Diet and Omega-3 Intervention Trial on Atherosclerosis (DOIT)

Ullevaal University Hospital

Status and phase: Completed; Phase 3

Conditions: Atherosclerosis

Treatments: Dietary Supplement: No dietary counseling and omega-3 capsules; Dietary Supplement: Dietary counseling, placebo capsules for omega-3; Dietary Supplement: Omega-3 capsules and dietary counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT00764010

175

Details and patient eligibility

About

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.

Full 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.

Enrollment: 563 patients

Sex: Male

Ages: 64 to 76 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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563 participants in 4 patient groups

1

No Intervention group

Description:

No dietary counseling, placebo capsules for omega-3

2

Active Comparator group

Description:

Dietary counseling, placebo capsules for omega-3

Treatment:

Dietary Supplement: Dietary counseling, placebo capsules for omega-3

3

Active Comparator group

Description:

No dietary counseling, omega-3 capsules

Treatment:

Dietary Supplement: No dietary counseling and omega-3 capsules

4

Active Comparator group

Description:

Dietary counseling and omega-3 capsules

Treatment:

Dietary Supplement: Omega-3 capsules and dietary counseling