Status:
WITHDRAWN
Mechanisms of Metabolic Regulation of Resveratrol on Humans With Metabolic Syndrome
Lead Sponsor:
University of California, San Francisco
Conditions:
Insulin Resistance
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
Sirtuin activators may prove useful in treating age-related diseases and extending lifespan in humans. Resveratrol (RSV), a polyphenol found in red wine, has been shown in vitro to enhance SIRT1 activ...
Detailed Description
Hypotheses for this study: 4 weeks of supplementation with RSV 5.0 grams daily compared to placebo control in individuals with insulin resistance will: 1) Increase insulin sensitivity (assessed by th...
Eligibility Criteria
Inclusion
- Adults ages 50 years or older
- Women ages 50 years and older who are postmenopausal, defined as no menses for the previous 12 months
- BMI 25 to 35
- Waist-to-hip circumference ratios for men \>0.95, for women \>0.85
- HOMA-IR score from fasting plasma glucose and serum insulin levels \>2.7
- A diet consisting of \> 40% calories from fat; and
- Sedentary, defined as no formal exercise program and less than 30 minutes physical activity weekly.
Exclusion
- Active malignancy or tumor or other condition that would severely limit life expectancy
- Any type of major surgery during the last 3 months
- Psychiatric disorders with currently active manifestations
- Insulin-dependent diabetes
- Any chronic medications except for hormone replacement therapy. Vitamin supplements (of any type) are not allowed during the study, but are acceptable if the participant agrees to a 2 week washout period before participation in the study
- Active symptoms suggestive of an acute coronary syndrome or decompensated heart failure
- Currently on low fat diet or special diet (i.e. weight loss)
- Excessive alcohol intake (\>3 glasses of wine/1 six pack of beer daily)
- Concurrent participation in any drug studies or studies that require sample of a body fluid (or having finished in the past 6 months)
- Non-English speakers
- Abnormal LFTs.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00654667
Start Date
May 1 2007
End Date
August 1 2008
Last Update
March 4 2015
Active Locations (1)
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1
University of California
San Francisco, California, United States, 94143-0608