Clinical trial NCT00764010: Diet and Omega-3 Intervention Trial on Atherosclerosis
Official title: Diet and Omega-3 Intervention Trial on Atherosclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atherosclerosis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Ultrasound Laboratory at Malmoe University Hospital, Sweden
name: Norwegian Retail Company RIMI
name: Norwegian Cardiovascular Council
First posted: 2008-10-01
Enrollment: 563
Sex: MALE
Minimum age (years): 64
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers
timeFrame: 1997-2010
Secondary outcomes:
measure: Genetical influence of the intervention principles ("Nutrigenetics")
timeFrame: 1997-2010
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ullevål University Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Harald Arnesen, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.