Diet and Omega-3 Intervention Trial on Atherosclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 563
- 试验地点
- 2
- 主要终点
- Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 64 Years 至 76 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Elderly men with long standing hypercholesterolemia (cholesterol > 6.45 mmol/L and < 8.00 mmol/L) with or without coronary heart disease.
排除标准
- •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.
结局指标
主要结局
Variables of atherosclerosis progression: IMT, Pulse Wave Propagation Time, Circulating biomarkers
时间窗: 1997-2010
次要结局
- Genetical influence of the intervention principles ("Nutrigenetics")(1997-2010)