resVida and Fat Oxidation
This study has been completed.
Sponsor:
Maastricht University Medical Center
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obesity |
Dietary Supplement: resVida Dietary Supplement: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of resVida on Fat Oxidation and Mitochondrial Biogenesis in Healthy Obese Subjects |
Resource links provided by NLM:
Further study details as provided by Maastricht University Medical Center:
Primary Outcome Measures:
- difference in fat oxidation between resVida and placebo treated group [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 18 |
| Study Start Date: | October 2009 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: resveratrol
|
Eligibility| Ages Eligible for Study: | 45 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00998504
Locations
| Netherlands | |
| Maastricht University Medical Center | |
| Maastricht, Limburg, Netherlands, 6200 MD | |
Sponsors and Collaborators
Maastricht University Medical Center
DSM Nutritional Products, Inc.
Top Institute Food and Nutrition
Investigators
| Principal Investigator: | Silvie Timmers, MSc | Maastricht UMC |
More Information
No publications provided
| Responsible Party: | Silvie Timmers, MSc, Top Institute Food and Nutrition |
| ClinicalTrials.gov Identifier: | NCT00998504 History of Changes |
| Other Study ID Numbers: | MEC 09-3-039 |
| Study First Received: | October 19, 2009 |
| Last Updated: | March 17, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht University Medical Center:
|
impaired fat oxidation fat accumulation mitochondrial dysfunction mitochondrial biogenesis |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Resveratrol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents, Phytogenic Antineoplastic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Platelet Aggregation Inhibitors Hematologic Agents Antimutagenic Agents Anticarcinogenic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013