Completed

Clinical Study to Evaluate Safety and Efficacy of Amino Acid in Healthy Individuals

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What is being tested

Amino Acid

Drug
Who is being recruted

From 18 to 50 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2021
See protocol details

Summary

Principal SponsorVedic Lifesciences Pvt. Ltd.
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: February 2, 2021Actual date on which the first participant was enrolled.

Insufficient physical activity is a global health problem and as per recent literature, approximately one-third of the world's adult population fails to achieve recommended levels of physical activity. An underappreciated primary cause of most chronic conditions is the lack of sufficient daily physical activity. Overwhelming evidence proves the notion that reductions in daily physical activity is primary causes of chronic diseases/conditions and also that exercise is rehabilitative therapy from the inactivity-caused dysfunctions. There are several underlying mechanisms responsible for exercise-induced benefits such as, organ-to-organ crosstalk that contributes to metabolic homeostasis and affects the inflammatory response related pathways and fibrotic changes. Some of the best recognized beneficial effects of exercise on muscles are mediated by the transcriptional factor peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α). Skeletal muscles are highly vascularized tissue and have secretory abilities. Not only muscles release amino acids for fulfilling increased energy demand and to fuel the liver for undergoing gluconeogenesis, but also proteins to mediate inter-tissue crosstalk. Robust research have identified numerous endogenous factors secreted by myocytes (muscle cells) known as myokines or "exercise factor" upon regular exercise via PGC-1α-dependent mechanism. It has been reported that the levels of these myokines are upregulated during aerobic physical exercise. Amino acid, a novel non-protein amino acid secreted by skeletal muscles which aids the cross-talk between skeletal muscles, liver, and adipose tissue at molecular levels. amino acid is generated by catabolism of the branched-chain amino acid valine. Existing literature states, amino acid induces body fat loss by increasing energy expenditure, stimulating free fatty acid (FFA) oxidation in the liver and skeletal muscle cell, and by enhancing oxygen consumption by adipose tissue and hepatocytes. It was observed that amino acid stimulated differentiation of energy storing white adipose tissue preadipocytes to an energy burning "beige" (brown to white) phenotype. Uptake of plasma nutrients such as glucose, triglycerides (TG)-rich very low-density lipoproteins (VLDL), and FFA by cold-activated brown adipose tissue might be responsible for modulatory effect of amino acid on lipid and glucose metabolism. It is believed that amino acid also exerts its metabolic effects by modulating other circulating signaling molecules such as leptin. amino acid affects lipid metabolism and insulin sensitivity via restoring leptin levels in individuals with leptin deficiency. As about 5-10% of the obese population are low leptin secretor, amino acid might be an ideal intervention for fat loss in such population. It has also been demonstrated that amino acid supplementation activates several "thermogenic programs" similar to those activated by physical exercise. Furthermore, amino acid has been also shown to protect the osteocytes from ROS-induced apoptosis through the MRGPRD and by also maintaining mitochondria integrity. This protective capacity decreases with age as to the down regulation of Mrgprd expression in osteocytes.

Official TitleClinical Study to Evaluate Safety and Efficacy of Amino Acid in Healthy Individuals 
NCT04785170
Principal SponsorVedic Lifesciences Pvt. Ltd.
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
13 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
MaleBiological sex of participants that are eligible to enroll.
From 18 to 50 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

Inclusion Criteria: 1. Males aged ≥ 18 and ≤ 50 years. 2. Participants with a BMI within the range of ≥ 18.5 kg/m2 to ≤ 29.9 kg/m2 3. Participants deemed healthy by the investigator. 4. Participants willing to abstain from taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, gastrointestinal medications, antibiotics, anti-inflammatory drugs, dietary supplements including fiber supplements, prebiotics and probiotics, etc. 5. Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, blood sample collection procedures and study visit schedule) 6. Participants who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights. 7. Participants who are able to give written informed consent. Exclusion Criteria: 1. Presence of type II diabetes mellitus (Indicated by FBS ≥126 mg/dL, with or without drugs) 2. Presence of hypertension (Defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg, with or without drugs) 3. Participants with deranged CMP of severity ≥ grade II as per CTCAE v5.0. 4. Participants with deranged CBC of severity ≥ grade II as per CTCAE v5.0. 5. Participants with ESR \< 2 mm/hr or \> 15 mm/hr. 6. Participants with heavy alcohol consumption, defined as: - For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day. (NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, which is equivalent to 12 ounces of beer (\~5% alcohol), 8.5 ounces of malt liquor (\~9% alcohol), 5 ounces of wine (\~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; \~40% alcohol). 7. Binge drinkers, defined as 5 or more SAD for men, in a 2-hour time frame. 8. Individuals having a history (in past 2 years) of smoking or currently smoking or using any form of smokeless tobacco. 9. Consumption of nicotine, alcohol, coffee, and vigorous physical activity within 48 hours prior to all pre-determined assessment visits. 10. Abnormal Thyroid Stimulating Hormone (TSH) value which is \< 0.35 or \> 4.94 µIU/mL. 11. Evidence of any infection or inflammatory condition at screening. 12. Participants who have clinically active state of systemic illness which includes but is not limited to cardiovascular, endocrine, immune, respiratory, hepatobiliary, kidney and genitourinary, neuropsychiatric, and gastrointestinal system. 13. Participants diagnosed with any malignancy. 14. Participants having tumors that are being treated or planned for surgery. 15. Participants taking medicines (Prescription, OTC, etc), health functional foods or herbal medicines related to weight reduction within 1 month prior to screening. 16. Participant with significant medication use (inhaled beta agonists, central alpha agonists, hormonal contraceptives, corticosteroid use within three months prior to screening). 17. Participants who participated in another human trial within last 30 days prior to screening. 18. Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Dose: 1000 mg/day (500 mg/Capsule) Regimen: One capsule after breakfast \& one capsule after dinner to be taken with a glass of water. Duration: 14 Days

A novel non-protein amino acid secreted by skeletal muscles which aids the cross-talk between skeletal muscles, liver, and adipose tissue at molecular levels. amino acid is generated by catabolism of the branched-chain amino acid valine. Existing literature states, amino acid induces body fat loss by increasing energy expenditure, stimulating free fatty acid (FFA) oxidation in the liver and skeletal muscle cell, and by enhancing oxygen consumption by adipose tissue and hepatocytes. It was observed that amino acid stimulated differentiation of energy storing white adipose tissue preadipocytes to an energy burning "beige" (brown to white) phenotype.
Study Objectives
Primary Objectives

Any Adverse Event / Serious Adverse Event during Treatment Period

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Vedic Life Sciences Pvt. Ltd.Thane, IndiaSee the location
CompletedOne Study Center