Long-term Resveratrol and Metabolism

Effects of Long-term Resveratrol Supplementation on Metabolic Health

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.

Study Overview

• Status: Completed
• Conditions: Pre-diabetes
• Intervention / Treatment: Dietary supplement: resveratrol; Dietary supplement: placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6200 MD
      • Maastricht University and Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: resVida (99% trans-resveratrol)
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.	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.

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: DSM Nutritional Products, Inc.; Diabetes Fonds
• Investigators: Principal Investigator: Patrick Schrauwen, Prof. Dr., Maastricht University Medical Centre

Publications and helpful links

General Publications

• de Ligt M, Bergman M, Fuentes RM, Essers H, Moonen-Kornips E, Havekes B, Schrauwen-Hinderling VB, Schrauwen P. No effect of resveratrol supplementation after 6 months on insulin sensitivity in overweight adults: a randomized trial. Am J Clin Nutr. 2020 Oct 1;112(4):1029-1038. doi: 10.1093/ajcn/nqaa125.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 28, 2019

Study Registration Dates

• First Submitted: September 30, 2015
• First Submitted That Met QC Criteria: September 30, 2015
• First Posted (Estimate): October 1, 2015

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Insulin Resistance; Diabetes Mellitus, Type 2; Resveratrol; Glucose Metabolism Disorders; Metabolic Diseases
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: 15-3-037

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No