Dehydration, Rehydration, and Blood Viscosity | NCT02118883

Studies
Dehydration, Rehydration, and Blood Viscosity

NCT02118883

Sponsor

Essentia Water, LLC

Status

Completed

Last Update Posted

Jul 16, 2014Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Dehydration

Interventions

Essentia Water
Bottled water

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Jun 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Apr 16, 2014

First Submission Date that Met QC Criteria

Apr 17, 2014

First Posted Date

Apr 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2014

Last Update Posted Date

Jul 16, 2014Estimated

Name	Class
Health Onvector Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Essentia Water	Other	Essentia Water, electrolyzed high-pH water	Other: Essentia Water
Bottled Water	Other	Purified bottle water	Other: Bottled water

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Essentia Water	Other		Essentia Water	Electrolyzed high-pH water
Bottled water

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in whole blood viscosity from dehydrated state	Blood viscosity measured using a scanning capillary viscometer	120 min following rehydration

Secondary Outcomes

Measure	Description	Time Frame
Change in whole blood viscosity from dehydrated state	Blood viscosity measured using scanning capillary viscometer	15, 30, 60, and 90 min following rehydration
Change in plasma osmolality from dehydrated state

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gregory Fridman, PhD	A.J. Drexel Plasma Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Health Onvector Inc		Camden	New Jersey	08103	United States

Condition Browse Module

MeSH Terms

ID	Term
D003681	Dehydration
D009043	Motor Activity

Ancestor Terms

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D060766	Drinking Water

Ancestor Terms

ID	Term
D014867	Water
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838

Browse Leaves

Not provided

Browse Branches

Not provided