DESC:HERBAL ENHANCED GAINING FORMULA
Technical Field of the Invention
The present invention relates to a herbal composition for weight gaining The herbal composition disclosed herein are meant for increasing the testosterone levels, balance the digestion and appetite stimulation in athletes involved in muscle mass gaining, weight gaining and body building. This herbal composition is a unique blend of three ingredients especially herbs, probiotics and prebiotics that act synergistically to produce the desired effect. The current invention is formulated to increase the testosterone levels and balance the digestion issues along with improving the appetite to help increase the calorie intake.

BACKGROUND OF INVENTION
In the modern society, where the world is grappling with an obesity crisis, the desire to gain weight may appear to be a strange one. The reason people are looking for gaining weight is because fat is a beauty substance and being underweight affects the performance, mental health and immunity. Further to build muscles, excess energy in the form of calories is required. Also, gaining weight in the form of muscle mass improves the fat to muscle ratio which is highly desired by the athletes and gym goers.
Gym goers are generally low on fat intake which negatively impacts the anabolic hormone resulting in reduced serum concentrations of hormones such as testosterone, IGF-1 and insulin. Testosterone is a steroidal hormone responsible for the development of male sexual characteristics and it has been proven in various studies that testosterone impacts the weight gaining and also helps in providing strength. More specifically, the low levels of testosterone lead to muscle loss. According to a review, low testosterone increases fat deposits in the body especially in the belly region due to the production of an enzyme called aromatase. This enzyme converts testosterone to estrogen. Estrogen causes more fat to be deposited in the chest, hips, and thighs.
Today’s sports and nutrition market is flooded with a number of weight gaining, muscle mass gaining and strength providing products. With the advancement in the knowledge among athletes along with heavy training and exercise they consume these products which brings a lot of changes in physiology. These formulations combines high calories, fast and slow releasing proteins. These proteins in the body break down into amino acids, which remains in bloodstream till absorption. The slow releasing protein i.e. casein impacts the digestion and appetite of the consumer as it stays in body for more than 4 to 5 hours, giving the feeling of satiety to the consumer for long time. Moreover, it is reported that whey protein though a fast releasing protein, induced satiety for long by suppressing the hunger and appetite. High protein supplements led to gut issues by depleting gut microflora like bifidobacterium longum in athletes. This consequently has negative repercussions on athlete’s health. High protein supplements give the feeling of fullness early for long time which is a negative point in case of a person struggling for weight gain. With voluminous protein intake, more peptides enter the systemic circulation and the distal parts of the GI tract, and proteolytic fermentation may occur; this may emphasize gastrointestinal (GI) related symptoms, cause immune system disturbance and promote inflammation, damage, and dysfunction in the GI tract. Microbiota contributes to amino acid absorption and synthesis and participates in energetic pathway regulation in skeletal muscle which may affect, for instance, muscle metabolism, size and composition. Supplementation with both protein and probiotic Bacillus coagulans has been found to decrease recovery time after 24 and 72 hours in a strength exercise study protocol, and to reduce muscle damage, muscle soreness, and decline in peak power. The negative effects of high-protein diets and harmful amino acid fermentation products might also be reduced by adding prebiotics, such as resistant starch, vegetables, and fiber, to the diet as this promotes gut colonization by benign microbes, increases saccharolytic fermentation, decreases protein fermentation, increases GI inflammation control, and gut permeability reduction. Gut microbiota dysbiosis may, alter the host energy homeostasis and facilitate fat accumulation in adipose tissue by interfering with insulin sensitivity. According to the International Society of Sports Nutrition (ISSN), in athletic populations, certain probiotics strains can increase absorption of important nutrients needed for optimal performance and recovery (such as amino acids from protein), can strengthen a weakened immune system from training overload, can improve gut strength that may have eroded after prolonged exercise in heat, and provide anti-inflammatory benefits linked to improved recovery from muscle-damaging exercise. Additionally, the ISSN says there are many more potential benefits to an athletic population being researched including improved body composition and lean body mass, normalizing age-related declines in testosterone levels, reductions in cortisol levels indicating improved responses to a physical or mental stressor, reduction of exercise-induced lactate, and increased neurotransmitter synthesis, cognition and mood.
Focusing on above parameters of impact of low testosterone levels and high protein-energy supplements on athletes or consumers looking for weight gaining, the inventors have come up with a novel idea of herbal enhanced gaining composition which is a combination of digestive enzyme blend of probiotics and prebiotics factor suitable for gut health; appetite blend; and testosterone booster blend. It is a unique combination of various herbs like fennel, ashwagandha (Withania somnifera), Gokhru (Tribulus Terresteris), jeera (Cumin), Safed musli, fenugreek, peppermint extract etc. Additionally, probiotics, prebiotics, and digestive enzymes are added. All these not only stimulates the level of testosterone beneficial for weight gaining and providing strength but also helps in easing the digestion and stimulating the appetite positively.
SUMMARY OF THE INVENTION
In one general aspect, the present invention relates to a herbal composition which comprises:
testosterone boosting herbs;
appetite stimulating herbs; and
a digestive blend containing digestive enzymes, probiotics and prebiotics.
In one embodiment of the above aspect, the testosterone boosting herbs are selected from fenugreek, ashwagandha, safed musli, shatavri, ginseng, and Tribulus Terresteris, Ginseng, Asparagus racemosus (shatawari), Serenoa repens (Saw palmetto), Urtica dioica (Stinging nettle) and combinations thereof.
In another embodiment of the above aspect, the appetite stimulating herbs are selected from fennel, cumin, Ginger, peppermint, black pepper and combinations thereof.
In another embodiment of the above aspect, the digestive enzymes are selected from amylase, lactase and protease. The preferred protease enzymes are pepsin and trypsin.
In another embodiment of the above aspect, the probiotics are selected from probiotic strains of Bifido bacteria, Lacticaseibacillus, Ligilactobacillus, Lactiplantibacillus, Bacillus Subtilis, and Lactobacillus and combinations thereof.
In another embodiment of the above aspect, the prebiotics are selected from Fructo oligosaccharide (FOS), inulin and lactulose and combinations thereof.
DETAILED DESCRIPTION OF THE INVENTION
This herbal composition not only increase the testosterone levels but also help in gaining weight and muscle mass. Moreover, it will overcome the problems associated with other gaining products like, indigestion, feeling of fullness, gut health issues like diarrhoea, bloating etc.
TESTOSTERONE BOOSTING HERBS
Ashwagandha (Withania somnifera) also known as Indian ginseng belongs to solanaceae family. It is a best known natural supplement for boosting testosterone levels. It is rich in wide variety of chemical compounds like withanolides, withaferins, saponins and alkaloids like isopelletierine and anaferine amino acids. It is a useful adjunct to overcome stress during strength training, gaining muscle mass, strength and reducing belly fat. Being an adaptogen, it helps in maintaining weight due to binge eating or stress. Ashwagandha can be used in the form of powder or the extract standardised to containing Withanaloids in amount of 2% to 35%.
Gokhru (Tribulus Terrestris) is a small leafy plant, also known as puncture vine. Traditionally has been used for a variety of potential effects, including enhancing libido, keeping the urinary tract healthy and increasing the testosterone levels. It has many chemical compounds, among which the best known are steroidal glycosides (saponins) and alkaloids. Gokhru could reduce inflammation by attenuating muscle damage and oxidative damage. Gokhru is useful for athletes because of its potential ergogenic effects on sports performance by facilitating recovery after exercise, improvement of strength and stimulation of skeletal muscle hypertrophy associated by increasing testosterone levels, and promoter of muscle anabolism. It has been suggested an effective weight gainer by increasing the testosterone levels in body. Gokhru may be used in the form of powder or extract for the same standardised to flavonoids, saponins and alkaloids.
Fenugreek (Trigonella foenum-graecum) is one of the oldest medicinal plants. Extensive pre-clinical and clinical investigations have demonstrated its broad spectrum pharmacological, medicinal, and therapeutic properties including antioxidant, antidiabetic, anti-hyperlipidemic, anti-inflammatory, antifungal, antibacterial, and galactogogue. Many studies have demonstrated its beneficial effects is sports nutrition, muscle building, and exercise. It contains compounds called furostanolic saponins, which are believed to increase testosterone production. Fenugreek supplements may improve testosterone levels and symptoms related to low testosterone. It can increase testosterone through an aromatase and 5a reductase inhibition. The oral administration of Fenugreek extract in clinical practice is expected to improve sports nutrition performance. It is an effective ergogenic aid for rapid improvement in exercise performance capabilities and body composition above and beyond that of resistance exercise.
Safed Museli (Chlorophytum borivilianum) belongs to family Liliaceae. It helps in strengthening the muscles, thus enhancing the body's endurance. It's also a natural remedy of stress and depression, which kills the appetite, make a person gain fat in adipose tissues around belly and reduces testosterone levels. Saponins, flavonoids, alkaloids, steroids, triterpenoids, phenolic acids, Gallo-tannins, vitamins, potassium, magnesium, calcium, rare elements such as zinc, copper, phosphorous, resins, glucose, protein, fibre, are major constituents of safed museli. The saponins present in safed musli have adaptogenic, health-restorative, and health-promoting qualities.
APPETITE STIMULATING HERBS
Cumin (Cuminum cyminum L) belongs to Apiaceae family and is used in traditional medicine including stomach disorders and diarrhea. It predominantly consists of fats that play a crucial role in maintaining our vascular system i.e., Mono unsaturated Fatty Acids. Many studies have proven the potential role of cumin in stimulating pancreatic enzymes, enhancing the digestive enzymes and anti-nutritional blocker activity like amylase, lipase, protease and phytase respectively which helps in digestion. It combats flatulence problems, eventually leading to better absorption and more satisfying food intake. It activates or stimulates the appetite by stimulating salivary glands. It contains thymoquinone which helps in removing toxins from the body, stimulating salivary glands, enzymes and bile, all of which are involved in the breakdown of food and availability of nutrients. The thymol stimulates the enzymes, which enables better secretion of digestive juices. Moreover, thymoquinone content has gastro-protective properties and is a carminative, which means it may help to relieve flatulence in the stomach and intestines, thereby improving digestion and appetite.
Fennel (Foeniculum vulgare) is a herb belonging to the Apiaceae family has been widely used for medicine and clinical studies. The principal constituents of the essential oil extracted are anethole (50–60 %), limonene and fenchone. It is a good source of vitamin C, a water-soluble vitamin critical for immune health, tissue repair, and collagen synthesis. It contains the mineral manganese, which is important for enzyme activation. Fennel is known to stimulate a healthy appetite and digestion; significantly shortening the food transit time. Fennel is an excellent stomach and intestinal remedy for treating flatulence and colic conditions. It stimulate the production of bile by the liver, thereby promoting digestion. Trans-anethole, is known to exhibit efficacy on appetite which is similar to catecholamine, and acts similarly to amphetamine with respect to appetite. Fennel seeds contain a rare combination of warming and cooling properties that helps in stimulating the appetite before meals and facilitate digestion afterwards. It helps in smoothening the blood flow to the stomach thus, helping the digestive system to work properly. The volatile oils estragole, fenchone and anethole in it help kick-start digestion by stimulating the production of gastric enzymes.
Black Pepper (Piper nigum) called as ‘the king of spices’ contains piperine. The piperine present in it helps in better absorption of nutrients. It increases nutrient absorption by increasing the metabolism. It will help in reducing mental stress by increasing the seratonin and dopamine levels. It has been used for stimulating the appetite along with increased saliva secretion and encouraging peristalsis. Piperine significantly enhances pancreatic lipase activity and stimulates secretion of pancreatic amylase, trypsin, and chymotrypsin.

DIGESTIVE BLEND CONTAINING DIGESTIVE ENZYMES
Digestive Enzymes are substances that help in digesting food. They are secreted by the salivary glands and cells lining of the stomach, pancreas and small intestine. There are a number of digestive enzymes with a specific role for example:
Amylase is important for digesting carbohydrates. It breaks down starches into sugars. Amylase is secreted by both the salivary glands and the pancreas.
Lactase (Lactase-phlorizin hydrolase) Lactose that is not absorbed rather it is fermented by bacteria in the gut. This can cause flatulence and an upset stomach. Hence, lactase enzyme is helpful as it breaks down lactose into the glucose and galactose. It is produced by cells known as enterocytes that line the intestinal tract.
Proteases also called peptidases, proteolytic enzymes, or proteinases. These digestive enzymes break down proteins into amino acids. Proteases are produced in the stomach and pancreas. The main ones are:
• Pepsin is secreted by the stomach to break down proteins into peptides or smaller groupings of amino acids. Those amino acids are then either absorbed or broken down further in the small intestine.
• Trypsin forms when an enzyme secreted by the pancreas is activated by an enzyme in the small intestine. Trypsin then activates additional pancreatic enzymes, such as carboxypeptidase A, B and chymotrypsin, to help break down peptides into individual, basic and free amino acids respectively.
PROBIOTICS AND PREBIOTICS
Gastrointestinal symptoms of nausea, vomiting, cramping or discomfort, and diarrhea in athletes may be caused by infections, adverse reactions to ingested food, or stresses to the gut during exercise. Probiotics are defined as ‘live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Possible mechanisms of action may include enhancing the natural barrier function of the normal intestinal mucosa and production of enzymatic activities and/or beneficial metabolites for the host.
Lactic Acid Bacteria (LAB): These are non-pathogenic, facultative aerobes, non-toxigenic, gram-positive and fermentative bacteria that are associated with the production of lactic acid from carbohydrates. Lactobacillus acidophilus strain of LAB is capable of creating antimicrobial compounds and lowering pH, which may contribute to its potential to enhance abundance of symbiotic bacteria within the gut microbiome. The present invention includes individual or combination of Lactobacillus (ssp. acidophilus, fermentum, plantarum, rhamnosus, casei, reuteri, gasseri), Streptococcus (e.g. salivarius, thermophilus) and Lactococcus etc. Bifidobacterium is selected from the group comprising Bifidobacterium lactis, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium breve. These strains have been known to have high tolerance to gastrointestinal conditions. Bifidobacterium bifidum strain is one of the most abundant in breast milk and has many established benefits for neonatal health. Strains of Bifidobacterium bifidis have been demonstrated to suppress irritable bowel syndrome and allergic responses.
Bacillus coagulans is a gram-positive, facultative anaerobic, nonpathogenic, spore-forming, lactic acid-producing bacteria. Digestive enzymes produced by B. coagulans are known to be active in the gut, and its proteases are found to regulate amino acid metabolism in the body. For example, a study has reported that consumption of B. coagulans PTA-6086 could increase absorption of branched-chain amino acids and amino acids involved in blood flow regulation (citrulline) or recovery (glutamine). Another research reported the synergistic effect of B. coagulans GBI-30, 6086 with casein protein to augment digestion and modulate absorption.
Bacillus Clausii is a rod-shaped, spore-forming, aerobic, Gram-positive probiotic bacterium that is acid resistant and able to colonize the gut that restores gut microflora, promotes immunity and is known to reduce diarrheal symptoms.
Bacillus Subtilis survives passage through the acidic environment of GI tract to help crowd out bacterial pathogens and maintain healthy gut barrier function by boosting immunity, preventing pathogen entry and improving gut health. Further research on the effects of supplementation during off season resistance training in female athletes produced significant improvements in body composition when consumed in conjunction with a high-protein recovery drink.
Prebiotics are described as a selectively fermented dietary ingredient that results in specific changes, in the composition and activity of the gastrointestinal microbiota, thus conferring benefits upon host health. These are found in plant-based foods, fructo oligosaccharides, inulin, lactulose etc. The undigestible fiber in these foods skips right past digestion and ferments in the gut to create fuel for the probiotics.
The majority of successful human trials on prebiotics show significantly increased intestinal levels of bifidobacteria and lactobacilli.
The use of prebiotics and probiotics together, known as synbiotics. Synbiotics are defined as ‘mixtures of probiotics and prebiotics that beneficially affect the host by improving the survival and implantation of live microbial dietary supplements in the gastrointestinal tract of the host. According to some studies, probiotics, prebiotics and synbiotics may benefit athletes indirectly by maintaining gastrointestinal function and health.
The herbal composition of the invention is prepared by mixing the required quantity of probiotics, prebiotics and digestive enzymes with a measured quantity of testosterone boosting, appetite stimulating herbs. The formula dosage would vary between 1-5 gram per 100 gram serving. The amount of the herbal composition is sufficient to elicit the beneficial effects to the consumer. The herbal compositions of the present invention may be formulated into a dosage form selected from dry powder form, liquid form, beverage, food product like bars, dietary supplement or any suitable form such as tablet, capsule or a sachet.
The presented examples illustrate the invention, but they should not be considered to limit the scope of the invention in any way.
This synergistic herbal enhanced gaining compositions include the powder / extracts/ live bacteria as mentioned below:

Example 1:
Active Ingredient Quantity (Grams)
Bifidobacterium breve 0.100
Bacillus Clausii 0.200
Bacillus Subtilis 0.400
Fenugreek extract 0.010
Bifidobacterium lactis 0.100
Lactobacillus acidophilus 0.500
Lactase 0.100
Shatavari 0.200
Fennel Extract 0.400
Inulin 0.100
Fructo oligosacharide (FOS) 0.200
TOTAL 2.3100

Example 2:
Active Ingredient Quantity (Grams)
Bifidobacterium breve 0.100
Bacillus Clausii 0.090
Bacillus Subtilis 0.070
Piperine extract 0.020
Bifidobacterium lactis 0.020
Bifidobacterium bifidum 0.100
Lactase 0.200
Fennel Extract 0.090
Safed musli extract 0.200
Inulin 0.100
Lactulose 0.200
TOTAL 1.1900

Example 3:
Active Ingredient Quantity (Grams)
Ginseng Extract 0.300
Ashwagandha Extract 0.500
Bacillus Subtilis 0.100
Piperine extract 0.300
Bifidobacterium lactis 0.100
Bifidobacterium bifidum 0.010
Amylase 0.300
Salam Panja 0.200
Lacticaseibacillus paracasei 0.300
Fennel Extract 0.100
Cumin Extract 0.200
FOS 0.400
Lactulose 0.200
TOTAL 3.010

Example 4:
Active Ingredient Quantity (Grams)
Ginseng Extract 0.100
Ashwagandha Extract 0.700
Bacillus Subtilis 0.200
Piperine extract 0.070
Bifidobacterium lactis 0.020
Ligilactobacillus salivarius 0.030
Amylase 0.500
Mucuna Puriens 0.200
Lacticaseibacillus paracasei 0.080
Fennel Extract 0.030
Cumin Extract 0.040
FOS 0.070
Lactulose 0.040
Protease 0.050
TOTAL 2.130

Example 5:
Active Ingredient Quantity (Grams)
Ginseng Extract 0.400
Ashwagandha Extract 0.600
Bacillus Subtilis 0.200
Piperine extract 0.020
Bifidobacterium lactis 0.040
Ligilactobacillus salivarius 0.050
Amylase 0.200
Lactase 0.050
Bacillus Coagulans 0.060
Fennel Extract 0.400
Cumin Extract 0.300
FOS 1.000
Shilajit 0.300
Lactulose 0.200
Protease 0.500
TOTAL 4.320

Example 6:
Active Ingredient Quantity (Grams)
Tribulus Terresteris 0.030
Ashwagandha Extract 0.060
Bacillus Coagulans 0.090
Piperine extract 0.080
Bifidobacterium lactis 0.060
Ligilactobacillus salivarius 0.090
Amylase 0.100
Lacticaseibacillus casei 0.300
Lactobacillus bulgaricus 0.500
Bacillus Coagulans 0.200
Fennel Extract 0.400
Cumin Extract 0.200
FOS 0.400
Lactulose 0.200
Protease 0.500
TOTAL 3.210

Example 7:
Active Ingredient Quantity (Grams)
Ginger extract 0.160
Lactiplantibacillus plantarum 0.100
Bifidobacterium longum 0.200
Lacticaseibacillus casei 0.300
Bacillus Coagulans 0.700
Fennel Extract 0.800
Inulin 0.600
Lactulose 0.600
Protease 0.070
TOTAL 3.530

Example 8:

Active Ingredient Quantity (Grams)
Ginger extract 0.070
Ashwagandha Extract 0.200
Cumin Extract 0.200
Piperine extract 0.010
Tribulus terrestris 0.300
Safed Musli 0.190
Protease 0.200
Amylase 0.100
Lactase 0.200
Bifidobacterium Lactis 0.010
Bifidobacterium Bifidum 0.020
Bifidobacterium Breve 0.030
Lactiplantibacillus plantarum 0.010
Bifidobacterium longum 0.007
Lacticaseibacillus casei 0.001
Ligilactobacillus salivarius 0.001`
Lactobacillus acidophillus 0.001
Bacillus Coagulans 0.020
Fennel Extract 0.800
Fenugreek Extract 0.080
Lacticaseibacillus paracasei 0.020
Lactiplantibacillus plantarum 0.020
Inulin 0.010
Fructo Oligosaccharides 0.020
Lactulose 0.060
Lactobacillus bulgaricus 0.010
TOTAL 2.518

Example 9:

Active Ingredient Quantity (Grams)
Vidarikand Extract 0.100
Ginger extract 0.100
Lactiplantibacillus plantarum 0.100
Bifidobacterium lactis, 0.100
Bifidobacterium longum 0.100
Ligilactobacillus salivarius 0.100
Lactase 0.100
Lacticaseibacillus casei 0.300
Bacillus Coagulans 0.200
Fennel Extract 0.100
Inulin 0.400
Lactulose 0.200
Protease 0.500
TOTAL 2.300

Example 10:

Active Ingredient Quantity (Grams)
Vidarikand Extract 0.100
Ginger extract 0.100
Lactiplantibacillus plantarum 0.100
Bifidobacterium lactis, 0.100
Bifidobacterium longum 0.100
Ligilactobacillus salivarius 0.100
Lactase 0.100
Lacticaseibacillus casei 0.300
Bacillus Coagulans 0.200
Fennel Extract 0.100
Inulin 0.400
Lactulose 0.200
Protease 0.500
TOTAL 2.400

Example 11:
Active Ingredient Quantity (Grams)
Pippali 0.190
Ashwagandha Extract 0.070
Cumin Extract 0.120
Piperine extract 0.110
Tribulus terrestris 0.030
Protease 0.020
Amylase 0.100
Lactase 0.220
Bifidobacterium Bifidum 0.120
Bifidobacterium longum 0.010
Lacticaseibacillus casei 0.040
Lactobacillus acidophillus 0.070
Bacillus Coagulans 0.060
Fennel Extract 0.500
Lacticaseibacillus paracasei 0.020
Inulin 0.600
Fructo Oligosaccharides 0.120
TOTAL 2.400

Example 12

Active Ingredient Quantity (Grams)
Phyllanthus emblica 0.160
Cumin Extract 0.020
Piperine extract 0.010
Safed Musli 0.050
Protease 0.300
Amylase 0.010
Lactase 0.020
Bifidobacterium Lactis 0.100
Bifidobacterium Bifidum 0.020
Bifidobacterium Breve 0.030
Lacticaseibacillus casei 0.350
Ligilactobacillus salivarius 0.050
Lactobacillus acidophillus 0.090
Fennel Extract 0.800
Lacticaseibacillus paracasei 0.070
Lactiplantibacillus plantarum 0.020
Fructo Oligosaccharides 0.120
TOTAL 2.220
,CLAIMS:1. A herbal composition which comprises:
a. testosterone boosting herbs;
b. appetite stimulating herbs; and
a digestive blend containing digestive enzymes, probiotics and prebiotics.

2. The herbal composition as claimed in claim 1, wherein the testosterone boosting herbs are selected fr.//.om fenugreek, ashwagandha, safed musli, shatavri, ginseng, and Tribulus Terresteris, Ginseng, Asparagus racemosus (shatawari), Serenoa repens (Saw palmetto), Urtica dioica (Stinging nettle) and combinations thereof.

3. The herbal composition as claimed in claim 1, wherein the appetite stimulating herbs are selected from fennel, cumin, Ginger, peppermint, black pepper and combinations thereof.

4. The herbal composition as claimed in claim 1, wherein the digestive enzymes are selected from amylase, lactase and protease.

5. The herbal composition as claimed in claim 4, wherein the protease enzymes are selected from are pepsin and trypsin.

6. The herbal composition as claimed in claim 1, wherein the probiotics are selected from probiotic strains of Bifido bacteria, Lacticaseibacillus, Ligilactobacillus, Lactiplantibacillus, Bacillus Subtilis, and Lactobacillus and combinations thereof.

7. The herbal composition as claimed in claim 1, wherein the prebiotics are selected from Fructo oligosaccharide (FOS), inulin and lactulose and combinations thereof.