Potential Beneficial Effects of Resveratrol

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150955
• Other study ID #: M-20100058
• Status: Completed
• Phase: N/A
• First received: June 24, 2010
• Last updated: March 21, 2012
• Start date: October 2010
• Est. completion date: November 2011

Study information

• Verified date: March 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity

Intervention

Dietary Supplement:
• Resveratrol
500 mg three times a day for five weeks.

Other:
• Placebo
Placebo (starch capsules) 500 mg three times a day for five weeks.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Endocrinology, MEA	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic parameters	Regarding glucose, protein and fat metabolism.	Five weeks	No
Secondary	Pathways of substrate metabolism.	Description of the biochemical pathways underpinning the interplay between calorie restriction, SIRT1, STAT5 and the GH/IGF-I axis.	Five weeks	No