Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
Status:
Completed
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
Summary
Nonalcoholic steatohepatitis (NASH) occurs in 2-3% of the US population and carries a 15-20%
chance of progression to cirrhosis. It is closely associated with obesity, hyperlipidemia and
insulin resistance. Therapy usually includes recommendations to increase exercise and to
begin weight reducing diets but these goals are variably achieved and their relative effects
in conjunction with pharmacological intervention have not been well defined. Moreover, these
lifestyle changes can confound results of treatment trials if not quantified through
conditioning testing and measures of body fat. Polyunsaturated fatty acids, especially
formulation rich in omega-3, are widely accepted and endorsed in the medical community for
their beneficial effects on hyperlipidemia and coronary disease risk reduction. Recent data
suggests that omega-3 fatty acids ameliorate hepatic steatosis in humans and in animal models
of NASH by reducing hepatic fat content. We hypothesize that a one year course of omega-3
fatty acid (3gm/day) will produce improvement in NASH histological injury independent of
changes in weight (BMI) or degree of conditioning measured by the lactate threshold. The
effects of the supplement will be compared to a placebo group and controlled for these
lifestyle changes.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Virginia
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)