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Potential Beneficial Effects of Resveratrol

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ClinicalTrials.gov Identifier: NCT01150955
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : March 22, 2012
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
University of Aarhus

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
Metabolic Syndrome Obesity Dietary Supplement: Resveratrol Other: Placebo

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 : Interventional  (Clinical Trial)
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 : October 2010
Primary Completion Date : November 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol
U.S. FDA Resources

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 Name: Fluxome Sciences.
Placebo Comparator: Placebo Other: Placebo
Placebo (starch capsules) 500 mg three times a day for five weeks.
Other Name: Starch

Primary Outcome Measures :
  1. Metabolic parameters [ Time Frame: Five weeks ]
    Regarding glucose, protein and fat metabolism.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150955

Aarhus University Hospital, Department of Endocrinology, MEA
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
The Ministry of Science, Technology and Innovation, Denmark
Study Chair: Jens Otto L Jørgensen, Professor,MD Aarhus University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01150955     History of Changes
Other Study ID Numbers: M-20100058
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: March 22, 2012
Last Verified: March 2012

Keywords provided by University of Aarhus:
Growth hormone
Substrate metabolism
Calorie restriction

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors