Long-term Resveratrol and Metabolism

Study 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.

Official Title
-----------------
Effects of Long-term Resveratrol Supplementation on Metabolic Health

Conditions
-----------------
Pre-diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: resveratrol
* Dietary Supplement: placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resveratrol<br>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. | Dietary Supplement: resveratrol<br>* 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.<br>* Other names: resVida (99% trans-resveratrol);|
| Placebo Comparator: Placebo<br>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. | Dietary Supplement: placebo<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glucose Tolerance | Matsuda Index calculated from double 2-hour Oral Glucose Tolerance Test (OGTT) | 2x baseline and 2x after 6 months of supplemenation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intra-hepatic lipid content | Intra-hepatic lipid content measured with 1H-MRS | 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 | baseline and after 6 months of supplemenation | 
| Change in Body composition | Body composition will be assessed by dual energy X-ray absorptimetry (DEXA) scan | 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 | 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 | 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 | baseline and after 6 months of supplemenation | 
| Change in Quality of life | 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 | baseline and after 6 months of supplemenation | 
| Change in Quality of sleep | Sleep quality will be measured by the 10-item Pittsburg Sleep Quality Index | baseline and after 6 months of supplemenation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resveratrol, Diabetes Mellitus, Type 2, Insulin Resistance, Metabolic Diseases, Glucose Metabolism Disorders