resVida and Fat Oxidation

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 01, 2014