resVida and Fat Oxidation

This study has been completed.
Sponsor:
Collaborators:
DSM Nutritional Products, Inc.
Top Institute Food and Nutrition
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00998504
First received: October 19, 2009
Last updated: March 17, 2011
Last verified: March 2011

October 19, 2009
March 17, 2011
October 2009
January 2011   (final data collection date for primary outcome measure)
difference in fat oxidation between resVida and placebo treated group [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998504 on ClinicalTrials.gov Archive Site
difference in mitochondrial biogenesis, function, and lipolysis in adipose and skeletal muscle tissue between resVida and placebo treated group [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
resVida and Fat Oxidation
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obesity
  • 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.
  • Placebo Comparator: placebo
    starch pill
    Intervention: Dietary Supplement: placebo
  • Active Comparator: resVida
    synthetic pill containing 75 mg of resveratrol
    Intervention: Dietary Supplement: resVida
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.
 
Completed
18
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Male
45 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00998504
MEC 09-3-039
No
Silvie Timmers, MSc, Top Institute Food and Nutrition
Maastricht University Medical Center
  • DSM Nutritional Products, Inc.
  • Top Institute Food and Nutrition
Principal Investigator: Silvie Timmers, MSc Maastricht UMC
Maastricht University Medical Center
March 2011

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