Sweat AnalysisNCT04679532
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
A study testing Gx sweat patch and Reference sweat patch in people with Sweat Analysis, run by PepsiCo Global R&D at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sweat Analysis
- What is being tested?
- Gx sweat patch and Reference sweat patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2020to 4 Nov 2021
- Phase
- Interventional
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years of age
- Subject is participating in training/competition with the NBA G-league
- Subject is participating in a coach led practice
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NBA G League Ignite Team Site Ultimate Fieldhouse, 2675 Mitchell Dr.
Walnut Creek, California, 94598
About this study
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
- Conditions
- Sweat Analysis
- Being tested
- Gx sweat patch, Reference sweat patch
- Keywords
- sweating rate, sweat electrolytes, sweat electrolyte concentration, sweat patch, wearable, epidermal, Gx patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gx sweat patchOther
Adhesive-backed flexible epidermal wearable regional sweat patch to collect and analyze sweat via microfluidics and colorimetric assay
Reference sweat patchOther
Adhesive Tegaderm with absorbent pad regional sweat patch to collect sweat, followed by standard benchtop gravimetry and ion chromatography methods to analyze sweat
| Study group | Role | What they receive |
|---|---|---|
| Validation. Gx sweat collection patch | Other | Left ventral forearm placement using Epicore Biosystems Gx patch Receives: Other: Gx sweat patch |
| Validation. Reference sweat collection patch | Other | Right ventral forearm placement using a well-established methodology as published in peer-reviewed journals Receives: Other: Reference sweat patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Average across a single practice session on 1 day
Secondary outcomes (2)
Regional sweating rate
Gx patch vs. reference patch during exercise. Gx patch analyzed by microfluidic reading with Smartphone. Reference patch analyzed with gravimetry
Measured: Average across the same single practice session on the same 1 day as the primary outcome
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: Measured one time to represent the average across the same single practice session on the same 1 day as the primary outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start8 Dec 2020
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sweat AnalysisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Each subject serves as their own control. Both devices are worn during the same exercise session.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lindsay B Baker, PhD, Principal investigator, PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI) Barrington, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679532
- Sponsor's protocol ID
- PEP-2001
- Status last verified
- Jun 2022
- First submitted
- 9 Dec 2020
- Last updated
- 23 Jun 2022
- 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 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04679532
- Acronym / sponsor ID
- PEP-2001
- Conditions
- Sweat Analysis
- Keywords
- sweating rate, sweat electrolytes, sweat electrolyte concentration, sweat patch, wearable, epidermal, Gx patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 22 Dec 2020 (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.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each subject serves as their own control. Both devices are worn during the same exercise session.
| Arm | Type | Receives |
|---|---|---|
| Validation. Gx sweat collection patch | Other | Other: Gx sweat patchLeft ventral forearm placement using Epicore Biosystems Gx patch |
| Validation. Reference sweat collection patch | Other | Other: Reference sweat patchRight ventral forearm placement using a well-established methodology as published in peer-reviewed journals |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-40 years of age
- Subject is participating in training/competition with the NBA G-league
- Subject is participating in a coach led practice
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Gx sweat patchAdhesive-backed flexible epidermal wearable regional sweat patch to collect and analyze sweat via microfluidics and colorimetric assay | Other | Validation. Gx sweat collection patch |
| Reference sweat patchAdhesive Tegaderm with absorbent pad regional sweat patch to collect sweat, followed by standard benchtop gravimetry and ion chromatography methods to analyze sweat | Other | Validation. Reference sweat collection patch |
Primary outcome
Regional sweat chloride concentration
Time frame: Average across a single practice session on 1 day
Gx patch vs. reference patch during exercise. Gx patch analyzed by colorimetry via smartphone app. Reference patch analyzed with ion chromatography
2 secondary outcomes
Regional sweating rate
Time frame: Average across the same single practice session on the same 1 day as the primary outcome
Whole body sweating rate
Time frame: Measured one time to represent the average across the same single practice session on the same 1 day as the primary outcome
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 23 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Lindsay B Baker, PhD principal investigator
PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI) Barrington, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gx sweat patch and Reference sweat patch in people with Sweat Analysis, 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 3 inclusion and 4 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 23 Jun 2022. 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 chloride concentration (time frame: Average across a single practice session on 1 day). 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 23 Jun 2022.