Trial | NCT00764010  Report issue

Official Title

Diet and Omega-3 Intervention Trial on Atherosclerosis

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    icosapent ethyl ...

  • Study Participants

    563
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.
Study Started
May 31
1997
Primary Completion
Dec 31
2001
Study Completion
Dec 31
2001
Last Update
Jul 01
2011
Estimate

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

1 No Intervention

No dietary counseling, placebo capsules for omega-3

2 Active Comparator

Dietary counseling, placebo capsules for omega-3

3 Active Comparator

No dietary counseling, omega-3 capsules

4 Active Comparator

Dietary counseling and omega-3 capsules

Criteria 

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.
No Results Posted