Phase
Condition
Obesity
High Cholesterol (Hyperlipidemia)
Hormone Deficiencies
Treatment
N/AClinical Study ID
Ages 30-60 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 orhypertension: 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 supplementswithin the last 30 days.
Willingness to avoid NSAIDS (advil, aleve, motrin, etc.) and aspirin for the entirestudy
Willingness to avoid ingestion of any foods containing peanuts, bilberries,blueberries, cranberries, strawberries, raspberries, grapes, grape juice, cocoapowder, dark chocolate, and red wine throughout the entire study, including run-inperiod.
Willingness to maintain weight for the duration of the study.
Willingness not to start an exercise regime during study participation
Exclusion
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 ofmed/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 withinthe last year (inhaled glucocorticosteroid use may be acceptable; this will bedetermined 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 normalupper 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 psychologicalcondition that would, in the opinion of the PI, impact the subject's ability tosuccessfully participate in the study.
Alcohol or drug abuse within the last 2 years
Any medications metabolized by cytochrome p450 3A4 (CYPA3A4) (see attachment of thesemedications as an appendix)
Any autoimmune disease (ie rheumatoid arthritis, systemic lupus erythematosis,psoriasis)
Physical condition requiring special diet (ie celiac disease)
Study Design
Study Description
Connect with a study center
The Rockefeller University
New York, New York 10065
United StatesSite Not Available

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