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Diet and Omega-3 Intervention Trial on Atherosclerosis

NCT00764010 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 563

Last updated 2011-07-01

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Oslo

    collaborator OTHER

  • Ultrasound Laboratory at Malmoe University Hospital, Sweden

    collaborator OTHER

  • Norwegian Retail Company RIMI

    collaborator UNKNOWN

  • Norwegian Cardiovascular Council

    collaborator UNKNOWN

  • Ullevaal University Hospital

    lead OTHER

Principal Investigators

  • Harald Arnesen, M.D, PhD · Ullevaal University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
64 Years
Max Age
76 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-05-31
Primary Completion
2001-12-31
Completion
2001-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00764010 on ClinicalTrials.gov