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Clinical Trials/NCT02118883
NCT02118883CompletedNot Applicable

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, LLC2 sites in 1 country100 target enrollmentStarted: April 2014Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
100
Locations
2
Primary Endpoint
Change in whole blood viscosity from dehydrated state
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
25 Years to 49 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Change in whole blood viscosity from dehydrated state

Time Frame: 120 min following rehydration

Blood viscosity measured using a scanning capillary viscometer

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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