Diet and Omega-3 Intervention Trial on Atherosclerosis

Phase 3

Completed

• Conditions: Atherosclerosis
• Interventions: Dietary Supplement: Omega-3 capsules and dietary counseling; Dietary Supplement: Dietary counseling, placebo capsules for omega-3; Dietary Supplement: No dietary counseling and omega-3 capsules

• Registration Number: NCT00764010
• Lead Sponsor: Ullevaal University Hospital

Brief 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.

Study Timeline

• Study Start: 1997-05
• Primary Completion: 2001-12
• Study Completion: 2001-12
• Status Verified: 2008-09
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-30
• Study First Posted: 2008-10-01
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 563

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
4	Omega-3 capsules and dietary counseling	Dietary counseling and omega-3 capsules
2	Dietary counseling, placebo capsules for omega-3	Dietary counseling, placebo capsules for omega-3
3	No dietary counseling and omega-3 capsules	No dietary counseling, omega-3 capsules

Primary Outcome Measures

Name	Time	Method
Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers	1997-2010

Secondary Outcome Measures

Name	Time	Method
Genetical influence of the intervention principles ("Nutrigenetics")	1997-2010

Trial Locations

Locations (1)

Ullevål University Hospital; 🇳🇴 Oslo, Norway