- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06995768
- Original Trial
Normative Data for Sweating Rate, Sweat Sodium Concentration and Sweat Sodium Loss in Female Athlete
Study Overview
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Rebecca Randell, PhD
- Phone Number: 414-520-7097
- Email: rebecca.randell@pepsico.com
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60607
- Recruiting
- Gatorade Sports Science Institute
-
Contact:
- Rebecca Randell, PhD
- Phone Number: 414-520-7097
- Email: rebecca.randell@pepsico.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Female team sports athletes aged 13 and over
Multiple athletic teams at locations in USA and UK
|
Wear sweat patch during regular team sports practice session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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
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
|
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)
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)
|
One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urine specific gravity (USG)
Time Frame: Pre-exercise at one coach-led normal training practice session.
|
Unit not applicable
|
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.
|
Weighing pre-filled bottles before and after exercise, beverage choice of water, and Gatorade, or G2
|
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.
|
Grams of carbohydrate consumed through food and beverages
|
One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rebecca Randell, PhD, PepsiCo R&D Life Sciences, Sports Science
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PEP-2506
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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