The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease

University of Edinburgh50 enrolled

Overview

There is preliminary evidence that Omega 3, a compound naturally found in fish oil, reduces the amount of fat stored in the liver and improves liver function. The purpose of this study is to see whether this observation is correct.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Non Alcoholic Fatty Liver Disease

Interventions

OmacorDRUG

Active comparator: omacor 4g/day

lactose tabletDRUG

placebo: lactose tablet 4g/day

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * a diagnosis of non-alcoholic fatty liver disease * fatty infiltration on ultrasound * abnormal serum liver function tests. Exclusion Criteria: * any other identified cause of chronic liver disease * the prescription of medication which would cause non-alcoholic fatty liver - disease (e.g. tamoxifen) * already taking supplementary fish oil * alcohol intake of \>20g/day for women, \>40g/ day for men * known allergy to fish oil * on anticoagulants (antiplatelets are permitted) * severe heart failure (NYHA class IV) * pregnancy/ lactation * age under 18 years.

Locations (1)

Royal Infirmary of Edinburgh

Edinburgh, Lothian, United Kingdom

Outcomes

Primary Outcomes

Liver appearance on ultrasound

The primary endpoint is improvement in grading on ultrasound assessment at six months. Liver brightness and posterior attenuation on ultrasound has previously been shown to correlate significantly with fat scores on liver biopsy.

Time frame: 6 months

Secondary Outcomes

Liver function tests

the effect of omega-3 fatty acids on serum liver function tests will be assessed following 6 months of treatment.

Time frame: 6 months

hepatocyte mitochondrial function

heptocyte mitochondrial function will be measured by breath testing following 6 months of omega-3 supplementation

Time frame: 6 months

Health-related Quality of Life

Health related quality of life scores will be compared with baseline following 6 months of omega-3 supplementation

Time frame: 6 months

Data from ClinicalTrials.gov

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