NCT02316808已完成不适用
Cholesterol-lowering Effects of Plant Stanol Ester
Raisio Group0 个研究点目标入组 91 人开始时间: 2011年8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
- 91
- 主要终点
- Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption.
研究概览
简要总结
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient administered in a smoothie is less well known.
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
- •total cholesterol concentration ≥ 200 mg/dL and < 300 mg/dL, and or LDL-C concentration ≥ 130 mg/dL and < 180 mg/dL
- •were willing to consume control or plant stanol ester smoothie drinks two bottles per day immediately after a meal for four weeks,
- •reachable by phone
- •willing to declare written informed consent
- •agreed in accordance with data protective stipulations and readiness to participate in the trial and to adhere to the study conditions.
排除标准
- •Pregnant women
- •diabetic subjects or subjects with random plasma glucose concentration > 200 mg/dL
- •hyperthyroidism, a history of metabolic, endocrine and kidney disorders
- •acute or chronic severe diseases possibly interfering with the evaluation of the outcome of the clinical trial (such as AIDS, tumor diseases, malignant hypertension, cardiac insufficiency according to NYHA III-IV)
- •taking lipid-lowering medication or other medications likely to affect lipid metabolism
结局指标
主要结局
Change (proportional) in LDL-C from baseline up to 4-weeks after plant stanol ester smoothie drink consumption.
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
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