Atherosclerosis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTNo dietary counseling and omega-3 capsules
Omega-3 2.4 g/day
DIETARY_SUPPLEMENTOmega-3 capsules and dietary counseling
Omega-3 2.4 g/day and Mediterranean-like diet
DIETARY_SUPPLEMENTDietary counseling, placebo capsules for omega-3
Mediterranean-like diet
Sponsors
University of Oslo
Ultrasound Laboratory at Malmoe University Hospital, Sweden
Norwegian Retail Company RIMI
Norwegian Cardiovascular Council
Ullevaal University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
64 Years to 76 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers | 1997-2010 |
Secondary
| Measure | Time frame |
|---|---|
| Genetical influence of the intervention principles (Nutrigenetics) | 1997-2010 |
Countries
Norway
Outcome results
None listed