Potential Beneficial Effects of Resveratrol

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT01150955
• Collaborator: The Ministry of Science, Technology and Innovation, Denmark (Other)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome; Obesity	Dietary Supplement: Resveratrol; Other: Placebo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Resveratrol Dietary supplement of resveratrol 500 mg three times a day over five weeks.	Dietary Supplement: Resveratrol; 500 mg three times a day for five weeks.; Other Names: Fluxome Sciences.
Placebo Comparator: Placebo	Other: Placebo; Placebo (starch capsules) 500 mg three times a day for five weeks.; Other Names: Starch

Outcome Measures

Primary Outcome Measures

1. Metabolic parameters [Five weeks]

   Regarding glucose, protein and fat metabolism.

Secondary Outcome Measures

1. Pathways of substrate metabolism. [Five weeks]

   Description of the biochemical pathways underpinning the interplay between calorie restriction, SIRT1, STAT5 and the GH/IGF-I axis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital, Department of Endocrinology, MEA	Aarhus		Denmark	8000

Sponsors and Collaborators

• University of Aarhus
• The Ministry of Science, Technology and Innovation, Denmark

Investigators

• Study Chair: Jens Otto L Jørgensen, Professor,MD, Aarhus University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT01150955
• Other Study ID Numbers: M-20100058
• First Posted: Jun 25, 2010
• Last Update Posted: Mar 22, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by University of Aarhus: Resveratrol; Diabetes; SIRT1; STAT5; IGF-I; Growth hormone; NAFLD; Longevity; Substrate metabolism; Calorie restriction
• Additional relevant MeSH terms: Obesity; Metabolic Syndrome; Syndrome; Resveratrol

Study Results

No Results Posted as of Mar 22, 2012