proprietary water for Dehydration

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of South Carolina Sport Science Lab, Columbia, SC
Dehydration+1 More
proprietary water - DietarySupplement
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

The purpose of this study is to determine if drinking proprietary water (PW) during a standardized daily plan as compared to distilled water (control) and carbohydrate-electrolyte (CE) drink can improve hydration status over time. Another purpose is to determine if PW, as compared to control and CE, can improve hydration status, perceptual responses, physiological responses, and cognition measures in a heat stressful environment. Healthy, physically active males and females aged 18 to 50y will be recruited for the study. Participants will be randomized into one of three groups: PW, CE, or Control. The participant will be given a daily standardized plan integrating their assigned fluid into daily hydration habits for five days. Participants will provide their first-morning urine sample, keep a daily food log, and answer questions about their perceptions of hydration. After the five days, they will participate in a treadmill exercise protocol within a warm environment (heat chamber). Multiple physiological, perceptual, and cognitive measures will be obtained while participants exercise and then recover.

Eligible Conditions

  • Dehydration
  • Hydration

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

17 Primary · 3 Secondary · Reporting Duration: Every morning of the 5 free living days and on the heat stress day time points; TP 2 (60 minutes). TP 3 (105 minutes). TP 4 (125 minutes). TP 5 (165 minutes). TP 6 (195 minutes). TP 7 (225 minutes).

Day 5
Changes in N-Back task
Changes in object hit and avoid
Changes in trail making task
Every morning of the 5 free living days and TP 1(0 minute) on the heat stress day.
Changes in urine specific gravity (USG) as a clinical marker of hydration status.
Every morning of the 5 free living days and on the heat stress day time points; TP 2 (60 minutes). TP 3 (105 minutes). TP 4 (125 minutes). TP 5 (165 minutes). TP 6 (195 minutes). TP 7 (225 minutes).
Changes in anger
Changes in depression
Changes in fatigue
Changes in tension
Every morning of the 5 free living days and on the heat stress day time points; TP 2 (60 minutes). TP 3 (105 minutes). TP 4 (125 minutes). TP 5 (165 minutes). TP 6 (195 minutes). TP 7 (225 minutes). 22:30 minute into 1st and 2nd 45 minute exercise
Changes in rating of perceived exertion
Changes in slosh sensation
Changes in thermal sensation
Changes in thirst sensation
On heat stress environment day. TP 1 (0 minute). TP 2 (60 minutes). TP 3 (105 minutes). TP 4 (125 minutes). TP 5 (165 minutes). TP 6 (195 minutes). TP 7 (225 minutes).
Changes in sweat rate as measured by body mass changes.
On heat stress environment day. TP 1 (0 minute). TP 2 (60 minutes). TP 3 (105 minutes). TP 4 (125 minutes). TP 5 (165 minutes). TP 6 (195 minutes). TP 7 (225 minutes). Every 10-minutes during the exercise protocol.
Changes in core body temperature measured by ingestible telemetric pills or rectal thermometer.
Changes in heart rate.
On heat stress environment day. TP 2 (60 minutes). TP 3 (105 minutes). TP 4 (125 minutes). TP 5 (165 minutes). TP 6 (195 minutes). TP 7 (225 minutes).
Changes in plasma volume measured by hematocrit and hemoglobin
On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).
Changes in antidiuretic hormone (ADH)
Changes in cortisol
Changes in lactate
Changes in plasma osmolality as a marker of hydration status.

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

carbohydrate-electrolyte drink
1 of 3
proprietary water
1 of 3
distilled water
1 of 3
Active Control
Experimental Treatment
Non-Treatment Group

42 Total Participants · 3 Treatment Groups

Primary Treatment: proprietary water · Has Placebo Group · N/A

proprietary water
DietarySupplement
Experimental Group · 1 Intervention: proprietary water · Intervention Types: DietarySupplement
distilled water
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
carbohydrate-electrolyte drink
Other
ActiveComparator Group · 1 Intervention: Active comparator · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: every morning of the 5 free living days and on the heat stress day time points; tp 2 (60 minutes). tp 3 (105 minutes). tp 4 (125 minutes). tp 5 (165 minutes). tp 6 (195 minutes). tp 7 (225 minutes).
Closest Location: University of South Carolina Sport Science Lab · Columbia, SC
Photo of columbia 1Photo of columbia 2Photo of columbia 3
2020First Recorded Clinical Trial
1 TrialsResearching Dehydration
5 CompletedClinical Trials

Who is running the clinical trial?

University of South CarolinaLead Sponsor
173 Previous Clinical Trials
93,792 Total Patients Enrolled
1 Trials studying Dehydration
16 Patients Enrolled for Dehydration
HydraVes Technologies Inc.UNKNOWN

Eligibility Criteria

Age 18 - 65 · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.