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Completed

NCT Number: NCT00998504

resVida and Fat Oxidation

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.

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Key information

Conditions

Obesity Body Weight Metabolic Diseases Mitochondrial Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6200 MD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

resVida

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.

Other names: resveratrol

Placebo

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.

Primary outcomes

  1. difference in fat oxidation between resVida and placebo treated group

    Time frame: 9 months

Secondary outcomes

  1. difference in mitochondrial biogenesis, function, and lipolysis in adipose and skeletal muscle tissue between resVida and placebo treated group

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Top Institute Food and Nutrition
  • dsm-firmenich Switzerland AG

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2009
Registry last updated
Mar 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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