Resveratrol in Patients With Non-alcoholic Fatty Liver Disease

NCT ID: NCT01464801

Last Updated: 2015-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-06-30

Brief Summary

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.

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.

Conditions

Fatty Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Resveratrol

Subjects are given resveratrol 500 mg 3 times daily for 6 months.

Group Type: EXPERIMENTAL

Resveratrol

Intervention Type: DIETARY_SUPPLEMENT

Tablet Resveratrol 500 mg 3 times daily for 6 months

Placebo

Subjects are given Placebo tablets 3 times daily for 6 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Tablet Placebo 3 times daily for 6 months

Interventions

Resveratrol

Tablet Resveratrol 500 mg 3 times daily for 6 months

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Tablet Placebo 3 times daily for 6 months

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Ministry of Science, Technology and Innovation, Denmark

OTHER_GOV

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henning Grønbæk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Hepatology and Gastroentology, Aarhus University Hospital

Locations

Aarhus University Hospital, Dept. of Hepatology and Gastroentology

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

LIRMOI 3

Identifier Type: -

Identifier Source: org_study_id