Diet and Omega-3 Intervention Trial on Atherosclerosis (DOIT)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|