Diet and Omega-3 Intervention Trial on Atherosclerosis (DOIT)
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
No dietary counseling and omega-3 capsules
Omega-3 capsules and dietary counseling
Dietary counseling, placebo capsules for omega-3
Sponsored by

About this trial
This is an interventional prevention trial for Atherosclerosis
Eligibility Criteria
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.
Sites / Locations
- Ullevål University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
No dietary counseling, placebo capsules for omega-3
Dietary counseling, placebo capsules for omega-3
No dietary counseling, omega-3 capsules
Dietary counseling and omega-3 capsules
Outcomes
Primary Outcome Measures
Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers
Secondary Outcome Measures
Genetical influence of the intervention principles ("Nutrigenetics")
Full Information
NCT ID
NCT00764010
First Posted
September 26, 2008
Last Updated
June 30, 2011
Sponsor
Ullevaal University Hospital
Collaborators
University of Oslo, Ultrasound Laboratory at Malmoe University Hospital, Sweden, Norwegian Retail Company RIMI, Norwegian Cardiovascular Council
1. Study Identification
Unique Protocol Identification Number
NCT00764010
Brief Title
Diet and Omega-3 Intervention Trial on Atherosclerosis
Acronym
DOIT
Official Title
Diet and Omega-3 Intervention Trial on Atherosclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
May 1997 (undefined)
Primary Completion Date
December 2001 (Actual)
Study Completion Date
December 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ullevaal University Hospital
Collaborators
University of Oslo, Ultrasound Laboratory at Malmoe University Hospital, Sweden, Norwegian Retail Company RIMI, Norwegian Cardiovascular Council
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
563 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
No dietary counseling, placebo capsules for omega-3
Arm Title
2
Arm Type
Active Comparator
Arm Description
Dietary counseling, placebo capsules for omega-3
Arm Title
3
Arm Type
Active Comparator
Arm Description
No dietary counseling, omega-3 capsules
Arm Title
4
Arm Type
Active Comparator
Arm Description
Dietary counseling and omega-3 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
No dietary counseling and omega-3 capsules
Intervention Description
Omega-3 2.4 g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 capsules and dietary counseling
Intervention Description
Omega-3 2.4 g/day and Mediterranean-like diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary counseling, placebo capsules for omega-3
Intervention Description
Mediterranean-like diet
Primary Outcome Measure Information:
Title
Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers
Time Frame
1997-2010
Secondary Outcome Measure Information:
Title
Genetical influence of the intervention principles ("Nutrigenetics")
Time Frame
1997-2010
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
64 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald Arnesen, M.D, PhD
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ullevål University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
30038669
Citation
Awoyemi A, Troseid M, Arnesen H, Solheim S, Seljeflot I. Markers of metabolic endotoxemia as related to metabolic syndrome in an elderly male population at high cardiovascular risk: a cross-sectional study. Diabetol Metab Syndr. 2018 Jul 21;10:59. doi: 10.1186/s13098-018-0360-3. eCollection 2018.
Results Reference
derived
PubMed Identifier
23428306
Citation
Weiss TW, Arnesen H, Seljeflot I. Components of the interleukin-6 transsignalling system are associated with the metabolic syndrome, endothelial dysfunction and arterial stiffness. Metabolism. 2013 Jul;62(7):1008-13. doi: 10.1016/j.metabol.2013.01.019. Epub 2013 Feb 19.
Results Reference
derived
PubMed Identifier
19331677
Citation
Einvik G, Ekeberg O, Klemsdal TO, Sandvik L, Hjerkinn EM. Physical distress is associated with cardiovascular events in a high risk population of elderly men. BMC Cardiovasc Disord. 2009 Mar 30;9:14. doi: 10.1186/1471-2261-9-14.
Results Reference
derived
Learn more about this trial
Diet and Omega-3 Intervention Trial on Atherosclerosis
We'll reach out to this number within 24 hrs