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

April 25, 2014 updated by: University of Aarhus

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Department of Endocrinology and Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • 25-65 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resveratrol
Resveratrol 500mg 3 times daily for six month
Dietary supplement: Resveratrol
500 mg 3 times daily for six month
Placebo Comparator: Placebo
Placebo 1 tablet 3 times daily for six month
Other: Placebo
1 placebo tablet 3 times daily for six month
No Intervention: Control group
Men without non-alcoholic fatty liver disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
Time Frame: six month
- Changes from baseline after treatment with either resveratrol or placebo
six month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Basal and insulin stimulated free fatty acid (FFA) and glucose turnover
Time Frame: six month
- Changes from baseline after treatment with either resveratrol or placebo
six month
VLDL-TG oxidation
Time Frame: six month
- Changes from baseline after treatment with either resveratrol or placebo
six month
Body composition (fat mass, fat-free mass, percent fat, visceral fat mass)
Time Frame: six month
- Changes from baseline after treatment with either resveratrol or placebo
six month
lipoprotein lipase activity and fat cell size in abdominal and femoral adipose tissue biopsy
Time Frame: six months
- Changes from baseline after treatment with either resveratrol or placebo
six months
Baseline data
Time Frame: Baseline
- Comparison of baseline data between intervention group and control group
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

The Ministry of Science, Technology and Innovation, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

October 3, 2011

First Submitted That Met QC Criteria

October 4, 2011

First Posted (Estimate)

October 5, 2011

Study Record Updates

Last Update Posted (Estimate)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 25, 2014

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20110172A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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