resVida and Fat Oxidation

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998504
• Other study ID #: MEC 09-3-039
• Status: Completed
• Phase: N/A
• First received: October 19, 2009
• Last updated: March 17, 2011
• Start date: October 2009
• Est. completion date: January 2011

Study information

• Verified date: March 2011
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	DSM Nutritional Products, Inc., Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in fat oxidation between resVida and placebo treated group		9 months	No
Secondary	difference in mitochondrial biogenesis, function, and lipolysis in adipose and skeletal muscle tissue between resVida and placebo treated group		9 months	No