Dehydration, Rehydration, and Blood Viscosity
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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 16, 2014
CompletedFirst Posted
Study publicly available on registry
April 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJuly 16, 2014
July 1, 2014
2 months
April 16, 2014
July 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in whole blood viscosity from dehydrated state
Blood viscosity measured using a scanning capillary viscometer
120 min following rehydration
Secondary Outcomes (4)
Change in whole blood viscosity from dehydrated state
15, 30, 60, and 90 min following rehydration
Change in plasma osmolality from dehydrated state
15, 30, 60, 90, and 120 min following rehydration
Change in bioelectrical impedance
45, 75, and 120 min following rehydration
Body mass change
45, 75, and 120 min following rehydration
Study Arms (2)
Essentia Water
OTHEREssentia Water, electrolyzed high-pH water
Bottled Water
OTHERPurified bottle water
Interventions
Eligibility Criteria
You may qualify if:
- Free from any medication for at least 1 week prior to the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Essentia Water, LLClead
- Health Onvector Inc.collaborator
Study Sites (1)
Health Onvector Inc
Camden, New Jersey, 08103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Fridman, PhD
A.J. Drexel Plasma Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2014
First Posted
April 21, 2014
Study Start
April 1, 2014
Primary Completion
June 1, 2014
Study Completion
July 1, 2014
Last Updated
July 16, 2014
Record last verified: 2014-07