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

Not Applicable

Completed

• Conditions: Nonalcoholic Fatty Liver Disease; Obesity
• Interventions: Dietary Supplement: Resveratrol; Other: Placebo

• Registration Number: NCT01446276
• Lead Sponsor: University of Aarhus

Brief Summary

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)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-10-03
• Study First Submitted QC: 2011-10-04
• Study First Posted: 2011-10-05
• Study Start: 2011-11
• Status Verified: 2013-10
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-25
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resveratrol	Resveratrol	Resveratrol 500mg 3 times daily for six month
Placebo	Placebo	Placebo 1 tablet 3 times daily for six month

Primary Outcome Measures

Name	Time	Method
Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance	six month	- Changes from baseline after treatment with either resveratrol or placebo

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Endocrinology and Internal Medicine; 🇩🇰 Aarhus C, Denmark