Long-term Resveratrol and Metabolism
Effects of Long-term Resveratrol Supplementation on Metabolic Health
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2019
CompletedApril 2, 2019
March 1, 2019
2.9 years
September 30, 2015
April 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Change in Intra-hepatic lipid content
baseline and after 6 months of supplemenation
Change in Resting energy expenditure
baseline and after 6 months of supplemenation
Change in Body composition
baseline and after 6 months of supplemenation
Change in Blood plasma markers
Once a month for a period of 6 months
Change in Blood pressure
Once a month for a period of 6 months
- +3 more secondary outcomes
Study Arms (2)
Resveratrol
ACTIVE COMPARATORresveratrol 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
PLACEBO COMPARATORplacebo will be given for 6 months, twice daily. One pill will be provided with lunch and the other pill will be provided with dinner.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Diabetes Fondscollaborator
- DSM Nutritional Products, Inc.collaborator
Study Sites (1)
Maastricht University and Medical Centre
Maastricht, Limburg, 6200 MD, Netherlands
Related Publications (1)
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.
PMID: 32492138DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Schrauwen, Prof. Dr.
Maastricht University Medical Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2015
First Posted
October 1, 2015
Study Start
April 1, 2016
Primary Completion
March 1, 2019
Study Completion
March 28, 2019
Last Updated
April 2, 2019
Record last verified: 2019-03