Non-Alcoholic Fatty Liver Disease: Role of Fatty Acid Composition and Gene Expression: A Pilot Study to Determine the Effect of Omega-3 Polyunsaturated Fatty Acids From Fish Oil on Patients With Non-Alcoholic Steatohepatitis (NASH)
Recruitment status was Recruiting
The purpose of this study is to determine the effect of Omega-3 Fish oil supplementation on hepatic gene expression in patients with Non Alcoholic Steatohepatitis (NASH)
Non-Alcoholic Fatty Liver Disease
Other: Omega-3 capsules-Fish Oil
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Pilot Study to Determine the Effect of Omega-3 Polyunsaturated Fatty Acids From Fish Oil on Patients With Non-Alcoholic Steatohepatitis (NASH|
- In NASH patients who consent to take Omega-3 over 12 months and have a second liver biopsy, the effect of Omega-3 supplementation on gene expression(main variable) will be assessed along with fatty acid composition, oxidative stress and histology [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
- Plasma and RBC fatty acid composition and PC:PE ratio [ Time Frame: At 3,6,12 months ] [ Designated as safety issue: Yes ]
- Blood biochemistry (blood sugar control, lipid profile, liver enzymes) [ Time Frame: At 3,6,12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Omega-3 capsules-Fish Oil
Omega-3 fatty acids in the form of fish oil capsules (2g/d)
Other: Omega-3 capsules-Fish Oil
Patients will take 2 capsules (1.0 g each) of n-3 PUFA (0.82/0.44 g of EPA/DHA) daily x 12 months. Since n-3 PUFA supplementation can be a potential treatment for NASH and since BMI will be< 30 kg/m2 for all subjects, patients will be told to keep their lifestyle, diet and medication stable (unless medically necessary) for the study duration in order to minimize environmental effect on gene expression.
Changes in fatty acid (FA) composition within the liver may influence lipid metabolism and inflammation. This is poorly understood in humans.
Especially omega-3 FA are important: They promote FA oxidation over storage and are important for export of lipids from the liver. Omega-3 FA have also anti-inflammatory properties.
Changes in liver FA composition may be influenced by dietary intake, high rate of lipid peroxidation (LP) or low delta-6 desaturase enzyme activity. We and others recently showed that NASH patients had lower hepatic n-3 and n-6 PUFA with increased lipid peroxidation and low antioxidant status when compared to patients with minimal findings on liver biopsy. The dietary intake of FA was similar among the 3 groups suggesting that the difference in hepatic FA composition may be related to high lipid peroxidation or low delta-6 desaturase activity. This difference in hepatic FA composition may be of significance in the pathogenesis of NAFLD since it may change gene expressions in regard to lipid metabolism.
This pilot study in NASH to assess the effect of n-3 PUFA supplementation on FA composition (liver and red blood cells), hepatic gene expression, and histology. We will also assess hepatic and red blood cell PC:PE ratio. Oxidative stress, insulin resistance and nutritional measurements will be performed to further characterize these patients
|Contact: Seham A Noureldin, Ph Demail@example.com|
|Contact: Bianca M Arendt, Ph Dfirstname.lastname@example.org|
|University Health Network, Toronto General Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 1Z5|
|Contact: Seham A Noureldin 416-340-4413|
|Principal Investigator: Johane P Allard, MD, FRCPC|
|Principal Investigator:||Johane P Allard, MD, FRCPC||University Health Network, Toronto|