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OpenTrials
Completed

NCT Number: NCT02118883

Dehydration, Rehydration, and Blood Viscosity

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.

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Key information

Conditions

Dehydration Behavior Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

25 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Onvector Inc

Camden, New Jersey, 08103, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Essentia Water

Other

Other names: Electrolyzed high-pH water

Bottled water

Other

Other names: Purified bottled water

Primary outcomes

  1. Change in whole blood viscosity from dehydrated state

    Time frame: 120 min following rehydration

    Blood viscosity measured using a scanning capillary viscometer

Secondary outcomes

  1. Change in whole blood viscosity from dehydrated state

    Time frame: 15, 30, 60, and 90 min following rehydration

    Blood viscosity measured using scanning capillary viscometer

  2. Change in plasma osmolality from dehydrated state

    Time frame: 15, 30, 60, 90, and 120 min following rehydration

    Plasma osmolality measured using freezing point osmometer

  3. Change in bioelectrical impedance

    Time frame: 45, 75, and 120 min following rehydration

    Impedance is measured to provide an estimation of body composition using a bioelectrical impedance analyzer (RJL Quantum IV).

  4. Body mass change

    Time frame: 45, 75, and 120 min following rehydration

Sponsors and collaborators

Lead sponsor

Essentia Water, LLC

Industry

Collaborators

  • Health Onvector Inc.

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 21, 2014
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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