Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
563 participants
INTERVENTIONAL
1997-05-31
2001-12-31
Brief Summary
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The evaluation of atherosclerosis were i) ultrasound measurement of carotid intima media thickening ii) pulse wave propagation time iii) circulating biomarkers of atherosclerosis.
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
TRIPLE
Study Groups
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1
No dietary counseling, placebo capsules for omega-3
No interventions assigned to this group
2
Dietary counseling, placebo capsules for omega-3
Dietary counseling, placebo capsules for omega-3
Mediterranean-like diet
3
No dietary counseling, omega-3 capsules
No dietary counseling and omega-3 capsules
Omega-3 2.4 g/day
4
Dietary counseling and omega-3 capsules
Omega-3 capsules and dietary counseling
Omega-3 2.4 g/day and Mediterranean-like diet
Interventions
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No dietary counseling and omega-3 capsules
Omega-3 2.4 g/day
Omega-3 capsules and dietary counseling
Omega-3 2.4 g/day and Mediterranean-like diet
Dietary counseling, placebo capsules for omega-3
Mediterranean-like diet
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
64 Years
76 Years
MALE
No
Sponsors
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University of Oslo
OTHER
Ultrasound Laboratory at Malmoe University Hospital, Sweden
OTHER
Norwegian Retail Company RIMI
UNKNOWN
Norwegian Cardiovascular Council
UNKNOWN
Ullevaal University Hospital
OTHER
Responsible Party
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Ulleval University Hospital, Oslo, Norway
Principal Investigators
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Harald Arnesen, M.D, PhD
Role: PRINCIPAL_INVESTIGATOR
Ullevaal University Hospital
Locations
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Ullevål University Hospital
Oslo, Oslo County, Norway
Countries
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References
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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.
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.
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.
Other Identifiers
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175
Identifier Type: -
Identifier Source: org_study_id
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