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
  Purpose

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


Condition Intervention
Metabolic Syndrome
Obesity
Dietary Supplement: Resveratrol
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Metabolic parameters [ Time Frame: Five weeks ] [ Designated as safety issue: No ]
    Regarding glucose, protein and fat metabolism.


Secondary Outcome Measures:
  • 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.


Enrollment: 24
Study Start Date: October 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150955

Locations
Denmark
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
  More Information

No publications provided by University of Aarhus

Additional 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
Study First Received: June 24, 2010
Last Updated: March 21, 2012
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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 X
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on August 21, 2014