Long-term Resveratrol and Metabolism

Pre-diabetes Clinical Trial

Official title:

Effects of Long-term Resveratrol Supplementation on Metabolic Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565979
• Other study ID #: 15-3-037
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

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