Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-01-03 @ 12:30 PM
Study NCT ID:
NCT04920266
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2021-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity of Smart Cap and Smart Sweat Patch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each subject will serve as his or her own control. We will compare the Test and Reference methods during moderate intensity self-paced training runs, coach-led fitness sessions, and/or group outdoor cycling rides.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-10', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-06-03', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fluid intake', 'timeFrame': 'Change from baseline to up to 1 hour of exercise', 'description': 'Smart Cap (sensor) versus Reference method (bottle weight)'}, {'measure': 'Regional sweating rate', 'timeFrame': 'Change from baseline to up to 2 hours of exercise', 'description': 'Sweat Patch versus Reference patch method'}, {'measure': 'Regional sweat chloride concentration', 'timeFrame': 'Change from baseline to up to 2 hours of exercise', 'description': 'Sweat Patch versus Reference patch method'}], 'secondaryOutcomes': [{'measure': 'Regional sweating rate with versus without tattoos', 'timeFrame': 'Change from baseline to up to 2 hours of exercise', 'description': 'Reference sweat patch method'}, {'measure': 'Regional sweat sodium and potassium with versus without tattoos', 'timeFrame': 'Change from baseline to up to 2 hours of exercise', 'description': 'Reference sweat patch method'}, {'measure': 'Whole body sweat rate', 'timeFrame': 'Body mass change from baseline to up to 2 hours of exercise', 'description': 'Scale weight'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sweat', 'hydration', 'wearable', 'exercise'], 'conditions': ['Fluid Intake in Athletes', 'Sweating Rate in Athletes', 'Sweat Chloride Concentration in Athletes']}, 'referencesModule': {'references': [{'pmid': '38821996', 'type': 'DERIVED', 'citation': 'Merritt JR, Ozga M, De Chavez PJD, Boolani A, Baker LB. No effect of tattoos on local sweat concentrations of select cytokines, cortisol, glucose, blood urea nitrogen, or lactate during exercise. Sci Rep. 2024 May 31;14(1):12570. doi: 10.1038/s41598-024-63057-0.'}, {'pmid': '35778519', 'type': 'DERIVED', 'citation': 'Keyes DM, Brown SD, King MA, Engel MD, Ciciora-Gold M, Chavez PJD, Baker LB. Multiple regression analyses to determine the effect of sweating rate and tattoo characteristics on sweat outcome measures during exercise. Eur J Appl Physiol. 2022 Oct;122(10):2163-2174. doi: 10.1007/s00421-022-04989-1. Epub 2022 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'The main objectives are to determine the validity of a Smart Cap in measuring fluid intake during running and fitness exercise and the validity of a Smart Sweat Patch in measuring sweat rate and sweat chloride concentration during outdoor cycling, running, and fitness exercise. A secondary objective is to compare regional sweating rate and sweat electrolyte concentrations (sodium, chloride, and potassium) on contralateral arms with vs. without tattoos.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is male or female\n* Subject is 16-65 years of age\n* Subject is moderately-trained (participates in regular outdoor fitness (\\~1 h), cycling (1-2 h), or running (0.5-1 h) sessions ≥2x per week)\n* Subject is participating in an instructor-led fitness session, typical training run, or group bicycle ride\n\nExclusion Criteria:\n\n* Subject is pregnant\n* Subject is a smoker\n* Subject is taking a medication or oral supplement that could interfere with study results\n* Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages)\n* Subject has ≥ 2 cardiovascular risk factors as assessed on the General Health History Questionnaire\n* Subject has participated in a clinical trial within past 30 days\n* Subject has participated in any PepsiCo trial within past 6 months\n* 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\n* 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.'}, 'identificationModule': {'nctId': 'NCT04920266', 'briefTitle': 'Validity of Smart Cap and Smart Sweat Patch', 'organization': {'class': 'INDUSTRY', 'fullName': 'PepsiCo Global R&D'}, 'officialTitle': 'Validity of a Smart Cap in Measuring Fluid Intake and a Smart Sweat Patch in Measuring Sweat Rate and Sweat Chloride Concentration During Exercise', 'orgStudyIdInfo': {'id': 'PEP-2104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smart sweat patch for sweat rate and sweat chloride concentration', 'description': 'Epidermal microfluidic patch that is a flexible 27 cm2 platform with an adhesive backing that collects sweat through a skin-facing inlet port. Custom software uses the smartphone camera to capture and analyze the microfluidic patch.', 'interventionNames': ['Device: Sweat Patch, all subjects- running, fitness, cycling']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Reference sweat patch for sweat rate and sweat electrolytes', 'description': 'Regional absorbent patch technique for sweat rate (gravimetry) and electrolytes (sodium, potassium, chloride) by ion chromatography', 'interventionNames': ['Device: Reference sweat patch, all subjects - running, fitness, cycling']}, {'type': 'EXPERIMENTAL', 'label': 'Smart Cap bottle fluid measurement', 'description': 'Fluid level sensor integrated into the squeeze bottle cap measures the amount of fluid remaining in the bottle via light reflection', 'interventionNames': ['Device: Smart Cap, running and fitness exercisers only']}, {'type': 'OTHER', 'label': 'Reference method bottle fluid measurement', 'description': 'Scale weight of bottle (gravimetry method) for Smart Cap bottles (running and fitness subjects) and non-Smart Cap bottles (cyclists)', 'interventionNames': ['Other: Bottle Scale, all subjects - running, fitness, cycling']}], 'interventions': [{'name': 'Smart Cap, running and fitness exercisers only', 'type': 'DEVICE', 'description': 'Bottle cap', 'armGroupLabels': ['Smart Cap bottle fluid measurement']}, {'name': 'Sweat Patch, all subjects- running, fitness, cycling', 'type': 'DEVICE', 'description': 'Regional contralateral forearm patch', 'armGroupLabels': ['Smart sweat patch for sweat rate and sweat chloride concentration']}, {'name': 'Reference sweat patch, all subjects - running, fitness, cycling', 'type': 'DEVICE', 'description': 'Regional contralateral forearm patch', 'armGroupLabels': ['Reference sweat patch for sweat rate and sweat electrolytes']}, {'name': 'Bottle Scale, all subjects - running, fitness, cycling', 'type': 'OTHER', 'description': 'Bottle weight', 'armGroupLabels': ['Reference method bottle fluid measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60010', 'city': 'Barrington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Gatorade Sports Science Institute (GSSI), 617 West Main Street', 'geoPoint': {'lat': 42.15391, 'lon': -88.13619}}, {'zip': '60601', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Grant Park, 337 E Randolph St', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60010', 'city': 'Deer Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cuba Marsh Forest Preserve, 24205 Cuba Rd', 'geoPoint': {'lat': 42.16086, 'lon': -88.08147}}], 'overallOfficials': [{'name': 'Lindsay Baker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PepsiCo Global R&D, Gatorade Sports Science Institute (GSSI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}