The Effect of Proprietary Water on Physiological and Perceptual Responses

NCT05451446 | Completed

• 1 other identifier: Pro00112790
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydration; Dehydration

Outcome Measures

Primary Outcomes (17)

• 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.

  On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).

• 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.

  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.

• Changes in heart rate.

  To determine if proprietary water has any effect on heart rate compared to an active comparator and placebo.

  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.

• 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.

  Every morning of the 5 free living days and TP 1(0 minute) on the heat stress day.

• 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.

  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).

• 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.

  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).

• 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.

  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

• 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.

  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

• 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.

  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

• 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.

  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

• 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.

  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).

• 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.

  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).

• 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.

  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).

• 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.

  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).

• Changes in antidiuretic hormone (ADH)

  To determine if proprietary water has any effect on antidiuretic hormone (ADH) compared to an active comparator and placebo.

  On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).

• Changes in cortisol

  To determine if proprietary water has any effect on cortisol compared to an active comparator and placebo.

  On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).

• Changes in lactate

  To determine if proprietary water has any effect on lactate compared to an active comparator and placebo.

  On heat stress environment day. TP 2 (60 minutes).TP 5 (165 minutes). TP 7 (225 minutes).

Secondary Outcomes (3)

• Changes in object hit and avoid

  Baseline day 0 and on heat stress environment day 5 timepoints: TP 1 (0 minute). TP 3 (105 minutes). TP 5(165 minutes).

• Changes in trail making task

  Baseline day 0 and on heat stress environment day 5 timepoints: TP 1 (0 minute). TP 3 (105 minutes). TP 5(165 minutes).

• Changes in N-Back task

  Baseline day 0 and on heat stress environment day 5 timepoints: TP 1 (0 minute). TP 3 (105 minutes). TP 5(165 minutes).

Study Arms (3)

proprietary water

EXPERIMENTAL

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

Dietary Supplement: proprietary water

carbohydrate-electrolyte drink

ACTIVE COMPARATOR

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

Other: Active comparator

distilled water

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

proprietary water 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.

proprietary water

Active comparator OTHER

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

carbohydrate-electrolyte drink

Placebo OTHER

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

distilled water

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• HydraVes Technologies Inc.: collaborator

Study Sites (1)

University of South Carolina Sport Science Lab

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind participants. They will not be told which group they are randomized to.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Between subjects, single-blind

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: July 11, 2022
• Study Start: July 15, 2022
• Primary Completion: December 15, 2022
• Study Completion: April 5, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

US (1)