Long-term Resveratrol and Metabolism

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.

Full Title of Study: “Effects of Long-term Resveratrol Supplementation on Metabolic Health”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2019

Interventions

  • 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.
  • Dietary Supplement: 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.

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Change in Intra-hepatic lipid content
    • Time Frame: baseline and after 6 months of supplemenation
    • Intra-hepatic lipid content measured with 1H-MRS
  • Change in Resting energy expenditure
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: baseline and after 6 months of supplemenation
    • Sleep quality will be measured by the 10-item Pittsburg Sleep Quality Index

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Maastricht University Medical Center
  • Collaborator
    • Diabetes Fonds
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Patrick Schrauwen, Prof. Dr., Principal Investigator, Maastricht University Medical Centre

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