Dehydration, Rehydration, and Blood Viscosity

Not Applicable

Completed

• Conditions: Dehydration
• Interventions: Other: Essentia Water; Other: Bottled water

• Registration Number: NCT02118883
• Lead Sponsor: Essentia Water, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-17
• Study First Posted: 2014-04-21
• Primary Completion: 2014-06
• Status Verified: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Essentia Water	Essentia Water	Essentia Water, electrolyzed high-pH water
Bottled Water	Bottled water	Purified bottle water

Primary Outcome Measures

Name	Time	Method
Change in whole blood viscosity from dehydrated state	120 min following rehydration	Blood viscosity measured using a scanning capillary viscometer

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Health Onvector Inc; 🇺🇸 Camden, New Jersey, United States