NCT01716390已完成不适用
The Effect of Plant Stanol Drink on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations
Raisio Group1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2011年1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
- 56
- 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.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy mildly to moderate hypercholesterolemic (serum total cholesterol 5.2-8.5 mmol/l) adults
- •signed written informed consent
排除标准
- •participation in a clinical study within 30 days prior to screening visit and throughout the study
- •severe obesity
- •consumption of lipid/cholesterol lowering medication 1 month prior to the screening visit and throughout the study
- •consumption of plant stanol or plant sterol containing food products such as Benecol or Becel pro active 1 month prior to visit 2
结局指标
主要结局
Change in serum LDL cholesterol
时间窗: 0 vs 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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