Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT00654667
Status:
WITHDRAWN
Last Update Posted:
2015-03-04
First Post:
2008-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mechanisms of Metabolic Regulation of Resveratrol on Humans With Metabolic Syndrome
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Mechanisms of Metabolic Regulation of Resveratrol on Humans With Metabolic Syndrome.
Status:
WITHDRAWN
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no participant enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RSV
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.
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: