NCT02118883已完成不适用
Randomized, Double-blind, Parallel Arm Study of the Effect of Essentia Water, an Electrolyzed High-pH Bottled Water, on Serial Blood Viscosity and Other Hydration Biomarkers in Healthy Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in whole blood viscosity from dehydrated state
研究概览
简要总结
The purpose of this study is to examine and compare the rehydration effect of Essentia Water, an electrolyzed high-pH bottled water, with industry-standard bottled water purified by reverse osmosis with minerals added, on (1) whole blood viscosity, (2) plasma osmolality, (3) bioelectrical impedance analysis, and (4) body mass change, using serial measurements in apparently healthy adults following exercise-induced dehydration in a controlled environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Free from any medication for at least 1 week prior to the study
排除标准
- •Any chronic condition requiring regular treatment or medical follow-up
- •Bleeding disorder or susceptible to prolonged or uncontrolled bleeding
- •Active infection
- •Current smoker
- •Subject has a BMI equal or greater than 30
- •Use of oral contraceptives in the previous 3 months
- •Subject is pregnant or breast-feeding
- •Currently menstruating
结局指标
主要结局
Change in whole blood viscosity from dehydrated state
时间窗: 120 min following rehydration
Blood viscosity measured using a scanning capillary viscometer
次要结局
- Change in plasma osmolality from dehydrated state(15, 30, 60, 90, and 120 min following rehydration)
- Change in whole blood viscosity from dehydrated state(15, 30, 60, and 90 min following rehydration)
- Body mass change(45, 75, and 120 min following rehydration)
- Change in bioelectrical impedance(45, 75, and 120 min following rehydration)
研究者
研究点 (2)
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