The Effect of Proprietary Water on Physiological and Perceptual Responses

Dehydration Clinical Trial

Official title:

The Effect of Proprietary Water on Physiological and Perceptual Responses in Activities of Daily Living and a Heat Stressful Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05451446
• Other study ID #: Pro00112790
• Status: Completed
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: April 5, 2023

Study information

• Verified date: April 2023
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will investigate the effects of drinking proprietary water over a five-day free-living period and then during a heat stress environment compared to distilled water and a carbohydrate-electrolyte drink on markers of hydration, performance, and cognition. This will be a single-blind between-subjects study design. Participants will report to The University of South Carolina for two visits. At the first visit, potential participants will be explained the procedures and risks of the study and then sign an informed consent. Anthropometrics and demographic data will next be collected. Lastly, participants will be familiarized with specific measures and the testing protocol. Participants will take home study products to consume over 5-free living days in which they will need to keep a food and drink log and collect their first urine void of the day to drop off at the laboratory. After the free-living days, participants will return to the laboratory for their heat stress environment test. They will consume a standardized breakfast, complete questionnaires, then perform a 45-minute exercise protocol in the heat chamber. After the first 45-minutes, there will be a break to complete cognitive measures and return to the heat chamber for another 45-minute exercise protocol. Throughout the exercise protocols, participants will be responding to perceptual questions and blood draws. Following, they will rest for 60 minutes, during which they will answer more perceptual questionnaires and blood measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 5, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• regularly completing aerobic exercise (at least 3 times a week for >150 minutes/week) in order to complete the estimated 12K in the study protocol

Exclusion Criteria:

• current musculoskeletal injury restricting normal physical activity
• a "no" on the PAR-Q
• allergy to food dyes
• previous heat illness in the last year
• pregnancy
• any condition that could make exercising in warm conditions not safe (diabetes, cancer, etc.)
• certain medications (affecting blood pressure during exercise or hydration status)
• contraindications to the temperature pill

Related Conditions & MeSH terms

• Dehydration
• Hydration

Intervention

Dietary Supplement:
• proprietary water
They are randomized to consume a proprietary water product for five-free living days and to drink on the heat stress chamber day.

Other:
• Active comparator
They are randomized to consume a carbohydrate drink for five-free living days and to drink on the heat stress chamber day.
• Placebo
They are randomized to consume water for five-free living days and to drink on the heat stress chamber day.

Locations

Country	Name	City	State
United States	University of South Carolina Sport Science Lab	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	HydraVes Technologies Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma osmolality as a marker of hydration status.	To determine if proprietary water has any effect on plasma osmolality compared to an active comparator and placebo.	On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).
Primary	Changes in core body temperature measured by ingestible telemetric pills or rectal thermometer.	To determine if proprietary water has any effect on core body temperatures compared to an active comparator and placebo.	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.
Primary	Changes in heart rate.	To determine if proprietary water has any effect on heart rate compared to an active comparator and placebo.	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.
Primary	Changes in urine specific gravity (USG) as a clinical marker of hydration status.	To determine if proprietary water has any effect on USG compared to an active comparator and placebo.	Every morning of the 5 free living days and TP 1(0 minute) on the heat stress day.
Primary	Changes in plasma volume measured by hematocrit and hemoglobin	To determine if proprietary water has any effect on plasma volume changes as compared to an active comparator and placebo.	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).
Primary	Changes in sweat rate as measured by body mass changes.	To determine if proprietary water has any effect on sweat rate compared to an active comparator and placebo. This will be measured by body mass changes divided by the activity time.	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).
Primary	Changes in thirst sensation	To determine if proprietary water has any effect on thirst sensation assessed by a 9-point scale on Thirst Sensation, compared to an active comparator and placebo. The min score is 1 and the max score is 9, with higher scores associated with worse outcomes.	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
Primary	Changes in thermal sensation	To determine if proprietary water has any effect on thirst sensation assessed by an 8-point scale on Thermal Sensation, compared to an active comparator and placebo. The min score is 0 and the max score is 8, with higher scores associated with worse outcomes.	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
Primary	Changes in slosh sensation	To determine if proprietary water has any effect on thirst sensation assessed by a 9-point scale on Slosh Sensation, compared to an active comparator and placebo. The min score is 1 and the max score is 9, with higher scores associated with worse outcomes.	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
Primary	Changes in rating of perceived exertion	To determine if proprietary water has any effect on thirst sensation assessed by Borgs RPE Scale, compared to an active comparator and placebo. The min score is 6 and the max score is 20, with higher scores associated with worse outcomes.	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
Primary	Changes in tension	To determine if the proprietary water has an impact on tension-anxiety (POMS sub-score) compared to placebo and active comparator. Min 0, max 36, higher scores are associated with worse outcomes.	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).
Primary	Changes in fatigue	To determine if the proprietary water has an impact on fatigue (POMS sub-score) compared to placebo and active comparator. Min 0, max 28, higher scores are associated with worse outcomes.	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).
Primary	Changes in anger	To determine if the proprietary water has an impact on anger (POMS sub-score) compared to placebo and active comparator. Min 0, max 48, and higher scores are associated with worse outcomes.	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).
Primary	Changes in depression	To determine if the proprietary water has an impact on depression (POMS sub-score) compared to placebo and active comparator. Min 0, max 60, higher scores are associated with worse outcomes.	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).
Primary	Changes in antidiuretic hormone (ADH)	To determine if proprietary water has any effect on antidiuretic hormone (ADH) compared to an active comparator and placebo.	On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).
Primary	Changes in cortisol	To determine if proprietary water has any effect on cortisol compared to an active comparator and placebo.	On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).
Primary	Changes in lactate	To determine if proprietary water has any effect on lactate compared to an active comparator and placebo.	On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).
Secondary	Changes in object hit and avoid	To determine if proprietary water has any effect on cognitive task of "object hit and avoid" compared to an active comparator and placebo.	Baseline day 0 and on heat stress environment day 5 timepoints: TP 1 (0 minute). TP 3 (105 minutes). TP 5(165 minutes).
Secondary	Changes in trail making task	To determine if proprietary water has any effect on cognitive task of "trail making task" compared to an active comparator and placebo.	Baseline day 0 and on heat stress environment day 5 timepoints: TP 1 (0 minute). TP 3 (105 minutes). TP 5(165 minutes).
Secondary	Changes in N-Back task	To determine if proprietary water has any effect on cognitive task of "N-Back Task" compared to an active comparator and placebo.	Baseline day 0 and on heat stress environment day 5 timepoints: TP 1 (0 minute). TP 3 (105 minutes). TP 5(165 minutes).