Diet and Omega-3 Intervention Trial on Atherosclerosis

Atherosclerosis Clinical Trial

— DOIT  

Official title:

Diet and Omega-3 Intervention Trial on Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764010
• Other study ID #: 175
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: June 30, 2011
• Start date: May 1997
• Est. completion date: December 2001

Study information

• Verified date: September 2008
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 563
• Est. completion date: December 2001
• Est. primary completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 64 Years to 76 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Dietary Supplement:
• No dietary counseling and omega-3 capsules
Omega-3 2.4 g/day
• Omega-3 capsules and dietary counseling
Omega-3 2.4 g/day and Mediterranean-like diet
• Dietary counseling, placebo capsules for omega-3
Mediterranean-like diet

Locations

Country	Name	City	State
Norway	Ullevål University Hospital	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
Ullevaal University Hospital	Norwegian Cardiovascular Council, Norwegian Retail Company RIMI, Ultrasound Laboratory at Malmoe University Hospital, Sweden, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers		1997-2010	No
Secondary	Genetical influence of the intervention principles ("Nutrigenetics")		1997-2010	No