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Mechanisms of Metabolic Regulation of Resveratrol on Humans With Metabolic Syndrome (RSV)

Primary Purpose

Insulin Resistance

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Placebo

Resveratrol

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring Resveratrol, Insulin Resistance, Metabolic Syndrome, Sirtuin 1, IGF-1, Satiety, Leptin, Adiponectin

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

University of California

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Experimental 1

Arm Description

Placebo

Resveratrol

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT00654667

First Posted

April 3, 2008

Last Updated

March 3, 2015

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT00654667

Brief Title

Mechanisms of Metabolic Regulation of Resveratrol on Humans With Metabolic Syndrome

Acronym

RSV

Official Title

Mechanisms of Metabolic Regulation of Resveratrol on Humans With Metabolic Syndrome.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Withdrawn

Why Stopped

no participant enrollment

Study Start Date

May 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Resistance

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Experimental 1

Arm Type

Experimental

Arm Description

Resveratrol

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Resveratrol

Primary Outcome Measure Information:

Title

Time Frame

one month

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Facility Information:

Facility Name

University of California

City

San Francisco

State/Province

California

ZIP/Postal Code

94143-0608

Country

United States

12. IPD Sharing Statement

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