NBA G-League Sweat Testing Study: Validity of the Gx Sweat Patch in Measuring Sweating Rate and Sweat Chloride Concentration During On-court Training With Basketball Players

Sweat Analysis Clinical Trial

Official title:

NBA G-League Sweat Testing Study: Validity of the Gx Sweat Patch in Measuring Sweating Rate and Sweat Chloride Concentration During On-court Training With Basketball Players

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04679532
• Other study ID #: PEP-2001
• Status: Completed
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: November 4, 2021

Study information

• Verified date: June 2022
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the validity of the Gx Sweat Patch in measuring sweating rate and sweat chloride concentration during moderate-high intensity practice against well-established reference methods in field conditions with basketball athletes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 4, 2021
• Est. primary completion date: November 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 18-40 years of age

• Subject is participating in training/competition with the NBA G-league

• Subject is participating in a coach led practice

Exclusion Criteria:

• Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages)

• Subject has participated in a clinical trial within past 30 days

• Subject has participated in any PepsiCo trial within past 6 months

• Subject has a condition the investigator believes would interfere with his/her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk

Related Conditions & MeSH terms

• Sweat Analysis

Intervention

Other:
• Gx sweat patch
Adhesive-backed flexible epidermal wearable regional sweat patch to collect and analyze sweat via microfluidics and colorimetric assay
• Reference sweat patch
Adhesive Tegaderm with absorbent pad regional sweat patch to collect sweat, followed by standard benchtop gravimetry and ion chromatography methods to analyze sweat

Locations

Country	Name	City	State
United States	NBA G League Ignite Team Site Ultimate Fieldhouse, 2675 Mitchell Dr.	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional sweat chloride concentration	Gx patch vs. reference patch during exercise. Gx patch analyzed by colorimetry via smartphone app. Reference patch analyzed with ion chromatography	Average across a single practice session on 1 day
Secondary	Regional sweating rate	Gx patch vs. reference patch during exercise. Gx patch analyzed by microfluidic reading with Smartphone. Reference patch analyzed with gravimetry	Average across the same single practice session on the same 1 day as the primary outcome
Secondary	Whole body sweating rate	Change in body mass from pre- to post-exercise, corrected for fluid/food intake and urine loss. Body mass measured to the nearest 0.01 kg using a digital platform scale	Measured one time to represent the average across the same single practice session on the same 1 day as the primary outcome