NCT02221297已完成不适用
Lowering Serum LDL-cholesterol With a Plant Stanol Ester Supplement Product
Raisio Group0 个研究点目标入组 103 人开始时间: 2014年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 主要终点
- Proportional change in serum LDL cholesterol
研究概览
简要总结
Purpose of the study is to determine the effect of the investigational products as consumed with a meal on serum lipids, primarily on LDL cholesterol.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male and female over 18 years old
- •serum LDL cholesterol > 3.0 mmol/L
- •BMI < 35
- •subjects must voluntarily sign the informed consent
排除标准
- •subjects using lipid lowering medication (ezetimibe, bile acid sequestrant, statin therapy)
- •subjects with any hepatic or renal disorder according to medical history
- •subjects who have history of myocardial infarction or unstable angina pectoris within six months prior to screening
- •subjects who have history of coronary artery bypass graft or percutaneous transluminal coronary angioplasty within six months prior to screening
- •subjects who have history of temporal ischemic attack or stroke within six months prior to screening
- •subjects who have a history of cancer or other malignant disease within the past five years
- •subjects who are consuming more than 15 portions of alcohol / week
- •subjects who are pregnant or lactating
- •subjects using cholesterol-lowering foods or dietary supplements within 14 days before start of the intervention
- •subjects with intolerance to any ingredient of the test product
结局指标
主要结局
Proportional change in serum LDL cholesterol
时间窗: 3 to 4 weeks
Proportional change \[end of intervention - start of intervention\] in serum LDL-cholesterol between intervention and control groups in subjects fulfilling the inclusion criteria at the beginning of the study.
次要结局
- Proportional change in serum triglycerides(3 to 4 weeks)
- Proportional change in total cholesterol(3 to 4 weeks)
- Proportional change in non-HDL-cholesterol(3 to 4 weeks)
- Proportional change in lipids in all study participants(3 to 4 weeks)
- Proportional change in lipids in subjects without metabolic derangements(3 to 4 weeks)
研究者
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