NCT01354340已完成不适用
Dose Effect of Limicol on (LDL)-Cholesterol Levels in Moderate Hypercholesterolaemia
Lescuyer Laboratory2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年4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
- 45
- 试验地点
- 2
- 主要终点
- Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus placebo group)
研究概览
简要总结
The principal objective of this study is to investigate the dose-effect of the Limicol food supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.
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
- Triple (Participant, Care Provider, Investigator)
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
- 是
入选标准
- •About 18 to 65 years (inclusive).
- •Subject has a stable weight for at least three months before the start of the study.
- •Subject able and willing to comply with the protocol and agreeing to give their consent in writing.
- •Subject affiliated with a social security scheme.
- •Subject willing to be included in the national register of volunteers who lend themselves to biomedical research.
排除标准
- 未提供
结局指标
主要结局
Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus placebo group)
时间窗: 4 weeks after baseline
次要结局
- Change from Baseline in blood LDL-cholesterol levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group)(4 weeks after baseline)
- Change from Baseline in blood total cholesterol, HDL-cholesterol and TAG levels after 4 weeks of supplementation (limicol double dose group versus limicol simple dose group versus placebo group)(4 weeks after baseline)
- Change from Baseline in blood LDL-cholesterol, total cholesterol, HDL-cholesterol and TAG levels 4 weeks after end of supplementation (limicol double dose group versus limicol simple dose group versus placebo group)(8 weeks after baseline)
- Change from Baseline in CK, LDH and other safety biomarkers levels after 4 weeks of supplementation (limicol double dose group versus placebo group versus placebo group)(4 weeks after baseline)
研究者
研究点 (2)
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