Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
A Randomized, Masked, Controlled Study of Omega-3 Polyunsaturated Fatty Acid vs Monounsaturated Fatty Acid Diet Supplementation for the Treatment of Nonalcoholic Fatty Liver Disease
The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids will decrease the amount of fat in liver.
NAFLD is the most common liver disease in the United States and is also a common cause of
abnormal liver tests in the United States. NAFLD includes mild as well as a more severe
nonalcoholic fatty liver disease involving liver cell inflammation and damage, called
Nonalcoholic Steatohepatitis (NASH). NAFLD is usually discovered because of abnormal liver
tests or from a liver ultrasound or CT scan in persons with normal liver enzymes. Liver
biopsy may show a mix of fat, inflammation and scarring in the liver. Patients with NAFLD do
not drink large amounts of alcohol that can cause this type of liver damage. NAFLD is
thought to be related to obesity and diabetes. Unfortunately, there is very little
information about important features of NAFLD. These include biochemical, genetic and other
features that may help to predict disease progression. The few known risk factors include
high blood sugar and lipid levels. Patients with NAFLD often have resistance to the normal
action of insulin, a hormone which is important for processing sugar and fat. Increased
resistance to insulin leads to fat in the liver. Currently, there is no proven treatment for
NAFLD. Several studies in animals suggest that diets containing high levels of omega-3
polyunsaturated fatty acids (PUFA) will decrease the amount of liver fat.
It has long been known that omega-3 fatty acids have several health benefits. For example, a
diet rich in these fatty acids reduces the amount of certain fats ("triglycerides") in
blood, and might improve the action of the important hormone insulin. Omega-3 fatty acids
are contained in certain plant oils (such as canola oil and linseed oil) and marine fish
(such as salmon). The purpose of this study is to determine the effect of dietary
supplementation with ω-3 polyunsaturated vs monounsaturated fatty acids on intrahepatic fat
content in patients with non-alcoholic fatty liver disease as determined by magnetic
resonance spectroscopy
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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