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Completed

NCT Number: NCT00764010

Diet and Omega-3 Intervention Trial on Atherosclerosis

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

64 year–76 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Ullevål University Hospital

Oslo, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No dietary counseling and omega-3 capsules

Dietary Supplement

Omega-3 2.4 g/day

Omega-3 capsules and dietary counseling

Dietary Supplement

Omega-3 2.4 g/day and Mediterranean-like diet

Dietary counseling, placebo capsules for omega-3

Dietary Supplement

Mediterranean-like diet

Primary outcomes

  1. Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers

    Time frame: 1997-2010

Secondary outcomes

  1. Genetical influence of the intervention principles ("Nutrigenetics")

    Time frame: 1997-2010

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Collaborators

  • Norwegian Cardiovascular Council
  • Norwegian Retail Company RIMI
  • Ultrasound Laboratory at Malmoe University Hospital, Sweden
  • University of Oslo

Registry information

Acronym: DOIT

Important dates

Study start
1997
Primary completion
2001
Study completion
2001
First posted
Oct 1, 2008
Registry last updated
Jul 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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