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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01446276
• Other study ID #: M-20110172A
• Status: Completed
• Phase: N/A
• First received: October 3, 2011
• Last updated: April 25, 2014
• Start date: November 2011
• Est. completion date: April 2014

Study information

• Verified date: October 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Nonalcoholic Fatty Liver Disease
• Obesity

Intervention

Dietary Supplement:
• Resveratrol
500 mg 3 times daily for six month

Other:
• Placebo
1 placebo tablet 3 times daily for six month

Locations

Country	Name	City	State
Denmark	Department of Endocrinology and Internal Medicine	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic VLDL-TG secretion and peripheral VLDL-TG clearance	- Changes from baseline after treatment with either resveratrol or placebo	six month	No
Secondary	Basal and insulin stimulated free fatty acid (FFA) and glucose turnover	- Changes from baseline after treatment with either resveratrol or placebo	six month	No
Secondary	VLDL-TG oxidation	- Changes from baseline after treatment with either resveratrol or placebo	six month	No
Secondary	Body composition (fat mass, fat-free mass, percent fat, visceral fat mass)	- Changes from baseline after treatment with either resveratrol or placebo	six month	No
Secondary	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	No
Secondary	Baseline data	- Comparison of baseline data between intervention group and control group	Baseline	No

External Links

•   Official web page for the LIRMOI (Long-term Investigation of Resveratrol, Metabolism, Obesity and Inflammation) project, back ground info and contact