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

Safety and Efficacy Clinical Trial

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

Status Completed

Clinical Trial Summary

In summary, all evidence points in the direction that amino acid supplementation is justified for augmenting desired fat loss associated with physical exercise as an obesity therapy. Nonetheless, the present clinical data concerning oral use of amino acid is insufficient for justifying its usage in humans as questions could arise with regards to its safety. Therefore, the present study was proposed to establish the safety profile of amino acid for human use by evaluating its use at a dose of 1000 mg per day in healthy individuals. The occurrence of adverse events will be monitored and reported as per the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0), whereas the cardiac safety will be assessed by changes in electrocardiogram parameters, blood pressure, and heart rate. Furthermore, the effect of amino acid consumption on lipid profile will also be assessed by measuring peripheral levels of leptin, adiponectin, total cholesterol, and triglycerides in healthy individuals.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Safety and Efficacy

• NCT number: NCT04785170
• Study type: Interventional
• Source: Vedic Lifesciences Pvt. Ltd.
• Status: Completed
• Phase: N/A
• Start date: February 2, 2021
• Completion date: March 26, 2021