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Pre-diabetesNCT02565979

Long-term Resveratrol and Metabolism

A study testing resveratrol in people with Pre-diabetes, run by Maastricht University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Pre-diabetes
What is being tested?
resveratrol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteNetherlands
Study dates
Apr 2016to 28 Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Maastricht University and Medical Centre

    Maastricht, Limburg, 6200 MD

Other trials in Netherlands

About this study

Official title: Effects of Long-term Resveratrol Supplementation on Metabolic Health

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.

Conditions
Pre-diabetes
Being tested
resveratrol, placebo
Keywords
Resveratrol, Diabetes Mellitus, Type 2, Insulin Resistance, Metabolic Diseases, Glucose Metabolism Disorders
Medical subject headings
Glucose Intolerance, Diabetes Mellitus, Type 2, Insulin Resistance, Metabolic Diseases, Glucose Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • resveratrolDietary supplement

    Also called resVida (99% trans-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.

  • placeboDietary 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.

Study groups in NCT02565979
Study groupRoleWhat they receive
ResveratrolActive 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.
Receives: Dietary Supplement: resveratrol
PlaceboPlacebo 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.
Receives: Dietary Supplement: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glucose Tolerance

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

    Measured: 2x baseline and 2x after 6 months of supplemenation

Secondary outcomes (8)

  1. Change in Intra-hepatic lipid content

    Intra-hepatic lipid content measured with 1H-MRS

    Measured: baseline and after 6 months of supplemenation

  2. 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

    Measured: baseline and after 6 months of supplemenation

  3. Change in Body composition

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

    Measured: baseline and after 6 months of supplemenation

  4. 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

    Measured: Once a month for a period of 6 months

  5. Change in Blood pressure

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

    Measured: Once a month for a period of 6 months

  6. 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

    Measured: baseline and after 6 months of supplemenation

  7. 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

    Measured: baseline and after 6 months of supplemenation

  8. Change in Quality of sleep

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

    Measured: baseline and after 6 months of supplemenation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2015 (estimated)
  2. Study startApr 2016
  3. Primary completionMar 2019
  4. Study completion28 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02565979
Sponsor's protocol ID
15-3-037
Status last verified
Mar 2019
First submitted
30 Sep 2015
Last updated
2 Apr 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32492138

Questions about this trial

What is this clinical trial studying?

A study testing resveratrol in people with Pre-diabetes, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glucose Tolerance (time frame: 2x baseline and 2x after 6 months of supplemenation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02565979, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.

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