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Potential Beneficial Effects of Resveratrol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01150955
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : March 22, 2012
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE June 24, 2010
First Posted Date  ICMJE June 25, 2010
Last Update Posted Date March 22, 2012
Study Start Date  ICMJE October 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
Metabolic parameters [ Time Frame: Five weeks ]
Regarding glucose, protein and fat metabolism.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
Pathways of substrate metabolism. [ Time Frame: Five weeks ]
Description of the biochemical pathways underpinning the interplay between calorie restriction, SIRT1, STAT5 and the GH/IGF-I axis.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Potential Beneficial Effects of Resveratrol
Official Title  ICMJE Potential Beneficial Effects of Resveratrol on Obesity, Metabolic Syndrome and Inflammation - Emphasis on Description of the Molecular Biology Underpinning the Interplay Between Calorie Restriction, SIRT1, STAT5 and the GH/IGF-I Axis
Brief Summary We want to investigate whether the food supplement resveratrol is able to counteract the detrimental effects of obesity.
Detailed Description The aim of this study is to investigate potential metabolic effects of resveratrol in healthy but obese men. We hypothesize that resveratrol will counteract some of the detrimental effects of obesity, and as an imitator of calorie restriction will give new insight into the basic biochemical pathways underpinning human metabolism. Of special interest is the potential connection between resveratrol, calorie restriction, SIRT1, STAT5b and the GH/IGF-I axis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Metabolic Syndrome
  • Obesity
Intervention  ICMJE
  • Dietary Supplement: Resveratrol
    500 mg three times a day for five weeks.
    Other Name: Fluxome Sciences.
  • Other: Placebo
    Placebo (starch capsules) 500 mg three times a day for five weeks.
    Other Name: Starch
Study Arms  ICMJE
  • Active Comparator: Resveratrol
    Dietary supplement of resveratrol 500 mg three times a day over five weeks.
    Intervention: Dietary Supplement: Resveratrol
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2012)
24
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2010)
30
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI > 30 kg/m2
  • Otherwise healthy
  • Written informed consent

Exclusion Criteria:

  • Any disease
  • Alcohol dependency
  • Allergy to trial medication
  • Present or previous malignancy
  • Participation in other clinical trials within three months before randomization
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01150955
Other Study ID Numbers  ICMJE M-20100058
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE The Ministry of Science, Technology and Innovation, Denmark
Investigators  ICMJE
Study Chair: Jens Otto L Jørgensen, Professor,MD Aarhus University Hospital
PRS Account University of Aarhus
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP