Long-term Resveratrol and Metabolism

Maastricht University Medical Center42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Pre-diabetes

Interventions

resveratrolDIETARY_SUPPLEMENT

Resveratrol will be given for 6 months, twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given.

placeboDIETARY_SUPPLEMENT

A placebo will given for 6 months, twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Maastricht University and Medical Centre

Maastricht, Limburg, Netherlands

Outcomes

Primary Outcomes

Change in Glucose Tolerance

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

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

Secondary Outcomes

Change in Intra-hepatic lipid content

Intra-hepatic lipid content measured with 1H-MRS

Time frame: baseline and after 6 months of supplemenation

Change in Resting energy expenditure

energy expenditure and substrate oxidation will be measured by an automated ventilated hood system (45 minutes) to determine whole body energy metabolism

Time frame: baseline and after 6 months of supplemenation

Change in Body composition

Body composition will be assessed by dual energy X-ray absorptimetry (DEXA) scan

Time frame: baseline and after 6 months of supplemenation

Change in Blood plasma markers

Markers related to energy metabolism (for instance glucose, insulin, free fatty acids, cholesterol, glycerol and triglycerides) will be measured regularly

Time frame: Once a month for a period of 6 months

Change in Blood pressure

blood pressure (diastolic and systolic blood pressure and heart rate) will be measured once a month

Time frame: Once a month for a period of 6 months

Change in Physical performance

Physical performance will be assessed by the following tests: the Timed Chair Stand Test; the 6-minute walk test while they wear a MOX Activity Monitor; and a dynamometer (Biodex) will be used to determine isometric and isokinetic muscle strength of the extensor and flexor muscles of the knee joint

Data from ClinicalTrials.gov

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