Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-02-25 @ 12:52 AM
Study NCT ID:
NCT07005895
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2025-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-27', 'studyFirstSubmitDate': '2025-05-12', 'studyFirstSubmitQcDate': '2025-05-27', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-reported measure of hydration status: Body mass', 'timeFrame': 'Before and after acute fluid ingestion during remote data collection at two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions', 'description': 'Home scale body mass, against the TOI hydration model prediction'}, {'measure': 'Self-reported measure of hydration status: Urine color', 'timeFrame': 'Before and after acute fluid ingestion during remote data collection at two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions', 'description': 'Urine color against the TOI hydration model prediction rated from very pale yellow to brown on a 7-color chart, against the TOI hydration model prediction'}, {'measure': 'Self-reported measure of hydration status: Perceived thirst', 'timeFrame': 'Before and after acute fluid ingestion during remote data collection at two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions', 'description': 'Thirst rating in the app using a 7-point categorical scale, against the TOI hydration model prediction'}, {'measure': 'Self-reported measure of hydration status: Feeling hydrated', 'timeFrame': 'Before and after acute fluid ingestion during remote data collection at two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions', 'description': 'Within the app, select Yes or No as to whether feeling sufficiently hydrated or not, against the TOI hydration model prediction'}], 'primaryOutcomes': [{'measure': 'User engagement and feasibility: Subjective and self-reported markers of hydration status', 'timeFrame': 'At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions', 'description': 'Understand user engagement and feasibility of remotely collecting subjective and self-reported markers of hydration status'}, {'measure': 'User engagement and feasibility: Markers of hydration using transdermal optical imaging (TOI)', 'timeFrame': 'At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions', 'description': 'Understand user engagement and feasibility of remotely collecting markers of hydration using transdermal optical imaging (TOI)'}], 'secondaryOutcomes': [{'measure': 'Understand the within subject variability of TOI features before and after acute fluid ingestion during remote data collection', 'timeFrame': 'At two identical 2-hour study sessions with at least one full day and a maximum of 6 days in between study sessions', 'description': 'Within subject variation in the tertiary outcomes listed in Other Pre-specified Outcomes 4-7'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transdermal optical imaging', 'TOI', 'app', 'user engagement'], 'conditions': ['Hydration']}, 'descriptionModule': {'briefSummary': 'This remote study will evaluate the feasibility of using the Gatorade Sports Science Institute (GSSI) Labs App for remotely collecting hydration related outcomes.', 'detailedDescription': 'The primary objective is to understand user engagement and feasibility of remotely collecting subjective and self-reported markers of hydration status as well as markers of hydration using transdermal optical imaging (TOI) within the Gatorade Sports Science Institute (GSSI) branded mobile application (adherence and dropout rates, and differences between demographics). The secondary objective is to understand the within subject variability of TOI features before and after acute fluid ingestion during remote data collection.\n\nTertiary objectives are to compare self-reported measures of hydration status against the TOI hydration model prediction before and after acute fluid ingestion during remote data collection.\n\nAn outside service was contracted for recruiting. Please do not contact the investigator to express interest.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Activity tracker-wearing adult', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 years of age, inclusive\n* Male or female. If female, subject is not pregnant, planning to get pregnant, or currently breast feeding\n* Able to speak, write, and read English\n* Provision of written consent to participate\n* Owns and wears an activity tracker daily, including during sleep, except when submerged underwater (i.e., swimming, bathing) and is willing to connect their device to the app, per GSSI Labs App requirements (Oura, WHOOP, Apple Watch, Garmin, Polar, Withings, or Fitbit).\n* Owns a bathroom scale\n* Able to drink 600mL (600 mL = 20 oz = 2 ½ cups) of water as directed.\n* Willing to avoid alcohol consumption 24 hours prior to study session(s)\n\nExclusion Criteria:\n\n* Subject is currently enrolled in a clinical trial or has participated in a clinical trial within the past 30 days.\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 product. 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': 'NCT07005895', 'briefTitle': 'Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'PepsiCo Global R&D'}, 'officialTitle': 'Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes: User Engagement and Individual Variability of Transdermal Optical Imaging Features Before and After Acute Fluid Ingestion', 'orgStudyIdInfo': {'id': 'PEP-2503'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy adult user of a wearable activity tracker', 'description': 'Male or female 18-65 who wears their own activity tracker daily', 'interventionNames': ['Other: Hydration assessment via mobile app']}], 'interventions': [{'name': 'Hydration assessment via mobile app', 'type': 'OTHER', 'description': "Open the Gatorade Sports Science Institute (GSSI) branded mobile application and click on 'Complete Hydration Assessment'", 'armGroupLabels': ['Healthy adult user of a wearable activity tracker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shellen Goltz: Do not contact to participate, PhD, RD', 'role': 'CONTACT'}], 'facility': 'Advanced Personalized Ideation Center (API) and Gatorade Sports Science Institute (GSSI), PepsiCo Global R&D - Life Sciences', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Shellen Goltz, PhD, RD', 'role': 'CONTACT', 'email': 'Shellen.Goltz@pepsico.com', 'phone': '312-821-3317'}], 'overallOfficials': [{'name': 'Shellen Goltz, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advanced Personalized Ideation Center (API) & Gatorade Sports Science Institute (GSSI), PepsiCo Global R&D - Life Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}