NCT02486224

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

5.3 years

First QC Date

June 8, 2015

Last Update Submit

October 5, 2021

Conditions

DehydrationPhysical ExertionSalivary Osmolar ConcentrationUrinary Osmolar Concentration

Keywords

deep sea mineral waterexercise recoveryhydrationsalivary osmolar concentrationurinary osmolar concentration

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in Urinary Osmolar Concentration during Exercise, Post-Exercise, Post-Rehydration

    0-180 minutes

  • Change in Lower body muscle power Pre-Exercise, Post-Exercise, Post-Rehydration

    0-180 minutes

Study Arms (3)

Kona Deep

EXPERIMENTAL

Subjects will receive Kona Deep post-exercise

Dietary Supplement: Kona Deep

Spring Water

PLACEBO COMPARATOR

Subjects will receive commercially available Spring Water post-exercise

Dietary Supplement: Spring Water

Sports Drink

ACTIVE COMPARATOR

Subjects will receive commercially available Sports Drink post-exercise

Dietary Supplement: Sports Drink

Interventions

Kona DeepDIETARY_SUPPLEMENT

Subjects will receive Kona Deep post exercise

Also known as: Deep Seawater
Kona Deep
Spring WaterDIETARY_SUPPLEMENT

Subjects will receive Spring Water post exercise

Spring Water
Sports DrinkDIETARY_SUPPLEMENT

Subjects will receive Sports Drink post exercise

Also known as: Gatorade
Sports Drink

Eligibility Criteria

Age20 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • prescription medications, BMI \> 24.9

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ina A. Gittings Building

Tucson, Arizona, 85721, United States

Location

Related Publications (8)

  • 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.

    PMID: 15516723BACKGROUND

  • 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.

    PMID: 15240926BACKGROUND

  • 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.

    PMID: 18175939BACKGROUND

  • Bohl CH, Volpe SL. Magnesium and exercise. Crit Rev Food Sci Nutr. 2002;42(6):533-63. doi: 10.1080/20024091054247.

    PMID: 12487419BACKGROUND

  • 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.

    PMID: 23402436BACKGROUND

  • 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.

    PMID: 9309637BACKGROUND

  • 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.

    PMID: 24853347BACKGROUND

  • 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.

    PMID: 30947727DERIVED

MeSH Terms

Conditions

Dehydration

Interventions

gatorade

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John P Konhilas, PhD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2015

First Posted

July 1, 2015

Study Start

September 1, 2015

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

October 14, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)