Non-alcoholic Fatty Liver Disease Clinical Trial
Official title:
The Effect of n-3 Polyunsaturated Fatty Acid Supplementation in Patients With Non-alcoholic Fatty Liver Disease
The principal purpose of this study is to determine whether increased intakes of n-3 polyunsaturated (omega-3) fatty acids will reduce the amount of fat stored in the liver in patients with non-alcoholic fatty liver disease.
Non-alcoholic fatty liver disease (NAFLD) is present in 10-24% of the general adult
population. The first step of NAFLD involves the accumulation of fat within the liver
(steatosis). Steatosis occurs either due to defective generation, metabolism or excretion of
fatty acids by the liver. The next step in NAFLD progression is inflammation, which commonly
occurs due to pro-inflammatory stimuli. Persistent inflammation results in end-stage liver
disease. NAFLD is associated with the metabolic syndrome, which is characterised by central
obesity, insulin resistance, raised triglycerides and hypertension. With the current obesity
epidemic, there is predicted to be greater numbers of patients with NAFLD in the future.
Polyunsaturated fatty acids (PUFAs) are essential components of our diet, though standard
Western intakes are lower than the recommended amounts. Supplementing the long chain n-3
PUFAs (commonly termed omega-3), EPA and DHA, improves many of the metabolic syndrome
features. They lower plasma triglycerides, and may improve insulin resistance.
The diet of NAFLD patients tends to be deficient in n-3 PUFAs and have an excessive intake
of the harmful n-6 PUFAs. This pattern is mirrored in their liver lipid content as assessed
at biopsy.
Currently there is no proven treatment for NAFLD. Animal studies and limited studies in
patients have been supportive of a benefit with n-3 polyunsaturated fatty acids. This needs
to be further assessed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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