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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02486224
Other study ID # 1502689413
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date December 31, 2020

Study information

Verified date October 2021
Source University of Arizona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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". 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 17
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 25 Years
Eligibility Inclusion Criteria: - Non-smokers, BMI: 18.5-24.9, 20-25 years of age, physically active Exclusion Criteria: - prescription medications, BMI > 24.9

Study Design


Intervention

Dietary Supplement:
Kona Deep
Subjects will receive Kona Deep post exercise
Spring Water
Subjects will receive Spring Water post exercise
Sports Drink
Subjects will receive Sports Drink post exercise

Locations

Country Name City State
United States Ina A. Gittings Building Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bohl CH, Volpe SL. Magnesium and exercise. Crit Rev Food Sci Nutr. 2002;42(6):533-63. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Muñoz CX, McKenzie AL, Armstrong LE. Optimal hydration biomarkers: consideration of daily activities. Obes Facts. 2014;7 Suppl 2:13-8. doi: 10.1159/000360655. Epub 2014 Apr 4. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Salivary Osmolar Concentration during Exercise, Post-Exercise, Post-Rehydration Saliva will be collected at regular intervals throughout the study protocol 0-180 minutes
Secondary Change in Urinary Osmolar Concentration during Exercise, Post-Exercise, Post-Rehydration Urine will be collected prior to, immediately following exercise and immediately following rehydration. 0-180 minutes
Secondary 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. 0-180 minutes
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