The Effect of Proprietary Water on Physiological and Perceptual Responses
Primary Purpose
Hydration, Dehydration
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
proprietary water
Active comparator
Placebo
Sponsored by
About this trial
This is an interventional other trial for Hydration
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
Sites / Locations
- University of South Carolina Sport Science Lab
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
proprietary water
carbohydrate-electrolyte drink
distilled water
Arm Description
Participants in this group will consume a proprietary water blend for 5-free living days and then throughout their heat stress environment day.
Participants in this group will consume a commercial carbohydrate-electrolyte drink for 5-free living days and then throughout their heat stress environment day.
Participants in this group will consume distilled water for 5-free living days and then throughout their heat stress environment day.
Outcomes
Primary Outcome Measures
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.
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.
Changes in heart rate.
To determine if proprietary water has any effect on heart rate compared to an active comparator and placebo.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Changes in antidiuretic hormone (ADH)
To determine if proprietary water has any effect on antidiuretic hormone (ADH) compared to an active comparator and placebo.
Changes in cortisol
To determine if proprietary water has any effect on cortisol compared to an active comparator and placebo.
Changes in lactate
To determine if proprietary water has any effect on lactate compared to an active comparator and placebo.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05451446
First Posted
June 7, 2022
Last Updated
April 10, 2023
Sponsor
University of South Carolina
Collaborators
HydraVes Technologies Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05451446
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
April 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina
Collaborators
HydraVes Technologies Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydration, Dehydration
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Between subjects, single-blind
Masking
Participant
Masking Description
Single-blind participants. They will not be told which group they are randomized to.
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
proprietary water
Arm Type
Experimental
Arm Description
Participants in this group will consume a proprietary water blend for 5-free living days and then throughout their heat stress environment day.
Arm Title
carbohydrate-electrolyte drink
Arm Type
Active Comparator
Arm 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.
Arm Title
distilled water
Arm Type
Placebo Comparator
Arm Description
Participants in this group will consume distilled water for 5-free living days and then throughout their heat stress environment day.
Intervention Type
Dietary Supplement
Intervention Name(s)
proprietary water
Intervention Description
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
Other
Intervention Name(s)
Active comparator
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
They are randomized to consume water for five-free living days and to drink on the heat stress chamber day.
Primary Outcome Measure Information:
Title
Changes in plasma osmolality as a marker of hydration status.
Description
To determine if proprietary water has any effect on plasma osmolality compared to an active comparator and placebo.
Time Frame
On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).
Title
Changes in core body temperature measured by ingestible telemetric pills or rectal thermometer.
Description
To determine if proprietary water has any effect on core body temperatures compared to an active comparator and placebo.
Time Frame
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.
Title
Changes in heart rate.
Description
To determine if proprietary water has any effect on heart rate compared to an active comparator and placebo.
Time Frame
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.
Title
Changes in urine specific gravity (USG) as a clinical marker of hydration status.
Description
To determine if proprietary water has any effect on USG compared to an active comparator and placebo.
Time Frame
Every morning of the 5 free living days and TP 1(0 minute) on the heat stress day.
Title
Changes in plasma volume measured by hematocrit and hemoglobin
Description
To determine if proprietary water has any effect on plasma volume changes as compared to an active comparator and placebo.
Time Frame
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).
Title
Changes in sweat rate as measured by body mass changes.
Description
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.
Time Frame
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).
Title
Changes in thirst sensation
Description
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.
Time Frame
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
Title
Changes in thermal sensation
Description
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.
Time Frame
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
Title
Changes in slosh sensation
Description
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.
Time Frame
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
Title
Changes in rating of perceived exertion
Description
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.
Time Frame
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
Title
Changes in tension
Description
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.
Time Frame
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).
Title
Changes in fatigue
Description
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.
Time Frame
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).
Title
Changes in anger
Description
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.
Time Frame
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).
Title
Changes in depression
Description
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.
Time Frame
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).
Title
Changes in antidiuretic hormone (ADH)
Description
To determine if proprietary water has any effect on antidiuretic hormone (ADH) compared to an active comparator and placebo.
Time Frame
On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).
Title
Changes in cortisol
Description
To determine if proprietary water has any effect on cortisol compared to an active comparator and placebo.
Time Frame
On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).
Title
Changes in lactate
Description
To determine if proprietary water has any effect on lactate compared to an active comparator and placebo.
Time Frame
On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).
Secondary Outcome Measure Information:
Title
Changes in object hit and avoid
Description
To determine if proprietary water has any effect on cognitive task of "object hit and avoid" compared to an active comparator and placebo.
Time Frame
Baseline day 0 and on heat stress environment day 5 timepoints: TP 1 (0 minute). TP 3 (105 minutes). TP 5(165 minutes).
Title
Changes in trail making task
Description
To determine if proprietary water has any effect on cognitive task of "trail making task" compared to an active comparator and placebo.
Time Frame
Baseline day 0 and on heat stress environment day 5 timepoints: TP 1 (0 minute). TP 3 (105 minutes). TP 5(165 minutes).
Title
Changes in N-Back task
Description
To determine if proprietary water has any effect on cognitive task of "N-Back Task" compared to an active comparator and placebo.
Time Frame
Baseline day 0 and on heat stress environment day 5 timepoints: TP 1 (0 minute). TP 3 (105 minutes). TP 5(165 minutes).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of South Carolina Sport Science Lab
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Proprietary Water on Physiological and Perceptual Responses
We'll reach out to this number within 24 hrs