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Long-term Investigation of Resveratrol on Fat Metabolism in Obese Men With Nonalcoholic Fatty Liver Disease

This study is currently recruiting participants.
Verified April 2013 by University of Aarhus
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01446276
First received: October 3, 2011
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to investigate potential metabolic effects of resveratrol in obese healthy men with non-alcoholic fatty liver disease.

The investigators hypothesize that resveratrol will:

  • decrease hepatic very-low-density-lipoprotein-triglyceride (VLDL-TG) secretion
  • decrease liver fat content
  • increase insulin sensitivity

The investigators will look at changes in:

  • lipid turnover (VLDL-TG kinetics, palmitate kinetics, indirect calorimetry)
  • liver fat content (MR liver spectroscopy)
  • insulin sensitivity (glucose kinetics during hyperinsulinaemic euglycaemic clamp)
  • body composition (DXA and MRI)
  • lipase activity and fat cell size (fat biopsy from abdominal and femoral adipose tissue)

Condition Intervention
Obesity
Nonalcoholic Fatty Liver Disease
 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, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Long-term Investigation of Resveratrol on Lipid Turnover in Obese Men With Nonalcoholic Fatty Liver Disease. Effects on Liver Fat Content and Basal and Insulin Stimulated FFA and VLDL-triglyceride Metabolism

Resource links provided by NLM:

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

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance [ Time Frame: six month ] [ Designated as safety issue: No ]
    - Changes from baseline after treatment with either resveratrol or placebo


Secondary Outcome Measures:
  • Basal and insulin stimulated free fatty acid (FFA) and glucose turnover [ Time Frame: six month ] [ Designated as safety issue: No ]
    - Changes from baseline after treatment with either resveratrol or placebo

  • VLDL-TG oxidation [ Time Frame: six month ] [ Designated as safety issue: No ]
    - Changes from baseline after treatment with either resveratrol or placebo

  • Body composition (fat mass, fat-free mass, percent fat, visceral fat mass) [ Time Frame: six month ] [ Designated as safety issue: No ]
    - Changes from baseline after treatment with either resveratrol or placebo

  • lipoprotein lipase activity and fat cell size in abdominal and femoral adipose tissue biopsy [ Time Frame: six months ] [ Designated as safety issue: No ]
    - Changes from baseline after treatment with either resveratrol or placebo

  • Baseline data [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    - Comparison of baseline data between intervention group and control group


Estimated Enrollment: 24
Study Start Date: November 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resveratrol
Resveratrol 500mg 3 times daily for six month
 Dietary Supplement: Resveratrol
500 mg 3 times daily for six month
Other Name: Resveratrol
Placebo Comparator: Placebo
Placebo 1 tablet 3 times daily for six month
 Other: Placebo
1 placebo tablet 3 times daily for six month
Other Name: Placebo
No Intervention: Control group
Men without non-alcoholic fatty liver disease

  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • 25-60 years
  • Obesity (BMI > 28 kg/m2, waist/hip ratio > 0,95)
  • Have nonalcoholic fatty liver disease (NAFLD)(intervention group) or do not have NAFLD (control group)
  • May have hypertension and/or hypercholesterolemia
  • Written informed consent

Exclusion Criteria:

  • Any other disease than NAFLD (e.g. diabetes, thyroid or parathyroid disease, heart, liver or kidney disease)
  • Present and previous malignancy
  • Alcohol dependency (more than 21 units of alcohol per week)
  • History of smoking
  • Participation in studies with radioactive isotopes within the last six months
  • Hemoglobin under normal range regarding to sex (under 8.3 mmol/l for men)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446276

Contacts
Contact: Marianne Kjær Poulsen, MD +45 78462171 maiapols@rm.dk

Locations
Denmark
Department of Endocrinology and Internal Medicine Recruiting
Aarhus C, Denmark, 8000
Contact: Marianne Kjær Poulsen, MD     +45 78462171        
Principal Investigator: Marianne Kjær Poulsen, MD            
Sponsors and Collaborators
University of Aarhus
The Ministry of Science, Technology and Innovation, Denmark
Investigators
Study Chair: Søren Nielsen, MD, associate professor, DMSc Department of Endocrinology and Internal Medicine
  More Information

Additional Information:
Official web page for the LIRMOI project, back ground info and contact  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01446276     History of Changes
Other Study ID Numbers: M-20110172A
Study First Received: October 3, 2011
Last Updated: April 3, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Obesity
Resveratrol
Nonalcoholic fatty liver disease
 Insulin sensitivity
Lipid turnover
Liver fat content

Additional relevant MeSH terms:
Resveratrol
Fatty Liver
Liver Diseases
Obesity
Digestive System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
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
Antimutagenic Agents
Anticarcinogenic Agents

ClinicalTrials.gov processed this record on May 22, 2013