Investigation of the Effectiveness of Plant Stanols as Ester on Change in Blood Cholesterol Level in Korean Adult
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- Change from baseline LDL-cholesterol at 4-week
研究概览
简要总结
The purpose of randomized, double-blind, placebo-controlled study was to determine whether yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) is effective in the control of blood cholesterol level in subjects with LDL-cholesterol level 130-159mg/dL.
详细描述
The objective of clinical trial was to evaluate the effect of yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) on blood cholesterol level. A randomized, double-blinded, placebo-controlled study was conducted on subjects with LDL-cholesterol level 130-159mg/dL. The subjects were randomly assigned to either a group ingesting yoghurt drink containing 2g plant stanols (3.4g as plant stanol esters) or a placebo group (yoghurt drink without plant stanols) for 4-week. The investigators assessed blood cholesterol level.
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
- 是
入选标准
- •LDL-cholesterol level 130-159mg/dL (not taking cholesterol-lowering medications)
排除标准
- •taking any medications (including anti-hypertensive, lipid lowering, anti-platelets, and anti-diabetic drugs)
- •history of serious cardiovascular, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease
- •history or presence of cancer
- •history of a psychiatric disorder and/or drug or alcohol abuse or dependency;
- •having a known intolerance to gluten or lactose
- •having a known allergy to any ingredient in the investigational product
- •women who are pregnant or desire to become pregnant during the study period or within 3 months of giving birth or breast feeding or within 3 months of cessation of breast feeding
- •having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study
结局指标
主要结局
Change from baseline LDL-cholesterol at 4-week
时间窗: at baseline and 4-week follow-up
Change from baseline total cholesterol at 4-week
时间窗: at baseline and 4-week follow-up
Change from baseline non-HDL-cholesterol at 4-week
时间窗: at baseline and 4-week follow-up
次要结局
- Change from baseline Apolipoprotein A1 at 4-week(at baseline and 4-week follow-up)
- Change from baseline triglyceride at 4-week(at baseline and 4-week follow-up)
- Change from baseline HDL-cholesterol at 4-week(at baseline and 4-week follow-up)
- Change from baseline Apolipoprotein B at 4-week(at baseline and 4-week follow-up)