Diet and Omega-3 Intervention Trial on Atherosclerosis (DOIT)
|ClinicalTrials.gov Identifier: NCT00764010|
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : July 1, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis||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||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||563 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Diet and Omega-3 Intervention Trial on Atherosclerosis|
|Study Start Date :||May 1997|
|Actual Primary Completion Date :||December 2001|
|Actual Study Completion Date :||December 2001|
No Intervention: 1
No dietary counseling, placebo capsules for omega-3
Active Comparator: 2
Dietary counseling, placebo capsules for omega-3
Dietary Supplement: Dietary counseling, placebo capsules for omega-3
Active Comparator: 3
No dietary counseling, omega-3 capsules
Dietary Supplement: No dietary counseling and omega-3 capsules
Omega-3 2.4 g/day
Active Comparator: 4
Dietary counseling and omega-3 capsules
Dietary Supplement: Omega-3 capsules and dietary counseling
Omega-3 2.4 g/day and Mediterranean-like diet
- Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers [ Time Frame: 1997-2010 ]
- Genetical influence of the intervention principles ("Nutrigenetics") [ Time Frame: 1997-2010 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764010
|Ullevål University Hospital|
|Oslo, Norway, 0407|
|Principal Investigator:||Harald Arnesen, M.D, PhD||Ullevaal University Hospital|