Diet and Omega-3 Intervention Trial on Atherosclerosis
Lead SponsorUniversity of Oslo
StatusCompleted No Results Posted
Intervention/Treatmenticosapent ethyl ...
The study was actuated to evaluate the effects of a 3-year intervention with diet and/or very long chain omega-3 (VLC n-3 PUFA), in a randomized 2x2 factorial design on the progression of atherosclerosis in a high risk population. A total of 563 elderly men were included and randomized to receive usual care and VLC n-3 placebo capsules (control group), dietary advice and VLC n-3 placebo capsules, usual care and VLC n-3 capsules, and finally both VLC n-3 capsules and dietary advice.
The evaluation of atherosclerosis were i) ultrasound measurement of carotid intima media thickening ii) pulse wave propagation time iii) circulating biomarkers of atherosclerosis.
The basis for recruitment was a follow up of subjects participating in the Oslo Diet and Anti Smoking Study (1972-1977) characterised as hypercholesterolemic in 1972.
Measurements of the outcome variables were performed at baseline and after 36 m; blood sampling also after 6 and 18 m.
In addition to the main outcome variables, a biobank was established for future analyses.
Clinical events were also recorded.
Omega-3 2.4 g/day
Omega-3 2.4 g/day and Mediterranean-like diet
No dietary counseling, placebo capsules for omega-3
Dietary counseling, placebo capsules for omega-3
No dietary counseling, omega-3 capsules
Dietary counseling and omega-3 capsules
Inclusion Criteria: Elderly men with long standing hypercholesterolemia (cholesterol > 6.45 mmol/L and < 8.00 mmol/L) with or without coronary heart disease. Exclusion Criteria: Cholesterol > 8.00 mmol/L, blood pressure > 170/100 Uncontrolled hypertension Socially or otherwise unsuitable subjects Anticipated non compliance Other major non cardiac illness expected to reduce life expectancy or interfere with study participation.