The Effect of Shuhua Milk Fortified With Plant Sterol Esters on Serum Cholesterol in Human
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Change in Total Cholesterol(TC) during and after intervention
研究概览
简要总结
The purpose of this study is to determine whether YiLi Xinhuo Shuhua Milk is effective in reducing the serum cholesterol in human with hypercholesterolemia.
详细描述
In a randomized, placebo-controlled double-blind mono-centric study,179 subjects with total cholesterol (TC) level above 5.18mmol/L and triglyceride (TG) level lower than 2.25mmol/L were assigned to 500ml of low lactose milk enriched with 1.58g plant sterol esters or 500ml plain milk without plant sterols (placebo) or without any dairy product consumption (control) for 60 days. Subjects were instructed to maintain stable diet pattern and physical activity. Plasma concentrations of TC,TG,LDL cholesterol(LDL-C) and HDL cholesterol(HDL-C) were measured at initial visits, after 30days and after 60 days. The primary measurement was the change in TC. Secondary measurements were changes in TG,LDL-C and HDL-C.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 18-65 yrs;
- •Serum TC ≥5.18mmol/L, and TG≤2.25mmol/L;
- •Normal blood pressure or able to control blood pressure within normal range;
- •Willing to consent to study participation and to comply with study requirements.
排除标准
- •Pregnant or breastfeeding women;
- •Known allergies to dairy and any substance in the study product.For example lactose intolerance;
- •Any comorbidity that could,in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes, including but not limited to cardiac disease, hepatic disease, renal disease, hematopoietic system disease and mental disease;
- •Recent use (within 2 weeks of screening) of any prescription or OTC medication that affects serum total cholesterol or that may confound study outcomes.
结局指标
主要结局
Change in Total Cholesterol(TC) during and after intervention
时间窗: Baseline & 1 months & 2 mongths
次要结局
- Change in LDL-C level during and after intervention(Baseline & 1 months & 2 mongths)
- Change in HDL-C level during and after intervention(Baseline & 1 months & 2 mongths)
- Change in Triglyceride(TG) during and after intervention(Baseline & 1 months & 2 mongths)