Clinical trial NCT06995768: Normative Data for Sweating Rate, Sweat Sodium Concentration and Sweat Sodium Loss in Female Athlete
Official title: Normative Data for Sweating Rate, Sweat Sodium Concentration and Sweat Sodium Loss in Female Athlete
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sweat Rate
Keywords: sweat
sodium loss
sweat patch
athlete
healthy volunteer
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2025-05-29
Enrollment: 500
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy female athletes in coach-led team sports

Brief summary: The main objectives are to determine sweat sodium concentration \[Na+\], whole body sweat rate (WBSR) and rate of sweat sodium loss (RSSL) in female athletes aged 13 and above during their normal planned training session across various sports (basketball, soccer, volleyball, cheer, flag football and softball).

Detailed description: The testing procedures will follow the standardized Gatorade Sports Sciences GSSI sweat testing protocol using the absorbent sweat patch technique, to measure local sweat \[Na+\], which will be normalized to whole-body sweat \[Na+\]. Whole-body sweat rate (WBSR) will be calculated based on changes in exercise body mass, pre to post training, and adjusted for food and fluid intake, as well as urine and stool loss. The rate of sweat sodium loss (RSSL) will be determined as the product of sweat \[Na+\] and WBSR.

Secondary outcomes are pre-exercise hydration status measured by urine specific gravity (USG) and estimation of menstrual cycle phase collected by self-report date of last menstrual cycle.

Athletes will complete a single day of testing, unless a repeat test is requested by the team's performance staff. In this case, athletes will undergo the exact same protocol as described above.

Eligibility criteria: Inclusion Criteria:

Subject is female

* Subject is 13yrs+
* Subject has been cleared for sport participation by their personal or team physician and/or coach-led practice/training.
* Subject is participating in sport on the youth/ amateur/ collegiate/professional/elite level
* If under 18, a parental/guardian consent form will be completed.

Exclusion Criteria:

* As this study is undertaken at the athletes training facility, the medical staff at the team/club will advise on who should/ should not take part.
* Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages

Primary outcomes:
measure: Regional sweat [Na+]
timeFrame: One day from start through end of a single coach-led normal training practice session. Practice duration will be dictated by coaching staff.
measure: Whole body sweat rate (WBSR) WBSR
timeFrame: One day from start through end of a single coach-led training normal training practice session. Practice duration will be dictated by coaching staff.A
measure: Rate of sweat sodium loss (RSSL)
timeFrame: One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.
Secondary outcomes:
measure: Urine specific gravity (USG)
timeFrame: Pre-exercise at one coach-led normal training practice session.
measure: Fluid intake
timeFrame: One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.
measure: Carbohydrate intake
timeFrame: One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Gatorade Sports Science Institute
state: Illinois
Study officials:
affiliation: PepsiCo R&D Life Sciences, Sports Science
name: Rebecca Randell, PhD
role: PRINCIPAL_INVESTIGATOR
References: