resVida and Fat Oxidation

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: resVida
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>starch pill | Dietary Supplement: placebo<br>* 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.<br>|
| Active Comparator: resVida<br>synthetic pill containing 75 mg of resveratrol | Dietary Supplement: resVida<br>* 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.<br>* Other names: resveratrol;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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impaired fat oxidation, fat accumulation, mitochondrial dysfunction, mitochondrial biogenesis