Mechanisms of Metabolic Regulation of Resveratrol on Humans With Metabolic Syndrome

NCT00654667 | Withdrawn Phase 2

• 1 other identifier: CTSI - SOS
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 activity. RSV is associated with some of the beneficial effects of red wine or the "French Paradox". Recently RSV has been associated with increasing lifespan in mice on a high calorie diet and improved metabolic profile and activity levels. The effect of this small molecule in humans is unknown. Preclinical observations suggest that RSV is safe and has enormous potential in the treatment of obesity and insulin resistance in humans. This pilot study will examine the effect of RSV on improving the metabolic profile of adults with insulin resistance. Specifically, this randomized double blind placebo controlled study will examine the effects of 4 weeks of supplementation with RSV 5.0 grams daily, compared to placebo control (PC) on the metabolic profile of 36 men and women over the age of 50 with insulin resistance (IR) consuming a typical western diet consisting of at least 40% calories from fat.

Conditions

Insulin Resistance

Keywords

Resveratrol; Insulin Resistance; Metabolic Syndrome; Sirtuin 1; IGF-1; Satiety; Leptin; Adiponectin

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity (assessed by the insulin sensitivity index as derived from glucose and insulin levels obtained during a 2 hour oral glucose tolerance test (OGTT)1, 2 and insulin growth factor (IGF)-1 levels3

  one month

Secondary Outcomes (1)

• Improve cholesterol metabolism (lower LDL, raise HDL and lower triglyceride (TG) levels); and 3) physical activity levels measured by pedometer and 7 day physical activity recall (PAR)

  one month

Study Arms (2)

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Experimental 1

EXPERIMENTAL

Resveratrol

Drug: Resveratrol

Interventions

Placebo DRUG

Placebo, no active drug, take 5 capsules by mouth daily for one month

2

Resveratrol DRUG

Experimental 1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California

San Francisco, California, 94143-0608, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Metabolic Syndrome

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 9, 2008
• Study Start: May 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 4, 2015

Record last verified: 2015-03

Locations

US (1)