Clinical trial NCT02565979: Long-term Resveratrol and Metabolism
Official title: Effects of Long-term Resveratrol Supplementation on Metabolic Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Keywords: Resveratrol
Diabetes Mellitus, Type 2
Insulin Resistance
Metabolic Diseases
Glucose Metabolism Disorders
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Diabetes Fonds
name: DSM Nutritional Products, Inc.
First posted: 2015-10-01
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Glucose Tolerance
timeFrame: 2x baseline and 2x after 6 months of supplemenation
Secondary outcomes:
measure: Change in Intra-hepatic lipid content
timeFrame: baseline and after 6 months of supplemenation
measure: Change in Resting energy expenditure
timeFrame: baseline and after 6 months of supplemenation
measure: Change in Body composition
timeFrame: baseline and after 6 months of supplemenation
measure: Change in Blood plasma markers
timeFrame: Once a month for a period of 6 months
measure: Change in Blood pressure
timeFrame: Once a month for a period of 6 months
measure: Change in Physical performance
timeFrame: baseline and after 6 months of supplemenation
measure: Change in Quality of life
timeFrame: baseline and after 6 months of supplemenation
measure: Change in Quality of sleep
timeFrame: baseline and after 6 months of supplemenation
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University and Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University Medical Centre
name: Patrick Schrauwen, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.