Ignite Creation Date:
2024-05-05 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 9:47 AM
Study NCT ID:
NCT00654667
Status:
WITHDRAWN
Last Update Posted:
2015-03-04
First Post:
2008-04-03
Brief Title:
Mechanisms of Metabolic Regulation of Resveratrol on Humans With Metabolic Syndrome
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
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WITHDRAWN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 50 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 50 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 OGTTand 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 50 grams daily in individuals with IR will result in 1No change in energy intake as measured by food intake by 3 day food diary 2No change in body fat mass or distribution via dual x-ray absorptiometry DEXA body mass index BMI and waist-to-hip ratio and 3Improved 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 50 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 OGTTand 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 50 grams daily in individuals with IR will result in 1No change in energy intake as measured by food intake by 3 day food diary 2No change in body fat mass or distribution via dual x-ray absorptiometry DEXA body mass index BMI and waist-to-hip ratio and 3Improved 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:
None
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?:
None