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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

October 3, 2011
April 3, 2013
November 2011
November 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01446276 on ClinicalTrials.gov Archive Site
  • 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
  • Basal and insulin stimulated FFA and glucose turnover [ Time Frame: six month ] [ Designated as safety issue: No ]
    - Changes from baseline after treatment with either resveratrol or placebo
  • FFA and VLDL-TG oxidation [ Time Frame: six month ] [ Designated as safety issue: No ]
    - Changes from baseline after treatment with either resveratrol or placebo
  • VLDL-TG uptake in abdominal and femoral adipose tissue [ 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
Not Provided
Not Provided
 
Long-term Investigation of Resveratrol on Fat Metabolism in Obese Men With Nonalcoholic Fatty Liver Disease
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

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)
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Obesity
  • Nonalcoholic Fatty Liver Disease
  • Dietary Supplement: Resveratrol
    500 mg 3 times daily for six month
    Other Name: Resveratrol
  • Other: Placebo
    1 placebo tablet 3 times daily for six month
    Other Name: Placebo
  • Experimental: Resveratrol
    Resveratrol 500mg 3 times daily for six month
    Intervention: Dietary Supplement: Resveratrol
  • Placebo Comparator: Placebo
    Placebo 1 tablet 3 times daily for six month
    Intervention: Other: Placebo
  • No Intervention: Control group
    Men without non-alcoholic fatty liver disease
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
August 2014
November 2013   (final data collection date for primary outcome measure)

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)
Male
25 Years to 60 Years
No
Contact: Marianne Kjær Poulsen, MD +45 78462171 maiapols@rm.dk
Denmark
 
NCT01446276
M-20110172A
No
University of Aarhus
University of Aarhus
The Ministry of Science, Technology and Innovation, Denmark
Study Chair: Søren Nielsen, MD, associate professor, DMSc Department of Endocrinology and Internal Medicine
University of Aarhus
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP