[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590183":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":21,"responsibleParty":42,"collaborators":7,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":7,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":7,"studyType":57,"phases":7,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":24,"whyStopped":7,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"PepsiCo Global R&D","INDUSTRY",null,[9],{"name":10,"affiliation":11,"role":12},"Corey Ungaro, do not contact to enroll, PhD","PepsiCo R&D Life Sciences, Sports Science","PRINCIPAL_INVESTIGATOR",[14,18],{"name":10,"role":15,"phone":16,"phoneExt":7,"email":17},"CONTACT","815-382-3213","corey.ungaro1@pepsico.com",{"name":19,"role":15,"phone":7,"phoneExt":7,"email":20},"Eric Freese, do not contact to enroll, PhD","eric.freese@pepsico.com",[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Remote study, no physical site. Managed by Gatorade Sports Science Institute. Do not contact investigators to enroll. Recruitment is handled by an independent agency.","RECRUITING","Chicago","Illinois","60607","United States","US",{"type":31,"coordinates":32},"Point",[33,34],-87.65005,41.85003,{"lat":34,"lon":33},[37,40],{"name":38,"role":15,"phone":16,"phoneExt":7,"email":39},"Corey Ungaro, do not contact to participate, PhD","corey1.ungaro@pepsico.com",{"name":41,"role":15,"phone":7,"phoneExt":7,"email":20},"Eric Freese, do not contact to participate, PhD",{"type":43,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100590183","exploring-the-relationship-between-heart-rate-variability-hrv-training-load-and-endurance-performance-100590183",false,"NCT06964100","Exploring the Relationship Between Heart Rate Variability (HRV), Training Load, and Endurance Performance","Inclusion Criteria:\n\nActively participating in cardiovascular training (3-5 days\u002Fweek).\n\nAble to run a 5K (3.1 miles) distance at a self-selected location, three times over 8 weeks.\n\nAge 18-65 years.\n\nSubject is willing to refrain from vigorous exercise (light physical activity only) 24 hours prior to timed 5K assessment.\n\nSubject is willing to avoid alcohol consumption 24 hours prior to 5K assessment.\n\nSubject is willing to provide consent.\n\nSubject is able to continuously wear their activity tracker, including during sleep, except when submerged underwater (i.e., swimming, bathing).\n\nSubjects must have compatible wearable device (Android, Apple Health, Dexcom, Fitbit, Garmin, Health Connect, Oura, Polar, Whoop, and Withings).\n\nExclusion Criteria:\n\nIndividual has a condition the Investigator believes would interfere with his ability to provide informed consent, comply with the project\u002Fstudy protocol, which might confound the interpretation of the project\u002Fstudy results or put the person at undue risk.\n\nThose with a medical history that would interfere with the results of this study.\n\nThose that have ≥1 risk factor for cardiovascular disease according to the American College of Sports Medicine.\n\nAge: Men ≥ 45 yrs; Women ≥ 55 yrs.\n\nFamily History: Heart attack, \"bypass surgery\", or sudden death before the age of 55 yrs for father\u002Fbrother, or before 65 yrs for mother\u002Fsister.\n\nCigarette Smoking: Current smoker, or have quit \\\u003C 6 months, or exposed to environmental smoke.\n\nSedentary lifestyle: Not participating in moderate (sweating) physical activity at least 3 days\u002Fweek for 3-months.\n\nObesity: Body mass index ≥ 30 kg\u002Fm2 or waist girth 102 cm (40 inches) for men and 88 cm (35 inches) for women.\n\nHypertension: Systolic Blood Pressure ≥ 140 mmHg and\u002For Diastolic ≥90 mmHg, or taking medication.\n\nDyslipidemia: LDL ≥130 mg\u002Fdl, or HDL \\\u003C 40 mg\u002Fdl, or taking medication. Or triglycerides (TG) \\> 200 \\> mg\u002Fdl.\n\nPre-diabetes: Impaired fasting glucose (IFG) ≥ 100 mg\u002Fdl or oral glucose tolerance test (OGTT) ≥ 140 or ≤ 199 mg\u002Fdl confirmed by two different measurements.\n\nUnder the care of a physician.\n\nSleep disorders.\n\nUsing prescription medications that would impact sleep.\n\nIf female, you are not pregnant, planning to get pregnant or currently breast feeding.\n\nNot able to wear activity tracker continuously.\n\nLack of proficiency in English.\n\nLack of proficiency or access to the internet and email address.\n\nParticipation in another clinical trial within the past 30 days.\n\nSubject 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.",true,"ALL","18 Years","65 Years",{"count":55,"type":56},200,"ESTIMATED","OBSERVATIONAL","The ability of smart phones, aided by wearable devices (e.g. smart watches), to collect a variety of data, including physical activity, heart rate, and other exercise metrics, may provide a unique opportunity to understand real-world variability. The primary objective of this study is to test user engagement, app functionality, and feasibility of the newly developed Gatorade Sports Science Institute (GSSI) Labs App to conduct Real-World research studies. The secondary purpose of this study is to determine if Training Intensity (%Heart Rate maximum) in minutes during low heart rate variability (HRV) periods (below HRV baseline consecutive days) will have a negative relationship with post-study 5K (5 kilometer) running times as measured by their activity tracker, which could lead to personalized training recommendations using HRV. This study is conducted remotely, there are no in-person visits.",[60],"Heart Rate Variability",[62,63,64,65,66,67,68],"heart rate variability","HRV","real world","activity tracker","app engagement","app functionality","remote","2025-04-30",{"date":71,"type":72},"2025-05-09","ACTUAL",{"date":74,"type":72},"2025-04-04",{"date":76,"type":56},"2025-12-30",{"name":5,"class":6},1]