Resveratrol and the Metabolic Syndrome

This is an interventional treatment trial for Obesity focused on measuring Obesity, Insulin resistance, Metabolic syndrome, Pre-diabetes Read More

Inclusion Criteria:

• Age 30 - 60 year old men
• Willingness to be randomized to resveratrol or placebo.
• BMI 30-40

• Evidence of insulin resistance with one of the following:

  2 hr oral glucose tolerance result =/>120mg/dl at 2hrs acanthosis nigricans, or HgA1C 5.7 - 7.9%, or FBS >/= 100 mg/dl AND at least 2 of the following: waist circumference > 102 cm triglycerides > 150 but < 500 mg/dL HDL < 40 mg/dL Pre- hypertension or hypertension: BP>120/80 mmHg but <150/90 mmHg

• Willingness to consume only study food and drink during the in-pt phases
• Willingness to avoid the use of over-the-counter medications, herbs, or supplements within the last 30 days.
• Willingness to avoid NSAIDS (advil, aleve, motrin, etc.) and aspirin for the entire study
• Willingness to avoid ingestion of any foods containing peanuts, bilberries, blueberries, cranberries, strawberries, raspberries, grapes, grape juice, cocoa powder, dark chocolate, and red wine throughout the entire study, including run-in period.
• Willingness to maintain weight for the duration of the study.
• Willingness not to start an exercise regime during study participation

Exclusion Criteria:

• Tobacco smoker any time within the last 3 months
• Bleeding disorder by history or by Bleeding Questionnaire results
• History, physical or EKG findings suggestive of CV disease including angina, MI, hx of med/surg tx of atherosclerotic heart disease, or congestive heart disease
• BP > 145/90 after 10 minutes of rest on 2 or more screening visits
• Fasting glucose > 165 mg/dL at screening
• HbA1C > 8.0 at screening
• Current use of oral hypoglycemic agents
• Chronic glucocorticosteroid use or use of oral glucocorticosteroids for 5 days within the last year (inhaled glucocorticosteroid use may be acceptable; this will be determined by the PI)
• Current use of over the counter or prescription weight loss medication
• Current use or within the last 30 days, any cholesterol lowering medications (statins, fibrates, red yeast rice, niacin).
• Hyperthyroidism or untreated hypothyroidism
• Obstructive sleep apnea, or significant symptoms suggestive of this condition.
• Current use of anticoagulants
• Known history of chronic hepatitis or liver enzymes (ALT or AST > 2.5 times the normal upper limit)
• Known HIV infection or confirmed positive test for HIV antibodies at screening
• Inflammatory bowel disease
• Active cancer (currently under treatment)
• Other medical condition that may cause significant weight loss or gain
• Chronic or acute renal disease
• Seizure disorder
• History of any psychiatric hospital admission within the last 2 years
• History of schizophrenia, psychosis, or bipolar disease
• History, physical, social or lab findings suggestive of any medical or psychological condition that would, in the opinion of the PI, impact the subject's ability to successfully participate in the study.
• Alcohol or drug abuse within the last 2 years
• Any medications metabolized by cytochrome p450 3A4 (CYPA3A4) (see attachment of these medications as an appendix)
• Any autoimmune disease (ie rheumatoid arthritis, systemic lupus erythematosis, psoriasis)
• Physical condition requiring special diet (ie celiac disease)