NCT00764010

Diet and Omega-3 Intervention Trial on Atherosclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 563 (actual)
• Sponsor: Ullevaal University Hospital · Academic / Other
• Sex: Male
• Age: 64 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Atherosclerosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	No dietary counseling and omega-3 capsules	Omega-3 2.4 g/day
DIETARY_SUPPLEMENT	Omega-3 capsules and dietary counseling	Omega-3 2.4 g/day and Mediterranean-like diet
DIETARY_SUPPLEMENT	Dietary counseling, placebo capsules for omega-3	Mediterranean-like diet

Timeline

• Start date: 1997-05-01
• Primary completion: 2001-12-01
• Completion: 2001-12-01
• First posted: 2008-10-01
• Last updated: 2011-07-01

Locations

1 site across 1 country: Norway