The Effect of Plant Stanol Esters on Serum Total and Lipoproteins Lipids, Non-cholesterol Sterols and Apolipoproteins in Subjects With Elevated Blood Lipid Concentration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- plasma lipids
研究概览
简要总结
This study aims to measure the effect of plant stanol esters on serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins in subjects with elevated fasting blood lipid concentrations
详细描述
The link between high serum low-density lipoprotein (LDL) cholesterol and cardiovascular disease has long been recognized. Dietary plant stanol esters have been shown to effectively reduce serum levels of total and LDL cholesterol. Plant stanols decrease the absorption of both biliary and dietary cholesterol from the small intestine and thereby reduce serum LDL cholesterol levels.
This study aims to verify the effect of plant stanol esters on blood lipids. Subjects with elevated fasting blood lipid concentrations will be randomized to study groups. The groups consume yoghurt type minidrink containing plant stanol ester (2 g plant stanols per day) or similar minidrink without plant stanol esters. After 10 weeks study period serum total and lipoproteins lipids, non-cholesterol sterols and apolipoproteins will by analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elevated blood lipids
- •Body Mass Index < 35 kg/m2
- •Stable body weight
排除标准
- •Receiving medications or supplements other than stable statin therapy known to affect lipid metabolism
- •Severe obesity
- •Hyperglycemia
- •Severe diseases (inc. diabetes, unstable CVD, malignant disease, inflammatory disease, gastrointestinal disease)
- •Hepatic, kidney or thyroid disease or disorder
- •Pregnancy or breast feeding
- •Severe intolerance or allergy to any ingredient of test product
结局指标
主要结局
plasma lipids
时间窗: 10 weeks
次要结局
- plasma lipoprotein lipids non-cholesterol sterols(10 weeks)