resVida and Fat Oxidation

NCT ID: NCT00998504

Last Updated: 2011-03-18

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-01-31

Brief Summary

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There is now a general consensus that the combination of excessive energy intake and a low capacity to oxidize fat will lead to muscular fat accumulation and insulin resistance. It is known for many years that physical exercise is the most powerful treatment to combat insulin resistance, but it is also known that it is difficult to get people to exercise. A major breakthrough has come from the nutrition field, with the finding that resveratrol, a natural polyphenolic compound, could serve as an "exercise mimetic" by protecting mice from many detrimental effects of diet-induced obesity. Therefore the researchers would like to investigate if resVida can increase skeletal muscle mitochondrial function and fat oxidative capacity in obese subjects. The researchers hypothesize that an increased mitochondrial function together with an increased intrinsic activity will lead to a better control of fatty acid handling in muscle, upon a high-fat challenge.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

starch pill

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

resVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given.

resVida

synthetic pill containing 75 mg of resveratrol

Group Type ACTIVE_COMPARATOR

resVida

Intervention Type DIETARY_SUPPLEMENT

resVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given.

Interventions

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resVida

resVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given.

Intervention Type DIETARY_SUPPLEMENT

placebo

resVida or placebo will be given for 30 days, twice daily. One pill, which contains 75 mg of resVida, will be provided with lunch, and the other pill will be provided with diner. So in total, 150 mg/day will be given.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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resveratrol

Eligibility Criteria

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Inclusion Criteria

* male sex
* age 45-65 years
* body fat percentage \> 25%, BMI 30-35 kg/m2
* sedentary
* stable dietary habits
* willingness to abstain from ingestion of resveratrol-containing foods
* healthy

Exclusion Criteria

* female sex
* unstable body weight (weight gain or loss \> 3 kg in the last three months)
* total body fat percentage \< 25%
* fasting plasma glucose \> 6.1 mmol/l
* hemoglobin \< 7.8 mmol/l
* engagement in programmed exercise \> 2 hours total per week
* impaired kidney and/ or liver function
* first- or second-degree family member with type 2 diabetes mellitus
* any medical condition requiring treatment and/ or medication use
* intake of dietary supplements except vitamins and minerals
* unwilling to restrict high-resveratrol containing foods
* current alcohol consumption \> 20 grams/day
* participation in another biomedical study within 1 month before the screening visit
* a contraindication to MRI scanning. These contraindications include patients with the following devices:
* central nervous system aneurysm clips
* implanted neural stimulator
* implanted cardiac pacemaker or defibrillator
* cochlear implant
* insulin pump
* or metal containing corpora aliena in the eye or brains
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role collaborator

Top Institute Food and Nutrition

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Top Institute Food and Nutrition

Principal Investigators

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Silvie Timmers, MSc

Role: PRINCIPAL_INVESTIGATOR

Maastricht UMC

Locations

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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Knop FK, Konings E, Timmers S, Schrauwen P, Holst JJ, Blaak EE. Thirty days of resveratrol supplementation does not affect postprandial incretin hormone responses, but suppresses postprandial glucagon in obese subjects. Diabet Med. 2013 Oct;30(10):1214-8. doi: 10.1111/dme.12231. Epub 2013 Jun 7.

Reference Type DERIVED
PMID: 23663119 (View on PubMed)

Other Identifiers

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MEC 09-3-039

Identifier Type: -

Identifier Source: org_study_id

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