Effect of Omega-3 Polyunsaturated Fat on Endothelial Function and Inflammatory Parameters in Familial Hypercholesterolemia - a Double Blind, Placebo-controlled Crossover Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Reactive Hyperemia Index (RHI)
研究概览
简要总结
Background
Familial hypercholesterolemia (FH) is an inherited disease in which the level of bad cholesterol (LDL-cholesterol) is increased, leading to an increase in coronary heart disease even if adequately treated with cholesterol lowering medication (statins). Polyunsaturated fatty acids (PUFA) including omega-3 is known to affect the risk for coronary disease, however its effect on patients with FH is not known.
The purpose of the study is to assess the effect of PUFA on patients with FH, with regard to inflammation measured in the blood and the effect on the blood vessels'ability to relax (endothelial function) by means of tonometry.
Hypothesis
Treatment with 4 grams of PUFA a day for 4 months will lead to an improvement in the endothelial function, and the treatment will also lead to a decrease in in several markers of inflammation and in lipids in the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •documented familial hypercholesterolemia
- •age 18-60 years
- •on statin treatment for at least 12 months
排除标准
- •pregnancy or planned pregnancy
- •breast feeding
- •non-compliance
- •PUFA/omega-3 < 3 months before inclusion
研究组 & 干预措施
Omega-3
Omega-3 fatty acids
干预措施: Omega-3 (Drug)
Placebo
Placebo/olive oil
干预措施: placebo (Drug)
结局指标
主要结局
Reactive Hyperemia Index (RHI)
时间窗: 9 months
Measure of endothelial function
次要结局
- Markers of inflammation(Baseline)
- Inflammatory markers(9 months)