Resveratrol in Patients With Non-alcoholic Fatty Liver Disease (LIRMOI3)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01464801

First Posted: November 4, 2011

Last Update Posted: June 15, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

The Ministry of Science, Technology and Innovation, Denmark

Aarhus University Hospital

Information provided by (Responsible Party):

University of Aarhus

Purpose

Non-alcoholic fatty liver disease (NAFLD) and fatty liver hepatitis (NASH) are very common in the Western world and strongly associated with obesity. No known effective treatment is known. From animal studies, it is known that the compound resveratrol perhaps has the potential to neutralize obesity-induced diseases. Resveratrol is already widely used as a food supplement though the precise effects are unknown. This project focuses on the effect of Resveratrol on fatty liver disease. The researchers plan to investigate the effects of Resveratrol or placebo treatment for 6 months on NAFLD/NASH in obese patients.

Condition	Intervention
Fatty Liver	Dietary Supplement: Resveratrol Dietary Supplement: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Long-term Investigation of Resveratrol on Management of Metabolic Syndrome, Osteoporosis and Inflammation, and Identification of Plant Derived Anti-inflammatory Compounds, Study 3

Resource links provided by NLM:

Genetics Home Reference related topics: non-alcoholic fatty liver disease

MedlinePlus related topics: Fatty Liver Disease Liver Diseases

Drug Information available for: Resveratrol

Genetic and Rare Diseases Information Center resources: Visceral Steatosis

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Change in hepatic steatosis and inflammation [ Time Frame: 6 months ]
Changes in hepatic and inflammatory markers ind the blood such as ALT, hs-CRP, TNFa Changes in hepatic fat content, assessed by MR spectroscopy Changes in hepatic steatosis and inflammation, assessed histologically Changes in the expression of proteins in the relevant inflammatory pathways, assessed by gene expression studies

Secondary Outcome Measures:

Assessment of tolerability and side-effects [ Time Frame: 6 months ]
Assessment of tolerability and side-effects of Resveratrol versus placebo


Enrollment:	28
Study Start Date:	September 2011
Study Completion Date:	June 2015
Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Resveratrol Subjects are given resveratrol 500 mg 3 times daily for 6 months.	Dietary Supplement: Resveratrol Tablet Resveratrol 500 mg 3 times daily for 6 months
Placebo Comparator: Placebo Subjects are given Placebo tablets 3 times daily for 6 months.	Dietary Supplement: Placebo Tablet Placebo 3 times daily for 6 months

Detailed Description:

Obesity is associated with non-alcoholic fatty liver disease (NAFLD) and steatohepatitis (NASH) and recently, low-grade inflammation has been hypothesized to be the causative link. From animal studies, it is known that the compound resveratrol (RES) has strong anti-inflammatory and antioxidant effects and perhaps the potential to neutralize obesity-induced diseases. RES is already widely used as a food supplement though the precise effects are unknown. This project focuses on the effect of RES on fatty liver disease. In a double-blind controlled clinical trial, the researchers investigate the effects of RES 500 mg or placebo treatment x 3 daily for 6 months on NAFLD/NASH in 48 obese patients in a double-blind, randomised, controlled clinical trial. The researchers hypothesize that RES improves the ALT levels and reduces liver fat and inflammation assessed by MR spectroscopy and histological evaluation.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ALT ≥70 U/L for men and ≥45 U/L for women
steatosis of the liver, assessed by ultrasonography
one of the following:
- waist circumference ≥102 cm for men and ≥88 for women
- hypertension: BP ≥130/80 mmHg
- raised triglycerides ≥1,7 mmol/L
- reduced HDL cholesterol ≤1.0 mmol/L
BMI ≥ 25 kg/m²

Exclusion Criteria:

weight > 130 kg
comorbidity such as diabetes, cancer, metabolic or coagulation disorder, or significant liver-, heart- or kidney disease
MRI contraindication
treatment with glucocorticoids or methotrexate
alcohol intake >20g/daily for men and >12 for women

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464801

Locations


Denmark
Aarhus University Hospital, Dept. of Hepatology and Gastroentology
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

The Ministry of Science, Technology and Innovation, Denmark

Aarhus University Hospital

Investigators


Principal Investigator:	Henning Grønbæk, MD, PhD	Department of Hepatology and Gastroentology, Aarhus University Hospital

More Information


Responsible Party:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT01464801 History of Changes
Other Study ID Numbers:	LIRMOI 3
First Submitted:	September 29, 2011
First Posted:	November 4, 2011
Last Update Posted:	June 15, 2015
Last Verified:	August 2013

Keywords provided by University of Aarhus:


Non-alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis Resveratrol Human study

Additional relevant MeSH terms:


Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases Resveratrol Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs	Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents, Phytogenic Antineoplastic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Platelet Aggregation Inhibitors Antimutagenic Agents Anticarcinogenic Agents

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