NCT00812617已完成不适用
Effects of Mineral Water Consumption on Serum Lipid Parameters: a Double-Blind, Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Fasting total cholesterol, LDL cholesterol, and triglyceride levels
研究概览
简要总结
The purpose of the study is to determine the effect of a specific mineral water on serum lipid concentrations in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, 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
- •Healthy as based on medical history and physical examination
- •Fasting serum LDL cholesterol > 100 and/or fasting serum triglyceride > 100
- •Willing to drink mineral water for 12 weeks
- •Willing not to serve as blood donor during the study
- •Informed consent signed
排除标准
- •Female subjects who are pregnant or nursing a child
- •Participation in any clinical trial up to 90 days before Day 01 of this study
- •Renal or hepatic dysfunction
- •Heart disease
结局指标
主要结局
Fasting total cholesterol, LDL cholesterol, and triglyceride levels
时间窗: Every 4 weeks (Overall 20 weeks)
次要结局
- Fasting serum glucose and HbA1c levels(Every 4 weeks (Overall 20 weeks))
- Serum uric acid level(Every 4 weeks (Overall 20 weeks))
- Serum adiponectin and leptin levels(Week 0, Week 12)
- Urinary oxidative stress marker(Week 0, Week 12)
研究者
研究点 (2)
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