Effects of Branch Chain Amino Acids on Glucose Tolerance in Obese Pre-Diabetic Subjects
Condition: Prediabetic State
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      Branching chain amino acids (BCAA) have both beneficial and detrimental effects of on
      metabolism have been established and therefore warrants further investigation. In the
      preliminary study, the investigators 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.

      This study will examine 10 obese subjects with pre-diabetes and examine the effects of taking
      BCAA supplement and will monitor the subjects blood glucose, insulin, triglyceride levels and
      will have an oral glucose tolerance test on repeated occasions to see if any changes are
      noted in their glucose regulation.
    

Detailed description: 
      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.

      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
      adolescents.

      This is a 12-week, randomized, crossover study with 10 obese subjects with prediabetes.
      Subjects will be randomly assigned to take 20g BCAA or low-BCAA protein a day for 4 weeks,
      then switch to BCAA or low-BCAA protein for 4 weeks after a 2-week washout.

      At baseline and weeks 4, 6 and 10 weeks glucose, insulin and triglyceride levels will be
      tested at time 0, 30 min, 60 min, and 120 min after 75 grams of glucose load. In addition to
      laboratory tests vital signs, weight and body composition will be done.
    

Intervention name(s): BCAA High Protein supplement; BCAA Low Protein supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will be randomly assigned to take high BCAA or low-BCAA protein a day for 4 weeks, then switch to BCAA or low-BCAA protein for 4 weeks after a 2-week washout.; Subjects will be randomly assigned to take high BCAA or low-BCAA protein a day for 4 weeks, then switch to BCAA or low-BCAA protein for 4 weeks after a 2-week washout.
Other intervention name(s): INNOBIO Instanized high BCAA Powder; SunWarrior Warrior Blend Natural
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pre-diabetes; blood glucose regulation; branching chain amino acids; diabetes; lower blood sugar