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Metabolomic Analysis of the Impacts of Hydration Status on Exercise Performance

Primary Purpose

Dehydration, Physical Exertion, Salivary Osmolar Concentration

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kona Deep
Spring Water
Sports Drink
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dehydration focused on measuring deep sea mineral water, exercise recovery, hydration, salivary osmolar concentration, urinary osmolar concentration

Eligibility Criteria

20 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • prescription medications, BMI > 24.9

Sites / Locations

  • Ina A. Gittings Building

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Kona Deep

Spring Water

Sports Drink

Arm Description

Subjects will receive Kona Deep post-exercise

Subjects will receive commercially available Spring Water post-exercise

Subjects will receive commercially available Sports Drink post-exercise

Outcomes

Primary Outcome Measures

Change in Salivary Osmolar Concentration during Exercise, Post-Exercise, Post-Rehydration
Saliva will be collected at regular intervals throughout the study protocol

Secondary Outcome Measures

Change in Urinary Osmolar Concentration during Exercise, Post-Exercise, Post-Rehydration
Urine will be collected prior to, immediately following exercise and immediately following rehydration.
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.

Full Information

First Posted
June 8, 2015
Last Updated
October 5, 2021
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT02486224
Brief Title
Metabolomic Analysis of the Impacts of Hydration Status on Exercise Performance
Official Title
Metabolomic Analysis of the Impacts of Hydration Status on Exercise Performance
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19 shutdown prevented study enrollment. Staff was subsequently lost to execute trial aims.
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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". 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration, Physical Exertion, Salivary Osmolar Concentration, Urinary Osmolar Concentration
Keywords
deep sea mineral water, exercise recovery, hydration, salivary osmolar concentration, urinary osmolar concentration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kona Deep
Arm Type
Experimental
Arm Description
Subjects will receive Kona Deep post-exercise
Arm Title
Spring Water
Arm Type
Placebo Comparator
Arm Description
Subjects will receive commercially available Spring Water post-exercise
Arm Title
Sports Drink
Arm Type
Active Comparator
Arm Description
Subjects will receive commercially available Sports Drink post-exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
Kona Deep
Other Intervention Name(s)
Deep Seawater
Intervention Description
Subjects will receive Kona Deep post exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
Spring Water
Intervention Description
Subjects will receive Spring Water post exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
Sports Drink
Other Intervention Name(s)
Gatorade
Intervention Description
Subjects will receive Sports Drink post exercise
Primary Outcome Measure Information:
Title
Change in Salivary Osmolar Concentration during Exercise, Post-Exercise, Post-Rehydration
Description
Saliva will be collected at regular intervals throughout the study protocol
Time Frame
0-180 minutes
Secondary Outcome Measure Information:
Title
Change in Urinary Osmolar Concentration during Exercise, Post-Exercise, Post-Rehydration
Description
Urine will be collected prior to, immediately following exercise and immediately following rehydration.
Time Frame
0-180 minutes
Title
Change in Lower body muscle power Pre-Exercise, Post-Exercise, Post-Rehydration
Description
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.
Time Frame
0-180 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Non-smokers, BMI: 18.5-24.9, 20-25 years of age, physically active Exclusion Criteria: prescription medications, BMI > 24.9
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Konhilas, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ina A. Gittings Building
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
15516723
Citation
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.
Results Reference
background
PubMed Identifier
15240926
Citation
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.
Results Reference
background
PubMed Identifier
18175939
Citation
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.
Results Reference
background
PubMed Identifier
12487419
Citation
Bohl CH, Volpe SL. Magnesium and exercise. Crit Rev Food Sci Nutr. 2002;42(6):533-63. doi: 10.1080/20024091054247.
Results Reference
background
PubMed Identifier
23402436
Citation
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.
Results Reference
background
PubMed Identifier
9309637
Citation
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.
Results Reference
background
PubMed Identifier
24853347
Citation
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.
Results Reference
background
PubMed Identifier
30947727
Citation
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.
Results Reference
derived

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Metabolomic Analysis of the Impacts of Hydration Status on Exercise Performance

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