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Dehydration, Rehydration, and Blood Viscosity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02118883
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : July 16, 2014
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

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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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   25 Years to 49 Years   (Adult)
Sexes Eligible for Study:   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

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 identifier (NCT number): NCT02118883

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United States, New Jersey
Health Onvector Inc
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
Essentia Water, LLC
Health Onvector Inc.
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Principal Investigator: Gregory Fridman, PhD A.J. Drexel Plasma Institute
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Responsible Party: Essentia Water, LLC Identifier: NCT02118883    
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:
alkaline water
blood viscosity
plasma osmolality
Additional relevant MeSH terms:
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Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes