Resveratrol in Patients With Non-alcoholic Fatty Liver Disease

Fatty Liver Clinical Trial

— LIRMOI3  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464801
• Other study ID #: LIRMOI 3
• Status: Completed
• Phase: N/A
• First received: September 29, 2011
• Last updated: June 12, 2015
• Start date: September 2011
• Est. completion date: June 2015

Study information

• Verified date: August 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver

Intervention

Dietary Supplement:
• Resveratrol
Tablet Resveratrol 500 mg 3 times daily for 6 months
• Placebo
Tablet Placebo 3 times daily for 6 months

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Dept. of Hepatology and Gastroentology	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assessment of tolerability and side-effects	Assessment of tolerability and side-effects of Resveratrol versus placebo	6 months	Yes

External Links

•   Official web page for the LIRMOI project. Information about the project