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

University of Aarhus

Status: Completed

Conditions: Nonalcoholic Fatty Liver Disease; Obesity

Treatments: Other: Placebo; Dietary Supplement: Resveratrol

Study type: Interventional

Funder types: Other

Identifiers

NCT01446276

M-20110172A

Details and patient eligibility

About

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)

Enrollment: 26 patients

Sex: Male

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 3 patient groups, including a placebo group

Resveratrol

Experimental group

Description:

Resveratrol 500mg 3 times daily for six month

Treatment:

Dietary Supplement: Resveratrol

Placebo

Placebo Comparator group

Description:

Placebo 1 tablet 3 times daily for six month

Treatment:

Other: Placebo

Control group

No Intervention group

Description:

Men without non-alcoholic fatty liver disease