Mechanisms of Metabolic Regulation of Resveratrol on Humans With Metabolic Syndrome (RSV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00654667|
Recruitment Status : Withdrawn (no participant enrollment)
First Posted : April 9, 2008
Last Update Posted : March 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance||Drug: Placebo Drug: Resveratrol||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Mechanisms of Metabolic Regulation of Resveratrol on Humans With Metabolic Syndrome.|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
Placebo Comparator: 2
Placebo, no active drug, take 5 capsules by mouth daily for one month
Experimental: Experimental 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 [ Time Frame: one month ]
- 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) [ Time Frame: one month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00654667
|United States, California|
|University of California|
|San Francisco, California, United States, 94143-0608|