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

Long-term Investigation of Resveratrol on Management of Metabolic Syndrome, Osteoporosis and Inflammation, and Identification of Plant Derived Anti-inflammatory Compounds, Study 3

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.

Study Overview

• Status: Completed
• Conditions: Fatty Liver
• Intervention / Treatment: Dietary supplement: Resveratrol; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hepatic steatosis and inflammation	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of tolerability and side-effects	Assessment of tolerability and side-effects of Resveratrol versus placebo	6 months

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; The Ministry of Science, Technology and Innovation, Denmark
• Investigators: Principal Investigator: Henning Grønbæk, MD, PhD, Department of Hepatology and Gastroentology, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: November 1, 2011
• First Posted (Estimate): November 4, 2011

Study Record Updates

• Last Update Posted (Estimate): June 15, 2015
• Last Update Submitted That Met QC Criteria: June 12, 2015
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Resveratrol; Non-alcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease; Human study
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: LIRMOI 3