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Completed

NCT Number: NCT01446276

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

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)

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Key information

Conditions

Obesity Body Weight Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nonalcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology and Internal Medicine

Aarhus C, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Resveratrol

Dietary Supplement

500 mg 3 times daily for six month

Placebo

Other

1 placebo tablet 3 times daily for six month

Primary outcomes

  1. Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance

    Time frame: six month

    • Changes from baseline after treatment with either resveratrol or placebo

Secondary outcomes

  1. 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

  2. VLDL-TG oxidation

    Time frame: six month

    • Changes from baseline after treatment with either resveratrol or placebo

  3. 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

  4. 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

  5. Baseline data

    Time frame: Baseline

    • Comparison of baseline data between intervention group and control group

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • The Ministry of Science, Technology and Innovation, Denmark

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 5, 2011
Registry last updated
Apr 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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