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Completed

NCT Number: NCT02565979

Long-term Resveratrol and Metabolism

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.

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Key information

Conditions

Pre-diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University and Medical Centre

Maastricht, Limburg, 6200 MD, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol

Dietary Supplement

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

Dietary Supplement

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 outcomes

  1. Change in Glucose Tolerance

    Time frame: 2x baseline and 2x after 6 months of supplemenation

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

Secondary outcomes

  1. Change in Intra-hepatic lipid content

    Time frame: baseline and after 6 months of supplemenation

    Intra-hepatic lipid content measured with 1H-MRS

  2. Change in Resting energy expenditure

    Time frame: baseline and after 6 months of supplemenation

    energy expenditure and substrate oxidation will be measured by an automated ventilated hood system (45 minutes) to determine whole body energy metabolism

  3. Change in Body composition

    Time frame: baseline and after 6 months of supplemenation

    Body composition will be assessed by dual energy X-ray absorptimetry (DEXA) scan

  4. Change in Blood plasma markers

    Time frame: Once a month for a period of 6 months

    Markers related to energy metabolism (for instance glucose, insulin, free fatty acids, cholesterol, glycerol and triglycerides) will be measured regularly

  5. Change in Blood pressure

    Time frame: Once a month for a period of 6 months

    blood pressure (diastolic and systolic blood pressure and heart rate) will be measured once a month

  6. Change in Physical performance

    Time frame: baseline and after 6 months of supplemenation

    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

  7. Change in Quality of life

    Time frame: baseline and after 6 months of supplemenation

    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

  8. Change in Quality of sleep

    Time frame: baseline and after 6 months of supplemenation

    Sleep quality will be measured by the 10-item Pittsburg Sleep Quality Index

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Diabetes Fonds
  • dsm-firmenich Switzerland AG

Registry information

Official study title

Effects of Long-term Resveratrol Supplementation on Metabolic Health

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2015
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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