Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-01 @ 5:09 AM
Study NCT ID:
NCT06995768
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normative Data for Sweating Rate, Sweat Sodium Concentration and Sweat Sodium Loss in Female Athlete
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2025-04-30', 'studyFirstSubmitQcDate': '2025-05-21', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Regional sweat [Na+]', 'timeFrame': 'One day from start through end of a single coach-led normal training practice session. Practice duration will be dictated by coaching staff.', 'description': 'Absorbent patch technique (3M TegadermTM + Pad; 3M, St. Paul, MN; pad size 10 cm2 with an absorbent capacity of \\~1.3 g) to left and right dorsal arm. An additional patch on the right scapula may be added depending on the accessibility to the sites on the body and the nature of the sport. Analyzed using a HORIBA (LAQUAtwin Na-11)'}, {'measure': 'Whole body sweat rate (WBSR) WBSR', 'timeFrame': 'One day from start through end of a single coach-led training normal training practice session. Practice duration will be dictated by coaching staff.A', 'description': 'Pre- versus post body mass on scale, taking into account food and fluid intake, urine and stool output'}, {'measure': 'Rate of sweat sodium loss (RSSL)', 'timeFrame': 'One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.', 'description': 'The rate of sodium sweat loss (RSSL) will be determined as the product of sweat \\[Na+\\] and whole-body sweat rate (WBSR)'}], 'secondaryOutcomes': [{'measure': 'Urine specific gravity (USG)', 'timeFrame': 'Pre-exercise at one coach-led normal training practice session.', 'description': 'Unit not applicable'}, {'measure': 'Fluid intake', 'timeFrame': 'One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.', 'description': 'Weighing pre-filled bottles before and after exercise, beverage choice of water, and Gatorade, or G2'}, {'measure': 'Carbohydrate intake', 'timeFrame': 'One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.', 'description': 'Grams of carbohydrate consumed through food and beverages'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sweat', 'sodium loss', 'sweat patch', 'athlete', 'healthy volunteer'], 'conditions': ['Sweat Rate']}, 'descriptionModule': {'briefSummary': 'The main objectives are to determine sweat sodium concentration \\[Na+\\], whole body sweat rate (WBSR) and rate of sweat sodium loss (RSSL) in female athletes aged 13 and above during their normal planned training session across various sports (basketball, soccer, volleyball, cheer, flag football and softball).', 'detailedDescription': "The testing procedures will follow the standardized Gatorade Sports Sciences GSSI sweat testing protocol using the absorbent sweat patch technique, to measure local sweat \\[Na+\\], which will be normalized to whole-body sweat \\[Na+\\]. Whole-body sweat rate (WBSR) will be calculated based on changes in exercise body mass, pre to post training, and adjusted for food and fluid intake, as well as urine and stool loss. The rate of sweat sodium loss (RSSL) will be determined as the product of sweat \\[Na+\\] and WBSR.\n\nSecondary outcomes are pre-exercise hydration status measured by urine specific gravity (USG) and estimation of menstrual cycle phase collected by self-report date of last menstrual cycle.\n\nAthletes will complete a single day of testing, unless a repeat test is requested by the team's performance staff. In this case, athletes will undergo the exact same protocol as described above."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy female athletes in coach-led team sports', 'genderDescription': 'Reason female only is lack of sports science sweat research data specific to female athletes', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubject is female\n\n* Subject is 13yrs+\n* Subject has been cleared for sport participation by their personal or team physician and/or coach-led practice/training.\n* Subject is participating in sport on the youth/ amateur/ collegiate/professional/elite level\n* If under 18, a parental/guardian consent form will be completed.\n\nExclusion Criteria:\n\n* As this study is undertaken at the athletes training facility, the medical staff at the team/club will advise on who should/ should not take part.\n* Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages'}, 'identificationModule': {'nctId': 'NCT06995768', 'briefTitle': 'Normative Data for Sweating Rate, Sweat Sodium Concentration and Sweat Sodium Loss in Female Athlete', 'organization': {'class': 'INDUSTRY', 'fullName': 'PepsiCo Global R&D'}, 'officialTitle': 'Normative Data for Sweating Rate, Sweat Sodium Concentration and Sweat Sodium Loss in Female Athlete', 'orgStudyIdInfo': {'id': 'PEP-2506'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Female team sports athletes aged 13 and over', 'description': 'Multiple athletic teams at locations in USA and UK', 'interventionNames': ['Other: Sweat patch']}], 'interventions': [{'name': 'Sweat patch', 'type': 'OTHER', 'description': 'Wear sweat patch during regular team sports practice session', 'armGroupLabels': ['Female team sports athletes aged 13 and over']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Randell, PhD', 'role': 'CONTACT', 'email': 'rebecca.randell@pepsico.com', 'phone': '414-520-7097'}], 'facility': 'Gatorade Sports Science Institute', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Rebecca Randell, PhD', 'role': 'CONTACT', 'email': 'rebecca.randell@pepsico.com', 'phone': '414-520-7097'}], 'overallOfficials': [{'name': 'Rebecca Randell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PepsiCo R&D Life Sciences, Sports Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PepsiCo Global R&D', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}