Pre-diabetes
Conditions
Keywords
Resveratrol, Diabetes Mellitus, Type 2, Insulin Resistance, Metabolic Diseases, Glucose Metabolism Disorders
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.
Interventions
DIETARY_SUPPLEMENTresveratrol
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.
DIETARY_SUPPLEMENTplacebo
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.
Sponsors
Diabetes Fonds
DSM Nutritional Products, Inc.
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 Intra-hepatic lipid content | baseline and after 6 months of supplemenation | Intra-hepatic lipid content measured with 1H-MRS |
| 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 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 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 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 |
Countries
Netherlands
Outcome results
None listed