Resveratrol in Patients With Non-alcoholic Fatty Liver Disease

Not Applicable

Completed

• Conditions: Fatty Liver
• Interventions: Dietary Supplement: Resveratrol; Dietary Supplement: Placebo

• Registration Number: NCT01464801
• Lead Sponsor: University of Aarhus

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-04
• Status Verified: 2013-08
• Primary Completion: 2015-02
• Study Completion: 2015-06
• Last Update Submitted: 2015-06-12
• Last Update Posted: 2015-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resveratrol	Resveratrol	Subjects are given resveratrol 500 mg 3 times daily for 6 months.
Placebo	Placebo	Subjects are given Placebo tablets 3 times daily for 6 months.

Primary Outcome Measures

Name	Time	Method
Change in hepatic steatosis and inflammation	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

Name	Time	Method
Assessment of tolerability and side-effects	6 months	Assessment of tolerability and side-effects of Resveratrol versus placebo

Trial Locations

Locations (1)

Aarhus University Hospital, Dept. of Hepatology and Gastroentology; 🇩🇰 Aarhus, Denmark