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Completed

NCT Number: NCT01464801

Resveratrol in Patients With Non-alcoholic Fatty Liver Disease

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Dept. of Hepatology and Gastroentology

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol

Dietary Supplement

Tablet Resveratrol 500 mg 3 times daily for 6 months

Placebo

Dietary Supplement

Tablet Placebo 3 times daily for 6 months

Primary outcomes

  1. 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 outcomes

  1. Assessment of tolerability and side-effects

    Time frame: 6 months

    Assessment of tolerability and side-effects of Resveratrol versus placebo

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • The Ministry of Science, Technology and Innovation, Denmark

Registry information

Official study title

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

Acronym: LIRMOI3

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 4, 2011
Registry last updated
Jun 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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