Effect of Fish-oil on Non-alcoholic Steatohepatitis (NASH)

NCT01056133 | Completed Phase 2

• 3 other identifiers: 08-0874-ACIHR Grant#89705MOP-123459
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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). In addition, effects of fish oil on intestinal microbiota will be assessed.

Conditions

Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis

Keywords

non-alcoholic fatty liver disease; non-alcoholic steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Liver histology

  Liver histology will be assessed for diagnosis of NASH (steatosis, inflammation, ballooning, fibrosis, mallory bodies, Non-alcoholic fatty liver disease activity score (NAS)

  Baseline, 12 months

Secondary Outcomes (6)

• Plasma and RBC fatty acid composition and PC:PE ratio

  At 3,6,12 months

• Blood biochemistry (blood sugar control, lipid profile, liver enzymes)

  Baseline, 6, 12 months

• Intestinal microbiota

  Baseline, 6, 12 months

• Plasma endotoxin

  Baseline, 6, 12 months

• Plasma free choline

  Baseline, 6, 12 months

Other Outcomes (1)

• Environmental questionnaire

  Baseline, 6, 12 months

Study Arms (1)

Omega-3 capsules-Fish Oil

EXPERIMENTAL

Omega-3 fatty acids in the form of fish oil capsules (2g/d)

Other: Omega-3 capsules-Fish Oil

Interventions

Omega-3 capsules-Fish Oil OTHER

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.

Also known as: Product Name: Amber 40/20 Ethyl ester (EE), 1000 mg capsules (lemon-lime flavor), Product Code: 4020PB1000CT

Omega-3 capsules-Fish Oil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with biopsy-proven NASH; male and female; age 18-65 years; BMI ≤ 40 kg/m2, alcohol consumption \<20g/d; non-smokers; if known to have hyperlipidemia or diabetes, need to be stable drug regimen.

You may not qualify if:

• Liver disease of other etiology; documented HIV infection, anticipated need for liver transplantation in one year or complications such as recurrent variceal bleeding, spontaneous portosystemic encephalopathy, ascites or jaundice; concurrent medical illnesses, abnormal coagulation or other reasons judged by the hepatologist to contraindicate a liver biopsy; chronic gastrointestinal diseases, previous gastrointestinal surgery modifying the anatomy, patients with diabetes requiring insulin; medications known to precipitate steatohepatitis in the 6 months prior to entry; regular intake of non-steroidal anti-inflammatory drugs, regular intake of antioxidant vitamin or omega-3/fish oil supplements, prebiotics, probiotics, antibiotics, or laxatives; ursodeoxycholic acid or any experimental drug in the 6 months prior to study entry; smokers; pregnancy or lactating; 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.

Sponsors & Collaborators

• Johane Allard: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• American College of Gastroenterology: collaborator

Study Sites (1)

University Health Network, Toronto General Hospital

Toronto, Ontario, M5G 1Z5, Canada

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Johane P Allard, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Gastroenterologist

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 26, 2010
• Study Start: October 1, 2009
• Primary Completion: January 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

CA (1)