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临床试验/NCT02118883
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

Essentia Water, LLC1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年4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
入组人数
100
试验地点
1
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

研究组 & 干预措施

Essentia Water

Other

Essentia Water, electrolyzed high-pH water

干预措施: Essentia Water (Other)

Bottled Water

Other

Purified bottle water

干预措施: Bottled water (Other)

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

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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