Synergistic nutraceutical composition to improve cardio-metabolic health

Abstract

The present invention pertains to the field of nutraceuticals, specifically to a synergistic nutraceutical composition designed to improve cardio-metabolic health. The composition, comprising berberine, anthocyanin(s), and astaxanthin, is intended to regulate aberrant metabolic biomarkers, including hyperglycemia, hypertriglyceridemia, elevated low-density lipoprotein (LDL) cholesterol, increased blood pressure, enhanced platelet aggregation, elevated serum transaminase activity and hypoadiponectinemia. This invention is particularly applicable to the therapeutic management of cardiometabolic pathologies, including Type 2 Diabetes Mellitus (T2DM), arterial hypertension, dyslipidemia, atherosclerosis, obesity, metabolic syndrome, non-alcoholic fatty liver disease (NAFLD), cerebrovascular accidents (stroke), and coronary artery disease, through the modulation of systemic metabolic homeostasis and by providing potential adjunctive efficacy alongside established pharmacotherapeutic regimens.

Description

[0001] SYNERGISTIC NUTRACEUTICAL COMPOSITION TO IMPROVE CARDIO-METABOLIC HEALTH

[0002] RELATED APPLICATION:

[0003] The present application claims benefit of the Indian Provisional Application No. IN202421066042 filed on, August 31st, 2024 the entire contents of which are hereby incorporated by reference.

[0004] FIELD OF THE INVENTION

[0005] The present invention pertains to the field of nutraceuticals, specifically to a synergistic nutraceutical composition designed to improve cardio-metabolic health. This composition, comprising berberine, anthocyanin(s), and astaxanthin, is intended to regulate aberrant metabolic biomarkers, including hyperglycemia, hypertriglyceridemia, elevated low-density lipoprotein (LDL) cholesterol, increased blood pressure, enhanced platelet aggregation, elevated serum transaminase activity and hypoadiponectinemia. This invention is particularly applicable to the therapeutic management of cardiometabolic pathologies, including Type 2 Diabetes Mellitus (T2DM), arterial hypertension, dyslipidemia, atherosclerosis, obesity, metabolic syndrome, non-alcoholic fatty liver disease (NAFLD), cerebrovascular accidents (stroke), and coronary artery disease, through the modulation of systemic metabolic homeostasis and by providing potential adjunctive efficacy alongside established pharmacotherapeutic regimens.

[0006] BACKGROUND OF THE INVENTION

[0007] Cardiometabolic health is an integrative assessment of cardiovascular and metabolic function, encompassing parameters such as blood glucose levels, lipid profiles, and blood pressure. Optimal cardiometabolic function is critical for the preservation of systemic physiological homeostasis and the prevention of chronic pathologies, including cardiovascular disease (CVD), Type 2 Diabetes Mellitus (T2DM), and metabolic syndrome. Cardiometabolic disorders represent a primary source of global morbidity and mortality, exacerbated by etiological factors including poor nutritional intake, physical inactivity, and genetic susceptibility.

[0008] Metabolic health is characterized by the maintenance of homeostatic levels of blood glucose, triglycerides, high-density lipoprotein (HDL) cholesterol, blood pressure, and waist circumference, without the requirement for pharmacological intervention. Optimal metabolic health mitigates the risk of developing metabolic disorders, which can substantially impair physiological function and increase the likelihood of adverse health outcomes, including chronic diseases.

[0009] Characteristics of Metabolic Health

[0010] 1. Glucose Levels: Maintaining normoglycemia as indicated by normal fasting plasma glucose levels is essential for preventing the onset of insulin resistance and the subsequent development of Type 2 diabetes mellitus.

[0011] 2. Lipid Profiles: Maintaining optimal concentrations of low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides is critical for mitigating the risk of atherosclerotic plaque formation and subsequent cardiovascular pathologies. 3. Blood Pressure: Maintaining optimal blood pressure parameters is essential for preventing the onset of hypertension, a primary etiological factor in the development of cardiovascular diseases.

[0012] Metabolic disorders manifest when the body’s homeostatic metabolic processes are impaired, frequently resulting from dysregulated biochemical pathways. Some of the most prevalent metabolic disorders include:

[0013] 1. Dyslipidemia: Characterized by abnormal lipid concentrations in the bloodstream, which potentiates the risk of atherosclerotic cardiovascular diseases.

[0014] 2. Obesity: Excess adiposity, which adversely affects metabolic homeostasis, is frequently associated with the pathogenesis of comorbid conditions such as Type 2 Diabetes Mellitus (T2DM) and cardiovascular diseases. 3. Type 2 Diabetes Mellitus (T2DM): A chronic metabolic disorder that impairs glucose homeostasis, resulting in sustained hyperglycemia.

[0015] 4. Metabolic Syndrome: It refers to a constellation of interrelated metabolic and cardiovascular risk factors that coexist, significantly elevating the likelihood of atherosclerotic cardiovascular disease, cerebrovascular events, and Type 2 Diabetes Mellitus (T2DM).

[0016] Metabolic disorders, including dyslipidemia, obesity, and Type 2 Diabetes Mellitus (T2DM), have become progressively more prevalent, driven by a complex interplay of genetic predisposition and environmental factors, particularly those related to lifestyle. Principal determinants in the pathogenesis and progression of these metabolic disorders include physical inactivity, excessive caloric intake, and genetic susceptibility, which collectively disrupt metabolic homeostasis.

[0017] A sedentary lifestyle, characterized by insufficient physical activity, contributes to adiposity, insulin resistance, and dysregulated metabolic function, exacerbating overall metabolic dysfunction.. Chronic physical inactivity induces disturbances in glucose homeostasis and lipid metabolism, thereby exacerbating the risk of developing metabolic syndrome and associated comorbidities.

[0018] Excessive nutrient intake, particularly the overconsumption of calories from unhealthy dietary sources, contributes to obesity and disrupts metabolic homeostasis. Diets characterized by excessive intake of refined sugars, trans fatty acids, and ultra-processed foods exacerbate metabolic dysregulation and facilitate the onset of associated pathological conditions.

[0019] Genetic predisposition significantly influences an individual's susceptibility to metabolic disorders by modulating key physiological pathways involved in metabolic homeostasis and insulin sensitivity. Inherited genetic variations can modulate insulin sensitivity, lipid metabolism, and adipose tissue distribution, thereby augmenting the risk of developing metabolic disorders, even in the presence of moderate environmental and lifestyle risk factors. Nutraceuticals are bioactive compounds derived from food sources that confer therapeutic effects and health benefits beyond their basic nutritional contributions. They play a significant role in improving metabolic health by delivering bioactive compounds that improve key metabolic parameters.

[0020] CN 1526409 discloses a composition of essential fatty acid, composite vitamins, carnitine and nucleic acid; and the composition is used as the material for producing food products, especially slimming food, as well as beverage, seasoning, health article, cosmetics, medicine, etc. The composition can eliminate alcohol harm fast and radically, reduce cholesterol, saturated fatty acid and fat stored in body, reduce weight without rebound, and prevent and treat fatty liver, diabetes, cardiac and cerebral vascular diseases.

[0021] EP2019720 describes the use of complex organic compounds for treating muscular disorders, improving muscle function, and addressing lipid metabolism and glucose issues. The compounds aim to enhance physical performance, prevent muscle loss, and improve body shape in mammals, including humans. This patent faces limitations due to the complexity of its organic compounds, which involve intricate and costly synthesis processes, reducing accessibility.

[0022] W02005032559 claims novel compounds including polyphenol and flavonoid that donate nitric oxide and scavenge free radicals, inducing ApoAl expression to increase HDL and reduce cholesterol levels. These compounds aim to address endothelial dysfunction, vascular oxidative stress, and hyperlipidemia in cardiovascular disorders. Formulation of this patent is limited by the low bioavailability of polyphenols and flavonoids, potentially reducing their therapeutic efficacy. The patent focuses narrowly on nitric oxide donation and free radical scavenging, which do not address all underlying mechanisms of cardiovascular disorders. CN1443562 provides a dual-purpose product for preventing and treating SARS, respiratory diseases, and obesity. It combines Chinese-medicinal materials, vitamins, trace elements, and nucleotides to enhance immunity and overall health, offering a safe approach to weight reduction.

[0023] There remains a growing need for safe and effective approaches to manage these complex conditions, particularly through preventive and adjunctive therapies that support overall metabolic health.

[0024] Effective management of metabolic health typically involves a multi-pronged approach including lifestyle modifications, pharmacological interventions, and the use of nutraceuticals. Lifestyle interventions may involve adopting a balanced diet, increasing physical activity, and maintaining a healthy body weight. Pharmacological treatments commonly include statins for dyslipidemia and antidiabetic agents for T2DM.

[0025] However, due to the limitations associated with existing therapeutic options and prior-art nutraceuticals, there remains an unmet need for the development of an improved nutraceutical formulation that effectively addresses the multifactorial nature of metabolic disorders.

[0026] The present invention relates to a novel and synergistic nutraceutical composition specifically designed to improve cardio-metabolic health. More particularly, the invention provides a composition comprising Berberine, anthocyanin(s), and Astaxanthin. This composition is effective in managing various metabolic parameters like hyperglycemia, hypertriglyceridemia, elevated low-density lipoprotein (LDL) cholesterol, enhanced platelet aggregation, elevated serum transaminase activity and hypoadiponectinemia.

[0027] The synergistic nutraceutical composition of the present invention may be used either independently or as an adjunct to synthetic drugs, such as statins and antidiabetic agents. It presents a natural and efficacious modality for modulating cardiometabolic parameters, with the potential to reduce the therapeutic dosages of synthetic pharmacological agents, thereby mitigating the risk of associated adverse effects.

[0028] This invention presents a novel strategy for managing cardiometabolic health by targeting multiple metabolic pathways through a single, synergistic formulation. The combination of berberine, anthocyanin(s), and astaxanthin enhances therapeutic efficacy through complementary mechanisms of action, providing a comprehensive solution for improving metabolic health and mitigating the risk of associated disorders.

[0029] By providing a natural and well-tolerated alternative or adjunct to conventional pharmacotherapy, the present invention has the potential to offer significant benefits to public health — particularly in light of the increasing global burden of metabolic diseases. Its ability to function synergistically with existing pharmacological treatments further enhances its clinical utility and strengthens its role in long-term disease management strategies.

[0030] OBJECTIVE OF THE INVENTION

[0031] The primary objective of the present invention is to provide a synergistic nutraceutical composition comprising Berberine, Anthocyanin(s), and Astaxanthin.

[0032] Another objective of the present invention is to provide a synergistic nutraceutical composition comprising Berberine, Anthocyanin(s), and Astaxanthin to enhance cardio-metabolic health in the body.

[0033] One more objective of the present invention is to develop a nutraceutical composition that effectively improves cardio-metabolic health by targeting metabolic parameters such as hyperglycemia, hypertriglyceridemia, elevated low- density lipoprotein (LDL) cholesterol, enhanced platelet aggregation, elevated serum transaminase activity and hypoadiponectinemia.

[0034] Another objective of the present invention is to create a synergistic combination of Berberine, anthocyanin(s), and Astaxanthin that works together more effectively than the individual components alone, thereby maximizing health benefits.

[0035] Yet another objective of the present invention is to offer a solution for managing cardiometabolic pathologies, including Type 2 diabetes mellitus (T2DM), arterial hypertension, dyslipidemia, atherosclerosis, obesity, non-alcoholic fatty liver disease (NAFLD), cerebrovascular accidents (stroke) and coronary artery disease by improving metabolic parameters.

[0036] One more objective of the present invention is to provide a nutraceutical composition that can be used alongside synthetic drugs (such as statins and antidiabetics) to enhance their efficacy and potentially reduce their required dosage.

[0037] Another objective of the present invention is to utilize naturally derived ingredients: berberine from Berberis species or other plant sources, or synthesized through chemical or fermentation processes; anthocyanin(s) from natural sources like plants or animals, or synthesized through chemical or fermentation processes; and astaxanthin from algae or yeast, or synthesized through chemical or fermentation processes, to ensure the product is safe and has minimal side effects.

[0038] One more objective of the present invention is to formulate a composition that addresses a wide spectrum of cardio-metabolic conditions by targeting dyslipidemia, hyperglycemia, hypertransaminasemia, hyperplatelet activity, high blood pressure, and hypoadiponectinemia.

[0039] Yet another objective of the present invention is to determine the optimal ratios of Berberine, anthocyanin(s), and Astaxanthin to maximize their synergistic effects and provide flexible dosing options tailored to individual needs.

[0040] One more objective of the present invention is to enhance the bioavailability of the active components to ensure they are effectively absorbed and utilized by the body, thereby increasing their therapeutic efficacy.

[0041] Another objective of the present invention is to specifically address and improve cardiovascular health by reducing risk factors such as dyslipidemia, platelet hyperactivity and hypoadiponectinemia, which are critical in preventing cardiovascular diseases.

[0042] Yet another objective of the present invention is to create a nutraceutical composition that not only provides immediate health benefits but also supports long-term health by maintaining healthy levels of glucose and lipids, thereby preventing the onset of metabolic disorders.

[0043] Another objective of the present invention is to provide a synergistic bioactive composition comprising Berberine, Anthocyanin(s), and Astaxanthin or pharmaceutically acceptable salts, derivatives, isomers, metabolites thereof, wherein the composition is in the form of tablets, capsules, powder, pill, hard capsule filled with liquid or solids, soft capsules, granules, pellets, caplets, minitablets, gummies, syrup, suspension, sachet, modified release or any other formulations intended for oral administration.

[0044] Another objective of the present invention is to provide a synergistic bioactive composition comprising Berberine, Anthocyanin(s), and Astaxanthin or pharmaceutically acceptable salts, derivatives, isomers, metabolites thereof, wherein the composition further comprises pharmaceutically acceptable excipients are selected from a diluent, disintegrant, binder, solubilizing agent (surfactant), lubricant, glidant, or a mixture thereof. Another objective of the present invention is to provide a synergistic bioactive composition comprising Berberine, Anthocyanin(s), and Astaxanthin or pharmaceutically acceptable salts, derivatives, isomers, metabolites thereof, wherein the composition is for the management of Type 2 Diabetes Mellitus (T2DM), arterial hypertension, dyslipidemia, atherosclerosis, obesity, nonalcoholic fatty liver disease (NAFLD), metabolic syndrome, cerebrovascular accidents (stroke), and coronary artery disease.

[0045] Another objective of the present invention is to provide a kit comprising Berberine, Anthocyanin(s), and Astaxanthin or pharmaceutically acceptable salts, derivatives, isomers, metabolites thereof.

[0046] Another objective of the present invention is to provide a kit comprising Berberine, Anthocyanin(s), and Astaxanthin or pharmaceutically acceptable salts, derivatives, isomers, metabolites thereof, wherein the kit for the management of Type 2 Diabetes Mellitus (T2DM), arterial hypertension, dyslipidemia, atherosclerosis, obesity, non-alcoholic fatty liver disease (NAFLD), metabolic syndrome, cerebrovascular accidents (stroke), and coronary artery disease.

[0047] SUMMARY OF THE INVENTION

[0048] The present invention relates to the field of nutraceuticals, and more specifically, to a synergistic nutraceutical composition formulated for the management of cardiometabolic diseases. The composition comprises a combination of Berberine, anthocyanin(s) and Astaxanthin.

[0049] The invention provides a composition effective in addressing multiple metabolic parameters such as hyperglycemia, hypertriglyceridemia, elevated low-density lipoprotein (LDL) cholesterol, increased blood pressure, enhanced platelet aggregation, elevated serum transaminase activity and hypoadiponectinemia. By modulating these parameters, the composition is aimed at the management and prevention of cardiometabolic disorders such as Type 2 Diabetes Mellitus (T2DM), arterial hypertension, dyslipidemia, atherosclerosis, obesity, non-alcoholic fatty liver disease (NAFLD), metabolic syndrome, cerebrovascular accidents (stroke), and coronary artery disease.

[0050] The composition may be administered orally in the form of tablets, capsules, powders, or other suitable delivery systems and may be formulated with acceptable pharmaceutical or nutraceutical excipients.

[0051] The composition may be used alone or in combination with conventional pharmacological agents, such as statins or antidiabetic drugs, thereby serving as an adjunct therapy. This dual -use approach provides flexibility in clinical management and may reduce the required dosage and adverse effects associated with synthetic medications.

[0052] Accordingly, the present invention offers a novel, natural, and effective means for managing metabolic disorders such as Type 2 Diabetes Mellitus (T2DM), arterial hypertension, dyslipidemia, atherosclerosis, obesity, non-alcoholic fatty liver disease (NAFLD), metabolic syndrome, cerebrovascular accidents (stroke), and coronary artery disease for promoting overall cardio-metabolic health.

[0053] The synergistic action of the constituents in the composition contributes to improved metabolic homeostasis and may offer adjunctive benefits when administered alongside standard pharmacological treatments for cardio-metabolic conditions. The invention therefore provides a potentially multifunctional approach to supporting metabolic health.

[0054] BRIEF DESCRIPTION OF THE DRAWINGS

[0055] Figure 1: Change in Serum Triglycerides

[0056] Figure 2: Change in Systolic blood pressure Figure 3: Change in Fasting blood glucose

[0057] Figure 4: Change in Serum LDL

[0058] Figure 5: Change in Serum SGPT

[0059] Figure 6: Change in Serum SGOT

[0060] Figure 7: Change in Platelet aggregation by adenosine

[0061] Figure 8: Change in Serum SIRT 1

[0062] Figure 9: Change in Serum adiponectin

[0063] DETAILED DESCRIPTION OF THE INVENTION

[0064] The following detailed description of the present subject matter provides various embodiments described in sufficient detail to enable those skilled in the art to practice the invention. Other embodiments may be utilized, and modifications may be made without departing from the scope of the present invention. References to “an,” “one,” or “various” embodiments are not necessarily to the same embodiment, and such references contemplate more than one embodiment. Therefore, the following detailed description is not to be taken in a limiting sense, and the scope is defined only by the appended claims and their full legal equivalents.

[0065] The invention described herein comprises in various objects and their description as mentioned above, with respect to characteristics and processes adopted. While these aspects are emphasized in the invention, any variations of the invention described above are not to be regarded as departure from the spirit and scope of the invention as described.

[0066] The present invention relates to the field of nutraceutical compositions designed to improve cardio-metabolic health. Specifically, the invention pertains to a potent bioactive composition comprising a synergistic combination of Berberine, anthocyanin(s), and Astaxanthin or their pharmaceutically acceptable salts, along with pharmaceutically acceptable excipients. In one of the embodiment, the present invention provides a synergistic nutraceutical composition comprising Berberine, Anthocyanin(s), and Astaxanthin.

[0067] In another embodiment, the present invention provides a synergistic nutraceutical composition comprising Berberine, Anthocyanin(s), and Astaxanthin and suitable excipients.

[0068] In another embodiment, the present invention provides a synergistic nutraceutical composition comprising Berberine, Anthocyanin(s), and Astaxanthin to enhance cardio-metabolic health in the body.

[0069] In another embodiment, the present invention provides a synergistic nutraceutical composition designed to improve cardio-metabolic health, where the unique combination of Berberine, anthocyanin(s), and Astaxanthin acts synergistically to enhance various metabolic parameters.

[0070] One aspect of the present invention is the use of this synergistic nutraceutical composition to manage metabolic health by improving critical parameters such as hyperglycemia, hypertriglyceridemia, elevated low-density lipoprotein (LDL) cholesterol, increased blood pressure, enhanced platelet aggregation, elevated serum transaminase activity, and hypoadiponectinemia are addressed, thereby targeting multiple aspects of metabolic health simultaneously.

[0071] According to the present invention, Berberine, Anthocyanin(s), and Astaxanthin include their pharmaceutically or nutraceutically acceptable salts, derivatives, isomers, or metabolites.

[0072] Berberine is sourced, isolated, extracted, or derived from botanical parts of various Berberis like Argemone Mexicana, Berberis vulgaris, Berberis aristata, Berberis lyceum, Berberis asiatica, Berberis aquifolium, Berberis floribunda, Berberis congestiflora, Berberis croaticci, Berberis petiolaris, Berberis tinctoria, Berberis thunbergii, Coelocline polycarpa, Coptis chinensis, Coptis japonica, Eschscholzia californicci, Hydrastis Canadensis, Mahonia aquifolium, Phellodendron amurense, Papaver dubium, Papaver hybridum, Rollinia deliciosa, Xanthorhiza simplicissima, Tinospora cordifolia, Xylopia macrocarpa, Fibraurea tinctoria or any other plant source or synthesized through chemical or fermentation process.

[0073] Anthocyanin(s) are derived, extracted, or isolated from natural plant sources such as Berries, cherries, plums, vegetables, flowers, legume, fruits or any other plant source or synthesized through chemical or fermentation process or from any other plants or animals, or it may be synthesized chemically or through fermentation.

[0074] Astaxanthin is derived from yeast, algae, lobster, shrimp, fish, Adonis or any other plant species or synthesized through chemical or fermentation process.

[0075] One further aspect of the invention is its potential to serve as an adjunctive therapy alongside synthetic drugs such as statins and antidiabetics, thereby enhancing the overall management of metabolic health and potentially reducing the dosage and side effects of synthetic medications.

[0076] An additional aspect relates to the formulation ratios of Berberine, Anthocyanin(s), and Astaxanthin, where flexible ratios are allowed to maximize the synergistic effect, ensuring that the combination works more effectively than each component individually.

[0077] In one embodiment, the synergistic composition comprises Berberine, Anthocyanin(s), and Astaxanthin or pharmaceutically acceptable salts, derivatives, isomers, or metabolites, wherein Berberine, Anthocyanin(s), and Astaxanthin are present in a ratio of 1:0.000125:0.000125 to 1:300:5. According to the invention, the ratio of Berberine, Anthocyanin(s), and Astaxanthin is 1: 0.000125: 0.000125 to 1:300:5; 1: 0.001: 0.0007 to 1:250:5; 1:0.0009:0.0006 to 1:200:4; 1:0.0008:0.0005 to 1: 150:3; 1:0.0007:0.0004 to 1: 100: 1; 1:0.0006:0.0003 to 1:50:0.5; 1:0.0005:0.00025 to 1: 10:0.2.

[0078] In another embodiment, the synergistic composition comprises Anthocyanin(s) and Berberine in a ratio of 1 :0.0033 to 1 :8000. In another embodiment, Astaxanthin and Berberine are in a ratio of 1:0.2 to 1:8000, while in another embodiment, Astaxanthin and Anthocyanin(s) are in a ratio of 1:0.01 to 1:6000.

[0079] In one embodiment, the amount of Berberine is in the range of 0.1976% to 99.7258% w / w, 1% to 98% w / w, 2% to 97% w / w, 5% to 96% w / w, 10% to 95% w / w, 15% to 95% w / w, or 20% to 90% w / w of the total composition. The amount of Anthocyanin(s) is in the range of 0.0083% to 99.3213% w / w, 0.0083% to 90% w / w, 0.1% to 80% w / w, 0.5% to 70% w / w, l% to 70% w / w, 2% to 60% w / w, 2.5% to 50% w / w, 2.6% to 40% w / w, 2.8% to 30% w / w, 3% to 25% w / w, or 3% to 20% w / w of the total composition. The amount of Astaxanthin is in the range of 0.0056% to 70.9220% w / w, 0.005% to 60% w / w, 0.005% to 50% w / w, 0.005% to 40% w / w, 0.005% to 30% w / w, 0.005% to 20% w / w, 0.005% to 10% w / w, 0.005% to 7.5% w / w, 0.005% to 5% w / w, or 0.005% to 4% w / w of the total composition.

[0080] Berberine may be present in an amount ranging from 10 mg to 4000 mg, Anthocyanin(s) from 0.5 mg to 3000 mg, and Astaxanthin from 0.5 mg to 50 mg. According to the invention, Berberine is present in amounts ranging from 10 mg to 4000 mg, 50 mg to 3500 mg, 100 mg to 3000 mg, 150 mg to 3000 mg, 200 mg to 2750 mg, 250 mg to 2500 mg, 250 mg to 2250 mg, or 250 mg to 2000 mg. Anthocyanin(s) is present in amounts ranging from 0.5 mg to 3000 mg, 0.5 mg to 2500 mg, 0.5 mg to 2250 mg, 2.5 mg to 2000 mg, 5 mg to 1750 mg, 7.5 mg to 1750 mg, 10 mg to 1500 mg, 15 mg to 1400 mg, 15 mg to 1300 mg, or 15 mg to 1200 mg. Astaxanthin is present in amounts ranging from 0.5 mg to 50 mg, 0.5 mg to 45 mg, 0.5 mg to 40 mg, 0.5 mg to 35 mg, 0.5 mg to 30 mg, 0.5 mg to 25 mg, or 0.5 mg to 20 mg. The dose may be administered once, twice, or thrice a day, either as a single or divided dose, depending on the therapeutic need. Another embodiment emphasizes improving the bioavailability of the active components to ensure effective absorption and utilization by the body, thereby enhancing therapeutic efficacy and health benefits. The composition is also intended to address a variety of cardio-metabolic conditions, including Type 2 Diabetes Mellitus (T2DM), arterial hypertension, dyslipidemia, obesity, nonalcoholic fatty liver disease (NAFLD), metabolic syndrome, cerebrovascular accidents (stroke), atherosclerosis, and coronary artery disease, making it a versatile solution for multiple metabolic disorders.

[0081] The pharmaceutically acceptable excipients included in the composition ensure the development of a suitable dosage form and the effectiveness of the formulation. These excipients include diluents, binders, surfactants, lubricants, glidants, disintegrants, additives, solvents, or mixtures thereof.

[0082] Diluents are selected from one or more of calcium carbonate, dicalcium phosphate, tricalcium phosphate, magnesium carbonate, calcium sulfate, magnesium oxide, microcrystalline cellulose, cellulose powder, maltodextrin, lactose anhydrous, lactose monohydrate, sucrose, mannitol, sorbitol, xylitol, starch, pregelatinized starch, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, polyvinylpyrrolidone, xanthan gum, or a mixture thereof, in amounts ranging from 1% to 98% w / w of the total composition.

[0083] Binders are selected from one or more of microcrystalline cellulose, carboxymethylcellulose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, Hypromellose, low-substituted hydroxypropyl cellulose, methylcellulose, pregelatinized starch, starch, povidone, polyvinylpyrrolidone, copovidone, carbomer, sodium alginate, acacia, agar, guar gum, maltodextrin, pectin, or tragacanth, in amounts ranging from 0. 1% to 12% w / w.

[0084] Lubricants are selected from one or more of magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate, talc, polyethylene glycol, colloidal silicon dioxide, glyceryl behenate, or zinc stearate, in amounts ranging from 0.5% to 10% w / w.

[0085] Glidants are selected from one or more of colloidal silicon dioxide, hydrophobic colloidal silica, silicon dioxide, talc, tribasic calcium phosphate, or mixtures thereof, in amounts ranging from 0.5% to 10% w / w.

[0086] Disintegrants are selected from one or more of alginic acid, calcium alginate, carboxymethylcellulose calcium, carboxymethylcellulose sodium, microcrystalline cellulose, chitosan, com starch, pregelatinized starch, croscarmellose sodium, crospovidone, docusate sodium, low-substituted hydroxypropyl cellulose, methylcellulose, povidone, sodium alginate, sodium starch glycolate, cross-linked hydroxypropyl cellulose, or mixtures thereof, in amounts ranging from 0.4% to 15% w / w.

[0087] Surfactants are selected from one or more of polysorbates, sorbitan esters, polyethylene glycol esters, polyoxyethylene stearates, polyoxyethylene castor oil derivatives, poloxamers, sodium lauryl sulfate, sodium dodecyl sulfate, sodium stearate, sodium dioctyl sulfosuccinate, benzalkonium chloride, benzethonium chloride, cetylpyridinium chloride, lecithin, phosphatidylcholine, lauryl betaine, or mixtures thereof.

[0088] The composition of the present invention can be prepared using conventional methods known in the art for formulating oral dosage forms. Depending on the desired final product, the formulation may be prepared through direct compression, wherein the active pharmaceutical ingredient is blended with suitable excipients such as fillers, binders, disintegrants, and lubricants, followed by compression into tablets. Alternatively, the composition may be processed through granulation techniques, including wet or dry granulation, to enhance flow properties and compressibility. The prepared formulation can be filled into sachets or capsules for ease of administration. Additionally, the composition can be supplied as a powder or granules for reconstitution into an oral suspension. Other suitable processes may also be employed to achieve the desired dosage form while ensuring stability, efficacy, and patient compliance. The processes for the preparation of nutraceutical compositions are well known in the art.

[0089] In another embodiment, oral administration of an effective dose improves cardio- metabolic health. The nutraceutical composition is designed for oral administration, offering convenience, non-invasiveness, and suitability for long-term use.

[0090] The composition may be formulated into tablets, capsules, powders, or liquids, depending on the preferences and needs of the target population, thus ensuring widespread applicability. The composition of the present invention is in the form of tablets, capsules, powder, pill, hard capsule filled with liquid or solids, soft capsules, granules, pellets, caplets, mini-tablets, syrup, suspension, sachet, modified release formulations, gummies or any other oral dosage form. The preferred dosage for is oral dosage form.

[0091] In another embodiment, the present invention provides a kit comprising Berberine, Anthocyanin(s), and Astaxanthin or their pharmaceutically / nutraceutically acceptable salts, derivatives, isomers, or metabolites. The kit may be configured to include: (a) one or more containers holding the active components separately or as a preformulated composition; (b) optional excipients or co-administered agents; and (c) printed instructions or guidelines for administration, dosing, and use. The kit is intended for the management, or prevention of metabolic conditions such as Type 2 Diabetes Mellitus (T2DM), arterial hypertension, dyslipidemia, obesity, nonalcoholic fatty liver disease (NAFLD), metabolic syndrome, cerebrovascular accidents (stroke), atherosclerosis, and coronary artery disease., or related cardio- metabolic disorders. The packaging of the kit may be designed for convenient daily, weekly, or monthly use, and may include single-dose units, blister packs, sachets, or bottles, depending on the formulation. The kit may also optionally include instructions for adjunctive use with synthetic drugs (e.g., statins, antihypertensives, antidiabetics), highlighting the potential for dose reduction or side effect minimization when used in combination therapy.

[0092] In another embodiment, the present invention provides a composition comprising Berberine, Anthocyanin(s), and Astaxanthin, wherein the composition comprises Berberine in an amount ranging from 10 mg to 4000 mg, Anthocyanin(s) in an amount ranging from 0.5 mg to 3000 mg, and Astaxanthin in an amount ranging from 0.5 mg to 50 mg. The composition further provides that Berberine, Anthocyanin(s), and Astaxanthin are present in a ratio of 1:0.000125:0.000125 to 1:300:5. The composition is formulated for oral administration. Oral administration of the composition regulates glucose homeostasis by reducing fasting serum glucose levels by at least 31.72% and improves lipid homeostasis by reducing serum triglyceride levels by at least 19.28% beyond the combined individual effects of Berberine, Anthocyanin(s), and Astaxanthin, thereby demonstrating a synergistic therapeutic effect.

[0093] In another embodiment, the present invention provides a composition comprising Berberine, Anthocyanin(s), and Astaxanthin, wherein the composition comprises Berberine in an amount ranging from 10 mg to 4000 mg, Anthocyanin(s) in an amount ranging from 0.5 mg to 3000 mg, and Astaxanthin in an amount ranging from 0.5 mg to 50 mg. Oral administration of the composition regulates glucose homeostasis by reducing fasting serum glucose levels by at least 31.72% compared to the combined individual effects of Berberine, Anthocyanin(s), and Astaxanthin, thereby demonstrating a synergistic therapeutic effect.

[0094] In another embodiment, the present invention provides a composition comprising Berberine, Anthocyanin(s), and Astaxanthin, wherein the composition comprises Berberine in an amount ranging from 10 mg to 4000 mg, Anthocyanin(s) in an amount ranging from 0.5 mg to 3000 mg, and Astaxanthin in an amount ranging from 0.5 mg to 50 mg. Oral administration of the composition reduces systolic blood pressure by at least 26.81% compared to the combined individual effects of Berberine, Anthocyanin(s), and Astaxanthin, thereby demonstrating a synergistic antihypertensive effect.

[0095] In another embodiment, the present invention provides a composition comprising Berberine, Anthocyanin(s), and Astaxanthin, wherein the composition comprises Berberine in an amount ranging from 10 mg to 4000 mg, Anthocyanin(s) in an amount ranging from 0.5 mg to 3000 mg, and Astaxanthin in an amount ranging from 0.5 mg to 50 mg. Oral administration of the composition regulates lipid homeostasis by reducing serum triglyceride levels by at least 19.28% and low- density lipoprotein (LDL) levels by at least 20.31% compared to the combined individual effects of Berberine, Anthocyanin(s), and Astaxanthin, thereby demonstrating a synergistic lipid-lowering effect.

[0096] In another embodiment, the present invention provides a composition comprising Berberine, Anthocyanin(s), and Astaxanthin, wherein the composition comprises Berberine in an amount ranging from 10 mg to 4000 mg, Anthocyanin(s) in an amount ranging from 0.5 mg to 3000 mg, and Astaxanthin in an amount ranging from 0.5 mg to 50 mg. Oral administration of the composition regulates liver function by reducing serum glutamic pyruvic transaminase (SGPT) levels by at least 27.33% and serum glutamic -oxaloacetic transaminase (SGOT) levels by at least 50.54% compared to the combined individual effects of Berberine, Anthocyanin(s), and Astaxanthin, thereby demonstrating a synergistic hepatoprotective effect.

[0097] In another embodiment, the present invention provides a composition comprising Berberine, Anthocyanin(s), and Astaxanthin, wherein the composition comprises Berberine in an amount ranging from 10 mg to 4000 mg, Anthocyanin(s) in an amount ranging from 0.5 mg to 3000 mg, and Astaxanthin in an amount ranging from 0.5 mg to 50 mg. The synergistic bioactive composition regulates adipose tissue homeostasis by increasing serum adiponectin levels by at least 43.59% compared to the combined individual effects of Berberine, Anthocyanin(s), and Astaxanthin, thereby demonstrating enhanced adipose tissue regulation.

[0098] In another embodiment, the present invention provides a composition comprising Berberine, Anthocyanin(s), and Astaxanthin, wherein the composition comprises Berberine in an amount ranging from 10 mg to 4000 mg, Anthocyanin(s) in an amount ranging from 0.5 mg to 3000 mg, and Astaxanthin in an amount ranging from 0.5 mg to 50 mg. The composition increases serum SIRT-1 levels by at least 96.00% compared to the combined individual effects of Berberine, Anthocyanin(s), and Astaxanthin, thereby demonstrating a synergistic effect on metabolic regulation and cellular longevity pathways.

[0099] In another embodiment, the present invention provides a composition comprising Berberine, Anthocyanin(s), and Astaxanthin, wherein the composition comprises Berberine in an amount ranging from 10 mg to 4000 mg, Anthocyanin(s) in an amount ranging from 0.5 mg to 3000 mg, and Astaxanthin in an amount ranging from 0.5 mg to 50 mg. The composition reduces platelet aggregation by at least 45.43% compared to the combined individual effects of Berberine, Anthocyanin(s), and Astaxanthin, thereby demonstrating a synergistic antithrombotic effect.

[0100] According to the present invention, the composition may also be provided as three separate compositions, wherein one composition comprises Berberine, another composition comprises Anthocyanin(s), and the third composition comprises Astaxanthin, with all three compositions intended for simultaneous administration to a person in need thereof. EXAMPLES

[0101] EXAMPLE-1: COMPOSITION

[0102] Following is a general composition formula as per the present invention:

[0103] EXAMPLE-1A: COMPOSITION

[0104] Process for preparation of example 1 and 1 A: 1. Accurately weigh each ingredient in separate containers.

[0105] 2. Sift the previously weighed active ingredients and excipients through a sieve.

[0106] 3. Combine the contents from step 2 to prepare suitable oral dosage form.

[0107] EXAMPLE 2A: TABLET COMPOSITION

[0108] Manufacturing process for example 2A:

[0109] 1. Accurately weigh each ingredient in separate containers. 2. Sift the previously weighed berberine, anthocyanin(s), astaxanthin, diluent(s), and optionally disintegrating agent(s) separately through a #40 sieve.

[0110] 3. Combine the contents from step 2 in a rapid mixer granulator (RMG) using a slow-speed impeller. 4. Binder solution preparation: Weigh the binding agent(s) and optionally solubilizing agent(s) in a separate container, dissolve them in the solvent(s) (i.e. granulating fluid), and then add the anthocyanin(s) to the same solution.

[0111] 5. Add the binder solution to the mixture from step 3 in the RMG, using a slow impeller speed. 6. Sift and dry the granulated wet mass in a fluid bed dryer at 50°C ± 5 °C until the blend's level of dryness (LOD) is reduced to below 1.5% w / w.

[0112] 7. Sift the semi-dried granules through sieve #20, followed by sieve #30.

[0113] 8. Sift the previously weighed lubricant(s) or glidant(s) separately through sieve #40, then mix them with the material from Step 7. 9. Compress the blend from Step 8 to form tablets containing berberine, anthocyanin(s), and astaxanthin.

[0114] EXAMPLE 2B: CAPSULE COMPOSITION

[0115] Manufacturing process of capsule composition of example 2B:

[0116] 1. Accurately weigh each ingredient in separate containers.

[0117] 2. Sift the previously weighed active ingredients, and excipients through a #40 sieve. 3. The active ingredient(s) and excipients are blended to create a uniform powder or granulate (Formulation preparation).

[0118] 4. The empty hard gelatin or HPMC capsule is separated into two halves — the body and the cap (Capsule separation).

[0119] 5. The capsule body is filled with the prepared uniform blend (Filling).

[0120] 6. The filled body is rejoined with the cap to close the capsule (Capsule joining)

[0121] 7. The filled capsules are cleaned to remove any powder residue and are inspected for quality (e.g., weight, integrity, and fill consistency) (Polishing and Inspection).

[0122] 8. Final capsules are packaged in suitable containers (e.g., bottles or blister packs) for distribution (Packaging).

[0123] EXAMPLE 2C: SACHET COMPOSITION

[0124] Manufacturing process of Sachet composition of example 2C:

[0125] 1. Accurately weigh each ingredient in separate containers.

[0126] 2. Sift the previously weighed active ingredients and excipients through a sieve. 3. Combine the contents from step 2.

[0127] 4. Fill the mixture of step 3 into a Sachet.

[0128] EXAMPLE 3: ANIMAL STUDY

[0129] Objective of the animal study: To Evaluate the Synergistic Effect of Berberine, Anthocyanin(s) and Astaxanthin in Cardiometabolic Disease in Rats.

[0130] Materials and Method: Male wistar rats, aged 9-10 weeks and weighing 150-210 g at the start of the experiments, were divided into different groups, each containing 6 rats.

[0131] All the animals were divided into the different groups as mentioned below. Normal control group, Disease control group, Test group- 1, Test group-2, Test group-3 and Test group-4 are denoted as N, D, Tl, T2, T3 and T4 respectively. Animals in Group-N were given a normal diet throughout the study and did not receive any treatment. Group- D was served HFD from week 0 to 7 & 0.5% CMC from week 4 to 7. Group Tl, T2, T3 and T4 were served HFD from week 0 to 7 & respective treatments from week 4 to 7. At week 2, animals of group D, Tl, T2, T3 and T4 were subjected to an overnight fast and injected with STZ (35 mg / kg b.wt i.p. in 0.1 M citrate buffer, pH 4.5). In week 3, blood samples were collected using the retro- orbital plexus method to assess fasting blood glucose levels and ensure the development of cardiometabolic disease. At the end of week 7, all animals were anesthetized with ketamine at a dose of 100 mg / kg body weight by intraperitoneal (i.p.) injection. Blood samples were obtained from the abdominal aorta. Blood sampling was carefully performed to avoid lysis. Serum was separated from blood after centrifugation (4000 rpm for 10 minutes by using centrifuge machine (Make: DLAB, Model: D3024R) & analyzed for respective serum parameters.

[0132] HFD: The treatment groups were fed HFD daily, as described in the table below.

[0133] All the animals of group D, Tl, T2, T3 and T4 received the treatments as per the table mentioned below: b.wt.: Body weight

[0134] BID: Twice daily

[0135] Evaluation parameters:

[0136] Cardiometabolic parameters: 1. Systolic blood pressure (at week 7) . Fasting serum glucose levels (at week 3 and week 7)

[0137] 3. Serum triglycerides levels (at week 7)

[0138] 4. Serum low density Lipoprotein levels (LDL) (at week 7)

[0139] 5. Serum SGPT levels (at week 7)

[0140] 6. Serum SGOT levels (at week 7)

[0141] 7. ADP induced Platelet aggregation (at week 7)

[0142] Elisa parameters:

[0143] 1. Serum SIRT-l(at week 7)

[0144] 2. Serum Adiponectin (at week 7)

[0145] Test Parameters details:

[0146] Serum glucose level: Blood glucose, commonly referred to as blood sugar, plays a vital role in the human body. It serves as a primary source of energy, enabling cells and tissues to function optimally. Glucose homeostasis is the body's ability to maintain stable blood glucose levels. However, maintaining the right balance of blood glucose is crucial, as both high and low levels can lead to severe health complications. Apart from insulin, other hormones, such as glucagon, epinephrine, and cortisol, also play a role in this delicate balance. These hormones counteract the effects of insulin and raise blood glucose levels when needed, such as during fasting or physical activity. Cardiometabolic disorders involves higher serum glucose levels and therefore, reduced serum glucose level is required for the management of cardiometabolic diseases. The study results are provided in table 2 and figure 3.

[0147] Systolic blood pressure: Blood pressure (BP) reduction is a well-known primary and secondary preventive strategy for cardiovascular events in addition to diabetes. The pressure in the arteries when the heart contracts (systole) is called systolic blood pressure. Cardiovascular event rates increase steeply with systolic pressure at all ages. High systolic blood pressure (SBP) is a major risk factor for ischemic heart disease (IHD), the leading cause of death worldwide. Hence, systolic blood pressure control is can help in managing cardiometabolic diseases. The study results are provided in table 1 and figure 2.

[0148] Serum triglycerides (TG) and low density lipoproteins (LDL): Dyslipidaemia, characterized by high low-density lipoprotein cholesterol (LDL-C) and triglyceride (TG) levels and low high -density lipoprotein cholesterol (HDL-C) levels, is closely associated with atherosclerotic cardiovascular diseases. Hypertriglyceridaemia can be caused by increased TG production, altered processing and catabolism of TG- rich lipoproteins (TRL), and reduced TG clearance. A high-circulating LDL-C concentration is the causal risk factor for the development of coronary artery disease (CAD). Lower LDL-C levels associated with lower cardiovascular disease (CVD) risk. Hence, control of high TG and LDL can be effective way of managing cardiometabolic diseases. The study results are provided in table 3 and 4 and figure 1 and 4 of Serum triglycerides and Serum LDL respectively.

[0149] Serum Glutamic Pyruvic Transaminase (SGPT) and Serum Glutamic- Oxaloacetic Transaminase (SGOT): The liver is considered as major site for the insulin clearance. SGPT and SGOT are liver enzymes. High incidence of liver enzyme malfunctions among diabetics. The liver enzymes are found to be an important indicator of liver deterioration due to increased blood sugar. Increased SGPT and SGOT levels as markers for non-alcoholic fatty liver disease among diabetics. Hence, cardiometabolic diseases management requires control of elevated SGPT and SGOT levels. The study results are provided in table 5 and 6 and figure 5 and 6 of Serum SGPT and Serum SGOT respectively.

[0150] Serum adiponectin levels: Adiponectin is a protein hormone of 244 amino acids produced and secreted by adipose tissue having anti-diabetic, anti-atherogenic, cardioprotective and anti-inflammatory action. Adiponectin expression and serum levels are decreased in obese and metabolic syndrome patients. Adiponectin concentration is also inversely correlated to body mass index (BMI), glucose, insulin and triglyceride levels, degree of insulin resistance and visceral fat accumulation. Hypoadiponectinemia is a key etiological factor contributing to almost all the major pathological conditions of cardiometabolic diseases. The study results are provided in table 9 and figure 9.

[0151] Serum SIRT-1: Sirtuins (SIRTs) are a nicotinic adenine dinucleotide (+) - dependent histone deacetylase that regulates critical signaling pathways in prokaryotes and eukaryotes. SIRT protein family plays critical role in cardiovascular diseases. In the cardiovascular system, activation of SIRT1 can not only protect against oxidative stress at the cellular level, but can also offer increased survival at the systemic level to limit coronary heart disease and cerebrovascular disease. SIRT1 deficiency leads to development of endocrine and metabolic system, thereby developing into obesity, diabetes, hyperuricemia, hyperlipidemia, hypertension etc. Hence stimulatory activity of SIRT-1 can produce beneficial effects in the management of cardiometabolic diseases. The study results are provided in table 8 and figure 8.

[0152] Adenosine Diphosphate (ADP) induced platelet aggregation: Historically, ADP was the first low-molecular-weight platelet aggregating agent to be identified. ADP-induced platelet aggregation plays a major role in the development and extension of arterial thrombosis. ADP not only causes primary aggregation of platelets but is also responsible for secondary aggregation induced by ADP and other agonists. ADP induces a change in the shape of platelets, transforming them from their normal disc form into a more spherical shape, on which pseudopodia appear. These shape-changed platelets immediately begin to aggregate. Subsequently, many hundreds of thousands of platelets participate in the platelet aggregates that form. ADP interacts directly with two purinergic receptors, known as P2Y i and P2Y 12, and it is the combined effect of ADP at these two receptors that leads to platelet activation, followed by platelet aggregation. Reduced ADP- induced platelet aggregation indicates a reduced risk of thrombus / clot formation and therefore can prevent the cardiovascular incidences. The study results are provided in table 7 and figure 7. Method of the evaluation of parameters:

[0153] Systolic blood pressure: The tail-cuff method is a non-invasive technique used to measure blood pressure in rats, involving placing a cuff on the tail, inflating it to occlude blood flow, and then monitoring the return of blood flow as the cuff deflates to determine systolic and diastolic pressures. The animal is placed in the restraining holder and animal is warmed for a period of time before and during the procedure to maintain a stable temperature. After that tail cuff is placed on the animal's tail. The cuff is inflated to a pressure that occludes blood flow in the tail and cuff is slowly deflated, and the pressure sensor monitors the changes in blood flow as it returns to the tail. Measurement of blood pressure. The pressure at which the pulse reappears during cuff deflation is taken as the systolic pressure.

[0154] ADP induced platelet aggregation: Blood samples were collected from abdominal aorta in 1:9 (v / v) of ACD-C (12.4 mM sodium citrate, 13 mM citric acid, 11 mM glucose). Platelet-rich plasma (PRP) was obtained by centrifugation of whole blood at 200 g for 15 min at room temperature. Five milliliters of PRP were added to 7 ml of washing buffer (140 mM NaCl, 0.5 mM KC1, 12 mM trisodium citrate, 10 mM glucose, 12.5 mM saccharose, pH6), and centrifuged (800 g, 13 min). The pellet was resuspended in washing buffer, and the procedure was repeated once. The platelets were gently suspended in Krebs solution (118 mM NaCl, 25 mM NaHCO3, 1.2 mM KH2PO4, 1.7 mM MgSO4, 5.6 mM glucose, pH 7.4). The platelet number was adjusted to 1.2 x 108platelets / ml in the presence of 1 mM CaC12. Platelet aggregation was measured in a two channel aggregometer (Siemens) at 37°C with stirring (1000 rpm). Platelet aggregation assays were carried using ADP (10 pM).

[0155] Serum levels of fasting glucose, triglycerides, low density lipoprotein (LDL), SGPT and SGOT: were measured using biochemistry analyzer (Make-Mindray).

[0156] Serum adiponectin and SIRT-1: were measured using Multimode Reader (Biotek Instruments), Cytation 5 model Serial no. 1909161E using respective ELISA kit (of Krishgen Biosystems) leaflet under biosafety cabinet.

[0157] All the data are represented below as mean ± standard deviation and are statistically analyzed by two-way ANOVA followed by Tukey's multiple comparison test, p- value <0.05 indicates statistically significant difference between the groups.

[0158] Animal study results:

[0159] Table 1:

[0160] * - in combination group (T4) compared to the sum of change in individual test groups (T1+T2+T3)

[0161] Groups Tl, T2, T3, and T4 showed a reduction in systolic blood pressure compared to the control group. However, the T4 group showed a statistically significant reduction in systolic blood pressure compared to the individual and combined effects of Tl, T2, and T3. This confirms the synergistic effect of the ingredients present in group T4.

[0162] Table 2:

[0163] All treatment groups Tl, T2, T3 and T4 exhibited reduced fasting blood glucose levels compared to the control group. Notably, the T4 group demonstrated a statistically significant reduction in fasting blood glucose levels relative to both the individual and combined effects of Tl, T2, and T3. This demonstrates the synergistic effect of the ingredients in group T4.

[0164] Table 3: * - in combination group (T4) compared to the sum of change in individual test groups (T1±T2±T3)

[0165] All treatment groups Tl, T2, T3 and T4 showed reduced serum triglyceride levels compared to the control group. Notably, the T4 group exhibited a statistically significant reduction in serum triglyceride levels compared to both the individual and combined effects of T 1 , T2, and T3. This highlights the synergistic effect of the ingredients in group T4.

[0166] Table 4:

[0167] All treatment groups Tl, T2, T3 and T4 demonstrated reduced serum LDL levels compared to the control group. Notably, the T4 group achieved a statistically significant reduction in serum LDL levels relative to both the individual and combined effects of Tl, T2, and T3. This illustrates the synergistic effect of the ingredients in group T4.

[0168] Table 5: * - in combination group (T4) compared to the sum of change in individual test groups (T1+T2+T3)

[0169] All treatment groups Tl, T2, T3 and T4demonstrated reduced serum SGPT levels compared to the control group. Significantly, the T4 group showed a statistically meaningful reduction in serum SGPT levels compared to both the individual and combined effects of Tl, T2, and T3. This demonstrates the combined synergistic effect of the ingredients in group T4.

[0170] Table 6:

[0171] All treatment groups Tl, T2, T3 and T4 demonstrated reduced serum SGOT levels compared to the control group. Notably, the T4 group exhibited a statistically significant reduction in serum SGOT levels compared to both the individual and combined effects of Tl, T2, and T3. This showcases the synergistic effect of the ingredients in group T4.

[0172] Table 7: * - in combination group (T4) compared to the sum of change in individual test groups (T1+T2+T3)

[0173] All treatment groups Tl, T2, T3 and T4 showed a reduction in platelet aggregation compared to the control group. Importantly, the T4 group exhibited a statistically significant decrease in platelet aggregation relative to both the individual and combined effects of Tl, T2, and T3. This emphasizes the synergistic effect of the ingredients in group T4.

[0174] Table 8:

[0175] * - in combination group (T4) compared to the sum of change in individual test groups (T1+T2+T3) All treatment groups Tl, T2, T3 and T4 showed an increase in serum SIRT1 levels compared to the control group. Importantly, the T4 group demonstrated a statistically significant elevation in serum SIRT1 levels relative to both the individual and combined effects of Tl, T2 and T3. This confirms the synergistic interaction of the ingredients in group T4.

[0176] Table 9:

[0177] All treatment groups Tl, T2, T3 and T4 showed increased serum adiponectin levels compared to the control group. Notably, the T4 group demonstrated a statistically significant elevation in serum adiponectin levels relative to both the individual and combined effects of Tl, T2 and T3. This highlights the synergistic interaction of the ingredients in group T4.

[0178] The results of the study as presented in the tables above clearly demonstrate that the nutraceutical composition comprising berberine, anthocyanin(s), and astaxanthin provides synergistic therapeutic benefits compared to the individual components. The composition demonstrates enhanced efficacy in improving cardiometabolic health by improving glucose and lipid homeostasis, regulating blood pressure, enhancing liver function, controlling platelet hyperactivity and increasing serum levels of SIRT1 and adiponectin. These synergistic effects result in significantly superior clinical outcomes, including reductions in fasting serum glucose, triglycerides, LDL levels, systolic blood pressure, platelet hyperactivity, SGPT, and SGOT, as well as improvements in adiponectin and SIRT-1 levels, underscoring the remarkable advantages of the present invention over prior-art compositions. Furthermore, the invention provides a comprehensive and multitargeted approach for the management and prevention of Type 2 Diabetes Mellitus (T2DM), arterial hypertension, dyslipidemia, obesity, non-alcoholic fatty liver disease (NAFLD), metabolic syndrome, cerebrovascular accidents (stroke), atherosclerosis and coronary artery disease by effectively normalizing critical metabolic health biomarkers. Overall, the invention addresses a critical unmet medical need in the management of cardiometabolic disorders and demonstrates significant therapeutic superiority, clinical benefits, and enhanced safety profiles relative to conventional monotherapies and existing nutraceutical interventions.

Claims

I / WE CLAIM:

1. A synergistic composition comprising:(a) Berberine;(b) Anthocyanin(s); and(c) Astaxanthin; or pharmaceutically acceptable salts, derivatives, isomers, or metabolites thereof.

2. The synergistic composition as claimed in claim 1, wherein Berberine, Anthocyanin(s) and Astaxanthin are in a ratio of 1:0.000125:0.000125 to 1:300:5.

3. The synergistic composition as claimed in claim 1, wherein the amount of:(a) Berberine is present in the range of 0.1976 to 99.7258 % w / w;(b) Anthocyanin(s) is present in the range of 0.0083 to 99.3213 % w / w; and(c) Astaxanthin is present in the range of 0.0056 to 70.9220 % w / w, by weight of the total composition.

4. The synergistic bioactive composition as claimed in claim 1, wherein:(a) Berberine is present in an amount ranging from 10 mg to 4000 mg;(b) Anthocyanin(s) is present in an amount ranging from 0.5 mg to 3000 mg; and(c) Astaxanthin is present in an amount ranging from 0.5 mg to 50 mg.

5. The synergistic bioactive composition as claimed in claim 1, wherein the composition is in the form of a tablet, capsule, powder, pill, hard capsule filled with liquid or solids, soft capsule, granule, pellet, caplet, mini-tablet, gummy, syrup, suspension, sachet, modified release formulation, or any other formulation intended for oral administration.

6. The synergistic bioactive composition as claimed in claim 1, further comprising one or more pharmaceutically acceptable excipients selected from a diluent, disintegrant, binder, solubilizing agent, lubricant, glidant, solvent, or a mixture thereof.

7. The synergistic bioactive composition claimed in claim 1, wherein:(a) Oral administration of the composition regulates glucose homeostasis by reducing fasting serum glucose levels by at least 31.72% more than the combined individual effects of berberine, anthocyanin(s) and astaxanthin; or(b) Oral administration of the composition reduces systolic blood pressure by at least 26.81% more than the combined individual effects of berberine, anthocyanin(s) and astaxanthin; or(c) Oral administration of the composition regulates lipid homeostasis by reducing serum triglycerides and low density lipoproteins by at least 19.28% and at least 20.31% respectively more than the combined individual effects of berberine, anthocyanin(s) and astaxanthin; or(d) Oral administration of the composition regulates liver functions by reducing Serum Glutamic Pyruvic Transaminase (SGPT) and Serum Glutamic-Oxaloacetic Transaminases (SGOT) by at least 27.33% and at least 50.54% respectively more than the combined individual effects of berberine, anthocyanin(s) and astaxanthin; or(e) The synergistic bioactive composition claimed in claim 1, regulates adipose tissue homeostasis by increasing serum adiponectin by at least 43.59% more than the sum of individual effects of berberine, anthocyanin(s) and astaxanthin; or(f) The synergistic bioactive composition claimed in claim 1, increases serum SIRT-1 levels by at least 96.00% more than the sum of individual effects of berberine, anthocyanin(s) and astaxanthin; or(g) The synergistic bioactive composition claimed in claim 1, reduces platelet aggregation by at least 45.43% more than the sum of individual effects of berberine, anthocyanin(s) and astaxanthin.

8. The synergistic bioactive composition as claimed in claim 1, wherein the composition is for the treatment or management of a condition selected from metabolic syndrome, dyslipidemia, hypertension, diabetes mellitus, and obesity.

9. A kit comprising:(a) Berberine;(b) Anthocyanin(s);(c) Astaxanthin; or pharmaceutically acceptable salts, derivatives, isomers, metabolites thereof;wherein the kit for the treatment or management of a condition selected from metabolic syndrome, dyslipidemia, hypertension, diabetes mellitus, and obesity.

10. The synergistic bioactive composition as claimed in claim 1, wherein the composition comprises:(a) Berberine in an amount ranging from 10 mg to 4000 mg;(b) Anthocyanin(s) in an amount ranging from 0.5 mg to 3000 mg;(c) Astaxanthin in an amount ranging from 0.5 mg to 50 mg; wherein berberine, anthocyanin(s) and astaxanthin are in a ratio of 1:0.000125:0.000125 to 1:300:5; wherein the composition is for oral administration; and wherein oral administration of the composition regulates glucose homeostasis by reducing fasting serum glucose levels by at least 31.72% and improves lipid homeostasis by reducing serum triglyceride levels by 19.28% more than the combined individual effects of berberine, anthocyanin(s), and astaxanthin.

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