Effect of Fish Oil Supplementation on Postprandial Lipid Metabolism in Familial Hypercholesterolaemia
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Postprandial changes in triglyceride-rich lipoprotein concentrations
研究概览
简要总结
The purpose of this study is to determine whether fish oil supplementation is effective in the treatment of abnormal fat metabolism in subjects with elevated cholesterolaemia.
详细描述
The use of statin therapy in familial hypercholesterolaemia (FH) is known to reduce cardiovascular risk and is a first line recommendation, however, there is considerable residual risk predicted by the presence of fasting and post-prandial hypertriglyceridaemia.
This study will examine the effect of oral n-3 fatty acid ethyl esters supplementation (4g/day, Omacor) on postprandial hypertriglyceridaemia and post-prandial arterial function when administrated to FH patients at increased risk of cardiovascular disease due to their residual fasting hypertriglyceridaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with FH (genetically defined LDL-receptor mutation or Dutch score >8) on statin treatment only
- •Hypertriglyceridaemia on a random blood sample (triglycerides >1.5mml/L)
排除标准
- •Subjects with diabetes mellitus
- •major systemic illness or use of steroids or other lipid-regulating drugs (such as niacin, fibrate and colesevelam)
- •patients on hypocaloric diets or LDL apheresis; anaemia, haemorrhage and pregnancy.
研究组 & 干预措施
Fish oil
干预措施: Fish oil capsule (Dietary Supplement)
Placebo
FH subjects with standard treatment (statin treatment)
干预措施: HMG Coenzyme reductase (Drug)
结局指标
主要结局
Postprandial changes in triglyceride-rich lipoprotein concentrations
时间窗: 12 weeks
Incremental area-under-the-curve (AUC) for triglycerides, apoB-48 and retinyl palmitate
次要结局
- Triglyceride-rich lipoprotein kinetics(12 weeks)
研究者
Dick C Chan
Assistant Professor
The University of Western Australia