Long-term Resveratrol and Metabolism
- Conditions
- Pre-diabetes
- Interventions
- Dietary Supplement: placeboDietary Supplement: resveratrol
- Registration Number
- NCT02565979
- Lead Sponsor
- Maastricht University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo placebo will be given for 6 months, twice daily. One pill will be provided with lunch and the other pill will be provided with dinner. Resveratrol resveratrol 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 of 75 mg will be provided with dinner. So in total 150 mg/day of resveratrol will be given.
- Primary Outcome Measures
Name Time Method Change in Glucose Tolerance 2x baseline and 2x after 6 months of supplemenation Matsuda Index calculated from double 2-hour Oral Glucose Tolerance Test (OGTT)
- Secondary Outcome Measures
Name Time Method Change in Resting energy expenditure baseline and after 6 months of supplemenation energy expenditure and substrate oxidation will be measured by an automated ventilated hood system (45 minutes) to determine whole body energy metabolism
Change in Body composition baseline and after 6 months of supplemenation Body composition will be assessed by dual energy X-ray absorptimetry (DEXA) scan
Change in Quality of life baseline and after 6 months of supplemenation Quality of life (QoL) will be tested using a 32-item questionnaire. This measure quantifies QoL on the dimensions Social, Spiritual, Emotional, Cognitive, Physical, Activities of Daily Living, and Integrated QoL
Change in Blood plasma markers Once a month for a period of 6 months Markers related to energy metabolism (for instance glucose, insulin, free fatty acids, cholesterol, glycerol and triglycerides) will be measured regularly
Change in Blood pressure Once a month for a period of 6 months blood pressure (diastolic and systolic blood pressure and heart rate) will be measured once a month
Change in Physical performance baseline and after 6 months of supplemenation 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
Change in Quality of sleep baseline and after 6 months of supplemenation Sleep quality will be measured by the 10-item Pittsburg Sleep Quality Index
Change in Intra-hepatic lipid content baseline and after 6 months of supplemenation Intra-hepatic lipid content measured with 1H-MRS
Trial Locations
- Locations (1)
Maastricht University and Medical Centre
🇳🇱Maastricht, Limburg, Netherlands