The Alpha Omega Trial was set up to assess the effect of omega-3 fatty acids on major cardiovascular events in 4,837 post-myocardial infarction patients. Patient recruitment took place from 2002-2006 and involved 32 cardiology centers in the Netherlands.
Patients (78% male) were on average 69 years old at the start of the study and had their (last) myocardial infarction approximately 4 years ago. Twenty-one per cent had diabetes. Extensive baseline measurements took place, which included the assessment of cardiovascular risk factors, dietary intake, lifestyle and medication use.
The trial had a 2x2 factorial design, and patients were randomized to receive one of four treatments, for 40 months, namely (1) fish fatty acids EPA + DHA, 400 mg/day, (2) alpha-linolenic acid (ALA), 2 g/day, (3) both EPA + DHA and ALA, or (4) placebo. Omega-3 fatty acids were incorporated in margarines. The trial was completed in 2009 and the main findings were reported in 2010 in the New England Journal of Medicine. The Alpha Omega Trial is currently used as a prospective cohort study to examine predictors of survival in post-myocardial infarction patients.
The Alpha Omega Trial was funded by the Netherlands Heart Foundation and the National Institute of Health. Margarines were provided by Unilever.