DESC:FIELD
The present disclosure relates to a millet extract composition and a process for its preparation. Particularly, the present disclosure relates to a horse gram composition for improving vitality, growth, endurance, performance, and physical fitness in human beings.
DEFINITIONS
As used in the present disclosure, the following term is generally intended to have the meaning as set forth below, except to the extent that the context in which they are used indicates otherwise.
Endurance: The term ‘endurance’ refers to the ability of a person to perform repetitive work over an extended period of time.
Performance: The term ‘performance’ refers to the execution of tasks or movements involving the body, particularly in sports, exercise, and the like. It focuses on the quality and effectiveness of actions related to strength, agility, coordination, and other physical attributes.
Vitality: The term ‘vitality’ refers to overall well-being, including physical health, and mental alertness. It reflects an individual's capacity to engage actively in daily activities.
Growth: The term ‘growth’ refers to an increase in height, weight, and development of various physiological systems.
Sprout: The term ‘sprout’ refers to germinated horse gram seeds. Sprouting is the process of soaking and germinating seeds, which results in the development of young shoots or sprouts.
VO2 max (maximal oxygen consumption): The term ‘VO2 max’ refers to the maximum amount of oxygen a person can use during intense exercise.
Therapeutically effective amount refers to the amount of the composition which can provide the desired effect when administered to subjects/patients, without leading to undesired adverse effects.
BACKGROUND
The background information herein below relates to the present disclosure but is not necessarily prior art.
Endurance and physical fitness are the essential abilities of a person to exert, resist, remain active to perform daily activities and recover from physical strain or fatigue. The energy for daily activities is primarily met through the intake of food. However, the quality of food we consume these days does not provide all the essential nutrition required for the body. Consequently, people prefer convenient and comprehensive nutritional sources to support their daily routines. Lack of appropriate and necessary daily nutrients to the body leads to a decline in stamina, strength, and overall vitality. This, in turn, negatively impacts endurance and physical fitness, hindering the ability to perform daily activities effectively.
Animal derived nutrients are widely considered as the main source in the human diet. Over recent years, there has been a significant shift in people’s preference towards vegan foods, accelerating the pace of the global drive toward the use of nutrient sources from plant based products. Nutrient rich cereals and grains are being considered widely to meet these requirements. Most of the plant nutrient sources seen or reported are either in crude form or indigestible forms. Though these plant nutrient sources are rich in nutrients, they are not readily absorbed.
The conventional nutritional compositions consist of artificial vitamins, minerals, and nutrients which are not recommended for prolonged use due to their adverse effects. The plant based nutritional compositions consist of wholesome ingredients and are devoid of adverse effects. There exists a need to develop nutraceutical compositions that provide desired levels of protein, amino acids, phytonutrients including glycosides, polyphenols along with tannins, phenolic acids, and the like while minimizing the use of synthetic ingredients.
Therefore, there is a need to provide a millet extract composition that overcomes the drawbacks mentioned hereinabove or at least provides a useful alternative.
OBJECTS
Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:
It is an object of the present disclosure to ameliorate one or more problems of the background or to at least provide a useful alternative.
An object of the present disclosure is to provide a millet extract composition.
Another object of the present disclosure is to provide a millet extract composition that can be used for improving endurance and physical fitness.
Yet another object of the present disclosure is to provide a millet extract composition that can be used for improving vitality, growth, and performance.
Still another object of the present disclosure is to provide a millet extract composition that can be used for improving the growth of human beings, particularly muscles, height, weight, and overall development.
Yet another object of the present disclosure is to provide a millet extract composition that uses natural extracts of horse gram.
Still another object of the present disclosure is to provide a millet extract composition that enriches nutritional and bioactive properties.
Yet another object of the present disclosure is to provide a millet extract composition that is free from chemicals, and preservatives.
Yet another object of the present disclosure is to provide a simple and economical process for the preparation of a millet extract composition.
Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.
SUMMARY
The present disclosure relates to a millet extract composition. In an aspect, the millet extract composition comprising a) at least one glycoside extract of horse gram (Macrotyloma uniflorum) in the range of 4 mass% to 20 mass% with respect to the total mass of the composition; b) at least one of protein extract or peptide extract of horse gram (Macrotyloma uniflorum) in the range of 70 mass% to 95 mass% with respect to the total mass of the composition and optionally at least one pharmaceutically acceptable excipient in the range of 1 wt% to 20 wt% with respect to the total mass of the composition.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING
The present disclosure will now be described with the help of the accompanying drawing, in which:
Figure 1A illustrates changes in time of exhaustion upon administration of vehicle, MR2-S, MR2-P, and MR2-PT;
Figure 1B illustrates changes in distance covered during the swim test upon administration of vehicle, MR2-S, MR2-P, and MR2-PT;
Figure 2A illustrates changes in time of exhaustion at baseline and after 14-day supplementation of a placebo, EP4 and EP5; and
Figure 2B illustrates changes in VO2 Max at baseline and after 14-day supplementation of placebo, EP4, and EP5.
DETAILED DESCRIPTION
The present disclosure relates to a millet extract composition and a process for its preparation. Particularly, the present disclosure relates to a horse gram composition for improving vitality, growth, endurance, performance, and physical fitness in human beings.
Embodiments, of the present disclosure, will now be described with reference to the accompanying drawing.
Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.
The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising," “including,” and “having,” are open ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units and/or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed.
The terms first, second, third, etc., should not be construed to limit the scope of the present disclosure as the aforementioned terms may be only used to distinguish one element, component, region, layer or section from another component, region, layer or section. Terms such as first, second, third etc., when used herein do not imply a specific sequence or order unless clearly suggested by the present disclosure.
As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed elements.
Animal derived nutrients are widely considered as the main source for the human diet. Over the recent years, there has been a significant shift in the people’s preference towards vegan foods, accelerating the pace of the global drive towards the use of nutrient source from plant based products. Nutrient rich cereals and grains are being considered widely to meet these requirements. Most of the plant nutrient sources seen or reported are either in crude form or as indigestible forms. Though these plant nutrient sources are rich in nutrients, these vegetable-based nutrient sources are not readily absorbed.
The conventional nutritional compositions consist of artificial vitamins, minerals, and nutrients which are not recommended for prolonged use due to their adverse effects. The plant based nutritional compositions consist of wholesome ingredients and are devoid of adverse effects. There exists a need to develop nutraceutical compositions that provide desired levels of protein, amino acids, phytonutrients including glycosides, polyphenols along with tannins, phenolic acids, and the like, while minimizing the use of synthetic ingredients.
The present disclosure provides a millet extract composition and a process for its preparation. The millet extract composition of the present disclosure improves endurance and physical fitness, is devoid of adverse effects, and is made of GRAS (Generally Recognized as Safe) ingredients.
In an aspect of the present disclosure, there is provided a millet extract composition.
The millet extract composition comprises a) at least one glycoside extract of horse gram (Macrotyloma uniflorum) in the range of 4 mass% to 20 mass% with respect to the total mass of the composition; b) at least one of protein extract or peptide extract of horse gram (Macrotyloma uniflorum) in the range of 70 mass% to 95 mass% with respect to the total mass of the composition and optionally at least one pharmaceutically acceptable excipient in the range of 1 wt% to 20 wt% with respect to the total mass of the composition.
In accordance with the embodiments of the present disclosure, the horse gram seed glycoside extract is in the range of 4 mass% to 20 mass% with respect to the total mass of the composition.
In accordance with the embodiments of the present disclosure, the horse gram seed glycoside extract is in the form selected from liquid and powder.
In accordance with the embodiments of the present disclosure, the glycosides comprise flavonoids and saponins.
In accordance with the embodiments of the present disclosure, the amount of glycosides, protein, and polyphenols in horse gram seed glycoside extract are in the range of 80 mass% to 95 mass%, 3 mass% to 10 mass% and 1 mass% to 5 mass% respectively with respect to the total mass of the glycoside extract.
Some glycosides are bitter/astringent-tasting compounds found in plants, that are generally considered secondary metabolites with significant therapeutic potential. They are capable of providing various beneficial properties by penetrating the cell membrane permeability to exert virucidal actions and antimicrobial effects. Additionally, these compounds are also known for their ability to enhance blood circulation and reduce lipid levels. Further, some glycosides have been found to reduce the generation of reactive oxygen species (ROS) linked to hyperglycemia and exhibit properties similar to insulin.
In accordance with the embodiments of the present disclosure, the predetermined amount of horse gram seed protein extract or horse gram seed peptide extract is in the range of 70 mass% to 95 mass% with respect to the total mass of the composition.
In accordance with the embodiments of the present disclosure, at least one horse gram seed extract is selected from the group of extracts consisting of protein extract and peptide extract.
In accordance with the embodiments of the present disclosure, the horse gram seed extract is a protein extract.
In accordance with the embodiments of the present disclosure, the horse gram seed extract is a peptide extract.
In accordance with the embodiments of the present disclosure, the horse gram seed protein extract, and horse gram seed peptide extract are in the form selected from liquid and powder.
In accordance with the embodiments of the present disclosure, the amount of protein, glycosides, and polyphenols in the horse gram seed protein extract is in the range of 75 mass% to 95 mass%, 5 mass% to 15 mass%, and 0.5 mass% to 2 mass% respectively with respect to the total mass of the protein extract.
In accordance with the embodiments of the present disclosure, the amount of peptide, glycosides, and polyphenols in the horse gram seed peptide extract is in the range of 75 mass% to 90 mass%, 5 mass% to 15 mass%, and 1 mass% to 3 mass% respectively with respect to the total mass of the peptide extract.
Protein is an essential element that plays a critical role in humans such as facilitating the formation of new cells, supporting the immune system, enabling communication between the body and the brain, and promoting growth and development in children, teenagers, pregnant women, and the like. Additionally, protein plays a vital role in maintaining the physical well-being of elderly individuals.
In accordance with the embodiments of the present disclosure, the glycoside extract, the protein extract, and the peptide extract comprise other chemical constituents such as carbohydrates.
In accordance with the embodiments of the present disclosure, the millet extract composition of the present disclosure comprises carbohydrates.
In accordance with the embodiments of the present disclosure, the pharmaceutically acceptable excipient is at least one selected from the group consisting of binders, stabilizers, flavours, colour, fillers, disintegrants, lubricants, emulsifiers, and preservatives.
In accordance with the embodiments of the present disclosure, the predetermined amount of pharmaceutically acceptable excipients can be in the range of 1 mass% to 20 mass% with respect to the total mass of the composition.
In accordance with the embodiments of the present disclosure, the binder is at least one selected from the group consisting of xanthan gum, guar gum, acacia, tragacanth, starch, maltodextrin, gelatin, tragacanth, methylcellulose, sodium carboxymethylcellulose, magnesium carbonate, natural sugars such as glucose or beta- lactose, corn sweeteners.
In accordance with the embodiments of the present disclosure, the stabilizer is at least one selected from the group consisting of modified starch, pectin, and lecithin.
In accordance with the embodiments of the present disclosure, the flavour is at least one selected from the group consisting of cocoa, coffee, almond, and vanilla.
In accordance with the embodiments of the present disclosure, the colour is at least one selected from the group consisting of beet, paprika, curcumin, annatto, and anthocyanin.
In accordance with the embodiments of the present disclosure, the sweetening agent is at least one selected from the group consisting of stevia, and sucralose.
In accordance with the embodiments of the present disclosure, the millet extract composition of the present disclosure comprises:
• horse gram seed glycosides in an amount in the range of 5 mass% to 25 mass% with respect to the total mass of the composition;
• at least one of horse gram seed protein or horse gram seed peptide in an amount in the range of 60 mass% to 85 mass% with respect to the total mass of the composition;
• horse gram seed polyphenols in an amount in the range of 1 mass% to 5 mass% with respect to the total mass of the composition; and
• optionally pharmaceutically acceptable excipients in an amount in the range of 1 mass% to 20 mass% with respect to the total mass of the composition.
In accordance with the embodiments of the present disclosure, the millet extract composition of the present disclosure comprises horse gram seed glycosides in an amount in the range of 10 mass% to 20 mass% with respect to the total mass of the composition.
In accordance with the embodiments of the present disclosure, the millet extract composition of the present disclosure comprises horse gram seed glycosides in an amount in the range of 14 mass% to 20 mass% with respect to the total mass of the composition.
In accordance with the embodiments of the present disclosure, the millet extract composition of the present disclosure comprises horse gram seed protein in an amount in the range of 75 mass% to 85 mass% with respect to the total mass of the composition.
In accordance with the embodiments of the present disclosure, the millet extract composition of the present disclosure comprises horse gram seed peptide in an amount in the range of 75 mass% to 85 mass% with respect to the total mass of the composition.
In accordance with the embodiments of the present disclosure, the millet extract composition of the present disclosure comprises horse gram seed peptide in an amount in the range of 75 mass% to 82 mass% with respect to the total mass of the composition.
In accordance with the embodiments of the present disclosure, the millet extract composition of the present disclosure comprises horse gram seed polyphenols in an amount in the range of 1 mass% to 3 mass% with respect to the total mass of the composition.
In accordance with the embodiments of the present disclosure, the millet extract composition of the present disclosure comprises horse gram seed polyphenols in an amount in the range of 1.5 mass% to 2.5 mass% with respect to the total mass of the composition.
In accordance with the embodiments of the present disclosure, the millet extract composition comprises other chemical constituents present in the extracts.
In accordance with the embodiments of the present disclosure, other chemical constituents such as carbohydrates.
In accordance with the embodiments of the present disclosure, the millet extract composition is in the form selected from powder, granules, capsules, solution, tablets, gels, and gummies.
In accordance with the embodiments of the present disclosure, provides a method for enhancing endurance, physical fitness, muscle strength, and overall vitality in a subject comprising administering to the subject, in need thereof, a therapeutically effective amount of millet extract composition of the present disclosure.
In accordance with the embodiments of the present disclosure, the millet extract composition is useful in enhancing endurance, physical fitness, muscle strength, and overall vitality.
In accordance with the embodiments of the present disclosure, the millet extract composition is in the form selected from powder, granules, capsules, solution, tablets, gels, and gummies.
In accordance with the embodiments of the present disclosure, the millet extract composition is stable and directly compressible.
In accordance with the embodiment of the present disclosure, the millet extract composition of the present disclosure when administered to humans at a therapeutically effective amount provides the desired effect.
In accordance with the embodiments of the present disclosure, the millet extract composition of the present disclosure is suitably administered orally.
In another aspect, the present disclosure envisages a process for preparing a millet extract composition.
In accordance with the embodiments of the present disclosure, the process of preparing the millet extract composition is simple, easy to prepare, economical, and efficient process.
In another embodiment of the present disclosure, the horse gram seed is selected from a whole seed or sprouted seed form.
In accordance with the embodiments of the present disclosure, the millet extract is produced from Horse gram (Macrotyloma uniflorum). Horse gram is a superfood legume crop native to tropical southern Asia, known for its distinct taste and texture, and widely used legume in many cuisines. It is also known for human consumption for its rich nutrients and reputed medicinal properties. It is commonly grown for horse feed, hence the name “horse gram”. It is consumed in many parts of India to gain nutrients that is not normally found in their sattvic (vegetarian) diet. Horse gram seed contains, approximately, carbohydrate (57.2% w/w), protein (22% w/w), dietary fiber (5.3% w/w), fat (0.50% w/w), calcium (287 mg), phosphorus (311 mg), iron (6.77 mg) and calories (321 kcal) as well as vitamins like thiamine (0.4 mg), riboflavin (0.2 mg) and niacin (1.5 mg) per 100 grams of dry matter. Additionally, horse gram contains several chemical compounds like flavonoids, phenolics, phytosterols, saponins, terpenoids, proteins, and alkaloids that have potent health-promoting actions.
The foregoing description of the embodiments has been provided for purposes of illustration and is not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but, are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.
The present disclosure is further described in light of the following experiments, which are set forth for illustration purposes only and not to be construed as limiting the scope of the disclosure. The following experiments can be scaled up to an industrial/commercial scale, and the results obtained can be extrapolated to an industrial scale.
There may be several embodiments of the same formulation with tweaking of an individual component of the composition/ formulation. In addition, several further combinations may be prepared using the base composition along with certain other available compounds and/ or formulations.
The invention is now detailed with non-limiting example(s) along with the details of the invention through working example(s).
EXPERIMENTAL DETAILS:
Example 1: Process for the preparation of horse gram glycoside extract
1000 gm of horse gram seeds (grown in the Karnataka region, procured from S.K. Agencies, Groundnut Kernal Merchants, Old Market, Aluva, Kerala 683101, India) was flaked and pulverized to obtain horse gram seed powder having a particle size in the range of 850 microns to 2000 microns. The so obtained horse gram seed powder was charged into the reactor followed by adding 3500 mL of aqueous ethanol (not less than 60% ethanol) and heated to 50°C to 60°C for 2 hours to obtain a first mixture. The so obtained first mixture was filtered through 300-micron nylon cloth to obtain a first filtrate and first residue. The first residue was mixed with 3500 mL of aqueous ethanol (not less than 60% ethanol) and heated to 50°C to 60°C for 2 hours to obtain a second mixture. The second mixture was filtered through 300-micron nylon cloth to obtain a second filtrate and second residue. The second residue was mixed with 3500 mL of aqueous ethanol (not less than 60% ethanol) and heated to 50°C to 60°C for 2 hours to obtain a third mixture. The third mixture was filtered through 300-micron nylon cloth to obtain a third filtrate and third residue.
The first, second, and third filtrates were mixed to obtain a first extract. The first extract comprises glycosides, protein, and polyphenols.
10 g of the first extract was mixed with 100 mL of double distilled water, followed by passing through a polymeric resin to obtain a second extract. The second extract was washed with water followed by subjecting it to column chromatography by using aqueous ethanol (containing not less than 70% ethanol) as an eluent to obtain the horse gram glycoside extract followed by drying at 65°C using a rotary vacuum evaporator to obtain horse gram seed glycoside extract powder.
The horse gram seed glycoside extract powder comprises glycosides, protein, and polyphenol content in the amount of 86.7%, 6.1%, and 2.6% respectively with respect to the total mass of the glycoside extract.
Example 2: Process for the preparation of horse gram glycoside extract
1000 gm of horse gram seeds (grown in the Karnataka region procured from S.K. Agencies, Groundnut Kernal Merchants, Old Market, Aluva, Kerala 683101, India) was flaked and pulverized to obtain horse gram seed powder having a particle size in the range of 850 microns to 2000 microns. The so obtained horse gram seed powder was charged into the reactor followed by adding 4000 mL of aqueous ethanol (not less than 70% ethanol) and heated to 55°C to 65°C for 2 hours to obtain a first mixture. The so obtained first mixture was filtered through 300-micron nylon cloth to obtain a first filtrate and first residue. The first residue was mixed with 4000 mL of aqueous ethanol (not less than 70% ethanol) and heated to 55°C to 65°C for 2 hours to obtain a second mixture. The second mixture was filtered through 300-micron nylon cloth to obtain a second filtrate and second residue. The second residue was mixed with 4000 mL of aqueous ethanol (not less than 70% ethanol) and heated to 55°C to 65°C for 2 hours to obtain a third mixture. The third mixture was filtered through 300-micron nylon cloth to obtain a third filtrate and third residue.
The first, second, and third filtrates were mixed to obtain a first extract. The first extract comprises glycosides, protein, and polyphenols.
10 g of the first extract was mixed with 100 mL of double distilled water, followed by passing through a polymeric resin to obtain a second extract. The second extract was washed with water followed by subjecting it to column chromatography by using aqueous ethanol (containing not less than 90% ethanol) as an eluent to obtain the horse gram glycoside extract followed by drying at 65°C using a rotary vacuum evaporator to obtain horse gram seed glycoside extract powder.
The horse gram seed glycoside extract powder comprises glycosides, protein, and polyphenol content in the amount of 91.25%, 3.81%, and 3.23% respectively with respect to the total mass of the glycoside extract.
Example 3: Process for the preparation of horse gram protein extract
800 gm of third residue obtained in example 1 was dried and mixed with 2400 mL of alkali water (10 % potassium hydroxide solution) under stirring followed by filtering using 150-micron nylon cloth to obtain a first filtrate and first residue. The process of mixing 2400 mL of water followed by filtration was repeated four times, the filtrate was combined with the first filtrate to obtain a filtrate mixture. The so obtained filtrate mixture was concentrated under vacuum (600 to 700 mm/Hg) to obtain a concentrated filtrate mixture. The concentrated filtrate mixture was allowed to settle for 2 to 3 hours at 20°C to 25°C and decanted in a separate vessel to obtain a decanted filtrate.
The pH of the decanted filtrate was adjusted to 6 by using a dilute HCl solution to obtain a slurry. The so obtained slurry was filtered to obtain a mass. The mass was washed twice with water followed by drying at 70°C to obtain a horse gram seed protein extract.
50 gm of horse gram protein extract was mixed with 400 mL of double distilled water under stirring to obtain a solution. The solution was filtered by using an ultrafiltration membrane to obtain a filtrate followed by drying to obtain a horse gram seed protein extract powder.
The horse gram seed protein extract powder comprises protein, glycosides, and polyphenol content of 84.5%, 11.7%, and 1.8% respectively with respect to the total mass of the protein extract.
Example 4: Process for the preparation of horse gram protein extract
850 gm of third residue obtained in example 2 was dried and mixed with 3400 mL of alkali water (15 % potassium hydroxide solution) under stirring followed by filtering using 150-micron nylon cloth to obtain a first filtrate and first residue. The process of mixing 3400 mL of water followed by filtration was repeated four times, the filtrate was combined with the first filtrate to obtain a filtrate mixture. The so obtained filtrate mixture was concentrated under vacuum (600 to 700 mm/Hg) to obtain a concentrated filtrate mixture. The concentrated filtrate mixture was allowed to settle for 3 to 4 hours at 15°C to 20°C and decanted in a separate vessel to obtain a decanted filtrate.
The pH of the decanted filtrate was adjusted to 5.5 by using a dilute HCl solution to obtain a slurry. The so obtained slurry was filtered to obtain a mass. The mass was washed thrice with water followed by drying 70°C to obtain a horse gram seed protein extract.
40 gm of horse gram protein extract was mixed with 400 mL of double distilled water under stirring to obtain a solution. The solution was filtered by using an ultrafiltration membrane to obtain a filtrate followed by drying to obtain a horse gram seed protein extract powder.
The horse gram seed protein extract powder comprises protein, glycosides, and polyphenol content of 92.4%, 5.86%, and 1.32% respectively with respect to the total mass of the protein extract.
Example 5: Process for the preparation of horse gram peptide extract
5 gm of horse gram seed protein extract powder obtained in experiment 3 was mixed with 250 mg to 500 mg of protease enzyme to obtain a mixture. The mixture was heated at 40°C to 55°C for 2 hours to obtain a protein concentrate. The protein concentrate was heated to 90°C to 95°C for 5 min to 10 min for quenching the enzyme to obtain a peptide mixture. The so obtained peptide mixture was cooled and dried at 70°C using a rotary vacuum evaporator to obtain a horse gram seed peptide extract powder (horse gram protein hydrolysate).
The horse gram seed peptide extract powder comprises peptide, glycosides, and polyphenol content in an amount of 81.5%, 13.1%, and 1.8% respectively with respect to the total mass of the peptide extract.
Example 6: Process for the preparation of peptide extract
5 gm of horse gram seed protein extract powder obtained in experiment 4 was mixed with 250 mg to 500 mg of protease enzyme to obtain a mixture. The mixture was heated at 40°C to 55°C for 2 hours to obtain a protein concentrate. The protein concentrate was heated to 90°C to 95°C for 5 min to 10 min for quenching the enzyme to obtain a peptide mixture. The so obtained peptide mixture was cooled and dried at 70°C using a rotary vacuum evaporator to obtain a horse gram seed peptide extract powder (horse gram protein hydrolysate).
The horse gram seed peptide extract powder comprises peptide, glycosides, and polyphenol content in an amount of 88.16%, 9.15%, and 2.03% respectively with respect to the total mass of the peptide extract.
Example 7: Process for the preparation of millet extract composition of the present disclosure.
0.5 gm of horse gram glycoside extract obtained in Example 1 was mixed with 4.5 gm of horse gram protein extract obtained in Example 3 to obtain the millet extract composition of the present disclosure, having 19.2% of glycosides and 76.6% of protein content along with a polyphenol content of 1.8% with respect to the total mass of the millet extract composition.
Example 8: Process for the preparation of millet extract composition of the present disclosure
0.5 gm of horse gram glycoside extract obtained in Example 2 was mixed with 4.5 gm of horse gram protein extract obtained in Example 4 to obtain the millet extract composition of the present disclosure, having 14.4% of glycosides and 83.5% of protein content along with a polyphenol content of 1.5% with respect to total mass of the millet extract composition.
Example 9: Process for the preparation of millet extract composition of the present disclosure
0.4g of horse gram glycoside extract obtained in Example 1 was mixed with 4.6g of horse gram peptide extract obtained in Example 5 to obtain the millet extract composition of the present disclosure, having 18.9% of glycosides and 75.5% of peptide content along with a polyphenol content of 1.9 % with respect to total mass of the millet extract composition.
Example 10: Process for the preparation of millet extract composition of the present disclosure
0.4g of horse gram glycoside extract obtained in Experiment 2 was mixed with 4.6g of horse gram peptide extract obtained in Experiment 6 to obtain the millet extract composition of the present disclosure, having 15.71% of glycosides and 81.4% of peptide content along with a polyphenol content of 2.12% with respect to total mass of the millet extract composition.
Example 11: Process for the preparation of millet extract composition of the present disclosure
0.5 gm of horse gram glycoside extract obtained in Example 1, 4.5 gm of horse gram protein extract obtained in Example 3 were mixed with 0.5 gm of maltodextrin to obtain the millet extract composition of the present disclosure, having glycosides 17.25% and 69.63 protein content along with a polyphenol content of 1.63% with respect to the total mass of the millet extract composition.
Example 12: Process for the preparation of millet extract composition of the present disclosure
0.4g of horse gram glycoside extract obtained in Example 1, 4.6g of horse gram peptide extract obtained in Example 5 were mixed with 0.3 gm of maltodextrin followed by mixing with 0.2 gm of almond flavour to obtain the millet extract composition of the present disclosure, having 17.18% of glycosides and 68.63 of peptide content along with a polyphenol content of 1.72% with respect to the total mass of the millet extract composition.
Example 13: Evaluation of millet extracts of the present disclosure on the endurance activity
The endurance effect of the horse gram glycoside extract (Example 1, MR2-S), horse gram protein extract (Example 3, MR2-P), and horse gram peptide extract (Example 5, MR2-PT) was determined in rats by swimming till exhaustion.
20 Sprague Dawley rats (Aged > 12 months) were divided to 4 groups (n=5) as follows; Vehicle control, MR2-S, MR2-P & MR2-PT. Excluding vehicle control, all the other groups are administered with 250mg/kg b.wt MR2-S, MR2-P, or MR2-PT respectively once per day for 14 days by oral gavage. On the days 0, 7, 14, and 21 the rats were allowed to swim in a water tank (1500mm in diameter X 500mm height) till exhaustion. Exhaustion was determined as failure to stay above the water surface, loss of symmetrical movements, and/or remaining underwater for more than 5 s (Godoy et al., 2022). The time till exhaustion and the total distance travelled were measured by automated animal behaviour tracking software (AnyMaze TM), illustrated in Fig 1A and 1B. Statistical analysis (Mann-whitney test) was performed using graphpad prism 9.0.
A gradual increase in swim endurance was observed with supplementation of both MR2-S and MR2-P. However, the enhancement in endurance was more prominent in the MR2-PT-supplemented group. Distance covered also exhibited a similar trend. There were no significant changes in the body weight per group in any of the supplemented groups.
Example 14: Evaluation of millet extracts composition of the present disclosure on the performance activity
A total of 24 healthy subjects (aged 20–45 years) were recruited and were randomly divided into three groups of 8 each:
Group 1 (Placebo) - 5 g once daily after dinner (Microcrystalline cellulose)
Group 2 (EP4) - 5 g once daily after dinner (EP4 comprising millet extract composition of Example 7)
Group 3 (EP5) - 5 g EP5 (EP5 comprising millet extract composition of Example 9)
The subjects were administered with respective interventional products as per the schedule. On day 1, subjects were asked to report in the morning and the baseline exercise performance was assessed using the Modified Bruce Protocol, measuring time to exhaustion by measuring the VO2 max, heart rate recovery (HRR) at 1 minute and 3 minutes’ post-exercise, and systolic/diastolic blood pressure, pulse during exercise. To measure the parameters, the participants were advised to begin exercise at a self-selected speed between 3 and 6?km/h. The self-selected speed was maintained, while the treadmill elevation increased by 2% every 2?min during the test. Time to exhaustion was determined as the time that the subject could no longer maintain exercise intensity and/or reached volitional exhaustion. Following the baseline assessment, participants consumed their respective treatments for 14 days. All the performance assessments were repeated at the end of the study under identical conditions. Changes in parameters were statistically analysed. Within group comparison was done using paired sample t-test and between group analysis was performed using independent t-test, the details are provided below in Table 1, Fig. 2A and 2B.
Table 1. Changes in systolic, diastolic, and pulse rate before and after performance
Parameters Groups Baseline End of study
Before After Before After
Systolic BP Placebo 126.9 ± 11.17 144.81 ± 9.58 121.78 ± 9.95 142.00 ± 7.45
EP4 132.16 ± 16.57 135.65 ± 12.75 115.00 ± 11.31 136.35 ± 2.83
EP5 130.25 ± 18.89 133.57 ± 15.56 119.05 ± 13.27 141.28 ± 15.31
Diastolic BP Placebo 77.66 ± 7.00 78.73 ± 6.58 73.44 ± 7.13 76.22 ± 8.21
EP4 74.66 ± 10.38 75.84 ± 8.57 69.5 ± 2.12 73.5 ± 3.54
EP5 77.75 ± 12.71 76.54 ± 9.64 67.5 ± 3.15 75.2 ± 5.68
Pulse Placebo 73.4 ± 7.63 112.8 ± 15.54 73.78 ± 7.42 106.33 ± 11.25
EP4 74.21 ± 8.04 110.65 ± 12.78 76 ± 9.66 118± 13.41
EP5 71.6 ± 5.40 117.87 ± 15.25 68 ± 8.94 121± 6.13
The values are expressed as mean ± SD.
It is observed that the time of exhaustion for the EP4 group showed 53.83% increase compared to the baseline which is statistically significant. Compared with placebo, the increase in time of exhaustion was also significant (p<0.001; 36.43%). EP5 exhibited a 60.42% increase at the end of the study compared to baseline and 59.34% compared to placebo.
The increase in VO2 max for the EP4 group was 44.27% compared to baseline and 64.52 % compared to placebo at the end of the study. The change was statistically significant (p<0.001). EP5 group revealed a 70.32% increase in VO2 max from baseline and 69.56% compared to placebo.
TECHNICAL ADVANCEMENTS
The present disclosure described hereinabove has several technical advantages including, but not limited to, the realization of a millet extract composition, that:
• is used for improving endurance and physical fitness;
• is stable and compressible; and
• is free from harsh chemicals and preservatives;
and
• a simple, economical, and efficient process for the preparation of a millet extract composition.
The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein.
The foregoing description of the specific embodiments so fully reveals the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.
The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results.
Any discussion of documents, acts, materials, devices, articles or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application.
The numerical values mentioned for the various physical parameters, dimensions or quantities are only approximations and it is envisaged that the values higher/lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary.
While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.
,CLAIMS:1. A millet extract composition comprising
a. at least one glycoside extract of horse gram (Macrotyloma uniflorum) in the range of 4 mass% to 20 mass% with respect to the total mass of the composition;
b. at least one of protein extract or peptide extract of horse gram (Macrotyloma uniflorum) in the range of 70 mass% to 95 mass% with respect to the total mass of the composition; and
c. optionally at least one pharmaceutically acceptable excipient in the range of 1 mass% to 20 mass% with respect to the total mass of the composition.
2. The millet extract composition as claimed in claim 1, wherein the glycoside extract of horse gram is in the form selected from liquid or powder.
3. The millet extract composition as claimed in claim 1, wherein the glycoside extract of horse gram comprises glycosides, protein, and polyphenol in the range of 80 mass% to 95 mass%, 3 mass% to 10 mass% and 1 mass% to 5 mass% respectively with respect to the total mass of the glycoside extract.
4. The millet extract composition as claimed in claim 1, wherein the protein or peptide extract of horse gram is in the form selected from liquid or powder.
5. The millet extract composition as claimed in claim 1, wherein the protein extract of horse gram comprises protein, glycosides, and polyphenol in the range of 75 mass% to 95 mass%, 5 mass% to 15 mass%, and 0.5 mass% to 2 mass% respectively with respect to the total mass of the protein extract.
6. The millet extract composition as claimed in claim 1, wherein the peptide extract of horse gram comprises peptide, glycosides, and polyphenol in the range of 75 mass% to 90 mass%, 5 mass% to 15 mass%, and 1 mass% to 3 mass% respectively with respect to the total mass of the peptide extract.
7. The millet extract composition as claimed in claim 1, wherein the pharmaceutically acceptable excipient is at least one selected from the group consisting of binders, fillers, disintegrants, lubricants, emulsifiers, and preservatives.
8. The millet extract composition as claimed in claim 1, wherein the millet extract composition comprises
a. horse gram seed glycosides in an amount in the range of 5 mass% to 25 mass% with respect to the total mass of the composition;
b. at least one of horse gram seed protein or horse gram seed peptide in the range of 60 mass% to 85 mass% with respect to the total mass of the composition;
c. horse gram seed polyphenols in an amount in the range of 1 mass% to 5 mass% with respect to the total mass of the composition;
d. optionally pharmaceutically acceptable excipients in an amount in the range of 1 mass% to 20 mass% with respect to the total mass of the composition.
9. The millet extract composition as claimed in claim 1, wherein the millet extract composition is in the form selected from powder, granules, capsules, solution, tablets, gels, and gummies.
10. A method for enhancing endurance, physical fitness, muscle strength, and overall vitality in a subject comprising administering to the subject, in need thereof, a therapeutically effective amount of millet extract composition of claim 1.