Diet and Omega-3 Intervention Trial on Atherosclerosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diet and Omega-3 Intervention Trial on Atherosclerosis

Conditions
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Atherosclerosis

Intervention / Treatment
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* Dietary Supplement: No dietary counseling and omega-3 capsules
* Dietary Supplement: Omega-3 capsules and dietary counseling
* Dietary Supplement: Dietary counseling, placebo capsules for omega-3


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 64 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>No dietary counseling, placebo capsules for omega-3 | |
| Active Comparator: 2<br>Dietary counseling, placebo capsules for omega-3 | Dietary Supplement: Dietary counseling, placebo capsules for omega-3<br>* Mediterranean-like diet<br>|
| Active Comparator: 3<br>No dietary counseling, omega-3 capsules | Dietary Supplement: No dietary counseling and omega-3 capsules<br>* Omega-3 2.4 g/day<br>|
| Active Comparator: 4<br>Dietary counseling and omega-3 capsules | Dietary Supplement: Omega-3 capsules and dietary counseling<br>* Omega-3 2.4 g/day and Mediterranean-like diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers |  | 1997-2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetical influence of the intervention principles (Nutrigenetics) |  | 1997-2010 |