Dehydration, Rehydration, and Blood Viscosity

NCT ID: NCT02118883

Last Updated: 2014-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-07-31

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.

Detailed Description

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Conditions

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Dehydration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Essentia Water

Essentia Water, electrolyzed high-pH water

Group Type OTHER

Essentia Water

Intervention Type OTHER

Bottled Water

Purified bottle water

Group Type OTHER

Bottled water

Intervention Type OTHER

Interventions

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Essentia Water

Intervention Type OTHER

Bottled water

Intervention Type OTHER

Other Intervention Names

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Electrolyzed high-pH water Purified bottled water

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Onvector Inc.

INDUSTRY

Sponsor Role collaborator

Essentia Water, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Fridman, PhD

Role: PRINCIPAL_INVESTIGATOR

A.J. Drexel Plasma Institute

Locations

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Health Onvector Inc

Camden, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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ESSHOV102

Identifier Type: -

Identifier Source: org_study_id

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