DehydrationNCT02486224
Metabolomic Analysis of the Impacts of Hydration Status on Exercise Performance
A study testing Kona Deep, Spring Water and Sports Drink in people with Dehydration and Physical Exertion, run by University of Arizona at 1 site in United States.
Trial summary
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". Read more about this study
- Who is it for?
- Ages 20 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dehydration, Physical Exertion, Salivary Osmolar Concentration
- What is being tested?
- Kona Deep, Spring Water and Sports Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 31 Dec 2020
- 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 20 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smokers, BMI: 18.5-24.9, 20-25 years of age, physically active
Who cannot join
- prescription medications, BMI > 24.9
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dehydration, Physical Exertion, Salivary Osmolar Concentration, Urinary Osmolar Concentration
- Being tested
- Kona Deep, Spring Water, Sports Drink
- Keywords
- deep sea mineral water, exercise recovery, hydration, salivary osmolar concentration, urinary osmolar concentration
- Medical subject headings
- Dehydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kona DeepDietary supplement
Also called Deep Seawater
Subjects will receive Kona Deep post exercise
Spring WaterDietary supplement
Subjects will receive Spring Water post exercise
Sports DrinkDietary supplement
Also called Gatorade
Subjects will receive Sports Drink post exercise
| Study group | Role | What they receive |
|---|---|---|
| Kona Deep | Experimental | Subjects will receive Kona Deep post-exercise Receives: Dietary Supplement: Kona Deep |
| Spring Water | Placebo comparator | Subjects will receive commercially available Spring Water post-exercise Receives: Dietary Supplement: Spring Water |
| Sports Drink | Active comparator | Subjects will receive commercially available Sports Drink post-exercise Receives: Dietary Supplement: Sports Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Osmolar Concentration during Exercise, Post-Exercise, Post-Rehydration
Saliva will be collected at regular intervals throughout the study protocol
Measured: 0-180 minutes
Secondary outcomes (2)
Change in Urinary Osmolar Concentration during Exercise, Post-Exercise, Post-Rehydration
Urine will be collected prior to, immediately following exercise and immediately following rehydration.
Measured: 0-180 minutes
Change in Lower body muscle power Pre-Exercise, Post-Exercise, Post-Rehydration
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.
Measured: 0-180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startSep 2015
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Why it stopped: COVID-19 shutdown prevented study enrollment. Staff was subsequently lost to execute trial aims.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John P Konhilas, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486224
- Sponsor's protocol ID
- 1502689413
- Status last verified
- Oct 2021
- First submitted
- 8 Jun 2015
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
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.
PubMed 15516723Tsuchiya 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.
PubMed 15240926Katsuda 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.
PubMed 18175939Bohl CH, Volpe SL. Magnesium and exercise. Crit Rev Food Sci Nutr. 2002;42(6):533-63. doi: 10.1080/20024091054247.
PubMed 12487419Hou 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.
PubMed 23402436Galloway 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.
PubMed 9309637Munoz 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.
PubMed 24853347Harris 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.
PubMed 30947727
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Analysis of the Impacts of Hydration Status on Exercise Performance
- ClinicalTrials.gov ID
- NCT02486224
- Acronym / sponsor ID
- 1502689413
- Conditions
- Dehydration, Physical Exertion, Salivary Osmolar Concentration, Urinary Osmolar Concentration
- Keywords
- deep sea mineral water, exercise recovery, hydration, salivary osmolar concentration, urinary osmolar concentration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 shutdown prevented study enrollment. Staff was subsequently lost to execute trial aims.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 1 Jul 2015 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kona Deep | Experimental | Dietary Supplement: Kona DeepSubjects will receive Kona Deep post-exercise |
| Spring Water | Placebo comparator | Dietary Supplement: Spring WaterSubjects will receive commercially available Spring Water post-exercise |
| Sports Drink | Active comparator | Dietary Supplement: Sports DrinkSubjects will receive commercially available Sports Drink post-exercise |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Non-smokers, BMI: 18.5-24.9, 20-25 years of age, physically active
Key exclusion criteria (1 listed)
- prescription medications, BMI > 24.9
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 |
|---|---|---|
| Kona DeepAlso: Deep SeawaterSubjects will receive Kona Deep post exercise | Dietary supplement | Kona Deep |
| Spring WaterSubjects will receive Spring Water post exercise | Dietary supplement | Spring Water |
| Sports DrinkAlso: GatoradeSubjects will receive Sports Drink post exercise | Dietary supplement | Sports Drink |
Primary outcome
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
2 secondary outcomes
Change in Urinary Osmolar Concentration during Exercise, Post-Exercise, Post-Rehydration
Time frame: 0-180 minutes
Change in Lower body muscle power Pre-Exercise, Post-Exercise, Post-Rehydration
Time frame: 0-180 minutes
Results and safety
The study was stopped early (reason given: COVID-19 shutdown prevented study enrollment. Staff was subsequently lost to execute trial aims.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Background: PubMed 15516723Miyamura 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.
- Background: PubMed 15240926Tsuchiya 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.
- Background: PubMed 18175939Katsuda 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.
- Background: PubMed 12487419Bohl CH, Volpe SL. Magnesium and exercise. Crit Rev Food Sci Nutr. 2002;42(6):533-63. doi: 10.1080/20024091054247.
- Background: PubMed 23402436Hou 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.
- Background: PubMed 9309637Galloway 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.
- Background: PubMed 24853347Munoz 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.
- Derived from this study: PubMed 30947727Harris 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
John P Konhilas, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kona Deep, Spring Water and Sports Drink in people with Dehydration and Physical Exertion, run by University of Arizona 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 1 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: stopped early, as of the sponsor's last update on 14 Oct 2021. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: COVID-19 shutdown prevented study enrollment. Staff was subsequently lost to execute trial aims.). Results are not available in the source record.
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 Salivary Osmolar Concentration during Exercise, Post-Exercise, Post-Rehydration (time frame: 0-180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02486224, which also lists 8 linked publications.
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 14 Oct 2021.