The Effect of Proprietary Water on Physiological and Perceptual Responses

University of South Carolina

Status: Completed

Conditions: Hydration; Dehydration

Treatments: Other: Placebo; Other: Active comparator; Dietary Supplement: proprietary water

Study type: Interventional

Funder types: Other

Identifiers

NCT05451446

Pro00112790

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 3 patient groups, including a placebo group

proprietary water

Experimental group

Description:

Participants in this group will consume a proprietary water blend for 5-free living days and then throughout their heat stress environment day.

Treatment:

Dietary Supplement: proprietary water

carbohydrate-electrolyte drink

Active Comparator group

Description:

Participants in this group will consume a commercial carbohydrate-electrolyte drink for 5-free living days and then throughout their heat stress environment day.

Treatment:

Other: Active comparator

distilled water

Placebo Comparator group

Description:

Participants in this group will consume distilled water for 5-free living days and then throughout their heat stress environment day.

Treatment:

Other: Placebo