Sweat RateNCT06995768
Normative Data for Sweating Rate, Sweat Sodium Concentration and Sweat Sodium Loss in Female Athlete
An observational study of Sweat Rate, run by PepsiCo Global R&D at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sweat Rate
- What is being tested?
- Sweat patch
- How many people
- 516 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2025to 13 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Healthy female athletes in coach-led team sports
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Gatorade Sports Science Institute
Chicago, Illinois, 60607
About this study
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).
Read the 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.
- Conditions
- Sweat Rate
- Being tested
- Sweat patch
- Keywords
- sweat, sodium loss, sweat patch, athlete, healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweat patchOther
Wear sweat patch during regular team sports practice session
| Study group | Role | What they receive |
|---|---|---|
| Female team sports athletes aged 13 and over | Multiple athletic teams at locations in USA and UK Receives: Other: Sweat patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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)
Measured: 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)
Unit not applicable
Measured: Pre-exercise at one coach-led normal training practice session.
Fluid intake
Weighing pre-filled bottles before and after exercise, beverage choice of water, and Gatorade, or G2
Measured: One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.
Carbohydrate intake
Grams of carbohydrate consumed through food and beverages
Measured: One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start22 Apr 2025
- Primary completion13 Nov 2025
- Study completion13 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sweat RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rebecca Randell, PhD, Principal investigator, PepsiCo R&D Life Sciences, Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995768
- Sponsor's protocol ID
- PEP-2506
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Data for Sweating Rate, Sweat Sodium Concentration and Sweat Sodium Loss in Female Athlete
- ClinicalTrials.gov ID
- NCT06995768
- Acronym / sponsor ID
- PEP-2506
- Conditions
- Sweat Rate
- Keywords
- sweat, sodium loss, sweat patch, athlete, healthy volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female team sports athletes aged 13 and over | – | Other: Sweat patchMultiple athletic teams at locations in USA and UK |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy female athletes in coach-led team sports
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sweat patchWear sweat patch during regular team sports practice session | Other | Female team sports athletes aged 13 and over |
Primary outcome
Regional sweat [Na+]
Time frame: One day from start through end of a single coach-led normal training practice session. Practice duration will be dictated by coaching staff.
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)
Whole body sweat rate (WBSR) WBSR
Time frame: 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
Pre- versus post body mass on scale, taking into account food and fluid intake, urine and stool output
Rate of sweat sodium loss (RSSL)
Time frame: One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.
The rate of sodium sweat loss (RSSL) will be determined as the product of sweat [Na+] and whole-body sweat rate (WBSR)
3 secondary outcomes
Urine specific gravity (USG)
Time frame: Pre-exercise at one coach-led normal training practice session.
Fluid intake
Time frame: One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.
Carbohydrate intake
Time frame: One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Sweat Rate
Not yet recruiting
Betaine Addition to Water Loading Prior to Running Exercise
Exercise, Hydration
Not yet recruiting
Time Onset Sweat Sodium (TOSS) Study
Sweat Rate, Heat Effect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Randell, PhD principal investigator
PepsiCo R&D Life Sciences, Sports Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sweat Rate, run by PepsiCo Global R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional sweat [Na+] (time frame: One day from start through end of a single coach-led normal training practice session. Practice duration will be dictated by coaching staff.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.