Long-term Resveratrol and Metabolism

NCT ID: NCT02565979

Last Updated: 2019-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-03-28

Brief Summary

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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.

Detailed Description

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Conditions

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Pre-diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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 of 75 mg will be provided with dinner. So in total 150 mg/day of resveratrol will be given.

Group Type ACTIVE_COMPARATOR

resveratrol

Intervention Type 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.

Placebo

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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resVida (99% trans-resveratrol)

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diabetes Fonds

OTHER

Sponsor Role collaborator

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Schrauwen, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Centre

Locations

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Maastricht University and Medical Centre

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 32492138 (View on PubMed)

Other Identifiers

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15-3-037

Identifier Type: -

Identifier Source: org_study_id

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