AtherosclerosisPhase 3DOITNCT00764010
Diet and Omega-3 Intervention Trial on Atherosclerosis
A Phase 3 study testing No dietary counseling and omega-3 capsules and Omega-3 capsules and dietary counseling in people with Atherosclerosis, run by Ullevaal University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 64 to 76 years, men only
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- No dietary counseling and omega-3 capsules and Omega-3 capsules and dietary counseling
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 563 participants
- Where
- 1 siteNorway
- Study dates
- May 1997to Dec 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 64 to 76 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly men with long standing hypercholesterolemia (cholesterol > 6.45 mmol/L and < 8.00 mmol/L) with or without coronary heart disease.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- No dietary counseling and omega-3 capsules, Omega-3 capsules and dietary counseling, Dietary counseling, placebo capsules for omega-3
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No dietary counseling and omega-3 capsulesDietary supplement
Omega-3 2.4 g/day
Omega-3 capsules and dietary counselingDietary supplement
Omega-3 2.4 g/day and Mediterranean-like diet
Dietary counseling, placebo capsules for omega-3Dietary supplement
Mediterranean-like diet
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | No dietary counseling, placebo capsules for omega-3 |
| 2 | Active comparator | Dietary counseling, placebo capsules for omega-3 Receives: Dietary Supplement: Dietary counseling, placebo capsules for omega-3 |
| 3 | Active comparator | No dietary counseling, omega-3 capsules Receives: Dietary Supplement: No dietary counseling and omega-3 capsules |
| 4 | Active comparator | Dietary counseling and omega-3 capsules Receives: Dietary Supplement: Omega-3 capsules and dietary counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers
Measured: 1997-2010
Secondary outcomes (1)
Genetical influence of the intervention principles ("Nutrigenetics")
Measured: 1997-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2008 (estimated)
- Study startMay 1997
- Primary completionDec 2001
- Study completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Ultrasound Laboratory at Malmoe University Hospital, Sweden, Norwegian Retail Company RIMI, Norwegian Cardiovascular Council
- Investigators
- Harald Arnesen, M.D, PhD, Principal investigator, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764010
- Sponsor's protocol ID
- 175
- Acronym
- DOIT
- Status last verified
- Sep 2008
- First submitted
- 26 Sep 2008
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30038669Weiss 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.
PubMed 23428306Einvik 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.
PubMed 19331677
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Omega-3 Intervention Trial on Atherosclerosis
- ClinicalTrials.gov ID
- NCT00764010
- Acronym / sponsor ID
- DOIT / 175
- Conditions
- Atherosclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Ultrasound Laboratory at Malmoe University Hospital, Sweden, Norwegian Retail Company RIMI, Norwegian Cardiovascular Council
- Study start
- May 1997
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (actual)
- First posted
- 1 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –No dietary counseling, placebo capsules for omega-3 |
| 2 | Active comparator | Dietary Supplement: Dietary counseling, placebo capsules for omega-3Dietary counseling, placebo capsules for omega-3 |
| 3 | Active comparator | Dietary Supplement: No dietary counseling and omega-3 capsulesNo dietary counseling, omega-3 capsules |
| 4 | Active comparator | Dietary Supplement: Omega-3 capsules and dietary counselingDietary counseling and omega-3 capsules |
Who may qualify
- Ages
- 64 to 76 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elderly men with long standing hypercholesterolemia (cholesterol > 6.45 mmol/L and < 8.00 mmol/L) with or without coronary heart disease.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No dietary counseling and omega-3 capsulesOmega-3 2.4 g/day | Dietary supplement | 3 |
| Omega-3 capsules and dietary counselingOmega-3 2.4 g/day and Mediterranean-like diet | Dietary supplement | 4 |
| Dietary counseling, placebo capsules for omega-3Mediterranean-like diet | Dietary supplement | 2 |
Primary outcome
Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers
Time frame: 1997-2010
1 secondary outcome
Genetical influence of the intervention principles ("Nutrigenetics")
Time frame: 1997-2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
- Derived from this study: PubMed 30038669Awoyemi 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.
- Derived from this study: PubMed 23428306Weiss 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.
- Derived from this study: PubMed 19331677Einvik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Arnesen, M.D, PhD principal investigator
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing No dietary counseling and omega-3 capsules and Omega-3 capsules and dietary counseling in people with Atherosclerosis, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers (time frame: 1997-2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00764010, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2011.