Back to resultsDehydration, Rehydration, and Blood Viscosity
Primary Purpose
Dehydration
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Essentia Water
Bottled water
Sponsored by
About this trial
This is an interventional basic science trial for Dehydration focused on measuring exercise, hydration, dehydration, rehydration, alkaline water, blood viscosity, plasma osmolality, bioimpedance
Eligibility 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
Sites / Locations
- Health Onvector Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Essentia Water
Bottled Water
Arm Description
Essentia Water, electrolyzed high-pH water
Purified bottle water
Outcomes
Primary Outcome Measures
Change in whole blood viscosity from dehydrated state
Blood viscosity measured using a scanning capillary viscometer
Secondary Outcome Measures
Change in whole blood viscosity from dehydrated state
Blood viscosity measured using scanning capillary viscometer
Change in plasma osmolality from dehydrated state
Plasma osmolality measured using freezing point osmometer
Change in bioelectrical impedance
Impedance is measured to provide an estimation of body composition using a bioelectrical impedance analyzer (RJL Quantum IV).
Body mass change
Full Information
NCT ID
NCT02118883
First Posted
April 16, 2014
Last Updated
July 14, 2014
Sponsor
Essentia Water, LLC
Collaborators
Health Onvector Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02118883
Brief Title
Dehydration, Rehydration, and Blood Viscosity
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 Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Essentia Water, LLC
Collaborators
Health Onvector Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration
Keywords
exercise, hydration, dehydration, rehydration, alkaline water, blood viscosity, plasma osmolality, bioimpedance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Essentia Water
Arm Type
Other
Arm Description
Essentia Water, electrolyzed high-pH water
Arm Title
Bottled Water
Arm Type
Other
Arm Description
Purified bottle water
Intervention Type
Other
Intervention Name(s)
Essentia Water
Other Intervention Name(s)
Electrolyzed high-pH water
Intervention Type
Other
Intervention Name(s)
Bottled water
Other Intervention Name(s)
Purified bottled water
Primary Outcome Measure Information:
Title
Change in whole blood viscosity from dehydrated state
Description
Blood viscosity measured using a scanning capillary viscometer
Time Frame
120 min following rehydration
Secondary Outcome Measure Information:
Title
Change in whole blood viscosity from dehydrated state
Description
Blood viscosity measured using scanning capillary viscometer
Time Frame
15, 30, 60, and 90 min following rehydration
Title
Change in plasma osmolality from dehydrated state
Description
Plasma osmolality measured using freezing point osmometer
Time Frame
15, 30, 60, 90, and 120 min following rehydration
Title
Change in bioelectrical impedance
Description
Impedance is measured to provide an estimation of body composition using a bioelectrical impedance analyzer (RJL Quantum IV).
Time Frame
45, 75, and 120 min following rehydration
Title
Body mass change
Time Frame
45, 75, and 120 min following rehydration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Fridman, PhD
Organizational Affiliation
A.J. Drexel Plasma Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Onvector Inc
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dehydration, Rehydration, and Blood Viscosity
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