Resveratrol-Leucine Metabolite Synergy in Pre-diabetes
Condition: Impaired Glucose Tolerance
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The study will evaluate the effects of resveratrol/leucine and resveratrol/HMB for their
      ability to control glucose levels in persons without diabetes but with impaired fasting
      glucose. Secondary assessments will examine the effect of these nutritional supplements
      versus placebo on inflammation, fasting lipids, HbA1C, and fructosamine, longer term
      metabolic markers of risk in diabetes.
    

Detailed description: 
      This will be a 28-day randomized controlled trial of the effects of a nutraceutical
      preparation on glycemic control in non-diabetic individuals with impaired glucose tolerance
      (IGT). IGT will be defined by American Diabetes Association criteria, as outlined in the list
      of inclusion and exclusion criteria (copy attached). There will be two active treatment arms
      and a placebo arm (3 arms total, n=12 completed subjects per arm). Following screening for
      inclusion/exclusion criteria and obtaining informed consent, subjects will be enrolled in the
      study and provided instructions to maintain their usual dietary pattern and physical activity
      level. If recent physical examination and medical history are not available; H&P will be
      conducted and recorded for each enrolled subject. Subjects will be instructed to follow a
      12-hour fast starting on day -1, and on the morning of day 0 fasting blood is drawn for
      analyses indicated below and the supplements are distributed. Supplements are distributed
      using a blinding protocol and a variable, known pill allotment in order to assess compliance
      via standard pill counts. Pill bottles and all unused supplements are returned at seven day
      intervals, with new supplies being distributed at that time. Fasting blood samples are
      obtained on days 0, 7, 14 and 28. Samples from each day are analyzed for glucose and insulin.
      Samples from days 0, 14 and 28 are also analyzed for fructosamine, C-peptide, glucagon and
      F2-isoprostanes. A75 g oral glucose tolerance test administered on days 0 and 28.
    

Intervention name(s): Resveratrol; resveratrol /HMB; Placebo treatment
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): A blend of low dose resveratrol and either leucine or HMB will be useful nutraceutical strategies for the control of elevated blood glucose in non-diabetic individuals with elevated fasting glucose. The proposed project is designed to evaluate this hypothesis by comparing the effects of resveratrol (50 mg)/leucine (1.11 g) administered twice daily (bid).; resveratrol (50 mg)/HMB (500 mg) twice daily (bid) with placebo on fasting blood glucose, glucose tolerance, insulin, C-peptide, glucagon, fructosamine and F2-isoprostanes in non-diabetic subjects with elevated fasting blood glucose.; Placebo - one tablet taken twice a day by mouth
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Impaired glucose tolerance, pre-diabetes,glycemic control,; supplements