test Group Placebo Group P value (between) Visits Screening Day 90 Screening Day 90 Screening Day 90 MetZ Score 1.60 ± 0.42 0.73 ± 0.32 1.35 ± 0.38 1.09 ± 0.45 0.002 <0.001 (54.02%) (18.88%) P value <0.001 <0.001 - - (within)

[0093] Data is represented as Mean ± S.D (percent change). The data was analysed for within groups using Student t test dependent means and between groups using student t independent test. Significant at p value <0.05.

[0094] In order to ascertain the efficacy of the claimed formulation of the present invention, the effect of probiotic blend alone, and fiber blend alone on weight loss and at least a health- related parameter was also evaluated. It is to be noted that the probiotic blend alone, and fiber blend alone is as per Table 1.

[0095] For a test group administered the probiotic blend alone, after 30 days, a <0.5% change in weight (reduction) was observed, specifically 0.34%. For a teste group administered the fiber blend alone, after 30 days, <0.5% change in weight (reduction) was observed, specifically 0.30%.

[0096] In the group administered the probiotic blend alone, after 30 days a 4.50% reduction in waist circumference was observed, while in the group administered the fiber blend alone, a 4.30% reduction in waist circumference was observed.

[0097] In the group administered the probiotic blend alone or the fiber blend alone, after 30 days, in both cases, a 1.20% reduction in hip circumference was observed.

[0098] It can be appreciated from the results above that administration of the formulation of the present invention results in a 4.84% weight loss (see Table 3) as compared to 0.34% when the probiotic blend is administered alone, or 0.30% when the fiber blend is administered alone. In fact, the weight loss observed for administration of probiotic blend alone or fiber blend alone is even less than the weight loss observed in the placebo group (see Table 3), which clearly establishes that the effect of the probiotic blend alone or fiber blend alone is not significant.These data clearly establish the unexpected and surprising synergistic effect of the claimed formulation of the present invention.

[0099] While there was no meaningful significant difference in reduction in waist circumference between formulation treatment (see Table 5) and treatment with probiotic blend alone or fiber 5 blend alone, however, with regard to hip circumference reduction (see Table 6), there is a 4.10% reduction in hip circumference after 30 days upon treatment with the formulation of the present invention. In contrast, when treated with probiotic blend alone or fiber blend alone, the reduction was only 1.20%. These data clearly establish the unexpected and surprising synergistic effect of the claimed formulation of the present invention. 10

Claims

I / We claim:

1. A formulation, said formulation comprising: a. a probiotic blend comprising at least a microorganism selected from the group consisting of Bifidobacterium spp., Lactobacillus spp., Lactococcus spp., Streptococcus spp., Bacillus spp., Saccharomyces spp., Akkermansia spp., Anaerobutyricum spp., Faecalibacterium spp., Roseburia spp., Christensenella spp., Clostridium spp., and combinations thereof; and b. a fiber blend comprising at least a fiber selected from the group consisting of prebiotic fibers, soluble fibers, insoluble fibers, and combinations thereof.

2. The formulation as claimed in claim 1, wherein the probiotic blend comprises at least a microorganism selected from the group consisting of Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Lactobacillus gasseri, and Limosilactobacillus reuteri, and combinations thereof.

3. The formulation as claimed in claim 1, wherein the probiotic blend comprises at least a microorganism selected from the group consisting of Bifidobacterium lactis Bl-04, Bifidobacterium breve Bb-03, Bifidobacterium bifidum Bb-06, Bifidobacterium longum Bl-05, Lactobacillus gasseri Lg-36, and Limosilactobacillus reuteri 1E1, and combinations thereof.

4. The formulation as claimed in claim 1, wherein the prebiotic fiber is selected from the group consisting of Inulin, Fructooligosaccharides (FOS), Galactooligosaccharides (GOS), Galactomannans-based standardized fenugreek seeds extract (LMWGAL-TF), Wheat Dextrin, Maize Dextrin, Polydextrose, Isomalto-oligosaccharides (IMO), Gluco- oligosaccharides, Xylo-oligosaccharides (XOS), Gentio-oligosaccharides, Lactulose, Partially Hydrolyzed Guar Gum (PHGG), Resistant Dextrin, Acacia Fiber (Gum Arabic), and combinations thereof.

5. The formulation as claimed in claim 1, wherein the soluble fiber is selected from the group consisting of Psyllium Husk, Inulin, Beta-Glucan, Glucomannan, Flaxseed mucilage, Apple Fiber (pectin), Citrus Fiber (pectin), Chia Fiber (soluble component), Wheat Dextrin, Maize Dextrin, Polydextrose, Isomalto-oligosaccharides (IMO), Galactooligosaccharides (GOS), Gluco-oligosaccharides, Xylo-oligosaccharides (XOS), Gentio-oligosaccharides, Lactulose,Partially Hydrolyzed Guar Gum (PHGG), Pectin, Resistant Dextrin, Acacia Fiber (Gum Arabic), and combinations thereof.

6. The formulation as claimed in claim 1, wherein the insoluble fiber is selected from the group consisting of Chia Fiber, Citrus Fiber, Apple Fiber, Carrot Fiber, Cellulose, Lignin, Soya polysaccharides, Resistant Starch, and combinations thereof.

7. The formulation as claimed in claim 1, comprising at least a micronutrient selected from the group consisting of chromium picolinate, L-carnitine-L-tartrate, Lactoferrin, Vitamin-D, Omega 3-fat, B-Complex Vitamins, Choline Bitartarate, Conjugated Linoleic Acid (CLA), Alpha-Lipoic Acid (ALA) and combinations thereof.

8. The formulation as claimed in claim 1, comprising at least a botanical selected from the group consisting of L-Carnitine, Curcumin, Capsaicin, Green Tea Extract, Meratrim®, Merastin, Green Coffee Extract, Garcinia Cambogia, Berberine, Coleus forskohlii Root Extract, Caffeine, Phaseolus vulgaris Extract, Apple Cider Vinegar Extract, Japanese Matcha Extract, Ginger Extract, Cinnamon Extract, Saffron Extract, Piperine, and combinations thereof.

9. The formulation as claimed in claim 1, comprising at least one of: a. at least an acidity regulator; and b. at least a flavoring agent.

10. The formulation as claimed in claim 1, comprising (a) a probiotic blend comprising Bifidobacterium lactis Bl-04, Bifidobacterium breve Bb-03, Bifidobacterium bifidum Bb-06, Lactobacillus gasseri Lg-36, Bifidobacterium longum Bl-05, and Limosilactobacillus reuteri 1E1; (b) a prebiotic blend comprising glucomannan, resistant wheat dextrin, and fructooligosaccharides (FOS), inulin, and (c) micronutrients comprising chromium picolinate, and L-carnitine L-tartrate.

11. A dosage form of a formulation as claimed in claim 1, wherein said dosage form dosage form is selected from the group consisting of powder, tablet, and capsule, preferably powder form.

12. The dosage form as claimed in claim 11, comprising: a. Bifidobacterium animalis subsp. Lactis BL-04; b. Lactobacillus gasseri Lg-36;c. Bifidobacterium longum Bl-05; d. Bifidobacterium bifidum Bb-06; e. Bifidobacterium breve Bb-03; f. Limosilactobacillus reuteri 1E1; g. L carnitine; h. Chromium picolinate; i. Fructooligosaccharides (FOS); j. Inulin; k. Glucomannan; and l. Wheat Dextrin.

13. A single dosage powder form of the formulation as claimed in claim 1, comprising: a. Bifidobacterium animalis subsp. Lactis BL-04 in an amount of about 5 billion CFU; b. Lactobacillus gasseri Lg-36 in an amount of about 1 billion CFU; c. Bifidobacterium longum Bl-05 in an amount of about 1 billion CFU; d. Bifidobacterium bifidum Bb-06 in an amount of about 3 billion CFU; e. Bifidobacterium breve Bb-03 in an amount of about 5 billion CFU; f. Limosilactobacillus reuteri 1E1 in an amount of about 1 billion CFU; g. L carnitine in an amount of about 500mg; h. Chromium picolinate in an amount of about 400mcg; i. Fructooligosaccharides (FOS) in an amount of about 2.450g; j. Inulin in an amount of about 275mg; k. Glucomannan in an amount of about 1g; and l. Wheat Dextrin in an amount of about 5g.

14. The single dosage powder form as claimed in claim 13, wherein the single dosage consists of a first sachet and a second sachet, the first sachet comprising: Bifidobacterium animalis subsp. Lactis BL-04 in an amount of about 5 billion CFU; Lactobacillus gasseri Lg-36 in an amount of about 1 billion CFU; Bifidobacterium longum Bl-05 in an amount of about 1 billion CFU; Bifidobacterium bifidum Bb-06 in an amount of about 3 billion CFU; Bifidobacterium breve Bb-03 in an amount of about 5 billion CFU; Limosilactobacillus reuteri 1E1 in an amount of about 1 billion CFU; L carnitine in an amount of about 500mg; Chromium picolinate in an amount of about 200mcg; Fructooligosaccharides (FOS) in an amount of about 450mg; and Inulin in an amount of about 275mg; the second sachet comprising: Glucomannan in anamount of about 1g; Chromium picolinate in an amount of about 200mcg; Wheat Dextrin in an amount of about 5g; and Fructooligosaccharides (FOS) in an amount of about 2g.

15. The single dosage powder form as claimed in claim 13, comprising 1-500 billion CFU of probiotics, preferably 1-16 billion CFU of probiotics.

16. The single dosage powder form as claimed in claim 13, wherein fiber blend is present in a range of 0.5-10g, preferably in the range of 7-8g.

17. The single dosage powder form as claimed in claim 13, wherein at least a micronutrient is present in a range of 50-5000µg.

18. A kit comprising one or more of a dosage form as claimed in claim 11, or one or more of a single dosage powder form as claimed in claim 13.

19. A method of weight management in a subject, comprising orally administering to the subject in need of weight management, one or more of a dosage form as claimed in claim 11, or one or more of a single dosage powder form as claimed in claim 13.

20. A method of managing digestive health of a subject, comprising orally administering to the subject in need of digestive health management, one or more of a dosage form as claimed in claim 11, or one or more of a single dosage powder form as claimed in claim 13.

21. A method of managing at least a health parameter of a subject, comprising orally administering to a subject in need of health parameter management, one or more of a dosage form as claimed in claim 11, or one or more of a single dosage powder form as claimed in claim 13.

22. A formulation as claimed in claim 1, a dosage form as claim in claim 11, a single dosage powder form as claimed in claim 13, or a kit as claimed in claim 18, for use in any one or more of weight management in a subject, digestive health management in subject, and health parameters management in a subject.