Investigation of an Amino Acid Supplement on Glucose Levels in Obese Subjects
Condition: Pre-diabetes; Obese; Glucose Intolerance
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      This study aims to determine whether the use of Branched-Chain Amino Acids (BCAA's) regulate
      insulin and glucagon secretion, and whether the supplement has any effect on body weight and
      body composition. Subjects who participate in this study will receive an 8-week supply of
      supplement. The study supplements will be manufactured by Scientific Living, in Irvine, CA
      for high dose BCAA and the low dose BCAA is manufactured by Nutribiotic, Lakeport, CA. Timed
      blood collections will be used to measure how BCAA affect glucose metabolism/insulin
      sensitivity in human subjects.
    

Detailed description: 
      1. BCAA's multiple functions in cells In addition to participating in de novo protein
           synthesis, Branched-Chain Amino Acids (BCAAs, including leucine, isoleucine, and valine)
           regulate multiple cellular functions as nutrient signaling. For example, BCAAs regulate
           insulin and glucagon secretion and thus glucose metabolism1. BCAAs, especially leucine,
           is one key regulator of mTOR signaling, which is the central component of a complex
           signaling network of insulin signaling, cell growth, and proliferation. BCAAs also
           regulate protein synthesis and degradation in various tissues.

        2. Impact of BCAA supplemental or BCAA-enriched diet on metabolism In addition to the
           healthcare utilization of BCAAs for liver disorders and their complications and other
           diseases, BCAA supplementation is common amongst athletes and fitness professionals to
           improve muscle building and strength. Meanwhile, BCAA supplementation or BCAA-rich
           protein diets are often associated with positive effects on body weight and glucose
           homeostasis1. Increasing dietary uptake of BCAAs improved the parameters associated with
           obesity and T2DM, such as body composition and glycemia levels. However, these
           beneficial effects are not conclusive. Moreover, other studies have shown that
           circulating branched-chain amino acid concentrations are associated with obesity and
           future insulin resistance in children and adolescents2.

        3. Summary Both beneficial and detrimental effects of BCAA on metabolism have been
           established and therefore warrants further investigation. In the preliminary study, we
           found that BCAAs enhanced glucose metabolism in lean mice while they promoted glucose
           intolerance in obese mice. In lean mice, BCAAs decreased adiposity and enhanced glucose
           utilization and insulin sensitivity in different tissues. But in obese mice, BCAAs'
           effects were mediated by impaired insulin signaling in fat tissue.
    

Intervention name(s): BCAA
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will be randomly assigned to take either the 25g supplement (containing 4g BCAA) daily for 4 weeks followed by the 20g BCAA supplement daily for 4 weeks, or vice versa
Other intervention name(s): Branch Chain Amino Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: BCAA
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment