NCT01882517已完成不适用
The Cholesterol Lowering Efficacy of Plant Stanol Ester Yoghurt in a Turkish Population
Raisio Group1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2011年3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
- 70
- 试验地点
- 1
- 主要终点
- Change in serum LDL cholesterol
研究概览
简要总结
To determine the effect of investigational products on serum LDL cholesterol.
详细描述
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a yogurt is less well known.
Study was monitored by Foodfiles
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects must voluntarily sign the informed consent
- •subjects must be male or female aged 20 to 70 years
- •subjects must have a serum total cholesterol concentration of 5.2 - 7.5 mmol/l ( 205 - 290 mg/dl) at the screening visit (visit 1, -2 week)
排除标准
- •subjects using lipid lowering medication
- •subjects using ezetimibe
- •subjects with bile acid sequestrant medication
- •subjects with statin therapy
- •subjects using other medication significantly influencing on lipid values
- •subjects with diagnosis type 1 or type 2 diabetes
- •severe obesity (BMI>35.0 kg/m2)
- •serum fasting triglycerides > 4.0 mmol/l
- •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 with abnormal values of health screening variables measured at screening visit: serum gamma-glutamyltransferase> 2 x upper limit, serum alkaline phosphatase> 2 x upper limit or other abnormality in laboratory evaluations considered as clinically significant in the opinion of the study physician
- •subjects who are consuming more than 15 portions of alcohol / week
- •subjects who are pregnant or lactating
- •subjects using Benecol, Becelpro.activ, Danacol or other plant sterol enriched products within 30 days before visit 2
- •subjects with severe lactose intolerance, milk allergy or any other intolerance to the ingredients of test products
- •celiac disease
结局指标
主要结局
Change in serum LDL cholesterol
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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