The Effect of Proprietary Water on Physiological and Perceptual Responses

NCT ID: NCT05451446

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2023-04-05

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.

Conditions

Hydration; Dehydration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

proprietary water

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

Group Type: EXPERIMENTAL

proprietary water

Intervention Type: DIETARY_SUPPLEMENT

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

carbohydrate-electrolyte drink

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

Group Type: ACTIVE_COMPARATOR

Active comparator

Intervention Type: OTHER

They are randomized to consume a carbohydrate drink for five-free living days and to drink on the heat stress chamber day.

distilled water

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Active comparator

They are randomized to consume a carbohydrate drink for five-free living days and to drink on the heat stress chamber day.

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HydraVes Technologies Inc.

UNKNOWN

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Susan Yeargin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of South Carolina Sport Science Lab

Columbia, South Carolina, United States

Countries

United States

Other Identifiers

Pro00112790

Identifier Type: -

Identifier Source: org_study_id