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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01464801
Other study ID # LIRMOI 3
Secondary ID
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


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
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