Dehydration, Rehydration, and Blood Viscosity

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dehydration

Intervention / Treatment
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* Other: Essentia Water
* Other: Bottled water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Free from any medication for at least 1 week prior to the study Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Essentia Water<br>Essentia Water, electrolyzed high-pH water | Other: Essentia Water<br> <br> * Other names: Electrolyzed high-pH water;|
| Other: Bottled Water<br>Purified bottle water | Other: Bottled water<br> <br> * Other names: Purified bottled water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in whole blood viscosity from dehydrated state | Blood viscosity measured using a scanning capillary viscometer | 120 min following rehydration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in whole blood viscosity from dehydrated state | Blood viscosity measured using scanning capillary viscometer | 15, 30, 60, and 90 min following rehydration | 
| Change in plasma osmolality from dehydrated state | Plasma osmolality measured using freezing point osmometer | 15, 30, 60, 90, and 120 min following rehydration | 
| Change in bioelectrical impedance | Impedance is measured to provide an estimation of body composition using a bioelectrical impedance analyzer (RJL Quantum IV). | 45, 75, and 120 min following rehydration | 
| Body mass change |  | 45, 75, and 120 min following rehydration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, hydration, dehydration, rehydration, alkaline water, blood viscosity, plasma osmolality, bioimpedance