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

June 30, 2011 updated by: Ullevaal University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

563

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Ullevål University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

62 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers
Time Frame: 1997-2010
1997-2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Genetical influence of the intervention principles ("Nutrigenetics")
Time Frame: 1997-2010
1997-2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1997

Primary Completion (Actual)

December 1, 2001

Study Completion (Actual)

December 1, 2001

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

July 1, 2011

Last Update Submitted That Met QC Criteria

June 30, 2011

Last Verified

September 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 175

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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