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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02565979
Other study ID # 15-3-037
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date March 28, 2019

Study information

Verified date March 2019
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date March 28, 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given.
placebo
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.

Locations

Country Name City State
Netherlands Maastricht University and Medical Centre Maastricht Limburg

Sponsors (3)

Lead Sponsor Collaborator
Maastricht University Medical Center Diabetes Fonds, DSM Nutritional Products, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in Intra-hepatic lipid content Intra-hepatic lipid content measured with 1H-MRS baseline and after 6 months of supplemenation
Secondary 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
Secondary Change in Body composition Body composition will be assessed by dual energy X-ray absorptimetry (DEXA) scan baseline and after 6 months of supplemenation
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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