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
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Alcoholic Fatty Liver Disease Non-alcoholic Steatohepatitis |
Other: Omega-3 capsules-Fish Oil |
Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 40 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
Other Names:
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Detailed Description:
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
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who participated in our cross-sectional NAFLD study and who have biopsy-proven NASH; male and female, age 18-60 yr; BMI< 30 kg/m2, alcohol consumption <20g/d; non-smokers; if known to have hyperlipidemia or diabetes, need to be stable drug regimen.
Exclusion Criteria:
- Other causes of liver disease; complications of liver disease; conditions contraindicative for liver biopsy; concurrent medical illnesses; medications known to precipitate steatohepatitis in the 6 months prior to entry (corticosteroids, high dose estrogens, methotrexate, amiodarone, calcium channel blockers, spironolactone, sulfasalazine, naproxen or oxacillin) in the 6 months prior to entry; antioxidant vitamin or omega-3/fish oil supplementation; ursodeoxycholic acid or any other experimental drug in the 6 months prior to study entry; smokers; pregnancy or breastfeeding; female subjects who are not surgically sterile or postmenopausal and who are not using medically acceptable methods of birth control during the trial and for 30 days after the treatment period.
Contacts and Locations| Contact: Seham A Noureldin, Ph D | 416-340-4413 | snoureld@uhnresearch.ca |
| Contact: Bianca M Arendt, Ph D | 416-340-4104 | barendt@uhnresearch.ca |
| Canada, Ontario | |
| 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 |
More Information
No publications provided
| Responsible Party: | Dr. Johane Allard, University Health Network, Toronto General Hospital |
| ClinicalTrials.gov Identifier: | NCT01056133 History of Changes |
| Other Study ID Numbers: | 08-0874-A, CIHR Grant#89705 |
| Study First Received: | January 22, 2010 |
| Last Updated: | January 25, 2010 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
non-alcoholic fatty liver disease non-alcoholic steatohepatitis |
Additional relevant MeSH terms:
|
Fatty Liver Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013