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Long-term Resveratrol and Metabolism

Primary Purpose

Pre-diabetes

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
resveratrol
placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-diabetes focused on measuring Resveratrol, Diabetes Mellitus, Type 2, Insulin Resistance, Metabolic Diseases, Glucose Metabolism Disorders

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University and Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Resveratrol

Placebo

Arm Description

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 will be given for 6 months, twice daily. One pill will be provided with lunch and the other pill will be provided with dinner.

Outcomes

Primary Outcome Measures

Change in Glucose Tolerance
Matsuda Index calculated from double 2-hour Oral Glucose Tolerance Test (OGTT)

Secondary Outcome Measures

Change in Intra-hepatic lipid content
Intra-hepatic lipid content measured with 1H-MRS
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
Change in Body composition
Body composition will be assessed by dual energy X-ray absorptimetry (DEXA) scan
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
Change in Blood pressure
blood pressure (diastolic and systolic blood pressure and heart rate) will be measured once a month
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
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
Change in Quality of sleep
Sleep quality will be measured by the 10-item Pittsburg Sleep Quality Index

Full Information

First Posted
September 30, 2015
Last Updated
April 1, 2019
Sponsor
Maastricht University Medical Center
Collaborators
Diabetes Fonds, DSM Nutritional Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02565979
Brief Title
Long-term Resveratrol and Metabolism
Official Title
Effects of Long-term Resveratrol Supplementation on Metabolic Health
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Diabetes Fonds, DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
Resveratrol, Diabetes Mellitus, Type 2, Insulin Resistance, Metabolic Diseases, Glucose Metabolism Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
resveratrol
Other Intervention Name(s)
resVida (99% trans-resveratrol)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Glucose Tolerance
Description
Matsuda Index calculated from double 2-hour Oral Glucose Tolerance Test (OGTT)
Time Frame
2x baseline and 2x after 6 months of supplemenation
Secondary Outcome Measure Information:
Title
Change in Intra-hepatic lipid content
Description
Intra-hepatic lipid content measured with 1H-MRS
Time Frame
baseline and after 6 months of supplemenation
Title
Change in Resting energy expenditure
Description
energy expenditure and substrate oxidation will be measured by an automated ventilated hood system (45 minutes) to determine whole body energy metabolism
Time Frame
baseline and after 6 months of supplemenation
Title
Change in Body composition
Description
Body composition will be assessed by dual energy X-ray absorptimetry (DEXA) scan
Time Frame
baseline and after 6 months of supplemenation
Title
Change in Blood plasma markers
Description
Markers related to energy metabolism (for instance glucose, insulin, free fatty acids, cholesterol, glycerol and triglycerides) will be measured regularly
Time Frame
Once a month for a period of 6 months
Title
Change in Blood pressure
Description
blood pressure (diastolic and systolic blood pressure and heart rate) will be measured once a month
Time Frame
Once a month for a period of 6 months
Title
Change in Physical performance
Description
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
Time Frame
baseline and after 6 months of supplemenation
Title
Change in Quality of life
Description
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
Time Frame
baseline and after 6 months of supplemenation
Title
Change in Quality of sleep
Description
Sleep quality will be measured by the 10-item Pittsburg Sleep Quality Index
Time Frame
baseline and after 6 months of supplemenation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Schrauwen, Prof. Dr.
Organizational Affiliation
Maastricht University Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University and Medical Centre
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6200 MD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
32492138
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.
Results Reference
derived

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Long-term Resveratrol and Metabolism

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