resVida and Fat Oxidation

March 17, 2011 updated by: Maastricht University Medical Center

Effect of resVida on Fat Oxidation and Mitochondrial Biogenesis in Healthy Obese Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6200 MD
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
starch pill
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.
Active Comparator: resVida
synthetic pill containing 75 mg of resveratrol
Dietary supplement: 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.
Other Names:
  • resveratrol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference in fat oxidation between resVida and placebo treated group
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
difference in mitochondrial biogenesis, function, and lipolysis in adipose and skeletal muscle tissue between resVida and placebo treated group
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

DSM Nutritional Products, Inc.
Top Institute Food and Nutrition

Investigators

  • Principal Investigator: Silvie Timmers, MSc, Maastricht UMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

October 19, 2009

First Submitted That Met QC Criteria

October 19, 2009

First Posted (Estimate)

October 20, 2009

Study Record Updates

Last Update Posted (Estimate)

March 18, 2011

Last Update Submitted That Met QC Criteria

March 17, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 09-3-039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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