Nutritional formulation for muscle health

Abstract

The disclosed embodiment relates to a nutritional formulation for muscle health. The formulation comprises of active agents, protein blends, essential micronutrients, excipients and flavoring agents. Furthermore, the active agent comprises of calcium hydroxyl methyl butyrate (CaHMB), antioxidant blends, an anti-inflammatory agent, synbiotic blend and veg omega blend. The nutritional formulation activates the protein synthesis in muscles and decreases the rate of muscle breakdown, wherein the anti-oxidant and anti-inflammatory compounds help in reduction of oxidative stress and inflammation in muscles. The nutritional formulation targets muscle loss and wastage, muscle recuperation, and immune-boosting functions.

Description

NUTRITIONAL FORMULATION FOR MUSCLE HEALTHPRIORITY CLAIMThe instant patent application is related to and claims priority from the India provisional patent application entitled, “NUTRITIONAL FORMULATION FOR MUSCLE HEALTH”, Patent Application no: 202441011090, Filed on: 16thFebruary 2024, which is incorporated in its entirety herewith.BACKGROUND OF THE DISCLOSED EMBODIMENTTechnical field

[0001] The disclosed embodiment is in technical field of a nutritional formulation for muscle health. More particularly, the formulation comprises of active agents, protein blend, essential micronutrients, excipients and flavoring agent.Related art

[0002] Individuals experiencing malnutrition and cachexia encounter substantial nutritional hurdles that have a profound impact on their general health and well-being. These challenges perpetuate a cycle of weight loss, muscle wasting, and compromised immune functions, intensifying their condition. In addition to inadequate caloric intake, these individuals also contend with deficiencies in protein and micronutrients. Digestion issues leading to malabsorption, metabolic alterations resulting from the loss of muscle and fat tissue, inflammation, and other factors further contribute to the complexity of their situation.

[0003] On the other hand, athletes, individuals engaged in recreational sports, fitness enthusiasts, gym-goers, and those undergoing intense physical training have heightened nutritional needs, especially for protein and essential micronutrients like vitamins, minerals, trace elements, and antioxidants. Relying solely on their diet may prove insufficient to meet these increased requirements without the risk of excessive intake of fats, calories, sugar, salt, and excess carbohydrates. Furthermore, athletes and sports enthusiasts who follow a vegetarian diet face an additional challenge in meeting their heightened protein needs

[0004] Even senior citizens often struggle to meet their daily nutritional requirements through food due to factors such as reduced appetite, difficulty chewing, and slow digestion. These challenges can lead to mild to moderate micronutrient deficiencies, negatively impacting their overall health. And the process of recovering from surgery or illness is often challenging and timeconsuming.

[0005] Currently, there is no single comprehensive formulation available that encompasses all essential elements necessary for maintaining muscle health and recovery.

[0006] Therefore, there is an urgent need to develop a nutritional formulation for muscle health. The formulation would serve as a vital nutritional formulation for muscle recuperation, recovery, healing, and boosting immunity.SUMMARY OF THE DISCLOSED EMBODIMENT

[0007] The disclosed embodiment relates to a nutritional formulation for muscle health. The composition comprises of active agents, protein blend, essential micronutrients, excipients and flavoring agent.

[0008] According to an embodiment, a nutritional formulation for muscle health, wherein the formulation comprises of: a) active agent; b) protein blend; c) essential micronutrients; d) excipient; and e) flavouring agent.

[0009] According to one embodiment, wherein the active agent comprises of CalciumHydroxyl Methyl Butyrate (CaHMB), antioxidant blend, anti-inflammatory agent, digestive blend, synbiotic blend and veg omega blend; wherein the antioxidant blend comprises of glutathione, lycopene, and co enzyme Q10; wherein the anti-inflammatory agent is curcumin; wherein the digestive blend comprises of amylase, protease, cellulose and lactase; wherein the synbiotic blend comprises of prebiotics and probiotics; wherein the veg omega blend comprises of omega 3,6, and 9.

[0010] According to another embodiment, wherein the CaHMB ranges from 475-525 mg; wherein the glutathione ranges from 225-275 mg; wherein the co enzyme Q10 ranges from 70- 85; wherein the lycopene ranges from 13-16mg; wherein the digestive blend ranges from 45-55 mg; wherein the curcumin ranges from 80-120 mg; wherein the veg omega blend ranges from 175-225 mg.[Oi l] According to one more embodiment, wherein the protein blend comprises of whey protein concentrate; pea protein isolate, and brown rice protein isolate; wherein the whey protein concentrate ranges from 6000 -7500 mg; wherein the pea protein isolate ranges from 3000-4500 mg, and brown rice protein isolate ranges from 1000-2500 mg.

[0012] According to another embodiment, wherein the essential micronutrients comprise of vitamins, minerals and trace elements; wherein the vitamins comprise of vitamin A, D, E, K, Bcomplex, and C; wherein the minerals comprise of iron, calcium, zinc, phosphorus, iodine, magnesium, manganese, potassium, copper; wherein the trace elements comprise of selenium, chromium, and molybdenum.

[0013] According to another embodiment, wherein the vitamin A ranges from 0.375 - 0.420 mg; vitamin D ranges from 147.4 -174.2 mg; vitamin E ranges from 3.5 - 4.5 mg; vitamin K ranges from 0.018 - 0.024 mg; vitamin C ranges from 30 - 35 mg; vitamin Bl ranges from 0.65 - 0.75 mg, vitamin B3 ranges from 6- 7.5 mg, vitamin B5 ranges from 0.18 -0.24 mg, vitamin B6 ranges from 0.5 - 1.5 mg, vitamin B7 ranges from 0.015-0.017 mg, vitamin B9 ranges from 1-13 mg, vitamin B 12 ranges from 0.00075 - 0.000925 mg; vitamin C ranges from 30 - 35 mg.

[0014] According to another embodiment, wherein iron ranges from 1- 1.2 mg; calcium ranges from 375 - 425 mg; zinc ranges from 9.5-10.5 mg; phosphorus ranges from 250-500 mg, iodine ranges from 0.130 - 0.150 mg, magnesium ranges from 250-275 mg; manganese ranges from 3-5 mg; potassium ranges from 50-100 mg, copper ranges from 0.8- 1.2 mg; selenium ranges from 0.038 - 0.042 mg, chromium ranges from 0.045 - 0.055 mg, and molybdenum ranges from 0.042 - 0.048 mg.

[0015] According to one more embodiment, wherein the excipient is a sweetener blend; wherein the sweetener blend comprises of stevia and sucralose; wherein stevia ranges from 400-500 mg; sucralose ranges 400-500 mg; wherein the flavouring agent is selected from natural identical chocolate flavour, natural identical vanilla flavour, and natural identical mango flavour; wherein the flavouring agent ranges from 200-400 mg.

[0016] According to one more embodiment, wherein the formulation is a hard-shell capsule, softgel capsule, liquid fill capsules, tablet, effervescent granules, beverages, powdered drink mix, melt-in mouth sachets, juices, bakes goods, gummies, jelly sticks, candies, or any combinations thereof.

[0017] According to one more embodiment, wherein the formulation is safe, non-toxic, gluten- free, solvent-free, pesticide-free, aflatoxin-free and free of adverse effects.

[0018] According to further embodiment, a method for preparing the nutritional formulation; wherein the nutritional formulation comprises of: a) sterilizing the manufacturing equipment; verifying measurements and operations by IPQA; b) obtaining the raw materials (comprising active agent, protein blend, essential micronutrients, excipients and flavoring agent); subjecting to the processes of dedusting, staging; sampling the raw materials; screening for quality through OPRP; storing at ambient conditions;c) dispensing the raw materials in a batch-wise manner; re-weighing the dispensed materials; milling; sifting; mixing the raw materials comprising active agent, protein blend, essential micronutrients, excipients and flavoring agent into an octagonal blender for 45 minutes to 1 hour to obtain the nutritional formulation; d) obtaining the packing materials; subjecting to the processes of dedusting, staging, sampling; screening for quality through OPRP; collecting the nutritional formulation into containers; packing in sachets; loading into foiled pouches; subjecting the pouches into a hopper; sealing; overprinting; knurling; cutting; and e) examining the product quality by manual and quality inspection; dispatching the nutritional formulation for commercialization.

[0019] According to another embodiment, wherein the raw materials are blended through dry blending under temperature at 22 - 25°C and relative humidity at 50±5%, this is to ensure to retain the efficacy of the nutrients in the formulation.

[0020] According to another embodiment, a method for reducing the risk of operative mortality and major morbidity for cardiac surgery, wherein the method comprises: a) selecting cardiovascular subjects over the age of 60 years for a clinical survey; dividing the subjects into two groups; b) considering 47 male subjects and 12 female subjects under Group 1; considering 47 male subjects and 11 female subjects under Group 2; c) administering Group 1 subjects with any one sachet of commercial nutritional formulation and Group 2 with one sachet of nutritional formulation (composition of the present disclosure) for muscle health for 30 days from the date of surgery; d) assessing the quality of life in both the groups by conducting a SF-36 survey; evaluating the SF- 36 scores in both the groups through a statistical analysis and the recommending the required dose of nutritional formulation.

[0021] According to yet another embodiment, wherein both Group 1 and Group 2 had a high to very high risk of operative mortality and major morbidity for cardiac surgery with an STS risk score of more than 8%; wherein the male subjects in both groups had a score of 9.09; wherein the female subjects in both groups had a score of 11.03.

[0022] According to another embodiment, wherein the SF-36 survey was conducted after 30 days of cardiovascular surgery; wherein the SF-36 score of 35-75 was obtained in male subjects of Group 1 indicating poor to moderate quality of life; wherein the SF-36 score of 60-95 was obtained in male subjects of Group 2 indicating moderate to good quality of life; wherein the evaluation of SF-36 scores in both the groups indicate that male individuals consuming the nutritional formulationfor muscle health have better quality of life when compared to male individuals consuming commercial nutritional formulations.

[0023] According to another embodiment, wherein the SF-36 score of 27-60 was obtained in female subjects of Group 1 indicating poor to moderate quality of life; wherein the SF-36 score of 35-75 was obtained in female subjects of Group 2 indicating moderate to good quality of life; wherein the evaluation of SF-36 scores in both the groups indicate that female individuals consuming the nutritional formulation for muscle health have better quality of life when compared to female individuals consuming commercial nutritional formulations.

[0024] According to another embodiment, wherein the subject is a human being; wherein the formulation is administered through the oral route in 200 mL of milk / water as a dietary supplement.

[0025] According to another embodiment, wherein the nutritional formulation for muscle health targets immune functions, muscle repair and recovery, reduce oxidative stress and retains muscle mass.

[0026] Several aspects of the disclosed embodiment are described below with reference to examples for illustration. However, one skilled in the relevant art will recognize that the disclosed embodiment can be practiced without one or more of the specific details or with other methods, components, materials and so forth. In other instances, well-known structures, materials, or operations are not shown in detail to avoid obscuring the features of the disclosed embodiment. Furthermore, the features / aspects described can be practiced in various combinations, though only some of the combinations are described herein for conciseness.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Example embodiments of the disclosed embodiment will be described with reference to the accompanying drawings briefly described below.

[0028] FIG.l illustrates a flowchart for preparation of nutritional formulation for muscle health, according to the aspects of the present disclosure.

[0029] FIG.l illustrates a flowchart for conducting a clinical survey amongst cardiovascular subjects to evaluate the impact of nutritional formulation for muscle health, according to the aspects of the present disclosure.

[0030] In the drawings, like reference numbers generally indicate identical, functionally similar, and / or structurally similar elements. The drawing in which an element first appears is indicated by the leftmost digit(s) in the corresponding reference number.DETAILED DESCRIPTION OF THE DISCLOSED EMBODIMENT

[0031] It is to be understood that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description orillustrated in the drawings. The present disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0032] The use of “including”, “comprising” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “a” and “a” herein do not denote a limitation of quantity, but rather denote the presence of at least one of the referenced items. Further, the use of terms “first”, “second”, and “third”, and the like, herein do not denote any order, quantity, or importance, but rather are used to distinguish one element from another.

[0033] As used herein, the singular forms “a”, “an”, and “the” include both singular and plural referents unless the context clearly dictates otherwise. By way of example, “a dosage” refers to one or more than one dosage.

[0034] The terms “comprising”, “comprises” and “comprised of’ as used herein are synonymous with “including”, “includes” or “containing”, “contains”, and are inclusive or open- ended and do not exclude additional, non-recited members, elements or method steps.

[0035] All documents cited in the present specification are hereby incorporated by reference in their totality. In particular, the teachings of all documents herein specifically referred to are incorporated by reference.

[0036] Example embodiments of the disclosed embodiment are described with reference to the accompanying figures.

[0037] In the drawings, like reference numbers generally indicate identical, functionally similar, and / or structurally similar elements. The drawing in which an element first appears is indicated by the leftmost digit(s) in the corresponding reference number.

[0038] DEFINITIONS

[0039] The term “Calcium Hydroxyl Methyl Butyrate (CaHMB)” refers to a compound that is a derivative of the amino acid leucine, which is one of the essential amino acids. Leucine is known for its role in protein synthesis and muscle protein metabolism. CaHMB is a form of HMB (hydroxyl methyl butyrate) that is bound to calcium.

[0040] The term “mTOR pathway” refers to mechanistic target of rapamycin, a crucial cellular signalling pathway that regulates various aspects of cell growth, proliferation, survival, and metabolism.

[0041] The term “glutathione” refers to a tripeptide found in most of the tissues, especially in high concentrations in the liver, and plays an extremely important role in protecting hepatocytes, erythrocytes, and other cells against toxic injury.

[0042] The term “free radicals” refer to highly reactive molecules that can damage cell membranes, proteins, and DNA, potentially contributing to aging and various diseases.

[0043] The term “curcumin” refers to a bright yellow chemical produced by plants of the Curcuma longa species. It is the principal curcuminoid of turmeric (Curcuma longa), a member of the ginger family, Zingiberaceae .

[0044] The term “coenzyme Q10” refers to a vitamin-like substance that helps convert food into energy. It's found in almost every cell in the body, and it's a powerful antioxidant. It is also known as ubiquinone. The "Q" refers to the quinone group and the " 10" refers to the number of the isoprenyl chemical subunits in its tail.

[0045] The term “lycopene” refers to a non-pro vitamin A carotenoid that is responsible for the red to pink colors seen in tomatoes, pink grapefruit, and other foods.

[0046] The term “omega 3 Fatty Acids” refers to a group of polyunsaturated fats that are essential for various physiological functions in the body.

[0047] The term “probiotics” refers to live microorganisms, primarily beneficial bacteria and yeast that confer health benefits to the host when consumed in adequate amounts.

[0048] The term “prebiotics” refers to a type of non-digestible food ingredient that promotes the growth and activity of beneficial microorganisms (such as bacteria) in the intestines.

[0049] The term “synbiotic blend” refers to a combination of probiotics and prebiotics that work together to support and improve gut health.

[0050] The term “enzyme” refers to type of protein that acts as a biological catalyst, facilitating and accelerating chemical reactions in living organisms.

[0051] The term “pea protein isolate” refers to a highly concentrated form of protein derived from yellow peas (Pis um sativum). It is produced by extracting the protein content from the peas and removing most of the carbohydrates and fat, which results in a protein powder that is typically around 80-90% protein by weight.

[0052] The term “whey protein concentrate” refers to a dietary supplement derived from whey, the liquid byproduct of cheese production. It contains around 70-80% protein by weight.

[0053] The term “essential micronutrients” refers to the vitamins and minerals required in small amounts for proper functioning and maintenance of the human body.

[0054] The term “muscle regeneration” refers to the physiological process by which damaged or injured muscle tissue undergoes repair and renewal.

[0055] The term “veg omega blend” refers to a dietary supplement that combines various plant-based sources of omega-3, omega-6, and omega-9 fatty acids.

[0056] The term "immunity booster" refers to any substance, product, or activity that is believed to enhance or strengthen the body's immune system. The immune system is a complex network of cells, tissues, and organs that work together to defend the body against harmful pathogens such as bacteria, viruses, and other foreign invaders.

[0057] The term "dedusting" refers to removing dust and other particulate matter from food products. This is crucial for maintaining hygiene and ensuring product quality.

[0058] The term "staging" refers to preparation and organization of food products at different stages of processing. This includes sorting, grading, and arranging products based on quality and size.

[0059] The term “sampling” refers to taking representative samples of food products at various stages of processing to ensure quality control. This helps in detecting any deviations from the desired standards and allows for corrective actions to be taken promptly.

[0060] The term "hopper" refers to a container employed in food processing to store and transfer materials like grains, flour, and other bulk ingredients. It typically has an opening at the bottom for controlled discharge of the contents.

[0061] The term "sifting" refers to a method in food processing to separate particles of different sizes or to remove impurities from ingredients.

[0062] The term "OPRP" refers to an operational prerequisite program, used in food safety management systems to minimize the risk of food safety hazards. This program ensures hygiene standards to reduce the likelihood of contamination.

[0063] The term “AHU” refers to an air handling unit humidifier, a device integrated into an air handling unit (AHU) to control and maintain the humidity levels in the air.

[0064] The term “IPQA” refers to In-Process Quality Assurance. It refers to the systematic monitoring and evaluation of various aspects of a production process to ensure that the final product meets the required quality standards. This procedure is done by conducting checks and inspections at different stages of the manufacturing process

[0065] The term “STS risk score” refers to to the Society of Thoracic Surgeons (STS) risk score, which is used to estimate the risk of operative mortality and major morbidity associated with various cardiac and thoracic surgeries. Operative mortality refers to the death rate of patients during or immediately after surgery while major morbidity involves significant complications that occur during or after surgery, such as stroke, renal failure, or infections.

[0066] The term “SF-36” refers to (36-Item Short Form Health Survey), a self-reported survey used to measure health-related quality of life. It was developed as part of the Medical Outcomes Study by the RAND Corporation. It includes 36 questions that cover eight domains of health.

[0067] The term Group 1 (Control group)- means the group was allowed to take commercially available any nutritional supplements without monitoring the dosage whereas Group 2 (Test Group)- means the group was administered with one sachet of nutritional formulation for muscle health(of the present disclosure).(1) EMBODIMENT OF THE DISCLOSURE

[0068] The disclosed embodiment relates to a nutritional formulation for muscle health. More particularly, the composition comprises of active agents, protein blend, essential micronutrients, excipients and flavoring agent.

[0069] According to the aspect of disclosed embodiment, a protein-based nutrition drink is a beverage formulated to provide a significant amount of protein, along with other essential nutrients, in a convenient and liquid form. These drinks are designed to supplement one's diet with additional protein, which is crucial for various physiological functions in the body, including muscle repair, growth, and maintenance.

[0070] According to other embodiment, the present disclosure is a nutrition drink-mix that contains protein from whey and vegetarian sources along with key essential micronutrients that help promote recovery, healing without loading on unnecessary calories, fat, and sugar. It is gentle on the stomach, easier to digest, does not cause bloating and supports gut health. It is ideally suitable for all adults including senior citizens to maintain health and overall well-being.

[0071] A) NUTRITIONAL FORMULATION FOR MUSCLE HEALTH

[0072] The nutritional formulation for muscle health comprises of following ingredients:

[0073] 1) Active agent

[0074] 2)Protein blend

[0075] 3)Essential micronutrients

[0076] 4)Excipients

[0077] 5)Flavoring agent

[0078] In further embodiment, the components are described in detail.

[0079] I) ACTIVE AGENT BLEND

[0080] a) CaHMB

[0081] Calcium [3-Hydroxy P-Methylbutyrate (CaHMB) is a metabolite of the essential amino acid leucine, which is one of the building blocks of proteins and considered for muscle protein synthesis.

[0082] CaHMB plays a key role in protein anabolism by activating the mTOR pathway, a key regulator of muscle protein synthesis that helps in increasing the rate muscle protein synthesis, which is crucial for muscle growth and repair.

[0083] CaHMB also reduces muscle protein breakdown, which is especially important during periods of intense exercise or muscle damage. By decreasing the rate at which muscle proteins are broken down, it helps maintain muscle mass and supports muscle recovery.

[0084] b) Antioxidant blend

[0085] Antioxidants are substances that help neutralize or counteract the damaging effects of free radicals (unstable molecules) in the body.

[0086] Antioxidants work by donating electrons to stabilize free radicals, thereby preventing or reducing oxidative damage.

[0087] In an embodiment, the antioxidant blend involves glutathione, lycopene, and Co enzyme Q10.

[0088] (i) Glutathione

[0089] Glutathione is a tripeptide molecule composed of three amino acids: cysteine, glutamic acid, and glycine. It is a crucial antioxidant found in cells throughout the body, playing a key role in protecting cells from oxidative stress and supporting the immune system.

[0090] This tripeptide helps maintain a healthy muscle environment by reducing oxidative stress and inflammation, which can indirectly support muscle protein synthesis and overall muscle health.

[0091] Glutathione is a potent antioxidant that helps neutralize free radicals by maintaining the balance between free radicals and antioxidants in the body.

[0092] (ii) Lycopene

[0093] Lycopene is a natural pigment and a powerful antioxidant that belongs to the carotenoid family. Carotenoids are pigments that give many fruits and vegetables their red, orange, and yellow colors. It possesses strong antioxidant properties, helping to neutralize harmful free radicals in the body.

[0094] (iii) Co enzyme Q10:

[0095] Co enzyme Q10 is a naturally occurring compound found in the cells of the human body. It plays a crucial role in the production of energy within the cells and serves as an antioxidant.

[0096] CoQlO also acts as an antioxidant, helping to protect cells from damage caused by free radicals.

[0097] c) Anti-inflammatory agent

[0098] Anti-inflammatory refers to substances or measures that act to reduce inflammation in the body. Inflammation is a natural and necessary part of the body's immune response to injury, infection, or harmful stimuli.

[0099] In an embodiment, the anti-inflammatory agent is curcumin present in the form of tetra hydro curcuminoids.

[0100] Curcumin is a natural compound found in the root of the turmeric plant (Curcuma longa), a member of the ginger family. It has a strong anti-inflammatory effect, thus can inhibit various molecules involved in inflammation of muscles.

[0101] d) Digestive blend

[0102] Digestive enzymes are substances that help break down macronutrients (such as carbohydrates, proteins, and fats) into smaller and easily absorbable molecules.

[0103] A digestive blend that includes amylase, protease, lipase, cellulase, and lactase typically contains a combination of enzymes that support the digestion of various nutrients in the body. These enzymes play specific roles in breaking down different types of macromolecules into smaller, more absorbable components.

[0104] (i) Amylase: Amylase is an enzyme that helps breaks down carbohydrates, specifically starches, into simpler sugars like maltose and glucose, providing a quick source of energy for muscle activity and recovery.

[0105] (ii) Protease: Protease, or proteolytic enzymes, is responsible for breaking down proteins into smaller peptides and amino acids, which are essential for muscle repair, growth, and recovery post-exercise. Various forms of protease are produced in the stomach (e.g., pepsin) and the pancreas (e.g., trypsin and chymotrypsin).

[0106] (iii) Lipase: Lipase is an enzyme that aids in the digestion of fats (lipids). It breaks down the lipids into fatty acids and glycerol, which are vital for energy production and cell membrane integrity.

[0107] (iv) Cellulase: Cellulase is an enzyme that helps break down cellulose, a complex carbohydrate found in the cell walls of plants. Since humans lack the ability to produce cellulase naturally, so this enzyme is included in digestive blends to assist in the breakdown of plant fibers.

[0108] (v) Lactase: Lactase is an enzyme that plays a crucial role in the digestion of lactose, a sugar found in dairy products. This enzyme is naturally produced in the small intestine and breaks down lactose into glucose and galactose, which can then be easily absorbed by the body. When added to nutritional formulations, lactase can help individuals who are lactose intolerant enjoy dairy products without experiencing discomfort like bloating, gas, or diarrhoea.

[0109] e) Synbiotic blend

[0110] Synbiotic blend is a combination of probiotics and prebiotics, which is designed to support a healthy gut microbiome.

[0111] (i) Probiotics: Probiotics are live microorganisms, mainly bacteria and yeast, that confer health benefits to the host when consumed in adequate amounts.

[0112] Probiotics help maintain a healthy balance in the gut microbiome by inhibiting the growth of harmful bacteria, enhancing the gut barrier function, and modulating the immune response.

[0113] In one embodiment, a probiotic blend consists of three strains of gut health promoting bacteria, wherein two strains of Lactobacillus and one strain of Bifidus were taken in a quantity of 2.4Bcfu.

[0114] (ii) Prebiotics: Prebiotics are non-digestible fibers that serve as a food source for beneficial bacteria in the gut. They promote the growth and activity of probiotics, helping to maintain a healthy balance of microorganisms in the digestive system.

[0115] In another embodiment, the prebiotics component consists of fructo oligosaccharides (FOS); well-known prebiotics that help nourish the beneficial microbiota promoting gut health.

[0116] f) Veg omega blend

[0117] A veg omega blend refers to a dietary supplement or a food product that combines various plant-based sources of omega fatty acids. Omega fatty acids are essential polyunsaturated fats that are important for overall health, and they play a crucial role in various physiological functions.

[0118] In an embodiment, the veg omega blend (from flax seeds and black seeds) involves omega 3, 6, and 9.

[0119] II) PROTEIN BLEND

[0120] A protein blend refers to a combination of different protein sources that are mixed together to create a product with a diverse amino acid profile. Blending of proteins is done to enhance the overall nutritional quality of the product and to provide a complete and balanced source of amino acids which is essential for muscle repair and recovery.

[0121] In an embodiment, the protein blend involves whey protein concentrate, pea protein isolate, and brown rice protein isolate.

[0122] (i) Whey protein concentrate (WPC): Whey protein derived from milk, is a fastdigesting protein that contains all essential amino acids.

[0123] (ii) Pea protein isolate: Plant-based protein derived from yellow peas is chosen for its suitability for individuals with dairy allergies or those following a vegetarian or vegan diet.

[0124] (iii) Brown rice protein isolate: Brown rice isolate is another plant-based protein source chosen for its hypoallergenic properties.

[0125] III) ESSENTIAL MICRONUTRIENTS

[0126] Essential micronutrients are nutrients that the human body requires in small amounts but are crucial for maintaining good health and well-being. Micronutrients include vitamins and minerals, and each plays specific roles in various physiological processes. Since the body cannot produce these micronutrients in sufficient amounts, supplementation of these is essential for muscle health. The micronutrients present in the formulation are:

[0127] (a) Vitamins

[0128] Vitamin A: Vitamin A supports protein synthesis, which is necessary for muscle growth and repair and immune functions, including the immune response involved in recovery from muscle damage.

[0129] Vitamin D: Vitamin D supports calcium absorption and bone health, indirectly influencing muscle function and repair.

[0130] Vitamin E: Vitamin E behaves as an antioxidant, protecting muscle cells from oxidative stress during exercise and the subsequent recovery period.

[0131] Vitamin K: Vitamin K is involved in blood clotting and bone metabolism, both of which can be important in the healing and repair of injured tissues.

[0132] Vitamin B Complex: The vitamins, including B l, B2, B3, B5, B6, B7, B9, and B12, play crucial roles in energy metabolism, which is essential for the cellular processes involved in muscle repair and growth. These vitamins are crucial for energy metabolism, helping convert food into energy that can be utilized by the muscles. B 12, in particular, is important for red blood cell production for delivering oxygen to muscles.

[0133] Vitamin C: Vitamin C supports collagen synthesis, a protein that provides structural support to connective tissues, including those in muscles.

[0134] (b) Minerals

[0135] Iron: It is essential for the production of haemoglobin, which transports oxygen to muscles. Iron is important for sufficient oxygen delivery during periods of increased demand such as muscle repair.

[0136] Calcium: It is essential for muscle contraction and plays a role in the signaling pathways involved in muscle repair. Calcium also helps in the transmission of nerve impulses to muscles, enabling movement and coordination.

[0137] Zinc: Zinc is involved in protein synthesis, cell division, and immune function, which are relevant to muscle repair.

[0138] Phosphorus: A component of ATP (adenosine triphosphate), the energy currency of cells, and important for energy metabolism in muscles.

[0139] Iodine: Iodine is necessary for the production of thyroid hormones, which regulate metabolism and energy production. Proper thyroid function is important for muscle strength and recovery.

[0140] Magnesium: This mineral plays a role in muscle relaxation and contraction. It helps maintain normal muscle function and supports energy production.

[0141] Manganese: Manganese is involved in bone formation and cartilage formation, relevant to overall musculoskeletal health.

[0142] Potassium: Potassium is essential for maintaining proper muscle function. It helps regulate fluid balance and nerve signals, ensuring efficient muscle contractions.

[0143] Copper: Supports the formation of red blood cells, which transport oxygen to muscles. Copper plays a role in collagen synthesis, contributing to the structural integrity of connective tissues.

[0144] (c) Trace Elements (Selenium, Chromium, and Molybdenum): Trace elements are needed in smaller amounts, they are essential in metabolic processes and may indirectly influence muscle repair and function.

[0145] IV) EXCIPIENTS

[0146] Excipients refer to substances added to formulations or other products primarily for the purpose of enhancing taste.

[0147] A sweetener blend is a mixture of sweetening agents or sugar substitutes used to sweeten food and beverages. The purpose of creating a blend is often to achieve a specific taste profile, sweetness intensity, or to address certain functional or nutritional requirements.

[0148] In an embodiment, the sweetener blend involves stevia and sucralose.

[0149] (a) Stevia: Stevia is a natural sweetener derived from the leaves of the plant Stevia rebaudiana.

[0150] (b) Sucralose: Sucralose is a synthetic sweetener created by modifying sucrose(sugar) by replacing three of its hydrogen-oxygen groups with chlorine atoms.

[0151] V) FLAVORING AGENT

[0152] The flavor refers to the overall sensory profile, taste, and aroma of the formulation.

[0153] In an embodiment, the flavors added are natural identical chocolate flavor, natural identical vanilla flavor, and natural identical mango flavor.

[0154] Natural identical chocolate flavor refers to a flavoring substance that has been synthesized to mimic the taste and aroma of natural chocolate.

[0155] Natural identical vanilla flavor refers to a flavoring substance that has been synthesized to mimic the taste and aroma of natural vanilla.

[0156] Natural identical mango flavor refers to a flavoring substance that has been synthesized to mimic the taste and aroma of natural mango.

[0157] TABLE 1: CATEGORIES OF NUTRITIONAL FORMULATION FORMUSCLE HEALTH

[0158] TABLE 2: PREFERRED WEIGHT OF NUTRIENTS (IN MG) IN THENUTRITIONAL FORMULATION FOR MUSCLE HEALTH

[0159] IDENTIFICATION OF THE SYNERGISTIC PROTEIN BLEND IN THENUTRITIONAL FORMULATION

[0160] TABLE 3: IDENTIFICATION OF PROTEIN BLEND DOSE IN THENUTRITIONAL FORMULATION FOR MUSCLE HEALTH

[0161] Two different protein blends were prepared for the nutritional formulation. Protein blend 1 had a high concentration of whey protein while protein blend 2 had a high concentration of pea protein.

[0162] The protein blend 2 had reduced whey protein concentrate, rice protein isolate and increased pea protein isolate as pea protein is considered to be a complete protein source comprising all the nine essential amino acids, less likely to cause bloating and is free from a wide range of allergens like lactose, gluten, soy, making it suitable for people with food sensitivities or allergies and to obtain a holistic nutritional formulation.

[0163] SYNERGISTIC EFFECT OF THE NUTRITIONAL FORMULATION

[0164] HMB is a metabolite of the amino acid leucine. It plays a role in muscle recovery and reducing muscle breakdown. CaHMB helps reduce muscle damage and soreness after intense exercise. HMB supplementation can retain muscle mass and performance, especially when combined with resistance training.

[0165] The antioxidant blend comprises of Coenzyme Q10 (CoQlO), glutathione and lycopene. CoQlO is essential for energy production in cells, particularly in muscle cells. It helps improve exercise performance, reduces muscle fatigue, and enhances muscle recovery by reducing oxidative stress and inflammation. Glutathione is a strong antioxidant helps in combating oxidative stress, which can damage muscle cells. It supports muscle recovery, reduces inflammation, and enhances overall muscle function by neutralizing harmful free radicals. Lycopene is another powerful antioxidant that protects muscle cells from oxidative damage. It helps reduce inflammation, and may lower the risk of muscle -related injuries.

[0166] Curcumin is the active compound in turmeric and has potent anti-inflammatory and antioxidant properties. It helps reduce inflammation, which is beneficial for muscle recovery after exercise. Curcumin can reduce muscle damage and inflammation after intense exercise, which is beneficial for muscle repair and recovery.

[0167] The digestive blend comprising enzymes such as amylase, protease, lipase, cellulase, and lactase can significantly enhance muscle health by optimizing the digestion and absorption of various nutrients. Amylase breaks down carbohydrates for quick energy, protease digests proteins into amino acids essential for muscle repair and growth, lipase aids in fat digestion for energy production in muscles, cellulase breaks down plant cellulose to aid overall digestion, and lactase ensures efficient digestion of dairy products. Together, these enzymes help ensure that muscles receive the necessary nutrients for optimal performance, repair, and growth.

[0168] The synbiotic blend combining probiotics and prebiotics is added to enhance muscle health by promoting a balanced gut microbiota. The combination allows nutrient absorption, particularly amino acids, vitamins, and minerals, which are crucial for muscle repair, growth, and recovery. The combined action of probiotics and prebiotics optimizes nutrient utilization and supports muscle health.

[0169] Omega-3, 6, and 9 fatty acids are essential for muscle health. Omega-3 reduces muscle soreness, inflammation, support muscle recovery, and improve blood flow. Omega-6 is crucial for energy production and cellular function while omega-9 enhances heart health, improves blood lipid profiles, and support muscle function by increasing mitochondrial efficiency.

[0170] A protein blend comprising whey protein concentrate, pea protein isolate, and brown rice protein isolate offers a comprehensive amino acid profile that is beneficial for muscle health. Wheyprotein concentrate is rich in essential amino acids and is quickly absorbed, making it suitable for post-workout recovery. Pea protein isolate is a plant-based protein that is hypoallergenic and provides a good source of branched-chain amino acids (BCAAs), which are crucial for muscle repair. Brown rice protein isolate complements the blend by providing additional BCAAs and supporting muscle growth.

[0171] Vitamins play a crucial role in enhancing muscle health by supporting various bodily functions essential for muscle maintenance and growth. Vitamin D aids in calcium absorption, which is vital for muscle health. Vitamin C is important for collagen production and protects muscles from oxidative stress. Vitamin E supports muscle repair and shields cells from damage caused by free radicals. B vitamins help convert food into energy and aid red blood cell production, ensuring efficient oxygen delivery to muscles. Vitamin A is essential for protein synthesis, necessary for muscle growth, and also supports immune function, which can impact overall muscle health.

[0172] Minerals and trace elements are crucial for muscle health as they support various physiological functions. Iron and copper are vital for oxygen transport, while calcium and magnesium are essential for muscle contraction and relaxation. Zinc and manganese aid in protein synthesis and muscle repair, and potassium regulates fluid balance and nerve signals for proper muscle function. Phosphorus, iodine, selenium, chromium, and molybdenum play significant roles in energy production, metabolism, and protecting muscle cells from damage.

[0173] The synergistic effect of combining CaHMB, antioxidant blend, anti-inflammatory agents, synbiotic blend, omega fatty acids, protein blend, and essential micronutrients can significantly enhance muscle health and aid in muscle growth, particularly in older adults and those with muscle-wasting conditions. The proposed nutritional formulation can support immune functions, muscle repair and recovery, reduce oxidative stress and retain muscle mass.

[0174] B) METHOD FOR PREPARATION OF THE NUTRITIONAL FORMULATION FOR MUSCLE HEALTH

[0175] The method for preparation of the nutritional formulation for muscle health was performed by maintaining standard manufacturing and production protocols. The equipment required for preparation of the nutritional formulation were sterilized as per the approved Standard Operating Procedures (SOP). All weights and volume measurements specified in the batch record was be checked by production team and verified by IPQA (In-Process Quality Assurance). The manufacturing operations and controls were conducted under the supervision of production and IPQA. The areas of dispensing and manufacturing process were maintained under air handling unit humidifier (AHU) conditions of ISO Class-8 (HEPA H14, Filter Efficiency - 99.999%). Calibration for the manufacturing equipment was done before beginning with the operation (102).

[0176] The raw materials (comprising active agent, protein blend, essential micronutrients, excipients and flavoring agent) were gathered and subjected to de-dusting and staging. De-dusting was done to remove dust or particulate matter from the materials through vacuum systems, jet filters while staging prepares and organizes the materials before further processing and separates the food products based on size, quality, etc (104).

[0177] The raw materials were shifted to the store; they were sampled in Laminar Air Flow (LAF) and inspected for quality by the operational prerequisite program (OPRP) to maintain hygiene standards and reduce the risk of contamination. The materials which did not pass the OPRP were rejected while the others were stored at ambient conditions (106).

[0178] The materials were subjected to milling and sifting. Milling processes the raw materials into fine particles by grinding through roller milling or hammer and screen mills. Sifting involves separating particles based on size to ensure uniformity and remove impurities through rotatory sifters / vibratory separators (108).

[0179] The raw materials were dispensed batch- wise through standard sieves in the designated area under controlled conditions (Temperature: NMT 25°C, RH: 50±5%). The materials were then subjected to dry blending in a sequence where the protein (bulking agent) was initially added, followed by the fructo oligosachharides, active agent, essential micronutrients, excipient and flavouring agent into an octagonal blender under controlled temperature at 25°C and relative humidity of 50+5% for 45 minutes to 1 hour to obtain the nutritional formulation (110).

[0180] The blending operation was performed as per the batch record, and the blended material shall be unloaded into a double-lined poly bag containing cleaned HDPE containers. The final blend was approved by Quality Control (QC) before sachet filling.

[0181] Initial settings of the sachet machine were performed, and in-process checks were carried out as per the frequency specified in the batch record and proceeded with continuous batch packing.

[0182] The packing materials (sachets) were gathered, subjected to dedusting, staging, sampling and nitrogen flushing, screened for quality through OPRP for verification (112). The prepared nutritional formulation was collected into sterile containers, packed into sachets, and loaded into foiled pouches (114). The pouches were subjected to a hopper for controlled release, then underwent sealing, overprinting, knurling and cutting (116) and inspected twice by manual and quality inspection (118). Finally, the pouches comprising the nutritional formulation were re-screened through the OPRP to check for bacterial contamination, chemical residues, and physical hazards, ensuring the product is safe for consumption.

[0183] The screened nutritional formulation pouches were further dispatched and processed for commercialization (120) as illustrated in (FIG.l).

[0184] 2) EXAMPLE EMBODIMENT

[0185] The disclosed embodiment will be further described in the following examples. It should be understood that these examples are for illustrative purposes only and are not to be construed as limiting this disclosed embodiment in any manner.

[0186] EXAMPLE 1(A): VANILLA FLAVOR OF NUTRITIONAL FORMULATION FOR MUSCLE HEALTH

[0187] In an embodiment, the nutritional formulation for muscle health is of a vanilla flavour.

[0188] The vanilla flavor of nutritional formulation for muscle health comprises of whey protein cone., pea protein, brown rice protein, omega 3, 6, 9, calcium hydroxyl methyl butyrate (Ca-HMB), digestive enzyme blend, coenzyme Q10 40% CWD, fructo oligo saccharides, probiotic blend, lycopene 10%, 1-glutathione reduced, tetrahydro curcuminoids 95%, vitamin A, vitamin D, vitamin E, vitamin K, vitamin C, vitamin B9 (Folic acid), vitamin Bl, vitamin B3 (Niacinamide), vitamin B6, vitamin B 12, vitamin B5 (Pantothenic Acid), vitamin B7 (Biotin), choline, iron, calcium (Milk Calcium), magnesium, zinc, iodine, copper, selenium, chromium, manganese, molybdenum, sweetener blend, naturally identical flavor (Vanilla).

[0189] TABLE 4: VANILLA FLAVOURED NUTRITIONAL FORMULATION FOR MUSCLE HEALTH

[0190] EXAMPLE 1(B): MANGO FLAVOR OF NUTRITIONAL FORMULATION FOR MUSCLE HEALTH

[0191] In an embodiment, the nutritional formulation for muscle health is of a mango flavour.

[0192] The mango flavor of nutritional formulation for muscle health comprises of whey protein cone., pea protein, brown rice protein, omega 3, 6, 9, calcium hydroxyl methyl butyrate (Ca-HMB), digestive enzyme blend, coenzyme Q10 40% CWD, fructooligosaccharides, probiotic blend, lycopene 10%, 1-glutathione reduced, tetrahydrocurcuminoids 95%, vitamin A, vitamin D, vitamin E, vitamin K, vitamin C, vitamin B9 (Folic acid), vitamin Bl, vitamin B3 (Niacinamide), vitamin B6, vitamin B12, vitamin B5 (Pantothenic Acid), vitamin B7 (Biotin), choline, iron, calcium (Milk Calcium), magnesium, zinc, iodine, copper, selenium, chromium, manganese, molybdenum, sweetener blend, naturally identical flavor (Mango).

[0193] TABLE 5: MANGO FLAVOURED NUTRITIONAL FORMULATION FOR MUSCLE HEALTH

[0194] EXAMPLE 1(C): CHOCOLATE FLAVOR OF NUTRITIONAL FORMULATION FOR MUSCLE HEALTH

[0195] In an embodiment, the nutritional formulation for muscle health is of a chocolate flavour.

[0196] The mango flavor of nutritional formulation for muscle health comprises of whey protein cone., pea protein, brown rice protein, omega 3, 6, 9, calcium hydroxyl methyl butyrate (Ca-HMB), digestive enzyme blend, coenzyme Q10 40% CWD, fructooligosaccharides, probiotic blend, lycopene 10%, 1-glutathione reduced, tetrahydrocurcuminoids 95%, vitamin A, vitamin D, vitamin E, vitamin K, vitamin C, vitamin B9 (Folic acid), vitamin Bl, vitamin B3 (Niacinamide), vitamin B6, vitamin B 12, vitamin B5 (Pantothenic Acid), vitamin B7 (Biotin), choline, iron, calcium (Milk Calcium), magnesium, zinc, iodine, copper, selenium, chromium, manganese, molybdenum, sweetener blend, naturally identical flavor (Chocolate).

[0197] TABLE 6: CHOCOLATE FLAVOURED NUTRITIONAL FORMULATION FOR MUSCLE HEALTH

[0198] The disclosed embodiment is a unique nutrition-drink mix that will be available in singleserve sachets. To consume, it must be reconstituted with 200 ml of water or milk, at your preference of temperature whether cold, at room temperature, or warm. For optimal results, it should be consumed immediately.

[0199] EXAMPLE II: TOXICOLOGY STUDIES

[0200] Toxicology studies were conducted for the active agent ingredients of the nutritional formulation. The studies were performed for coenzyme Q10, lycopene, tetrahydro curcumin, whey protein concentrate, pea protein and omega 3,6 and 9.

[0201] a) Coenzyme Q10:

[0202] Objective: To assess the acute, subacute, and genetic toxicity of Coenzyme Q10 (CoQlO) in mice and rats.

[0203] Acute Toxicity:• LD50 of CoQlO (oral) was >20 g / kg body weight in both male and female mice.

[0204] Genotoxicity Assessment:• Ames test conducted on Salmonella typhimurium strains TA97, TA98, TAI 00, and TAI 02.• Bone marrow micronucleus test and sperm abnormality test performed in mice.• No mutagenicity, micronucleus formation, or sperm abnormalities detected.

[0205] Subacute (30-day) Toxicity Study in Rats:• Doses: 0, 0.56, 1.13, and 2.25 g / kg body weight (oral, daily).• Findings: No significant effects on: i.Body weight, food intake, behavior, or mortality. ii. Hematology, blood biochemistry, or vital organ weight. iii. Sperm abnormality, mutagenicity, or micronucleus formation.• No adverse effects or clinical signs observed.

[0206] Conclusion: Study supports the safety of CoQlO for oral consumption.

[0207] Safety assessment of coenzyme Q10 (CoQlO)

[0208] Safety Profile (Animal & Human Data):• Low toxicity, no serious adverse effects reported in humans.• Acceptable Daily Intake (ADI): 12 mg / kg / day.• NOAEL (No-Observed-Adverse-Effect Level): 1200 mg / kg / day (from a 52-week chronic toxicity study in rats).• Equivalent to 720 mg / day for a 60 kg person.

[0209] Risk & Safety Assessment:• Observed Safety Level (OSL): 1200 mg / day per person (based on clinical trial data).• No effect on endogenous CoQ9 / CoQ10 biosynthesis after supplementation.• No accumulation in plasma or tissues post-supplementation.

[0210] Conclusion:• CoQlO is highly safe as a dietary supplement.• Pharmacokinetic studies confirm safety and bioavailability.

[0211] b) Lycopene

[0212] Objective:Ninety-day oral toxicity study of lycopene from Blakeslea trispora in rats

[0213] Tested Substance: Lycopene (20% w / w suspension in sunflower oil)

[0214] Source: Derived from Blakeslea trispora (fungal biomass)

[0215] Study Design:• Subjects: 20 male & 20 female Wistar rats per group• Duration: 90 days (subchronic toxicity study)• Dietary Concentrations: 0%, 0.25%, 0.50%, 1.0%

[0216] Lycopene Intake:• Males: 0, 145, 291, 586 mg / kg body weight / day• Females: 0, 156, 312, 616 mg / kg body weight / day

[0217] Results:• No signs of toxicity at any dose level• No adverse effects on: i. Clinical & neurob ehavi oral observations ii. Motor activity iii.Body weight & food consumption iv. Ophthalmoscopic examination v.Hematology, clinical chemistry, urinalysis vi. Organ weights, gross pathology, histopathology

[0218] Conclusion:• No-Observed-Effect Level (NOEL): 1.0% in diet (highest dose tested)• Lycopene from Blakeslea trispora is non-toxic at dietary levels up to 1.0%

[0219] c) Tetrahydro curcumin

[0220] Subchronic and Reproductive / Devel opmental Toxicity Studies of Tetrahydrocurcumin in Rats

[0221] Substance Studied: Tetrahydrocurcumin (THC), a major metabolite of curcumin(Curcuma longa)

[0222] Objective:

[0223] To evaluate the preclinical safety profile of THC through a 90-day subchronic toxicity study and a reproductive / developmental toxicity study in Wistar rats• Study Design:• Doses Tested: 100, 200, and 400 mg / kg / day (oral administration)• Duration: 90 days + 14-day recovery period (for subchronic toxicity study)• Parameters Monitored: i.Morbidity and mortality ii.Clinical signs iii.Clinical pathology iv. Histopathology• Reproductive / Developmental Study: i.THC administered at the same doses ii.Effects on reproductive / developmental parameters in adult male & female rats and pups were observed

[0224] Results:• No significant treatment-related effects at any dose• No adverse impact on observed parameters in either study

[0225] Conclusion:• No-Observed-Adverse-Effect Level (NOAEL): 400 mg / kg / day• THC is well-tolerated and does not pose toxicity concerns at tested doses in Wistar rats

[0226] d) Whey Protein Concentrate

[0227] Toxicity study and blood pressure-lowering efficacy of whey protein concentrate hydrolysate in rat models, plus peptide characterization

[0228] Acute Toxicity:• No deaths or treatment-related complications.• Median lethal dose (LD50) > 2,500 mg / kg.

[0229] Subacute Toxicity (Doses: 200, 400, 800 mg / kg):• No toxicity observed in any dose group compared to controls.

[0230] Antihypertensive Study in Spontaneously Hypertensive Rats

[0231] Dosing: 400 mg / kg showed significant blood pressure reduction (-47.8 mm Hg).

[0232] Comparison: More effective than previous findings (-21 mm Hg).

[0233] Dose-Dependent Effect: Higher doses led to greater blood pressure reduction.

[0234] Peptide Identification & Mechanism

[0235] Identified Peptides (8 total):• Key Peptides: VLSELPEP and LEQVLPRD.• Mechanism: Strong in vitro inhibition of angiotensin-I converting enzyme (ACE).• ICso Values: i.VLSELPEP = 0.049 mM ii.LEQVLPRD = 0.043 mM

[0236] Conclusion:

[0237] Whey protein concentrate hydrolysate is safe and non-toxic at tested doses.

[0238] Demonstrates significant antihypertensive activity in vivo.

[0239] Potential as a natural functional food ingredient for blood pressure regulation.

[0240] e) Pea Protein

[0241] Efficacy of Pea Protein Supplementation in Combination with a Resistance Training Program on Muscle Performance in a Sedentary Adult Population.

[0242] Objective:

[0243] Compare pea protein (PPr) vs. whey protein (WPr) for muscle strength, body composition, product perception, and safety in sedentary adults during an 84-day resistance training program.

[0244] Study Design:

[0245] Participants: Sedentary adults randomized to PPr or WPr groups.

[0246] Duration: 84 days.

[0247] The parameters assessed were:• Whole-body muscle strength (WBMS) (handgrip, lower & upper body strength).• Body composition.• Product perception & likability.• Safety outcomes (adverse events, vital signs, clinical chemistry, hematology).

[0248] Results

[0249] Muscle Strength & Mass:• No significant difference between PPr and WPr groups.• PPr group: 16.1% improvement in WBMS (p = 0.01).• WPr group: 11.1% improvement in WBMS (p = 0.06).

[0250] Product Perception & Likability:• No significant differences between the two groups.

[0251] Safety & Tolerability:• Both supplements were safe & well-tolerated.• Adverse events (AE) classified as: mild, moderate, or severe.• AE relationship to the study product categorized as: not related, unlikely, possibly, probably, most probably.• No clinically significant abnormalities in clinical chemistry or hematology.

[0252] Blood Parameter Analysis

[0253] Hematology:• WBC count (neutrophils, lymphocytes, monocytes, eosinophils, basophils).• RBC count, hemoglobin, hematocrit, platelet count.• RBC indices (MCV, MCH, MCHC, MPV, RDW).

[0254] Clinical Chemistry:• Liver function: ALT, AST, ALP, total bilirubin.• Kidney function: Creatinine, electrolytes (Na, K, Cl), eGFR.• Glucose levels.

[0255] Analysis: Conducted at LifeLabs (London, ON, Canada) using standardized procedures.

[0256] Conclusion

[0257] Supplementation with PPr for 84 days was safe and well tolerated in the population investigated. No AEs were categorized as “most probable”, “probably”, or “possibly” related to the study product.

[0258] f) Omega 3,6,9 Combination

[0259] Selective Toxicity Effect of Fatty Acids Omega-3, 6 and 9 Combination on Glioblastoma Neurons through their Mitochondria

[0260] Objective:

[0261] Investigate the selective toxicity effects of omega-3, omega-6, and omega-9 combinations on mitochondria isolated from U87MG human glioma cells (GBM) and HEK293 cells (normal control).

[0262] Key Findings:

[0263] Selective Toxicity in GBM Cells:• Omega-3, 6, and 9 significantly reduced succinate dehydrogenase (SDH) activity in U87MG glioma cells.• No effect on mitochondria from normal HEK293 cells.

[0264] Mitochondrial Dysfunction in GBM Cells:• Increased reactive oxygen species (ROS) levels.• Collapse of mitochondrial membrane potential (MMP).• Mitochondrial swelling.• Cytochrome c release, indicating apoptosis induction.

[0265] Conclusion:

[0266] Omega-3, 6, and 9 combinations selectively induce mitochondrial toxicity in GBM cells, without affecting normal cells.

[0267] Potential as a complementary therapy for glioblastoma (GBM) treatment.

[0268] EXAMPLE III: CLINICAL STUDY

[0269] CLINICAL SURVEY CONDUCTED FOR CARDIAC SUBJECTS

[0270] A system / method for assessing the risk of operative / post-operative mortality and morbidity in a subject, wherein the method comprises:

[0271] Subjects over the age of 60 years were chosen for the clinical survey. Amongst them, 94 were males and all 23 females were over the age of 60 years. All subjects were risk stratified using the STS risk scoring system. There were then divided into two groups for the clinical study (202).

[0272] Group l(Control): 47 male subjects and 11 female subjects having high to very high risk (STS score of >8%) consuming commercial nutritional supplements. The dosage of this supplementation was randomized and not recorded.

[0273] Group 2(Test): 47 male subjects and 12 female subjects having high to very high risk (STS score of >8%) consuming nutritional formulation for muscle health (204). The formulation was supplemented in one sachet comprising 21 g per serving.

[0274] TABLE 7: REPRESENTATION OF AVERAGE AGE OF THE MALE AND FEMALE CARDIOVASCULAR SUBJECTS CHOSEN FOR THE CLINICAL STUDY

[0275] Group 1 was allowed to take commercially available any nutritional supplements without monitoring the dosage whereas Group 2 was administered with one sachet of nutritional formulation for muscle health(of the present disclosure), in addition to their regular diet for a period of 30 days from date of surgery (206). The SF-36 survey was conducted and measured the outcomes by conducting a SF-36 survey to assesses their quality of life and interpret the overall health status in the subjects (208) as illustrated in (FIG.2).

[0276] Optimisation / synergistic composition of protein dose in the nutritional formulation

[0277] Three different protein doses of the nutritional formulation were supplemented to the cardiac subjects:

[0278] Nutritional formulation sachets were supplemented with three different doses of protein to observe muscle recovery. The doses were 6-8g / serving, 8-10 g / serving and 12-15g / serving.

[0279] It was seen that sachets with 8-10 g of protein were suffice to observe muscle recovery and retain muscle mass in the subjects. As there are other ingredients like essential micronutrients (vitamins & minerals) and active agents to help in absorption of the proteins, the dose was considered optimal for enhancing muscle health.

[0280] SF-36 HEALTH SURVEY

[0281] A SF-36 health survey was conducted to analyse the health of a subject before and after consuming the nutritional formulation.

[0282] Several parameters were checked in the subjects including:

[0283] a) Limitation of activities

[0284] The limitation of activities parameter was checked if the subject is limited to physical activities ranging from a strenuous sport to walking. The activities include vigorous activities like running, lifting heavy objects, participation in sport, etc; moderate activities like moving a table, pushing a vacuum cleaner, bowling, or playing golf; simple activities like lifting or carrying groceries, climbing stairs, bending, kneeling, stooping, bathing and walking.

[0285] b) Physical health problems

[0286] The physical health of the subject was assessed with questions if the subject had spent time on any activities or faced difficulty in performing them.

[0287] c) Emotional health problems

[0288] The subjects were checked if they had any problems in performing routine activities due to emotional health problems.

[0289] d) Social activities

[0290] The social status of the individuals with their family / friends were checked by analysing if their activities were affected due to emotional health problems.

[0291] e) Pain

[0292] Pain was one of the parameters selected to predict the extent of body pain in an individual and if any work-related activities were affected.

[0293] e) Energy and emotions

[0294] The energy and emotions of the subjects were tested with questions including about nervousness, energy levels, peace, and negative emotions.

[0295] f) General health

[0296] The general health parameter was tested to know the health status of a subject from their perspective.

[0297] TABLE 8: REPRESENTATION OF THE SF-36 SCORES OBTAINED IN THE CLINICAL SURVEY

[0298] Both the groups were assessed for STS risk score. In males, the STS risk score was 9.09 for both the groups which means the subjects have a high risk of operative mortality and major morbidity for cardiac surgery. In females, the STS risk score was 11.03 for both the groups which means the subjects have a very high risk of operative mortality and major morbidity for cardiovascular surgery.

[0299] The SF-36 scores were evaluated after 30 days of nutritional supplementation by obtaining the SF-36 survey results from both the groups. A SF-36 score of 60-95 was obtained in male subjects consuming the nutritional formulation for muscle health, this score indicates that the male individuals have a moderate to good quality of health. However, male subjects who were consuming other commercial nutritional supplements had a SF-36 score of 35-75 indicating that the quality of health in these individuals is poor to moderate. The comparative evaluation of the SF-36scores suggests that male subjects consuming the nutritional formulation for muscle health have better health when compared to male subjects consuming other commercial nutritional supplements.

[0300] A SF-36 score of 35-75 was obtained in females taking nutritional formulation for muscle health, this score indicates that the female individuals have a moderate to good quality of health. However, females who were consuming other commercial nutritional supplements had a SF-36 score of 27-60 indicating that the health quality of these individuals is poor to moderate. The comparative evaluation of the SF-36 scores suggests that female subjects consuming the nutritional formulation for muscle health have better health when compared to female subjects consuming other commercial nutritional supplements.

[0301] 3) ADVANTAGES OF THE DISCLOSED EMBODIMENT

[0302] The disclosed embodiment is designed to offer balanced nutrition to consumers who are unable to meet their dietary requirements, ensuring the maintenance of a stable nutritional status.

[0303] The proposed formulation promotes faster recovery of individuals who have undergone life-saving surgeries such as heart surgery or facing serious illnesses.

[0304] The said nutritional formulation provides balanced nutrition with elevated levels of proteins and micronutrients in required doses.

[0305] The disclosed embodiment minimizes the dietary gaps; helps boost immunity and help maintain overall health and well-being.

[0306] 4) USES, APPLICATIONS AND BENEFITS OF THE DISCLOSED EMBODIMENT

[0307] The proposed formulation can serve as a nutrition supplement for recuperation, recovery, healing and boosting immunity.

[0308] The disclosed nutritional formulation is designed to enhance the nutritional status of adults recovering from illness / surgery as well as senior citizens.

[0309] The formulation with balanced nutrition comprises of 33 vital nutrients, with highly bioavailable nutrients.

[0310] The proposed formulation is gentle on stomach, with no bloating also helps in reducing inflammation.

[0311] The formulation is low in sodium and contains the nutrient Coenzyme Q 10 for benefits of heart health.

[0312] It is renal friendly because of its low sodium and potassium content as well as better net protein utilization because of the combination of dairy and plant protein sources of whey, pea and brown rice protein.

[0313] The formulation comprises of protein with a combination of plant and dairy protein for optimal benefit.

[0314] The proposed formulation is suitable for:

[0315] (i) Individuals with diabetes and recovering from cardiac arrest.

[0316] (ii) Oncology patients, particularly after undergoing chemotherapy and radiation, bedridden or critical care individuals with sarcopenic obesity.

[0317] (iii) Women with polycystic ovary syndrome.

[0318] (iv) Individuals aiming to enhance muscle health and involved in sports training.

[0319] 5) BEST MODE TO PRACTICE

[0320] Best mode to practice the disclosed embodiment is as protein-based nutrition drink-mix which provides key essential nutrients to help individuals in muscle recovery, recuperation, promote healing and boost immunity.

[0321] The disclosed nutritional formulation will be available in single serve sachets. Individuals can consume by reconstituting the powder with 200 mL of water or milk, either cold, room temperature or warm and consumed immediately for best results.

[0322] Merely for illustration, only representative number / type of graph, chart, block, and subblock diagrams were shown. Many environments often contain many more block and sub-block diagrams or systems and sub-systems, both in number and type, depending on the purpose for which the environment is designed.

[0323] While specific embodiments of the disclosed embodiment have been shown and described in detail to illustrate the inventive principles, it will be understood that the disclosed embodiment may be embodied otherwise without departing from such principles.

[0324] Reference throughout this specification to “one embodiment”, “an embodiment”, or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosed embodiment. Thus, appearances of the phrases “in one embodiment”, “in an embodiment” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.

[0325] It should be understood that the figures and / or screen shots illustrated in the attachments highlighting the functionality and advantages of the disclosed embodiment are presented for example purposes only. The disclosed embodiment is sufficiently flexible and configurable, such that it may be utilized in ways other than that shown in the accompanying figures.

[0326] It should be understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this applicationand scope of the appended claims. All publications, patents, and patent applications cited herein are hereby incorporated by reference in their entirety for all purposes.

Claims

I / We claim:1) A nutritional formulation for muscle health, wherein the formulation comprises of: a) active agent; b) protein blend; c) micronutrients; d) excipient; and e) flavouring agent.2) The formulation as claimed in claim 1, wherein the active agent comprises of Calcium Hydroxyl Methyl Butyrate (CaHMB), antioxidant blend, anti-inflammatory agent, digestive blend, synbiotic blend and veg omega blend; wherein the antioxidant blend comprises of glutathione, 10% lycopene, and co enzyme Q10; wherein the antiinflammatory agent is curcumin (95% tetrahydro curcuminoids); wherein the digestive blend comprises of amylase, protease, cellulose and lactase; wherein the synbiotic blend comprises of prebiotics and probiotics; wherein the veg omega blend comprises of omega 3,6, and 9.3) The formulation as claimed in claim 2, wherein CaHMB ranges from 475-525 mg; wherein glutathione ranges from 225-275 mg; wherein co enzyme Q10 ranges from 70- 85; wherein 10% lycopene ranges from 13-16 mg; wherein the digestive blend ranges from 45-55 mg; wherein 95% tetrahydro curcuminoids range from 80-100 mg; wherein the veg omega blend ranges from 175-225 mg.4) The formulation as claimed in claim 1 , wherein the protein blend comprises of whey protein concentrate; pea protein isolate, and brown rice protein isolate; wherein the whey protein concentrate ranges from 6000 -7500 mg; wherein the pea protein isolate ranges from 3000- 4500 mg, and brown rice protein isolate ranges from 1000-2500 mg.5) The formulation as claimed in claim 1, wherein the micronutrients comprise of vitamins, minerals and trace elements; wherein the vitamins comprise of vitamin A, D, E, K, B complex, and C; wherein the minerals comprise of iron, calcium, zinc, phosphorus, iodine, magnesium, manganese, potassium, copper; wherein the trace elements comprise of selenium, chromium, and molybdenum.6) The formulation as claimed in claim 5, wherein the vitamin A ranges from 0.375 - 0.420 mg; vitamin D ranges from 147.4 -174.2 mg; vitamin E ranges from 3.5 - 4.5 mg; vitamin K ranges from 0.018 - 0.024 mg; vitamin C ranges from 30 - 35 mg; vitamin B l ranges from 0.65 - 0.75 mg, vitamin B3 ranges from 6- 7.5 mg, vitamin B5 ranges from 0.18 -0.24 mg,vitamin B6 ranges from 0.5 - 1.5 mg, vitamin B7 ranges from 0.015-0.017 mg, vitamin B9 ranges from 1-13 mg, vitamin B 12 ranges from 0.00075 - 0.000925 mg; vitamin C ranges from 30 - 35 mg.7) The formulation as claimed in claim 5, wherein iron ranges from 1- 1.2 mg; calcium ranges from 375 - 425 mg; zinc ranges from 9.5-10.5 mg; phosphorus ranges from 250-500 mg, iodine ranges from 0.130 - 0.150 mg, magnesium ranges from 250-275 mg; manganese ranges from 3-5 mg; potassium ranges from 50-100 mg, copper ranges from 0.8- 1.2 mg; selenium ranges from 0.038 - 0.042 mg, chromium ranges from 0.045 - 0.055 mg, and molybdenum ranges from 0.042 - 0.048 mg.8) The formulation as claimed in claim 1, wherein the excipient is a sweetener blend; wherein the sweetener blend comprises of stevia and sucralose; wherein stevia ranges from 400-500 mg; sucralose ranges 400-500 mg; wherein the flavouring agent is selected from natural identical chocolate flavour, natural identical vanilla flavour, and natural identical mango flavour; wherein the flavouring agent ranges from 200-400 mg.9) The formulation as claimed in claim 1, wherein the formulation is a hard-shell capsule, softgel capsule, liquid fill capsules, tablet, effervescent granules, beverages, powdered drink mix, melt-in mouth sachets, juices, bakes goods, gummies, jelly sticks, candies, or any combinations thereof.10) The formulation as claimed in claim 1, wherein the formulation is safe, non-toxic, gluten- free, solvent-free, pesticide-free, aflatoxin-free and free of adverse effects.11) A method for preparing the nutritional formulation; wherein the method comprises of a) sterilizing the manufacturing equipment; verifying measurements and operations by IPQA; b) obtaining the raw materials (comprising active agent, protein blend, essential micronutrients, excipients and flavoring agent); subjecting to the processes of dedusting, staging; sampling the raw materials; screening for quality through OPRP; storing at ambient conditions; c) dispensing the raw materials in a batch-wise manner; re-weighing the dispensed materials; milling; sifting; mixing the raw materials comprising active agent, protein blend, essential micronutrients, excipients and flavouring agent into an octagonal blender for forty -five minutes to one hour to obtain the nutritional formulation; d) Obtaining the packing materials; subjecting to the processes of dedusting, staging, sampling; screening for quality through OPRP; collecting the nutritional formulationinto containers; packing in sachets; loading into foiled pouches; subjecting the pouches into a hopper; sealing; overprinting; knurling; cutting; and e) examining the product quality by quality inspection; dispatching the nutritional formulation for commercialization.12) The method as claimed in claim 11, wherein the raw materials are blended through dry blending under temperature at 22 - 25°C and relative humidity at 50+5%.13) A system / method for assessing the risk of operative / post-operative mortality and morbidity in a subject, wherein the system / method comprises: a) selecting cardiovascular subjects over the age of sixty years; dividing the subjects into two groups; b) considering forty-seven male subjects and twelve female subjects under Group 1 (Control group); considering forty-seven male subjects and eleven female subjects under Group 2 (Test group); c) allowing Group 1 subjects to consume one sachet of commercial nutritional formulation and administering Group 2 with one sachet of nutritional formulation for muscle health for 30 days from the date of surgery; d) assessing the quality of life and muscle health in Group 1 and Group 2 through a SF-36 survey; e) evaluating the SF-36 scores in Group 1 and Group 2 through a statistical analysis; and f) recommending the required dose of nutritional formulation for muscle health.14) The system / method as claimed in claim 13, wherein one sachet of nutritional formulation is of 21 g; wherein one sachet delivers 10 g of protein per serving.15) The system / method as claimed in claim 13, wherein both Group l(Control) and Group 2 (Test) had a high to very high risk of operative mortality and major morbidity for cardiac surgery with an STS risk score of more than 8%; wherein the male subjects in both groups had a score of 9.09; wherein the female subjects in both groups had a score of 11.03.16) The system / method as claimed in claim 13, wherein the SF-36 survey was conducted after 30 days of cardiovascular surgery; wherein the SF-36 score of 35-75 was obtained in male subjects of Group 1; wherein the SF-36 score of 60-95 was obtained in male subjects of Group 2.17) The system / method as claimed in claim 13, wherein the SF-36 score of 27-60 was obtained in female subjects of Group 1; wherein the SF-36 score of 35-75 was obtained in female subjects of Group 2.18) The system / method as claimed in claim 13, wherein the subject is a human being; wherein the formulation is administered through the oral route in a beverage product as a dietary supplement.19) The system / method as claimed in claim 13, wherein the nutritional formulation for muscle health enhances the physical fitness, emotional health and social status of the subjects at the end of thirty days of supplementation.20) The system / method as claimed in claim 13, wherein the nutritional formulation for muscle health targets immune functions, muscle loss / wastage, muscle repair and recovery, reduce oxidative stress and retains muscle mass.

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