Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-01 @ 5:09 AM
Study NCT ID:
NCT06995768
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normative Data for Sweating Rate, Sweat Sodium Concentration and Sweat Sodium Loss in Female Athlete
Sponsor:
PepsiCo Global R&D
Organization:
Study Overview
Official Title:
Normative Data for Sweating Rate, Sweat Sodium Concentration and Sweat Sodium Loss in Female Athlete
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: