NCT02044679已完成不适用
Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions
Danone Research1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2013年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Osmolality
研究概览
简要总结
Evaluate urine osmolality as a marker of fluid intake, in healthy subjects displaying a wide range of fluid intake behaviors
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy female and male subjects aged 20- 30 years old (both ages included).
- •BMI within the range 20-25 kg/m2 (both inclusive).
- •Height within the range 1.60-1.75 m (both inclusive) for female subjects and 1.70-1.85 m (both inclusive) for male subjects.
- •Monophasic contraceptive method (female subjects only)
- •Smoking less than 10 cigarettes/day
- •Fluid intake habits falling within one of three designated arms
排除标准
- •Pregnant woman (as determined by a pregnancy test) or woman planning to become pregnant during the study; breast-feeding woman.
- •Any clinically relevant acute or chronic diseases which could interfere with the subjects' safety during the trial, or expose them to undue risk, or which could interfere with the study objectives.
- •Having participated in a clinical study for the renal diseases or having received any treatment related to the kidneys, cardiovascular disease or to hypertension in the last 12 months.
研究组 & 干预措施
A = Increase water intake 1
Experimental
- 1,5 to 2,0 L/day of water
干预措施: Water (Other)
C = no change
Other
No change
干预措施: No intervention (Other)
B = Increase water intake 2
Experimental
- 1,0 to 1,5 L/day of water
干预措施: Water (Other)
结局指标
主要结局
Osmolality
时间窗: baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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