Sweat AnalysisNCT04240951
Sweat Patch Validation
A study testing Sweat patch in people with Sweat Analysis, run by PepsiCo Global R&D at 2 sites in United States.
Trial summary
To determine the validity of a prototype patch in measuring sweating rate and sweat electrolyte concentration during moderate intensity exercise against well-established reference methods in a controlled laboratory and in field conditions. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sweat Analysis
- What is being tested?
- Sweat patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Aug 2017to 24 Oct 2020
- 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 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Subject is male or female
- Subject is 15-45 years
- Subject is moderately-trained (engages in moderate-intensity, intermittent, or steady-state exercise at least 4 days per week for at least 1 hour at a time)
- Subject is capable of moderate-intensity, intermittent exercise for 1-2 hours as assessed by recent training history
- If participating in Study Session 1, 2, 3, or 4, subject has a treadmill VO2max ≥ 42 ml/kg/min if male or ≥ 38 ml/kg/min if female, as measured during the screening at the GSSI laboratory
- If participating in Study Session 1, 2, 3, or 4, subject has a normal fasting blood glucose (70-110 mg/dl), as measured during the screening at the GSSI laboratory
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- If participating in Study Session 1, 2, 3, or 4, subject has a normal resting blood pressure (< 140/90 mmHg), as measured during the screening at the GSSI laboratory
- If participating in Study Session 1, 2, 3, or 4, subject has a normal resting and graded exercise EKG, as measured during the screening at the GSSI laboratory
- If participating in Study Session 1, 2, 3, or 4, willing to be shaved at patch sites
- If participating in Study Session 3 or 4, willing to undergo a nude shower by an investigator of the same sex for collection of sweat electrolytes in the whole body wash procedure
- If participating in Study Session 5 or 6, subject is a trained team-sport athlete currently participating in training/competition at IMG Academy
Who cannot join
- Subject is pregnant (self-reported)
- Subject is a smoker
- Subject has a body weight that is lighter than 80 pounds
- Subject has a known or suspected obstructive disease of the gastrointestinal tract, such as diverticulitis or inflammatory bowel disease
- Subject has a history of problems with the gag reflex
- Subject has not had previous gastrointestinal surgery
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- Subject has problems with swallowing
- Subject is planning to have an MRI scan during the time that the CorTemp™ Core Body Temperature Sensor is in the body
- Subject has slow movement of the gastrointestinal tract
- Subject has a cardiac pacemaker or other implanted electronic device
- Subject has asthma or other condition in which breathing can become difficult/labored during exercise (applies to Study Session 1-4 only)
- Subject is allergic to adhesives
- Subject is currently taking a medication or oral supplement that could interfere with study results
- 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
- Subject has been enrolled into a PepsiCo-sponsored study within the past six months
- Subject has been enrolled into a clinical trial at a laboratory or clinic other than PepsiCo within the past 30 days
- Subject is employed by, or has a parent, guardian or other immediate family member employed by, a company that manufactures any products that compete with any Gatorade products. If subject is unsure if a company would be considered a competitor to Gatorade they will be asked to please let the study investigator know the name of the other company and the nature of their relationship to that company before they sign the informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Gatorade Sports Science Institute (GSSI)
Barrington, Illinois, 60010
Gatorade Sports Science Institute at IMG Academy
Bradenton, Florida, 34210
About this study
Official title: Validity of a Prototype Wearable Patch in Measuring Local Sweating Rate and Sweat Electrolyte Concentration During Exercise
To determine the validity of a prototype patch in measuring sweating rate and sweat electrolyte concentration during moderate intensity exercise against well-established reference methods in a controlled laboratory and in field conditions.
- Conditions
- Sweat Analysis
- Being tested
- Sweat patch
- Keywords
- sweating rate, sweat electrolytes, sweat patch, wearable, epidermal, sweat electrolyte concentrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweat patchOther
Flexible, epidermal, wearable skin patch to collect and analyze sweat
| Study group | Role | What they receive |
|---|---|---|
| Study Session 1 | Other | Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the laboratory Receives: Other: Sweat patch |
| Study Session 2 (repeat of Study Session 1) | Other | Arm Type: Validation: Regional sweat collection with prototype vs. reference patch in the laboratory Receives: Other: Sweat patch |
| Study Session 3 | Other | Arm Type: Validation. Prototype patch vs. whole body sweat collection in the laboratory Receives: Other: Sweat patch |
| Study Session 4 (repeat of Study Session 3) | Other | Arm Type: Validation. Prototype patch vs. whole body sweat collection in the laboratory Receives: Other: Sweat patch |
| Study Session 5 | Other | Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the field Receives: Other: Sweat patch |
| Study Session 6 (repeat of Study Session 5) | Other | Arm Type: Validation. Regional sweat collection with prototype vs. reference patch in the field Receives: Other: Sweat patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sweat chloride concentration
Prototype vs. reference method (regional absorbent patch technique) during exercise
Measured: 1.5 hours in sessions 1-6
Secondary outcomes (7)
Regional sweating rate
Prototype vs. reference method (gravimetry using the regional absorbent patch technique) during exercise
Measured: 1.5 hours in sessions 1-6
Whole body sweating rate
Prototype vs. reference method (changes in nude body mass corrected for fluid intake, urine output, respiratory water loss, and metabolic mass loss) during exercise
Measured: 1.5 hours in sessions 1-6
Whole body sweat chloride concentration
Prototype vs. reference method (whole body washdown technique) during exercise
Measured: 1.5 hours in sessions 3-4
Whole body sweat sodium concentration
Reference method only. Compare whole body sweat chloride concentration vs. whole body sweat sodium concentration during exercise
Measured: 1.5 hours in sessions 3-4
Self-ratings of perceived sweating vs. measured sweating rate
Multiple choice questionnaire vs. sweat patch analysis
Measured: Prior to the start of exercise at sessions 1-6
Self-ratings of perceived sweat saltiness vs. sweat electrolyte concentrations
Multiple choice questionnaire vs. sweat patch analysis
Measured: Prior to the start of exercise at sessions 1-6
History of exercise-associated muscle cramps
Multiple choice questionnaire
Measured: Prior to the start of exercise at sessions 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start21 Aug 2017
- Primary completion24 Oct 2020
- Study completion24 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 subject serves as their own control at each testing session. The prototype patch and reference method are both worn during each session.
- Masking
- None (open label)
- Enrolment
- 552 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) PI for Barrington siteKhalil Lee, PhD, Principal investigator, PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI) PI for Bradenton site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240951
- Sponsor's protocol ID
- PEP-1714
- Status last verified
- Mar 2021
- First submitted
- 14 Jan 2020
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
King MA, Brown SD, Barnes KA, De Chavez PJD, Baker LB. Regional and time course differences in sweat cortisol, glucose, and select cytokine concentrations during exercise. Eur J Appl Physiol. 2023 Aug;123(8):1727-1738. doi: 10.1007/s00421-023-05187-3. Epub 2023 Apr 2.
PubMed 37005963
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of a Prototype Wearable Patch in Measuring Local Sweating Rate and Sweat Electrolyte Concentration During Exercise
- ClinicalTrials.gov ID
- NCT04240951
- Acronym / sponsor ID
- PEP-1714
- Conditions
- Sweat Analysis
- Keywords
- sweating rate, sweat electrolytes, sweat patch, wearable, epidermal, sweat electrolyte concentrations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 24 Oct 2020 (actual)
- Study completion
- 24 Oct 2020 (actual)
- First posted
- 27 Jan 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 a prototype patch in measuring sweating rate and sweat electrolyte concentration during moderate intensity exercise against well-established reference methods in a controlled laboratory and in field conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Each subject subject serves as their own control at each testing session. The prototype patch and reference method are both worn during each session.
| Arm | Type | Receives |
|---|---|---|
| Study Session 1 | Other | Other: Sweat patchArm Type: Validation. Regional sweat collection with prototype vs. reference patch in the laboratory |
| Study Session 2 (repeat of Study Session 1) | Other | Other: Sweat patchArm Type: Validation: Regional sweat collection with prototype vs. reference patch in the laboratory |
| Study Session 3 | Other | Other: Sweat patchArm Type: Validation. Prototype patch vs. whole body sweat collection in the laboratory |
| Study Session 4 (repeat of Study Session 3) | Other | Other: Sweat patchArm Type: Validation. Prototype patch vs. whole body sweat collection in the laboratory |
| Study Session 5 | Other | Other: Sweat patchArm Type: Validation. Regional sweat collection with prototype vs. reference patch in the field |
| Study Session 6 (repeat of Study Session 5) | Other | Other: Sweat patchArm Type: Validation. Regional sweat collection with prototype vs. reference patch in the field |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Subject is male or female
- Subject is 15-45 years
- Subject is moderately-trained (engages in moderate-intensity, intermittent, or steady-state exercise at least 4 days per week for at least 1 hour at a time)
- Subject is capable of moderate-intensity, intermittent exercise for 1-2 hours as assessed by recent training history
- If participating in Study Session 1, 2, 3, or 4, subject has a treadmill VO2max ≥ 42 ml/kg/min if male or ≥ 38 ml/kg/min if female, as measured during the screening at the GSSI laboratory
Key exclusion criteria (17 listed)
- Subject is pregnant (self-reported)
- Subject is a smoker
- Subject has a body weight that is lighter than 80 pounds
- Subject has a known or suspected obstructive disease of the gastrointestinal tract, such as diverticulitis or inflammatory bowel disease
- Subject has a history of problems with the gag reflex
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 patchFlexible, epidermal, wearable skin patch to collect and analyze sweat | Other | Study Session 1, Study Session 2 (repeat of Study Session 1), Study Session 3, Study Session 4 (repeat of Study Session 3), Study Session 5, Study Session 6 (repeat of Study Session 5) |
Primary outcome
Sweat chloride concentration
Time frame: 1.5 hours in sessions 1-6
Prototype vs. reference method (regional absorbent patch technique) during exercise
7 secondary outcomes
Regional sweating rate
Time frame: 1.5 hours in sessions 1-6
Whole body sweating rate
Time frame: 1.5 hours in sessions 1-6
Whole body sweat chloride concentration
Time frame: 1.5 hours in sessions 3-4
Whole body sweat sodium concentration
Time frame: 1.5 hours in sessions 3-4
Self-ratings of perceived sweating vs. measured sweating rate
Time frame: Prior to the start of exercise at sessions 1-6
Self-ratings of perceived sweat saltiness vs. sweat electrolyte concentrations
Time frame: Prior to the start of exercise at sessions 1-6
History of exercise-associated muscle cramps
Time frame: Prior to the start of exercise at sessions 1-6
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 4 Mar 2021.
- Derived from this study: PubMed 37005963King MA, Brown SD, Barnes KA, De Chavez PJD, Baker LB. Regional and time course differences in sweat cortisol, glucose, and select cytokine concentrations during exercise. Eur J Appl Physiol. 2023 Aug;123(8):1727-1738. doi: 10.1007/s00421-023-05187-3. Epub 2023 Apr 2.
- Individual participant dataSharing planned: Undecided
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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) PI for Barrington site
Khalil Lee, PhD principal investigator
PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI) PI for Bradenton site
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sweat patch in people with Sweat Analysis, run by PepsiCo Global R&D at 2 sites 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 11 inclusion and 17 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Sweat chloride concentration (time frame: 1.5 hours in sessions 1-6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04240951, which also lists 1 linked publication.
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 4 Mar 2021.