[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06995768":3,"trial-entities:NCT06995768":103,"trial-summary:NCT06995768":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":38,"secondary_outcomes":51,"sex":62,"minimum_age":63,"maximum_age":26,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":75,"locations":79,"central_contacts":95,"overall_officials":97,"references":101,"see_also_links":102},"NCT06995768","PEP-2506","Normative Data for Sweating Rate, Sweat Sodium Concentration and Sweat Sodium Loss in Female Athlete","RECRUITING","2026-06-30","2025-05","2025-05-29","2025-04-22","PepsiCo Global R&D","INDUSTRY",false,"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).","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.",[18],"Sweat Rate",[20,21,22,23,24],"sweat","sodium loss","sweat patch","athlete","healthy volunteer","OBSERVATIONAL",null,[],{"count":29,"type":30},500,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"OTHER","Sweat patch","Wear sweat patch during regular team sports practice session",[37],"Female team sports athletes aged 13 and over",[39,43,47],{"measure":40,"description":41,"timeFrame":42},"Regional sweat [Na+]","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)","One day from start through end of a single coach-led normal training practice session. Practice duration will be dictated by coaching staff.",{"measure":44,"description":45,"timeFrame":46},"Whole body sweat rate (WBSR) WBSR","Pre- versus post body mass on scale, taking into account food and fluid intake, urine and stool output","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",{"measure":48,"description":49,"timeFrame":50},"Rate of sweat sodium loss (RSSL)","The rate of sodium sweat loss (RSSL) will be determined as the product of sweat \\[Na+\\] and whole-body sweat rate (WBSR)","One day from start through end of a single coach-led normal training practice session. Duration will be dictated by coaching staff.",[52,56,59],{"measure":53,"description":54,"timeFrame":55},"Urine specific gravity (USG)","Unit not applicable","Pre-exercise at one coach-led normal training practice session.",{"measure":57,"description":58,"timeFrame":50},"Fluid intake","Weighing pre-filled bottles before and after exercise, beverage choice of water, and Gatorade, or G2",{"measure":60,"description":61,"timeFrame":50},"Carbohydrate intake","Grams of carbohydrate consumed through food and beverages","FEMALE","13 Years",true,{"inclusion":66,"exclusion":71,"raw_text":74},[67,68,69,70],"Subject is 13yrs+","Subject has been cleared for sport participation by their personal or team physician and\u002For coach-led practice\u002Ftraining.","Subject is participating in sport on the youth\u002F amateur\u002F collegiate\u002Fprofessional\u002Felite level","If under 18, a parental\u002Fguardian consent form will be completed.",[72,73],"As this study is undertaken at the athletes training facility, the medical staff at the team\u002Fclub will advise on who should\u002F should not take part.","Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages","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\u002For coach-led practice\u002Ftraining.\n* Subject is participating in sport on the youth\u002F amateur\u002F collegiate\u002Fprofessional\u002Felite level\n* If under 18, a parental\u002Fguardian 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\u002Fclub will advise on who should\u002F should not take part.\n* Subject has an allergy to adhesives (e.g., experiences rash reactions to typical adhesive bandages",[76,77,78],"CHILD","ADULT","OLDER_ADULT",[80],{"facility":81,"status":7,"city":82,"state":83,"zip":84,"country":85,"contacts":86,"geoPoint":92},"Gatorade Sports Science Institute","Chicago","Illinois","60607","United States",[87],{"name":88,"role":89,"phone":90,"email":91},"Rebecca Randell, PhD","CONTACT","414-520-7097","rebecca.randell@pepsico.com",{"lat":93,"lon":94},41.85003,-87.65005,[96],{"name":88,"role":89,"phone":90,"email":91},[98],{"name":88,"affiliation":99,"role":100},"PepsiCo R&D Life Sciences, Sports Science","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":104,"biomarkers":106},[105],"Healthy Volunteer",[],{"nct_id":4,"found":64,"summary":108,"prompt_version":118},{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an observational study, meaning researchers will collect information without giving any specific treatments. It aims to enroll 500 female athletes.","completed","Observational Study of Sweat in Female Athletes","This study is looking at how much female athletes sweat and how much sodium (salt) is in their sweat during their regular sports practices. Researchers want to understand the typical sweat rates and sodium loss in female athletes aged 13 and older across various sports like basketball, soccer, and volleyball. You would wear a sweat patch during a single team practice session. The main goals are to measure the sodium concentration in your sweat, your overall sweat rate, and how much sodium you lose through sweat. This information can help us better understand hydration needs for female athletes.","Your sweat measurements will be taken during a single practice session, from start to end. There is no specified follow-up period after this session.",98,"You would participate in a single day of testing, wearing a sweat patch during one of your regular coach-led team sports practice sessions.","Not stated in the trial record.",[34],"v2"]