Atherosclerosis Clinical Trial
Official title:
Diet and Omega-3 Intervention Trial on Atherosclerosis
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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