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Diet and Omega-3 Intervention Trial on Atherosclerosis (DOIT)

This study has been completed.
Sponsor:
Collaborators:
University of Oslo
Ultrasound Laboratory at Malmoe University Hospital, Sweden
Norwegian Retail Company RIMI
Norwegian Cardiovascular Council
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00764010
First received: September 26, 2008
Last updated: June 30, 2011
Last verified: September 2008
History of Changes
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Diet and Omega-3 Intervention Trial on Atherosclerosis

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers [ Time Frame: 1997-2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Genetical influence of the intervention principles ("Nutrigenetics") [ Time Frame: 1997-2010 ] [ Designated as safety issue: No ]

Enrollment: 563
Study Start Date: May 1997
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Mediterranean-like diet
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

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.

  Eligibility

Ages Eligible for Study:   64 Years to 76 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764010

Locations
Norway
Ullevål University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
University of Oslo
Ultrasound Laboratory at Malmoe University Hospital, Sweden
Norwegian Retail Company RIMI
Norwegian Cardiovascular Council
Investigators
Principal Investigator: Harald Arnesen, M.D, PhD Ullevaal University Hospital
  More Information

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Harald Arnesen, Professor of Medicine, Ulleval University Hospital, Oslo, Norway
ClinicalTrials.gov Identifier: NCT00764010     History of Changes
Other Study ID Numbers: 175
Study First Received: September 26, 2008
Last Updated: June 30, 2011
Health Authority: Norway: Data Protection Authority
Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013