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Potential Beneficial Effects of Resveratrol

Primary Purpose

Metabolic Syndrome, Obesity

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Resveratrol
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring Resveratrol, Diabetes, SIRT1, STAT5, IGF-I, Growth hormone, NAFLD, Longevity, Substrate metabolism, Calorie restriction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Aarhus University Hospital, Department of Endocrinology, MEA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Resveratrol

Placebo

Arm Description

Dietary supplement of resveratrol 500 mg three times a day over five weeks.

Outcomes

Primary Outcome Measures

Metabolic parameters
Regarding glucose, protein and fat metabolism.

Secondary Outcome Measures

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

Full Information

First Posted
June 24, 2010
Last Updated
March 21, 2012
Sponsor
University of Aarhus
Collaborators
The Ministry of Science, Technology and Innovation, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01150955
Brief Title
Potential Beneficial Effects of Resveratrol
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 Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
The Ministry of Science, Technology and Innovation, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity
Keywords
Resveratrol, Diabetes, SIRT1, STAT5, IGF-I, Growth hormone, NAFLD, Longevity, Substrate metabolism, Calorie restriction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resveratrol
Arm Type
Active Comparator
Arm Description
Dietary supplement of resveratrol 500 mg three times a day over five weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol
Other Intervention Name(s)
Fluxome Sciences.
Intervention Description
500 mg three times a day for five weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Starch
Intervention Description
Placebo (starch capsules) 500 mg three times a day for five weeks.
Primary Outcome Measure Information:
Title
Metabolic parameters
Description
Regarding glucose, protein and fat metabolism.
Time Frame
Five weeks
Secondary Outcome Measure Information:
Title
Pathways of substrate metabolism.
Description
Description of the biochemical pathways underpinning the interplay between calorie restriction, SIRT1, STAT5 and the GH/IGF-I axis.
Time Frame
Five weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Otto L Jørgensen, Professor,MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital, Department of Endocrinology, MEA
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25050904
Citation
Clasen BF, Poulsen MM, Escande C, Pedersen SB, Moller N, Chini EN, Jessen N, Jorgensen JO. Growth hormone signaling in muscle and adipose tissue of obese human subjects: associations with measures of body composition and interaction with resveratrol treatment. J Clin Endocrinol Metab. 2014 Dec;99(12):E2565-73. doi: 10.1210/jc.2014-2215.
Results Reference
derived
PubMed Identifier
23193181
Citation
Poulsen MM, Vestergaard PF, Clasen BF, Radko Y, Christensen LP, Stodkilde-Jorgensen H, Moller N, Jessen N, Pedersen SB, Jorgensen 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.
Results Reference
derived

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Potential Beneficial Effects of Resveratrol

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