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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
Ullevaal University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis

Eligibility Criteria

64 Years - 76 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

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
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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

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Diet and Omega-3 Intervention Trial on Atherosclerosis

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