Clinical trial NCT05451446: The Effect of Proprietary Water on Physiological and Perceptual Responses
Official title: The Effect of Proprietary Water on Physiological and Perceptual Responses in Activities of Daily Living and a Heat Stressful Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydration
Dehydration
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: HydraVes Technologies Inc.
First posted: 2022-07-11
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Between subjects, single-blind
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in plasma osmolality as a marker of hydration status.
timeFrame: On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).
measure: Changes in core body temperature measured by ingestible telemetric pills or rectal thermometer.
timeFrame: 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.
measure: Changes in heart rate.
timeFrame: 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.
measure: Changes in urine specific gravity (USG) as a clinical marker of hydration status.
timeFrame: Every morning of the 5 free living days and TP 1(0 minute) on the heat stress day.
measure: Changes in plasma volume measured by hematocrit and hemoglobin
timeFrame: 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).
measure: Changes in sweat rate as measured by body mass changes.
timeFrame: 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).
measure: Changes in thirst sensation
timeFrame: 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
measure: Changes in thermal sensation
timeFrame: 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
measure: Changes in slosh sensation
timeFrame: 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
measure: Changes in rating of perceived exertion
timeFrame: 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
measure: Changes in tension
timeFrame: 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).
measure: Changes in fatigue
timeFrame: 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).
measure: Changes in anger
timeFrame: 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).
measure: Changes in depression
timeFrame: 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).
measure: Changes in antidiuretic hormone (ADH)
timeFrame: On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).
measure: Changes in cortisol
timeFrame: On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).
measure: Changes in lactate
timeFrame: On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).
Secondary outcomes:
measure: Changes in object hit and avoid
timeFrame: Baseline day 0 and on heat stress environment day 5 timepoints: TP 1 (0 minute). TP 3 (105 minutes). TP 5(165 minutes).
measure: Changes in trail making task
timeFrame: Baseline day 0 and on heat stress environment day 5 timepoints: TP 1 (0 minute). TP 3 (105 minutes). TP 5(165 minutes).
measure: Changes in N-Back task
timeFrame: Baseline day 0 and on heat stress environment day 5 timepoints: TP 1 (0 minute). TP 3 (105 minutes). TP 5(165 minutes).
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina Sport Science Lab
state: South Carolina
Study officials:
References: