Dehydration, Rehydration, and Blood Viscosity

Dehydration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118883
• Other study ID #: ESSHOV102
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: July 14, 2014
• Start date: April 2014
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Essentia Water, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dehydration

Intervention

Other:
• Essentia Water

• Bottled water

Locations

Country	Name	City	State
United States	Health Onvector Inc	Camden	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Essentia Water, LLC	Health Onvector Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in whole blood viscosity from dehydrated state	Blood viscosity measured using a scanning capillary viscometer	120 min following rehydration	No
Secondary	Change in whole blood viscosity from dehydrated state	Blood viscosity measured using scanning capillary viscometer	15, 30, 60, and 90 min following rehydration	No
Secondary	Change in plasma osmolality from dehydrated state	Plasma osmolality measured using freezing point osmometer	15, 30, 60, 90, and 120 min following rehydration	No
Secondary	Change in bioelectrical impedance	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	No
Secondary	Body mass change		45, 75, and 120 min following rehydration	No