- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02486224
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
Terminated
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
17
Phase
- 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
-
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Arizona
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Tucson, Arizona, United States, 85721
- Ina A. Gittings Building
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-
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
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 |
Intervention / Treatment |
---|---|
Experimental: Kona Deep
Subjects will receive Kona Deep post-exercise
|
Subjects will receive Kona Deep post exercise
Other Names:
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Placebo Comparator: Spring Water
Subjects will receive commercially available Spring Water post-exercise
|
Subjects will receive Spring Water post exercise
|
Active Comparator: Sports Drink
Subjects will receive commercially available Sports Drink post-exercise
|
Subjects will receive Sports Drink post exercise
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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
- Miyamura M, Yoshioka S, Hamada A, Takuma D, Yokota J, Kusunose M, Kyotani S, Kawakita H, Odani K, Tsutsui Y, Nishioka Y. Difference between deep seawater and surface seawater in the preventive effect of atherosclerosis. Biol Pharm Bull. 2004 Nov;27(11):1784-7. doi: 10.1248/bpb.27.1784.
- Tsuchiya Y, Watanabe A, Fujisawa N, Kaneko T, Ishizu T, Fujimoto T, Nakamura K, Yamamoto M. Effects of desalted deep seawater on hematologic and blood chemical values in mice. Tohoku J Exp Med. 2004 Jul;203(3):175-82. doi: 10.1620/tjem.203.175.
- Katsuda S, Yasukawa T, Nakagawa K, Miyake M, Yamasaki M, Katahira K, Mohri M, Shimizu T, Hazama A. Deep-sea water improves cardiovascular hemodynamics in Kurosawa and Kusanagi-Hypercholesterolemic (KHC) rabbits. Biol Pharm Bull. 2008 Jan;31(1):38-44. doi: 10.1248/bpb.31.38.
- Bohl CH, Volpe SL. Magnesium and exercise. Crit Rev Food Sci Nutr. 2002;42(6):533-63. doi: 10.1080/20024091054247.
- Hou CW, Tsai YS, Jean WH, Chen CY, Ivy JL, Huang CY, Kuo CH. Deep ocean mineral water accelerates recovery from physical fatigue. J Int Soc Sports Nutr. 2013 Feb 12;10(1):7. doi: 10.1186/1550-2783-10-7.
- Galloway SD, Maughan RJ. Effects of ambient temperature on the capacity to perform prolonged cycle exercise in man. Med Sci Sports Exerc. 1997 Sep;29(9):1240-9. doi: 10.1097/00005768-199709000-00018.
- Munoz CX, McKenzie AL, Armstrong LE. Optimal hydration biomarkers: consideration of daily activities. Obes Facts. 2014;7 Suppl 2(Suppl 2):13-8. doi: 10.1159/000360655. Epub 2014 Apr 4. No abstract available.
- Harris PR, Keen DA, Constantopoulos E, Weninger SN, Hines E, Koppinger MP, Khalpey ZI, Konhilas JP. Fluid type influences acute hydration and muscle performance recovery in human subjects. J Int Soc Sports Nutr. 2019 Apr 4;16(1):15. doi: 10.1186/s12970-019-0282-y.
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
September 1, 2015
Primary Completion (Actual)
December 31, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
June 8, 2015
First Submitted That Met QC Criteria
June 26, 2015
First Posted (Estimate)
July 1, 2015
Study Record Updates
Last Update Posted (Actual)
October 14, 2021
Last Update Submitted That Met QC Criteria
October 5, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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