Potential Beneficial Effects of Resveratrol

This study has been completed.
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01150955
First received: June 24, 2010
Last updated: March 21, 2012
Last verified: March 2012

June 24, 2010
March 21, 2012
October 2010
November 2011   (final data collection date for primary outcome measure)
Metabolic parameters [ Time Frame: Five weeks ] [ Designated as safety issue: No ]
Regarding glucose, protein and fat metabolism.
Same as current
Complete list of historical versions of study NCT01150955 on ClinicalTrials.gov Archive Site
Pathways of substrate metabolism. [ Time Frame: Five weeks ] [ Designated as safety issue: No ]
Description of the biochemical pathways underpinning the interplay between calorie restriction, SIRT1, STAT5 and the GH/IGF-I axis.
Same as current
Not Provided
Not Provided
 
Potential Beneficial Effects of Resveratrol
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

We want to investigate whether the food supplement resveratrol is able to counteract the detrimental effects of obesity.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
  • Metabolic Syndrome
  • Obesity
  • 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
  • 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
Poulsen MM, Vestergaard PF, Clasen BF, Radko Y, Christensen LP, Stødkilde-Jørgensen H, Møller N, Jessen N, Pedersen SB, Jørgensen JO. High-dose resveratrol supplementation in obese men: an investigator-initiated, randomized, placebo-controlled clinical trial of substrate metabolism, insulin sensitivity, and body composition. Diabetes. 2013 Apr;62(4):1186-95. doi: 10.2337/db12-0975. Epub 2012 Nov 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01150955
M-20100058
No
University of Aarhus
University of Aarhus
The Ministry of Science, Technology and Innovation, Denmark
Study Chair: Jens Otto L Jørgensen, Professor,MD Aarhus University Hospital
University of Aarhus
March 2012

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