Non-alcoholic Fatty Liver Disease Clinical Trial
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)
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.
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 polyunsaturated FA (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 NASH 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 the
ratio of phosphatidylcholine (PC) to phosphatidylethanolamine (PE) in liver and red blood
cells (RBC). Oxidative stress, insulin resistance and nutritional measurements will be
performed to further characterize these patients.
New research suggests that the composition of the gut flora (intestinal microbiota) may play
a role in the development of NASH. The effect of fish oil on the intestinal microbiota has
not been examined in humans. Therefore, intestinal microbiota is also measured before and
after intervention and associations between changes in microbiota and changes in liver
histology will be examined. In addition, bacterial products (short chain fatty acids in
stool, lipopolysaccharide in plasma, bacterial DNA in plasma), and plasma choline will be
measured. An environmental questionnaire will capture factors that can influence the
intestinal microbiota.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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