Metabolomic Analysis of the Impacts of Hydration Status on Exercise Performance

October 5, 2021 updated by: University of Arizona
Kona Deep is bottled water extracted from a depth of 3000 feet off the cost of Kona, Hawaii. Kona Deep claims that this unique source provides water that is "naturally free of pathogens, chemicals and pollutants and rich in nutrients and minerals that are readily absorbed by the body". The investigators wish to examine Kona Deep's claim that this water is "beneficial to the human body" by testing the impact of drinking Kona Deep on exercise performance and recovery. Subjects will be exercised to a safe level of dehydration and then will be rehydrated with Kona Deep water, or commercially available bottled spring water or Gatorade as controls. Subjects will perform a simple exercise to evaluate peak power performance. This measurement will be compared between rehydration methods for significant differences.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Exercise-induced dehydration is very common in athletes and regularly active individuals. Hypohydration, if sufficiently severe, can negatively impact physical performance and mental capacity. Development of an efficient rehydration therapy could prove beneficial in these circumstances. Multiple animal studies have shown the positive effects of desalinated deep-sea mineral water on various physiological conditions. The beneficial effects of deep-sea mineral water may be attributed to its unique mineral composition, particularly magnesium, which is highly abundant in deep-sea water. The investigators wish to evaluate whether a similar response occurs in post-exercise rehydration using deep ocean water from a different source. Kona Deep is marketed as Hawaiian glacier water drawn from a depth of 915 m off the Kona coast that is naturally rich in electrolytes and nutrients, and that is free of mercury, harmful bacterial, and pollutants, making it a desired drinking water source. Accordingly, the investigators will investigate whether subjects administered Kona Deep following an exercise challenge undergo more rapid rehydration and demonstrate higher peak power production compared to subjects administered commercially available liquids. Euhydrated subjects in this study will be exposed to an exercise-challenge protocol (stationary biking) under warm conditions (30°C) to accelerate dehydration. Dehydration will be measured as a body mass loss of 3-5% (maximum exercise time will be 180 minutes). A body mass loss of 3% is the minimal amount lost during a similar exercise-dehydration protocol but where significance was still observed in exercise performance, recovery, and physiological parameters. During the post-exercise recovery period, subjects will consume one of three liquids in a volume equivalent to 1.5 times the body mass lost. Rehydration measured by salivary and urinary osmolality and exercise recovery will be measured such as oxygen consumption (VO2) at 60% estimated maximal heart rate and peak power production by contraction of the knee extensors before exercise, immediately after exercise, and after the rehydration period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • Ina A. Gittings Building

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-smokers, BMI: 18.5-24.9, 20-25 years of age, physically active

Exclusion Criteria:

  • prescription medications, BMI > 24.9

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Kona Deep
Subjects will receive Kona Deep post-exercise
Dietary supplement: Kona Deep
Subjects will receive Kona Deep post exercise
Other Names:
  • Deep Seawater
Placebo Comparator: Spring Water
Subjects will receive commercially available Spring Water post-exercise
Dietary supplement: Spring Water
Subjects will receive Spring Water post exercise
Active Comparator: Sports Drink
Subjects will receive commercially available Sports Drink post-exercise
Dietary supplement: Sports Drink
Subjects will receive Sports Drink post exercise
Other Names:
  • Gatorade

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Salivary Osmolar Concentration during Exercise, Post-Exercise, Post-Rehydration
Time Frame: 0-180 minutes
Saliva will be collected at regular intervals throughout the study protocol
0-180 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Urinary Osmolar Concentration during Exercise, Post-Exercise, Post-Rehydration
Time Frame: 0-180 minutes
Urine will be collected prior to, immediately following exercise and immediately following rehydration.
0-180 minutes
Change in Lower body muscle power Pre-Exercise, Post-Exercise, Post-Rehydration
Time Frame: 0-180 minutes
Lower body muscle power will be determined prior to, immediately following exercise and immediately following rehydration. This will be executed using a Biodex Dynamometer to determine single leg extension and flexion torque.
0-180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arizona

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John P Konhilas, PhD, University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1502689413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The University of Arizona (UA) will assure the timely release and sharing of data no later than the acceptance for publication of the main findings from the final dataset and will protect the rights and privacy of human subjects who participate in NIH sponsored research by redacting all identifiers and adoption of other strategies to minimize risks of unauthorized disclosure of personal identifiers in accordance with authorization and consent documents. UA will share data resulting from sponsored projects with research colleagues by depositing data on a secure web-accessible data warehouses or arranging distribution of data, reagents, protein targets, and protocols to other researchers using established mechanisms and repositories. Manuscripts will be submitted for publication in high-quality peer-reviewed journals, adhering to NIH Public Access Policy guidelines. Additionally, findings will be presented and discussed at relevant national conferences.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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