Clinical Study to Evaluate Safety and Efficacy of Amino Acid in Healthy Individuals
Condition: Safety and Efficacy
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Amino Acid
Intervention type(s): Drug
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: safety and efficacy of amino acid in single arm group of Healthy Individuals.
Masking: None (Open Label)
Primary purpose: Treatment