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resVida and Fat Oxidation

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ClinicalTrials.gov Identifier: NCT00998504
Recruitment Status : Completed
First Posted : October 20, 2009
Last Update Posted : March 18, 2011
Sponsor:
Collaborators:
DSM Nutritional Products, Inc.
Top Institute Food and Nutrition
Information provided by:
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE October 19, 2009
First Posted Date  ICMJE October 20, 2009
Last Update Posted Date March 18, 2011
Study Start Date  ICMJE October 2009
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2009)
difference in fat oxidation between resVida and placebo treated group [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2009)
difference in mitochondrial biogenesis, function, and lipolysis in adipose and skeletal muscle tissue between resVida and placebo treated group [ Time Frame: 9 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE resVida and Fat Oxidation
Official Title  ICMJE Effect of resVida on Fat Oxidation and Mitochondrial Biogenesis in Healthy Obese Subjects
Brief Summary 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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 Name: resveratrol
  • 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.
Study Arms  ICMJE
  • Placebo Comparator: placebo
    starch pill
    Intervention: Dietary Supplement: placebo
  • Active Comparator: resVida
    synthetic pill containing 75 mg of resveratrol
    Intervention: Dietary Supplement: resVida
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 19, 2009)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 45 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00998504
Other Study ID Numbers  ICMJE MEC 09-3-039
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Silvie Timmers, MSc, Top Institute Food and Nutrition
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE
  • DSM Nutritional Products, Inc.
  • Top Institute Food and Nutrition
Investigators  ICMJE
Principal Investigator: Silvie Timmers, MSc Maastricht UMC
PRS Account Maastricht University Medical Center
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP