DehydrationNCT02118883
Dehydration, Rehydration, and Blood Viscosity
A study testing Essentia Water and Bottled water in people with Dehydration, run by Essentia Water, LLC at 1 site in United States.
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)… Read more about this study
- Who is it for?
- Ages 25 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration
- What is being tested?
- Essentia Water and Bottled water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free from any medication for at least 1 week prior to the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Dehydration
- Being tested
- Essentia Water, Bottled water
- Keywords
- exercise, hydration, dehydration, rehydration, alkaline water, blood viscosity, plasma osmolality, bioimpedance
- Medical subject headings
- Dehydration, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essentia WaterOther
Also called Electrolyzed high-pH water
Bottled waterOther
Also called Purified bottled water
| Study group | Role | What they receive |
|---|---|---|
| Essentia Water | Other | Essentia Water, electrolyzed high-pH water Receives: Other: Essentia Water |
| Bottled Water | Other | Purified bottle water Receives: Other: Bottled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in whole blood viscosity from dehydrated state
Blood viscosity measured using a scanning capillary viscometer
Measured: 120 min following rehydration
Secondary outcomes (4)
Change in whole blood viscosity from dehydrated state
Blood viscosity measured using scanning capillary viscometer
Measured: 15, 30, 60, and 90 min following rehydration
Change in plasma osmolality from dehydrated state
Plasma osmolality measured using freezing point osmometer
Measured: 15, 30, 60, 90, and 120 min following rehydration
Change in bioelectrical impedance
Impedance is measured to provide an estimation of body composition using a bioelectrical impedance analyzer (RJL Quantum IV).
Measured: 45, 75, and 120 min following rehydration
Body mass change
Measured: 45, 75, and 120 min following rehydration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DehydrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essentia Water, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Health Onvector Inc.
- Responsible party
- Sponsor
- Investigators
- Gregory Fridman, PhD, Principal investigator, A.J. Drexel Plasma Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118883
- Sponsor's protocol ID
- ESSHOV102
- Status last verified
- Jul 2014
- First submitted
- 16 Apr 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02118883
- Acronym / sponsor ID
- ESSHOV102
- Conditions
- Dehydration
- Keywords
- exercise, hydration, dehydration, rehydration, alkaline water, blood viscosity, plasma osmolality, bioimpedance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Essentia Water, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Health Onvector Inc.
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Essentia Water | Other | Other: Essentia WaterEssentia Water, electrolyzed high-pH water |
| Bottled Water | Other | Other: Bottled waterPurified bottle water |
Who may qualify
- Ages
- 25 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Free from any medication for at least 1 week prior to the study
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essentia WaterAlso: Electrolyzed high-pH water | Other | Essentia Water |
| Bottled waterAlso: Purified bottled water | Other | Bottled Water |
Primary outcome
Change in whole blood viscosity from dehydrated state
Time frame: 120 min following rehydration
Blood viscosity measured using a scanning capillary viscometer
4 secondary outcomes
Change in whole blood viscosity from dehydrated state
Time frame: 15, 30, 60, and 90 min following rehydration
Change in plasma osmolality from dehydrated state
Time frame: 15, 30, 60, 90, and 120 min following rehydration
Change in bioelectrical impedance
Time frame: 45, 75, and 120 min following rehydration
Body mass change
Time frame: 45, 75, and 120 min following rehydration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Fridman, PhD principal investigator
A.J. Drexel Plasma Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essentia Water and Bottled water in people with Dehydration, run by Essentia Water, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in whole blood viscosity from dehydrated state (time frame: 120 min following rehydration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.