NCT06995768

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Apr 2025Jun 2026

Study Start

First participant enrolled

April 22, 2025

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

April 30, 2025

Last Update Submit

May 21, 2025

Conditions

Keywords

sweatsodium losssweat patchathletehealthy volunteer

Outcome Measures

Primary Outcomes (3)

  • Regional sweat [Na+]

    Absorbent patch technique (3M TegadermTM + Pad; 3M, St. Paul, MN; pad size 10 cm2 with an absorbent capacity of \~1.3 g) to left and right dorsal arm. An additional patch on the right scapula may be added depending on the accessibility to the sites on the body and the nature of the sport. Analyzed using a HORIBA (LAQUAtwin Na-11)

    One day from start through end of a single coach-led normal training practice session. Practice duration will be dictated by coaching staff.

  • Whole body sweat rate (WBSR) WBSR

    Pre- versus post body mass on scale, taking into account food and fluid intake, urine and stool output

    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

  • Rate of sweat sodium loss (RSSL)

    The rate of sodium sweat loss (RSSL) will be determined as the product of sweat \[Na+\] and whole-body sweat rate (WBSR)

    One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.

Secondary Outcomes (3)

  • Urine specific gravity (USG)

    Pre-exercise at one coach-led normal training practice session.

  • Fluid intake

    One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.

  • Carbohydrate intake

    One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.

Study Arms (1)

Female team sports athletes aged 13 and over

Multiple athletic teams at locations in USA and UK

Other: Sweat patch

Interventions

Wear sweat patch during regular team sports practice session

Female team sports athletes aged 13 and over

Eligibility Criteria

Age13 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsReason female only is lack of sports science sweat research data specific to female athletes
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy female athletes in coach-led team sports

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gatorade Sports Science Institute

Chicago, Illinois, 60607, United States

RECRUITING

Study Officials

  • Rebecca Randell, PhD

    PepsiCo R&D Life Sciences, Sports Science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Randell, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2025

First Posted

May 29, 2025

Study Start

April 22, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations