Resveratrol in Patients With Non-alcoholic Fatty Liver Disease (LIRMOI3)
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Change in hepatic steatosis and inflammation [ Time Frame: 6 months ] [ Designated as safety issue: No ]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
- Assessment of tolerability and side-effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Assessment of tolerability and side-effects of Resveratrol versus placebo
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464801
|Contact: Sara Heebøll, MD, PhD stud||+ 45 email@example.com|
|Contact: Henning Grønbæk, MD, PhD||+45 firstname.lastname@example.org|
|Aarhus University Hospital, Dept. of Hepatology and Gastroentology||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Sara Heebøll 27338050 email@example.com|
|Principal Investigator:||Henning Grønbæk, MD, PhD||Department of Hepatology and Gastroentology, Aarhus University Hospital|