Clinical trial NCT01446276: Long-term Investigation of Resveratrol on Fat Metabolism in Obese Men With Nonalcoholic Fatty Liver Disease
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Nonalcoholic Fatty Liver Disease
Keywords: Obesity
Resveratrol
Nonalcoholic fatty liver disease
Insulin sensitivity
Lipid turnover
Liver fat content
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
First posted: 2011-10-05
Enrollment: 26
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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)


Eligibility criteria: 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)

Primary outcomes:
measure: Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance
timeFrame: six month
Secondary outcomes:
measure: Basal and insulin stimulated free fatty acid (FFA) and glucose turnover
timeFrame: six month
measure: VLDL-TG oxidation
timeFrame: six month
measure: Body composition (fat mass, fat-free mass, percent fat, visceral fat mass)
timeFrame: six month
measure: lipoprotein lipase activity and fat cell size in abdominal and femoral adipose tissue biopsy
timeFrame: six months
measure: Baseline data
timeFrame: Baseline
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Endocrinology and Internal Medicine
Study officials:
affiliation: Department of Endocrinology and Internal Medicine
name: Søren Nielsen, MD, associate professor, DMSc
role: STUDY_CHAIR
References:
citation: Poulsen MK, Nellemann B, Bibby BM, Stodkilde-Jorgensen H, Pedersen SB, Gronbaek H, Nielsen S. No effect of resveratrol on VLDL-TG kinetics and insulin sensitivity in obese men with nonalcoholic fatty liver disease. Diabetes Obes Metab. 2018 Oct;20(10):2504-2509. doi: 10.1111/dom.13409. Epub 2018 Jul 5.
citation: Poulsen MK, Nellemann B, Stodkilde-Jorgensen H, Pedersen SB, Gronbaek H, Nielsen S. Impaired Insulin Suppression of VLDL-Triglyceride Kinetics in Nonalcoholic Fatty Liver Disease. J Clin Endocrinol Metab. 2016 Apr;101(4):1637-46. doi: 10.1210/jc.2015-3476. Epub 2016 Feb 1.