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

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Obesity, Nonalcoholic Fatty Liver Disease

Intervention / Treatment
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* Dietary Supplement: Resveratrol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance | - 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 | - Changes from baseline after treatment with either resveratrol or placebo | six month | 
| VLDL-TG oxidation | - Changes from baseline after treatment with either resveratrol or placebo | six month | 
| Body composition (fat mass, fat-free mass, percent fat, visceral fat mass) | - 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 | - Changes from baseline after treatment with either resveratrol or placebo | six months | 
| Baseline data | - Comparison of baseline data between intervention group and control group | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Resveratrol, Nonalcoholic fatty liver disease, Insulin sensitivity, Lipid turnover, Liver fat content