Nonalcoholic Fatty Liver Disease, Obesity
Conditions
Keywords
Obesity, Resveratrol, Nonalcoholic fatty liver disease, Insulin sensitivity, Lipid turnover, Liver fat content
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)
Interventions
DIETARY_SUPPLEMENTResveratrol
500 mg 3 times daily for six month
OTHERPlacebo
1 placebo tablet 3 times daily for six month
Sponsors
The Ministry of Science, Technology and Innovation, Denmark
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
25 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance | six month | \- Changes from baseline after treatment with either resveratrol or placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed