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Sponsored by: |
University of California, San Francisco |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00654667 |
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.
Condition | Intervention | Phase |
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Insulin Resistance |
Drug: Placebo Drug: Resveratrol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Mechanisms of Metabolic Regulation of Resveratrol on Humans With Metabolic Syndrome. |
Estimated Enrollment: | 36 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Resveratrol
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Drug: Resveratrol
Resveratrol 5 grams daily for one month
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2: Placebo Comparator
Placebo
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Drug: Placebo
Placebo, no active drug, take 5 capsules by mouth daily for one month
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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 the insulin sensitivity index as derived from glucose and insulin levels obtained during a 2 hour oral glucose tolerance test (OGTT)and insulin growth factor (IGF)-1 levels) 2) 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).
Secondary hypotheses are: Treatment with RSV 5.0 grams daily in individuals with IR will result in: 1)No change in energy intake as measured by food intake by 3 day food diary; 2)No change in body fat mass or distribution (via dual x-ray absorptiometry (DEXA), body mass index (BMI) and waist-to-hip ratio; and 3)Improved Quality of life as assessed by SF-36, compared to PC group.
We will also examine self-reported appetite and satiety as well as biomarkers leptin and adiponectin in the RSV versus PC group. Finally, we will examine the effects of RSV on hepatic (serum Ala aminotransferase, asp aminotransferase, lactate dehydrogenase, alkaline phosphatase, bilirubin, albumin), pancreatic (serum amylase) and renal (BUN and creatinine), function and red blood cell count (CBC with differential) in the IR compared to the PC group.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Roberta K Oka, RN, ANP, DNSc | 415-514-3407 | roberta.oka@nursing.ucsf.edu |
United States, California | |
University of California | Recruiting |
San Francisco, California, United States, 94143-0608 | |
Principal Investigator: Roberta K Oka, RN, ANP, DNSc | |
Sub-Investigator: Cynthia Kenyon, PhD | |
Sub-Investigator: Morris Schemblain, MD | |
Sub-Investigator: Kathleen Mulligan, PhD |
Responsible Party: | UCSF ( Joan Kaiser ) |
Study ID Numbers: | CTSI - SOS |
Study First Received: | April 3, 2008 |
Last Updated: | April 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00654667 |
Health Authority: | United States: Institutional Review Board |
Resveratrol Insulin Resistance Metabolic Syndrome Sirtuin 1 |
IGF-1 Satiety Leptin Adiponectin |
Resveratrol Hyperinsulinism Metabolic Diseases Insulin Resistance |
Metabolic disorder Glucose Metabolism Disorders Insulin |
Anti-Inflammatory Agents Anticarcinogenic Agents Disease Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematologic Agents Physiological Effects of Drugs Antimutagenic Agents Enzyme Inhibitors Protective Agents Pharmacologic Actions |
Pathologic Processes Sensory System Agents Analgesics, Non-Narcotic Syndrome Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Platelet Aggregation Inhibitors Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents Antineoplastic Agents, Phytogenic |