Dehydration, Rehydration, and Blood Viscosity

July 14, 2014 updated by: Essentia Water, LLC

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Health Onvector Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Essentia Water
Essentia Water, electrolyzed high-pH water
Other: Essentia Water
Other Names:
  • Electrolyzed high-pH water
Other: Bottled Water
Purified bottle water
Other: Bottled water
Other Names:
  • Purified bottled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in whole blood viscosity from dehydrated state
Time Frame: 120 min following rehydration
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
Time Frame: 15, 30, 60, and 90 min following rehydration
Blood viscosity measured using scanning capillary viscometer
15, 30, 60, and 90 min following rehydration
Change in plasma osmolality from dehydrated state
Time Frame: 15, 30, 60, 90, and 120 min following rehydration
Plasma osmolality measured using freezing point osmometer
15, 30, 60, 90, and 120 min following rehydration
Change in bioelectrical impedance
Time Frame: 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).
45, 75, and 120 min following rehydration
Body mass change
Time Frame: 45, 75, and 120 min following rehydration
45, 75, and 120 min following rehydration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Essentia Water, LLC

Collaborators

Health Onvector Inc.

Investigators

  • Principal Investigator: Gregory Fridman, PhD, A.J. Drexel Plasma Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

April 16, 2014

First Submitted That Met QC Criteria

April 17, 2014

First Posted (Estimate)

April 21, 2014

Study Record Updates

Last Update Posted (Estimate)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESSHOV102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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