NCT05451446

The Effect of Proprietary Water on Physiological and Perceptual Responses

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hydration
• Dehydration

Interventions

Type	Name	Description
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.
OTHER	Placebo	They are randomized to consume water for five-free living days and to drink on the heat stress chamber day.

Timeline

• Start date: 2022-07-15
• Primary completion: 2022-12-15
• Completion: 2023-04-05
• First posted: 2022-07-11
• Last updated: 2023-04-11

Locations

1 site across 1 country: United States