Effects of Long-term Resveratrol Supplementation on Metabolic Health

Maastricht University Medical Center1 site in 1 country42 target enrollmentApril 2016

ConditionsPre-diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pre-diabetes
Sponsor: Maastricht University Medical Center
Enrollment: 42
Locations: 1
Primary Endpoint: Change in Glucose Tolerance
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of the study is to investigate if 6 months resveratrol supplementation can improve glucose tolerance in overweight/obese individuals. As secondary objectives we want to investigate whether resting energy metabolism, intra-hepatic lipid content, physical performance, body composition and quality of life change by 6 months resveratrol supplementation in these individuals.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

March 28, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Maastricht University Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men aged 40-70 years and postmenopausal women aged 50-70 years
•BMI: 27-35 kg/m2
•Stable dietary habits: no weight gain or loss \> 5kg in the last three months
•Willingness to limit consumption of resveratrol-containing food products and willingness to refrain from using resveratrol containing supplements
•Subjects will only be included when the dependent medical doctor of this study approves participation after evaluating data obtained during screening

Exclusion Criteria

•Uncontrolled hypertension
•HbA1c \> 6.5%
•Previously diagnosed with type 2 diabetes
•Medication use known to interfere with glucose homeostasis/metabolism
•Current alcohol consumption \> 20 grams alcohol/day
•Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study.
•Participation in another biomedical study within 1 month before the start of the intervention
•Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk

Outcomes

Primary Outcomes

Change in Glucose Tolerance

Time Frame: 2x baseline and 2x after 6 months of supplemenation

Matsuda Index calculated from double 2-hour Oral Glucose Tolerance Test (OGTT)

Secondary Outcomes

Change in Resting energy expenditure(baseline and after 6 months of supplemenation)
Change in Body composition(baseline and after 6 months of supplemenation)
Change in Quality of life(baseline and after 6 months of supplemenation)
Change in Blood plasma markers(Once a month for a period of 6 months)
Change in Blood pressure(Once a month for a period of 6 months)
Change in Physical performance(baseline and after 6 months of supplemenation)
Change in Quality of sleep(baseline and after 6 months of supplemenation)
Change in Intra-hepatic lipid content(baseline and after 6 months of supplemenation)