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Dehydration, Rehydration, and Blood Viscosity

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ClinicalTrials.gov Identifier: NCT02118883
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : July 16, 2014
Sponsor:
Collaborator:
Health Onvector Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dehydration Other: Essentia Water Other: Bottled water Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : April 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Essentia Water
Essentia Water, electrolyzed high-pH water
Other: Essentia Water
Other Name: Electrolyzed high-pH water

Bottled Water
Purified bottle water
Other: Bottled water
Other Name: Purified bottled water




Primary Outcome Measures :
  1. Change in whole blood viscosity from dehydrated state [ Time Frame: 120 min following rehydration ]
    Blood viscosity measured using a scanning capillary viscometer


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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).

  4. Body mass change [ Time Frame: 45, 75, and 120 min following rehydration ]


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Ages Eligible for Study:   25 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118883


Locations
United States, New Jersey
Health Onvector Inc
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
Essentia Water, LLC
Health Onvector Inc.
Investigators
Principal Investigator: Gregory Fridman, PhD A.J. Drexel Plasma Institute

Responsible Party: Essentia Water, LLC
ClinicalTrials.gov Identifier: NCT02118883     History of Changes
Other Study ID Numbers: ESSHOV102
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Keywords provided by Essentia Water, LLC:
exercise
hydration
dehydration
rehydration
alkaline water
blood viscosity
plasma osmolality
bioimpedance

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes