DESC:FIELD OF INVENTION:
The present invention relates to an oral, ready-to-drink, nutritional, non-carbonated, pleasant-tasting, energy revitalizing beverage composition comprising natural fruit juice concentrate(s), minerals, energy boosters, acidity regulator, vitamin, flavouring agents, and carbohydrates. More particularly, the ready to drink energy revitalizing beverage composition is enriched with electrolytes, fruit juice concentrates, essential vitamins and energy boosters.

BACKGROUND OF INVENTION:
The beverages that provide an individual with an energy surge that lasts for a variable period of time are broadly classified as energy drinks. Energy drinks are mainly composed of minerals, vitamin, fruit juices, energy boosters and simple sugars for restoring water and mineral imbalance, whilst providing energy to fatigued subjects. Each mineral has specific function e.g. Chloride aid in keeping the amount of fluid inside and outside of body cells in balance. It also helps maintain proper blood volume, blood pressure, and pH of body fluids. Sodium regulates body fluid volume, blood volume and thus helps to maintain normal blood pressure and normal function of muscles and nerves. Potassium is essential for maintaining proper fluid balance, transmitting nerve impulses, cardiac (heart muscle) contraction and maintaining normal blood pressure. Calcium and Magnesium are required for healthy bones and teeth, proper nervous system functioning, and energy metabolism. Zinc has role in cellular homeostasis, tissue growth and repair. Vitamin C is required for the growth and repair of tissues. Fruit juice boost immune system, diminish signs of aging, protect against cancer, augment cellular repair and metabolism, detoxify the body, improve circulation, helps maintain blood pressure, reduces inflammation, and lowers cholesterol levels. Carbohydrates, apart from acting as quick energy source, assist in rapid absorption of fluids in the gastro-intestinal tract. Coffee, the best known energy supplement, derives most of its energy enhancing properties from caffeine. Taurine is an organic acid that supports neurological development and helps to regulate the level of water and mineral in the blood. It is also thought to have role in conjugation of bile acids, antioxidation, membrane potential stabilization, and modulation of calcium signaling.

There is ample literature available on various forms of health drinks. US Patent Application 20060094734 discloses an alertness inducing composition containing caffeine and taurine as active ingredients.

US20030104107 discloses an aqueous beverage for maximizing endurance and hydration during physical exercise in the form of clear solution, which is made from natural ingredients, including vitamins and minerals.

A composition for enhancing function of the heart in a human consisting essentially of therapeutically effective amounts of pine bark extract, grape seed extract, stevia extract, coenzyme Q10, noni extract, resveratrol, acai extract, yerba mate' extract and ginkgo biloba extract, is disclosed in US8642097. This composition is provided in various forms such as sublingual spray, powder form and ready to drink form.

US20070172510 describes a nutritional drink formulation which comprises; one or more nootropic nutraceuticals selected from ginseng, L-Glutamine, and DL-Phenyalanine and a natural source of caffeine, wherein the formulation is provided as a tea to be brewed.

As is evident from the prior art, there are various health drinks available for inducing alertness, increasing endurance and hydration during physical exercise; enhancing the performance of heart and for causing a positive psychoactive effect etc. Majority of the energy drinks reported in the prior art addresses various health problems relating to heart, neuro, dehydration etc. Also, the reported health drinks are either carbonated or to be boiled and brewed as tea and some other formulations are in powder form or sublingual spray form.

Moreover, not all the existing formulations are appetizing and luscious to the consumers of age group of 12 yrs or above. While some of the prior art formulations lacked taste and flavour due to the constituents, others fail to provide sufficient energy repletion. Yet others were carbonated beverages thereby limiting their acceptability to the consumers of all age groups. Also, the prior art is failed to address the provision of non-carbonated wholesome energy revitalizing beverage composition that is acceptable to the consumers of age group of 12 yrs or above.

Therefore, there is a need in the art to provide non-carbonated wholesome energy revitalizing beverage composition that is enriched with electrolytes, essential vitamins, minerals and energy boosters that not only appetizing and luscious to the consumers of all age groups but also provides desired nutrition, alertness and energy thereby improves overall well-being.

Accordingly, to address the above unmet need of Non-carbonated wholesome energy drink, the present inventors have developed a pleasant-tasting, non-carbonated nutritional energy drink composition which provides immediate and sustained energy boost besides restoring body’s mineral pool.

OBJECT OF THE INVENTION:
Thus the principal object of this invention is to provide an oral, ready to drink, nutritional non-carbonated, flavored, vitamin and mineral fortified, energy revitalizing beverage composition that is acceptable to all the consumers in general and age group of 12 yrs or above in particular.

SUMMARY OF THE INVENTION:
In accordance with the above objective, the present invention discloses oral, ready to drink, non-carbonated nutritional energy drink, consisting of essential minerals and vitamins, natural fruit juices, carbohydrates, energy boosters, acidity regulator, fruit based flavouring agents; packed in state of the art automatic packing lines and made available in aseptic packing.
Accordingly, the present invention provides oral, non-carbonated, ready to drink, nutritional energy drink composition comprising of;
a) a nutritionally effective amount of mineral salts (mineral mixture) having mass of about 0.4 to about 0.5 part per 100 parts of the solution;
b) at least one Natural fruit Juice dissolved in a water base having total mass of about 0.5 to about 2 parts per 100 parts of the solution;
c) atleast one Vitamin having mass of about 0.01 to about 0.02 part per 100 parts of the solution;
d) atleast one simple sugar having mass of about 1.25 to about 1.5 parts per 100 parts of the solution;
e) at least one sweetening agent having mass of about 5 to about 15 parts per 100 parts of the solution;
f) at least one acidity regulator having mass of 0.2 to 0.5 part per 100 parts of the solution;
g) at least one energy booster having mass of 0.02 to 0.3 part per 100 parts of the solution and
h) atleast one fruit based flavouring agent having mass of 0.02 to 0.075 part per 100 parts of the solution.

In accordance with one embodiment of the invention, mineral salts(mineral mixture) comprise at least one selected from a group consisting of Chloride salts, Sodium salts, Zinc salts, Magnesium Salts, Calcium salts and Potassium salts.

In accordance with one embodiment of the invention, the Chloride Salt is at least one compound selected from a group of compounds consisting of Calcium Chloride, Ammonium Chloride, Potassium Chloride, Sodium Chloride and Magnesium Chloride. Typically, total mass of the Chloride Salts ranges from about 0.115 to about 0.3 part per 100 parts of the solution.

In accordance with another embodiment of the invention, the Sodium Salt is at least one compound selected from a group of compounds consisting of Sodium Bicarbonate, Sodium citrate and Sodium chloride. Typically, the mass of the Sodium salt ranges from about 0.1 to about 0.3 parts per 100 parts of the solution.

In accordance with another embodiment of the invention, the Zinc salt is selected from the class consisting of Zinc chloride, Zinc sulfate, and Zinc acetate. Typically, the mass of the Zinc salt ranges from about 0.005 to about 0.015 parts per 100 parts of the solution.

In accordance with another embodiment of the invention, Magnesium salt is selected from the class consisting of Magnesium sulphate and Magnesium chloride. Typically, the mass of the Magnesium salt ranges from about 0.025 to about 0.075 parts per 100 parts of the solution.

In accordance with another embodiment of the invention, the Calcium salt is at least one compound selected from a group of compounds consisting of Calcium lactate, Calcium Carbonate and Calcium gluconate. Typically, the mass of the Calcium salt ranges from about 0.02 to about 0.06 parts per 100 parts of the solution

In accordance with another embodiment of the invention, the Potassium Salt is at least one compound selected from a group of compounds consisting of Potassium Bicarbonate, Potassium Chloride, Potassium Citrate and Potassium Gluconate. Typically, the mass of the Potassium Salt ranges from about 0.1 to about 0.2 part per 100 parts of Energy Drink.

In accordance with another embodiment of the invention, the Natural fruit Juice is at least one fruit Juice selected from a group consisting of pineapple, orange, Lemon, Mango, Pomegranate, Red grape and strawberry having total mass of about 0.5 to about 2 parts per 100 parts of the solution.
In accordance with another embodiment of the invention, the vitamin is atleast one vitamin C supplement selected from group consisting of ascorbic acid, sodium ascorbate and calcium ascorbate, wherein mass of vitamin C (with 50% overages) range from 0.01 to 0.02 parts per 100 parts of Energy Drink.

In accordance with another embodiment of the invention, the simple sugar is atleast one monosaccharide selected from group consisting of dextrose, fructose, and glucose having mass in the range of 1.25 to 1.5 parts per 100 parts of Energy Drink.

In accordance with another embodiment of the invention, the sweetening agent is at least one compound selected from a group of compounds consisting of Fructose, and Sucrose. Typically, the mass of sweetening agent ranges from about 5 to about 15 parts per 100 parts of Energy Drink.

In accordance with another embodiment of the invention, the acidity regulator is at least one compound selected from a group of compounds consisting of acetic acid, Calcium acetate, Lactic acid, Malic acid, Fumaric acid, Citric acid, Tartaric acid. Typically, the mass of the acidity regulator ranges from about 0.2 to about 0.5 parts per 100 parts of Energy Drink.

In accordance with another embodiment of the invention, energy boosters are selected from the group consisting of amino acid, purine, guarana, sugars, taurine, caffeine, glucuronolactone, B vitamins, ginseng, gingko biloba, carnitine, white tea extract, inositol, aloe vera leaf extract, resveratrol, and coconut water, wherein mass of energy booster range from 0.02 to 0.3 parts per 100 parts of Energy Drink.

In accordance with another embodiment of the invention; the fruit based flavouring agents comprised of, but not limited to, lemon, orange, strawberry, mango, pomegranate, pineapple and red grape. Typically, the total mass of flavouring agent ranges from about 0.02 to about 0.075 parts per 100 parts of Energy Drink.

The energy revitalizing beverage composition according to the invention provides a balanced nutrition so as to make the person stay healthy and fit. The inventiveness of the present invention lies in the provision of the energy revitalizing beverage composition with enrichment of electrolytes; vitamins; energy boosters coupled with natural fruit concentrates, wherein, the product of the invention does not contain any preservatives.

DESCRIPTION OF INVENTION:

The invention now will be discussed in detail to reveal preferred mass range of components per 100 parts of energy drink, embodiments and methods of the present invention, which constitute the best modes of practicing the invention presently known to the inventors. It is to be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms. Therefore, specific details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for any aspect of the invention and/or as a representative basis for teaching one skilled in the art to variously employ the present invention.

Except where otherwise expressly indicated, all numerical quantities in this description indicates amounts of material and to be understood as modified by the word "atleast" in describing the broadest scope of the invention. Practice within the numerical range stated is generally preferred. Also, unless expressly stated to the contrary: percent, "parts of," and ratio values are weight by weight; the description of a group or class of materials as suitable or preferred for a given purpose in connection with the invention implies that mixing any two or more constituents of the group or class are equally suitable or preferred; description of constituents in chemical terms refers to the constituents at the time of addition to any combination specified in the description, and does not necessarily preclude chemical interactions among the constituents of a mixture once mixed; the first definition of an acronym or other abbreviation applies to all subsequent uses herein of the same abbreviation and applies mutatis mutandis to normal grammatical variations of the initially defined abbreviation; and, unless expressly stated to the contrary, measurement of a property is determined by the same technique as previously or later referenced for the same property. It is also to be understood that this invention is not limited to the specific embodiments and methods described below, as specific components and/or) conditions may, of course, vary. Furthermore, the terminology used herein is usedonly for the purpose of describing particular embodiments of the present invention and is not intended to be limiting in any way.

It must also be noted that, as used in the specification and the appended claims, the singular form "a," "an," and "the" comprise plural referents unless the context clearly indicates otherwise. For example, reference to a component in the singular is intended to comprise a plurality of components.

Throughout this application, where publications are referenced, the disclosures of these publications in their entireties are hereby incorporated by reference into this application to more fully describe the state of the art to which this invention pertains. The following description of the embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. Accordingly, the invention provides energy revitalizing beverage composition which is enriched with electrolytes, fruit juice concentrates such as pomegranate, red Grapes, Dextrose, vitamins, minerals and energy boosters such as taurine and caffeine.

In an embodiment of the present invention, an oral, ready to drink, fruit flavored, nutritional energy revitalizing beverage composition is provided which includes;
(i) a nutritionally effective amount of mineral salts (mineral mixture) having mass of about 0.4 to about 0.5 parts per 100 parts of the solution for regulating total amount of water content in body, maintaining normal balance of fluid and thus hydration of body;
(ii) at least one Natural fruit Juice is selected from a group consisting of pineapple, orange, Lemon, Mango, Pomegranate, Red grape and Strawberry having total mass of about 0.5 to about 2 parts per 100 parts of the solution to enhance taste whilst simultaneously providing energy;
(iii) atleast one vitamin, in particular, vitamin C supplement possessing antioxidant properties, selected from group consisting of ascorbic acid, sodium ascorbate and calcium ascorbate, wherein mass of vitamin C (with 50% overages) range from 0.01 to 0.02 parts per 100 parts of Energy Drink;
(iv) atleast one simple sugar as a source of energy selected from monosaccharide group consisting of dextrose, fructose, and glucose having mass in the range of 1.25 to 1.5 parts per 100 parts of Energy Drink;
(v) atleast one natural sweetening agent selected from group consisting of Fructose, sucrose and mannitol having mass in the range of 5 to 15 parts per 100 parts of Energy Drink;
(vi) atleast one acidity regulator selected from group consisting of acetic acid, Calcium acetate, Lactic acid, Malic acid, Fumaric acid, Citric acid, Tartaric acid, wherein mass of acidity regulator range from 0.2 to 0.5 parts per 100 parts of Energy Drink;
(vii) atleast one energy booster selected from group consisting of amino acids, purine, guarana, sugars, taurine, caffeine, glucuronolactone, B vitamins, ginseng, gingko biloba, carnitine, white tea extract, inositol, aloe vera leaf extract, resveratrol, and coconut water, wherein mass of energy booster range from 0.02 to 0.3 parts per 100 parts of Energy Drink; and
(viii) atleast one flavouring agent selected from group consisting of pineapple, apple, orange, Lemon, Mango, Pomegranate, Red grape and strawberry having mass the range from 0.02 to 0.075 parts per 100 parts of Energy Drink.

The ready to drink nutritional energy revitalizing beverage composition of the present invention provides a balanced nutrition so as to makes the person alert, energetic, hydrated and refreshed thereby improving overall well-being and quality of life of the person.

In accordance with one embodiment of the invention, mineral salts(mineral mixture) comprise at least one selected from a group consisting of Chloride salts, Sodium salts, Zinc salts, Magnesium Salts, Calcium salts and Potassium salts.

In accordance with one embodiment of the invention, the Chloride Salt is at least one compound selected from a group of compounds consisting of Calcium Chloride, Ammonium Chloride, Potassium Chloride, Sodium Chloride and Magnesium Chloride. Typically, total mass of the Chloride Salts ranges from about 0.115 to about 0.3 part per 100 parts of the solution.

In accordance with another embodiment of the invention, the Sodium Salt is at least one compound selected from a group of compounds consisting of Sodium Bicarbonate, Sodium citrate and Sodium chloride. Typically, the mass of the Sodium salt ranges from about 0.1 to about 0.3 parts per 100 parts of the solution.

In accordance with another embodiment of the invention, the Zinc salt is selected from the class consisting of zinc chloride, zinc sulfate, and zinc acetate. Typically, the mass of the Zinc salt ranges from about 0.005 to about 0.015 parts per 100 parts of the solution.

In accordance with another embodiment of the invention, Magnesium salt is selected from the class consisting of Magnesium sulphate and Magnesium chloride. Typically, the mass of the Magnesium salt ranges from about 0.025 parts to about 0.075 parts per 100 parts of the solution.

In accordance with another embodiment of the invention, the Calcium salt is at least one compound selected from a group of compounds consisting of Calcium lactate, Calcium Carbonate and Calcium gluconate. Typically, the mass of the Calcium salt ranges from about 0.02 to about 0.06 parts per 100 parts of the solution.

In accordance with another embodiment of the invention, the Potassium Salt is at least one compound selected from a group of compounds consisting of Potassium Bicarbonate, Potassium Chloride, Potassium Citrate and Potassium Gluconate. Typically, the mass of the Potassium Salt ranges from about 0.1 to about 0.2 part per 100 parts of Energy Drink.

In yet another embodiment, the invention established the safety and efficacy of the nutritional energy revitalizing beverage composition of the present invention in the human subjects for the increased alertness, energy levels, physical endurance, improved serum electrolytes and other biochemical parameters. The outcome of the clinical study conclusively establishes that the nutritional energy revitalizing beverage composition is safe and clinically effective in improving the endurance performance; improved serum electrolytes(improved hydration); improving energy levels; alertness and yet maintaining all the studied biochemical parameters un disturbed during the study period. The nutritional energy revitalizing beverage composition according to the present invention is a rich source of supplements which help in keeping an individual energetic, refreshed, alert and hydrated. Thus the nutritional energy revitalizing beverage composition of the present invention can overall improve the well-being and quality of life.

In a preferred embodiment, the mineral mixture consisting of the elements such as potassium in an amount of 78.5 mg (0.1168 part per 100 parts of the solution); sodium in an amount of 64.7 mg of sodium (0.064 part per 100 parts of the solution); calcium in an amount of 7.345 mg (0.0073 part per 100 parts of the solution); magnesium in an amount of 5 mg of magnesium ( 0.005 part per 100 parts of the solution); zinc in an amount of 2.27 mg ( 0.0022 part per 100 parts of the solution).

In another preferred embodiment, the invention provides brief manufacturing process of the nutritional energy revitalizing beverage composition of the present invention which comprises mixing all the ingredients except flavour in a mixing tank followed by transferring the ingredient mix into a blender and blended with the addition of RO water and flavour followed by transferring the blended product into sterilizer through 150 micron filter to obtain the product of the invention which is further pasteurized; aseptically filtered and filled into sterilized packs.

The following example will serve to illustrate the practice of this invention, it being understood that the particulars shown are by way of example and for purpose of illustrative discussion of one of the preferred embodiments of the invention.

Example: 1
Non-Carbonated Water based Flavoured energy revitalizing beverage Composition
S. No. Name of Item %Quantity
01 Sodium citrate 0.1-0.2
02 Potassium chloride 0.1-0.2
03 Sodium Chloride 0.05-0.1
04 Magnesium Sulphate 0.025-0.075
05 Calcium Lactate 0.02-0.06
06 Zinc Sulphate 0.005-0.015
07 Simple Sugar (Monosaccharide) 1.2-1.5
08 Sweetening Agent 5-15
09 Ascorbic Acid (with 50% Overages) 0.01-0.02
10 Pomegranate Juice (60 Brix) 0.5-1.0
11 Pomegranate Flavour 0.02-0.05
12 Red Grape Juice (65 Brix) 0.5-1.0
13 Red Grape Flavour 0.01-0.03
14 Caffeine Anhydrous 0.02-0.05
15 Taurine 0.1-0.3
16 Citric Acid (Acidity Regulator) 0.2-0.5
17 Water q.s
q.s.: Quantity Sufficient
Pomegranate Juice (60 Brix): 5.40% Reconstituted Juice
Red Grape Juice (65 Brix): 3.0% Reconstituted Juice

Example 2
Non-Carbonated Water based Flavoured energy revitalizing beverage Composition

Name of the ingredient concentration per 200 ML

Sugar (UHT) 20g
Dextrose 2.7g
Pomegranate Juice 1.8g
Red grape juice 1.4g
Citric Acid 640 mg
Taurine 400 mg
Sodium citrate 300 mg
Potassium chloride 300 mg
Magnesium Sulphate 100 mg
Calcium Lactate 80 mg
Pomegranate Flavour 70 mg
Caffiene Andydrous 64 mg
Sodium chloride 150 mg
Red Grape Flavour 40 mg
Ascorbic acid (with 50% overages) 30 mg
Zinc suphate 20 mg
Water 171.9 g

Example 3
Assessment of safety and clinical efficacy of the beverage composition
A study to evaluate safety and clinical efficacy of the energy drink as clinical outcomes in healthy human volunteers has been conducted in India. The study protocol includes open label, single arm, multi-centric study with 115 human adult subjects with proper inclusion and exclusion criteria. The exclusion criteria eliminates subjects such as pre diabetic & diabetic subjects; pre-hypertensive &hypertensive subjects; subjects addicted to alcohol; subjects addicted to Drugs; subjects having habit of tobacco; hypersensitivity to study product or any contents of the energy drink; presence of any major illness such as cancer, heart disease, COPD, Asthma etc.; subjects with current medical history of any major illness such as cancer, heart disease, COPD , Asthma etc. in the past; subjects with history of any acute or chronic illness that may affect the patient’s participation in the study; subjects with current use of vitamin or mineral supplements, nutritional supplements and or medical foods within 30 days prior to the beginning of the study and for the duration of the study; subjects with use of prescription medications and/or non-prescription medications for acute medical conditions, semi-acute medical conditions, and weight loss; subjects with acute illness or history of major or minor surgery in the past one year; female subjects who are currently pregnant and/or breast feeding and subjects receiving any medical therapy for any illness.
The clinical efficacy assessment of the subjects after the a trail period of 11 days includes physical Endurance tests; quality of life questionnaire; Stanford Sleepiness scale and energy level Scaling.
The clinical outcome measures defined as a) enhancement of energy level, physical endurance levels, alertness level, quality of life or b) no effect on energy level, physical endurance levels alertness level and quality of life.

The enrolled subjects have been provided with the energy revitalizing beverage composition of example 2 (1 pack of 200ml per day) to be consumed orally after lunch between 2 to 3 p.m. daily for 10 days. The enrolled subjects have been advised not to ingest any other energy drinks such as Red bull or other caffeine containing cola drinks such as Pepsi, coca cola etc. at any time of the day during the study period.

The following assessments were performed at site for the entire study period: a) treadmill test(TMT); b) alertness questionnaire (Stanford Sleepiness scale); c) energy level scaling and d) quality of Life questionnaire.
The Study Schedule and Procedure:
Day–0: Screening and Baseline (Visit 1):
The subjects will be screened in the study only after they provide a written informed consent.

After obtaining written informed consent, the subjects will undergo screening procedure.

Screening: Subjects will undergo an evaluation to determine eligibility to participate in this study based on the assessment by the investigator. The following clinical examinations and demographic measurements will be performed to evaluate the subject’s health status to participate in the study.

Demographic Measurements: Age, Gender, Weight and Height
? Physical Examination and vital signs: Pulse, Blood Pressure, Respiratory Rate
Body Temperature and Others
? Laboratory Assessments

A. Hematology: (Screening Visit and Final visit)
? Hematology: White blood cells (WBCs), Differential Leukocyte Count (DLC) along with Absolute Neutrophil Count(ANC), Platelet Count, Red Blood Cells (RBCs), Hemoglobin (Hb), Hematocrit, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), and Erythrocyte Sedimentation Rate (ESR)

B. Biochemistry: (Screening Visit and Final Visit)
? Liver Function Tests: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin
? Renal Function Tests: (Urea, Serum Creatinine, Serum Uric Acid)
? RBS (Random Blood Sugar)

C. Urine Routine and Microscopy Examination

D. Urine Pregnancy Test (only for female subjects of childbearing potential)

E. Serology Assessments (HIV, HBsAg and HCV antibody testing)

? Inclusion-Exclusion criteria check
? Medical History: Hypertension, Cardiac Diseases, Asthma, COPD, Thyroid Disorders Any Major Illness
Baseline efficacy tests:
? Fitness Tests (Physical Endurance): Treadmill tests
? Alertness Questionnaire (Stanford Sleepiness scale)
? Energy Level Scaling
? Quality of Life (QOL) Questionnaire

Day-1: (Visit 2)
After consumption of the first dose of Nutricharge? energy drink at the site, following assessments will be performed at site:
? Alertness Questionnaire (Stanford Sleepiness scale)
? Energy Level Scaling
? Quality of Life (QOL) Questionnaire
The subjects will be provided the alertness questionnaire and Quality of Life questionnaire at the site and will be explained the procedure of filling up these questionnaires.

3 Day-2 to Day-9:
All the enrolled subjects will consume the Nutricharge?energy drink daily at around 2-3 p.m. and provide a self-assessment of the following:
? Alertness Questionnaire (Stanford Sleepiness scale)
? Energy Level Scaling
The record of consumption will be maintained in the Patient Diary.
The subjects will be provided the alertness questionnaire and a format for Energy Level scaling and will be explained the procedure of filling up these questionnaires. The subjects will fill up these questionnaires daily on their own after consuming the energy drink.

Day-10 (Visit 3/Final Visit)
After consumption of the last dose of energy drink, the following assessments will be performed at site:
? Physical Examination and vital signs: Pulse, Blood Pressure, Respiratory Rate
Body Temperature and Others
? Laboratory Assessments

A. Hematology: (Screening Visit and Final visit)
? Hematology: White blood cells (WBCs), Differential Leukocyte Count (DLC) along with Absolute Neutrophil Count(ANC), Platelet Count, Red Blood Cells (RBCs), Hemoglobin (Hb), Hematocrit, Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), and Erythrocyte Sedimentation Rate (ESR)

B. Biochemistry: (Screening Visit and Final Visit)
? Liver Function Tests: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin
? Renal Function Tests: (Urea, Serum Creatinine, Serum Uric Acid)
? RBS (Random Blood Sugar)

C. Urine Routine and Microscopy Examination

Additional safety evaluation and test will perform, if required on the discretion of Investigator.
? Medical History: Hypertension, Cardiac Diseases, Asthma, COPD, Thyroid Disorders Any Major Illness
? Fitness Tests (Physical Endurance): Treadmill tests
? Alertness Questionnaire (Stanford Sleepiness scale)
? Energy Level Scaling
? Quality of Life (QOL) Questionnaire

Study consumption and Visit Schedule:
Tests Day-0 (Screening and Baseline)
(Visit-1) Day-1(Visit-2) Day-2 to Day-9
(Self- assessment) Day 10
(Visit-3)
Screening tests:
Blood pressure,
Blood glucose,
CBC with ESR,
RFT,
LFT,
Electrolytes,
Calcium
Urine Routine & Microscopic v v
Pregnancy v

Medical history v
Physical endurance: Treadmill tests v v
Alertness questionnaire v v v v
Energy Level Scaling v v v v
QOL questionnaire v v

The Statistical analysis of the clinical outcome is presented herein below in tables 1 to 5.
Table 1: Descriptive Statistics of Alertness Questionnaire Response by Day

(Baseline)
Day 0 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8 Day 9
N 99 154 155 157 156 157 157 158 156 158
Mean 1.6970 2.4026 2.4323 2.3822 2.4679 2.4522 2.4713 2.4873 2.4936 2.4304
SD 0.5016 1.5354 1.5493 1.4996 1.5376 1.5035 1.5333 1.5209 1.4785 1.4984

Alertness Questionnaire Response by Baseline vs change in baseline
Day 0 vs Day 1 Day 0 vs Day 2 Day 0 vs Day 3 Day 0 vs Day 4 Day 0 vs Day 5 Day 0 vs Day 6 Day 0 vs Day 7 Day 0 vs Day 8 Day 0 vs Day 9
p-value <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001
statistical significance Significant Significant Significant Significant Significant Significant Significant Significant Significant
Table 2: Statistical analysis for Alertness Questionnaire Response by baseline vs change in baseline

Table 3: Summary of Quality of Life Questionnaire Response

Energy level after exercise Consuming energy drink has mental and physical benefits Feel more alert after drinking ED Do you get headaches after drinking ED




p-value <0.00001 0.000655 0.00694 0.008002
Statistical significance Significant Significant Significant Significant

Table 4: Energy Level Scaling
Chi-square test for energy level at baseline vs. change in baseline
p-value statistical significance
Day 0 vs 1 0.011973 significant
Day 0 vs 2 0.000263 significant
Day 0 vs 3 0.000784 significant
Day 0 vs 4 0.001697 significant
Day 0 vs 5 0.000113 significant
Day 0 vs 6 0.001172 significant
Day 0 vs 7 0.002355 significant
Day 0 vs 8 0.000952 significant
Day 0 vs 9 0.009889 significant
Day 0 vs 10 0.024399 significant

Table 5: Descriptive statistics of Treadmill Test Results at Baseline and change in baseline to prove the enhancement in endurance performance

Treadmill result at Baseline Treadmill result Change in baseline
n 20 20
Mean 16.35 19.2
Variance 7.607894737 9.115789474
p-value 0.0034

Conclusion: As p-value(0.0034) < alpha (0.05), which concludes that there is significant difference between TMT Results at Baseline and change in baseline
The foregoing clinical outcome conclusively establishes that the nutritional energy revitalizing beverage composition is safe and clinically effective in improving the endurance performance; improvement in quality of life, improving energy levels; alertness and yet maintaining all the studied biochemical parameters un disturbed during the study period.
,CLAIMS:1. An oral, ready to drink, nutritional energy revitalizing beverage composition comprising;
(i) a mineral mixture having mass of about 0.4 to about 0.5 part per 100 parts of the solution;
(ii) at least one fruit Juice selected from a group consisting of Lemon, Red Grape Juice, Pineapple, Mango, Orange and Pomegranate Juice, wherein total amount of fruit juices is in the range of 0.5 to 2.0 parts per 100 parts of the energy revitalizing beverage composition;
(iii) atleast one vitamin C supplement selected from group consisting of ascorbic acid, sodium ascorbate and calcium ascorbate, wherein mass of vitamin C range from 0.010 to 0.020 parts per 100 parts of the energy revitalizing beverage composition;
(iv) atleast one simple sugar selected from group consisting of dextrose, fructose, and glucose having mass in the range of 1.25 to 1.5 parts per 100 parts of the energy revitalizing beverage composition;
(v) at least one natural sweetening agent selected from group consisting of Fructose, sucrose and mannitol having mass in the range of 5 to 15 parts per 100 parts of Energy Drink;
(vi) at least one acidity regulator selected from group consisting of acetic acid, Calcium acetate, Lactic acid, Malic acid, Fumaric acid, Citric acid, Tartaric acid, wherein mass of acidity regulator range from 0.2 to 0.5 parts per 100 parts of the energy revitalizing beverage composition;
(vii) at least one energy booster selected from group consisting of one amino acid and one purine, wherein mass of energy booster range from 0.02 to 0.3 parts per 100 parts of the energy revitalizing beverage composition; and
(viii) at least one flavouring agent selected from group consisting of Orange, Lemon, Mango, Pomegranate, Red grape and strawberry having mass the range from 0.02 to 0.075 parts per 100 parts of the energy revitalizing beverage composition.

2. The oral, ready to drink, nutritional energy revitalizing beverage composition according to claim 1, wherein the mineral mixture comprises Sodium citrate, Sodium chloride, Potassium chloride, Zinc sulphate, Magnesium sulphate and Calcium lactate.
3. The oral, ready to drink, nutritional energy revitalizing beverage composition according to claim 2, wherein the mass of Sodium citrate is in the range of 0.1 to 0.2 parts per 100 parts, mass of Sodium chloride is in the range of 0.05 to 0.1 parts per 100 parts, mass of Potassium chloride is in the range of 0.1 to 0.2 parts per 100 parts, mass of Zinc sulphate is in the range of 0.005 to 0.015 parts per 100 parts, mass of Magnesium sulphate is in the range of 0.025 to 0.075 parts per 100 parts and mass of Calcium lactate is in the range of 0.02 to 0.06 parts per 100 parts of the energy revitalizing beverage composition.

4. The oral, ready to drink, nutritional energy revitalizing beverage composition according to claim 1, wherein the natural fruit juices are Red Grape Juice having the mass ranges from about 0.5 to about 1.0 parts per 100 parts of the solution and Pomegranate Juice having the mass range from about 0.5 to about 1.0 parts per 100 parts of the energy revitalizing beverage composition.

5. The oral, ready to drink, nutritional energy revitalizing beverage composition according to claim 1, wherein the vitamin C supplement is ascorbic acid and mass of ascorbic acid (with 50% overages) range from 0.01 to 0.02 parts per 100 parts of the energy revitalizing beverage composition.

6. The oral, ready to drink, nutritional energy revitalizing beverage composition according to claim 1, wherein the simple sugar is dextrose and mass of dextrose is in the range of 1.2 to 1.5 parts per 100 parts of the energy revitalizing beverage composition.

7. The oral, ready to drink, nutritional energy revitalizing beverage composition according to claim 1, wherein the natural sweetening agent is sucrose having mass in the range of 5 to 15 parts per 100 parts of the energy revitalizing beverage composition.

8. The oral, ready to drink, nutritional energy revitalizing beverage composition according to claim 1, wherein the acidity regulator is citric acid and mass of citric acid range from 0.2 to 0.5 parts per 100 parts of the energy revitalizing beverage composition.

9. The oral, ready to drink, nutritional energy revitalizing beverage composition according to claim 1, wherein the energy boosters are taurine and caffeine having total mass ranges from 0.02 to 0.3 parts per 100 parts of the energy revitalizing beverage composition.

10. The oral, ready to drink, nutritional energy revitalizing beverage composition according to claim 1, wherein the flavouring agent are Pomegranate and Red Grape having total mass range from 0.02 to 0.075 parts per 100 parts of the energy revitalizing beverage composition.

11. The oral, ready to drink, nutritional energy revitalizing beverage Composition according to any one of the preceding claims comprising;
Name of the ingredient Concentration per 200 ML

Sugar (UHT) 20g
Dextrose 2.7g
Pomegranate Juice 1.65g
Red grape juice 0.9g
Citric Acid 640 mg
Taurine 400 mg
Sodium citrate 300 mg
Potassium chloride 300 mg
Magnesium Sulphate 100 mg
Calcium Lactate 80 mg
Pomegranate Flavour 70 mg
CaffieneAndydrous 64 mg
Sodium chloride 150 mg
Red Grape Flavour 40 mg
Ascorbic acid (with 50% overages) 30 mg
Zinc suphate 20 mg
Water q.s.