Design of the Alpha Omega Trial
The Alpha Omega Trial had a 2×2 factorial design. Patients were randomly allocated to one of the four groups that received either a targeted additional amount of 400 mg/day EPA-DHA, or 2 g/day ALA, or both, or a placebo containing the monounsaturated fatty acid oleic acid. An intake of 400 mg EPA-DHA and 2 g ALA per day is equivalent to the Recommended Dietary Allowances of these fatty acids.
To study the effect of EPA-DHA and ALA on major cardiovascular events, four different enriched margarines were developed by Unilever R&D, Vlaardingen, The Netherlands.
The margarines were produced by Unilever R&D every six months and stored at -20˚C. Upon inclusion in the study, the patients received six tubs of trial margarine to bridge the gap until the first delivery. Thereafter the patients received eight tubs of margarine every 12 weeks by refrigerated courier transport (Valid Express, Amsterdam), under supervision of a specialized logistics company (L.O.F. bv, Egmond aan den Hoef). Any remaining tubs were returned by the subjects to the same logistical company when the next delivery came. The number of returned tubs was registered to calculate actual margarine intake at the end of the study.
Participants consumed over 442,073 tubs of trial margarine, which were brought to them over the course of 66,503 deliveries.