resVida and Fat Oxidation

NCT00998504 | Completed

• 1 other identifier: MEC 09-3-039
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

impaired fat oxidation; fat accumulation; mitochondrial dysfunction; mitochondrial biogenesis

Outcome Measures

Primary Outcomes (1)

• difference in fat oxidation between resVida and placebo treated group

  9 months

Secondary Outcomes (1)

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

  9 months

Study Arms (2)

placebo

PLACEBO COMPARATOR

starch pill

Dietary Supplement: placebo

resVida

ACTIVE COMPARATOR

synthetic pill containing 75 mg of resveratrol

Dietary Supplement: resVida

Interventions

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.

Also known as: resveratrol

resVida

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.

placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• DSM Nutritional Products, Inc.: collaborator
• Top Institute Food and Nutrition: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6200 MD, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 23663119 DERIVED

MeSH Terms

Conditions

Obesity; Mitochondrial Diseases

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Silvie Timmers, MSc

  Maastricht UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 19, 2009
• First Posted: October 20, 2009
• Study Start: October 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 18, 2011

Record last verified: 2011-03

Locations

NL (1)