[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07520344":3,"trial-entities:NCT07520344":146,"trial-summary:NCT07520344":150},{"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":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":42,"sex":89,"minimum_age":90,"maximum_age":91,"healthy_volunteers":92,"eligibility_criteria":93,"std_ages":115,"locations":117,"central_contacts":141,"overall_officials":143,"references":144,"see_also_links":145},"NCT07520344","PEP-2516","Wearable Photoplethysmography for Non-invasive Hydration Assessment","RECRUITING","2026-10","2026-04","2026-04-09","2026-04-01","PepsiCo Global R&D","INDUSTRY",false,"Hydration status during exercise is often determined by measuring body mass change, fluid intake and urine output. However, obtaining these measurements can be an invasive, time-consuming process. Hydration status may be detectable by analyzing blood flow patterns of the superficial (just under the skin) blood vessels. Wearable devices are now abundant among the general population, and despite attempts from several groups, a hydration status metric based on noninvasive wearable device metrics has not been developed. With wearables, a light source connected to an optical sensor transmits and reflects light through the body. The light sensor detects absorption of the light based on wavelength measurements of the detected light. Absorption of specific wavelengths of light energy is dependent upon the amount of oxygenated blood in the vessels. When the vessels expand and relax, the amount of blood volume in the observed tissue increases and decreases potentially causing a shift in the photoplethysmography (PPG) wave detected by the wearable. The shift in the shape of the PPG wave may be detected in a way that indicates the relative change in tissue hydration levels. However, to our knowledge, no wrist worn device that utilizes PPG has been successfully able to predict hydration status. Therefore, this study aims to utilize photoplethysmography (PPG) technology in a wearable device to accomplish this approach to hydration monitoring.",null,[18],"Hydration Status",[],"INTERVENTIONAL","OTHER",[23],"NA",{"count":25,"type":26},30,"ESTIMATED",[28],{"type":21,"name":29,"description":30,"armGroupLabels":31},"Exercise","Perform stationary cycling exercise in the laboratory for 2 30- minute bouts at a standardized exercise intensity (wattage) that elicits 50-80% heart rate max determined by equation (208-(70% of age))",[32,33],"Dehydrated Group","Euhydrated Group",[35,39],{"measure":36,"description":37,"timeFrame":38},"Wearable Sensr Data","photoplethysmogram (PPG) waveform data- optical signals obtained from photoplethysmography, which measure blood volume changes in the microvascular bed of tissue.","Continuous data collection over 24 hours from start of exercise trial through completion of Day 2 measurements.",{"measure":40,"timeFrame":41},"Body Mass Change","Change in body mass during 60 min exercise bout and over 24 hours from baseline",[43,47,50,53,57,61,65,69,73,77,81,85],{"measure":44,"description":45,"timeFrame":46},"Urine Specific Gravity","au","Day 1: Baseline, post 1st and 2nd 30 min exercise sessions Day 2: 1st morning void collected at home and upon arrival at laboratory",{"measure":48,"description":49,"timeFrame":46},"Urine Volume","g",{"measure":51,"description":52,"timeFrame":46},"Urine Color","Scale of 1 (most hydrated) to 7 (most dehydrated)",{"measure":54,"description":55,"timeFrame":56},"Sweat Rate","\\[Body mass loss (kg) + fluid intake (mL)\\]\u002FDuration of exercise (hr)","Throughout entire duration of 60 min exercise bout",{"measure":58,"description":59,"timeFrame":60},"Fluid Intake","mL","documented by subject on provided log for 24 hours prior to exercise and experimental trials. Exercise bouts- DEH group restricted from fluid intake. EUH group fluid measured over duration of exercise bout (60 minutes).",{"measure":62,"description":63,"timeFrame":64},"Subjective Feelings of Thirst","Categorical Thirst Scale, on a scale of 1 (Not thirsty at all) to 7 (very, very thirsty).","Day 1 & 2: Following 5 min of rest",{"measure":66,"description":67,"timeFrame":68},"Heart Rate","bpm","At medical screening to determine eligibility. Day 1: Prior to start of exercise bouts during 5 min rest and every 10 min throughout entire duration of each 60 min exercise trial. Day 2: During 5 min rest, prior to body weight measurement.",{"measure":70,"description":71,"timeFrame":72},"Blood pressure","systolic\u002Fdiastolic (mmHg)","Medical Screening to determine eligibility",{"measure":74,"description":75,"timeFrame":76},"Subject Demographics","Age, Sex, Race, and Ethnicity","At baseline",{"measure":78,"description":79,"timeFrame":80},"Dietary Intake","Food intake logs","Completed for 24 hours prior to baseline and between visits.",{"measure":82,"description":83,"timeFrame":84},"Standardized Exercise Intensity","W","Every 10 min throughout entire duration of each 30 min exercise bout to reach 50-80% of heart rate max.",{"measure":86,"description":87,"timeFrame":88},"Rate of Perceived Exertion","Borg Scale, a scale of 6 (No exertion at all) to 20 (maximal exertion)","Every 10 min throughout entire duration of each 30 min exercise bout","ALL","18 Years","45 Years",true,{"inclusion":94,"exclusion":108,"raw_text":114},[95,96,97,98,99,100,101,102,103,104,105,106,107],"Study subject is 18-45 years of age, inclusive","Subject is male or female","If female, subject is not pregnant, planning to get pregnant, or currently breast feeding","Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)","Able to speak, write, and read English","Provision of written consent to participate","Subject is not taking medication that may interfere with the study, as indicated on the general health questionnaire (GHQ)","Subject has no health conditions that would prevent completion of the trial, as indicated on the GHQ","Subject is willing to fast overnight (no food or beverage, only water, \\~8- 10 hours)","Subject is willing to refrain from vigorous exercise for 24 hours","Subject is willing to eat the exact same food the day prior to each visit to the testing site","Subject is willing to undergo fluid restriction to induce dehydration","Subject is willing to wear a wrist worn wearable device for the duration of the study",[109,110,111,112,113],"Subject has participated or currently enrolled in a clinical trial within the past 30 days","Subject has participated in any PepsiCo trial within the past 3 months","Subject has a condition or is taking medication that the investigator believes would interfere with his\u002Fher 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, as indicated on the GHQ","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.","Subject has a health condition or is taking medication that can be worsened by fluid restriction, as indicated on the GHQ","Inclusion Criteria:\n\n* Study subject is 18-45 years of age, inclusive\n* Subject is male or female\n* If female, subject is not pregnant, planning to get pregnant, or currently breast feeding\n* Subject is willing to avoid alcohol consumption 24 hours prior to visit(s)\n* Able to speak, write, and read English\n* Provision of written consent to participate\n* Subject is not taking medication that may interfere with the study, as indicated on the general health questionnaire (GHQ)\n* Subject has no health conditions that would prevent completion of the trial, as indicated on the GHQ\n* Subject is willing to fast overnight (no food or beverage, only water, \\~8- 10 hours)\n* Subject is willing to refrain from vigorous exercise for 24 hours\n* Subject is willing to eat the exact same food the day prior to each visit to the testing site\n* Subject is willing to undergo fluid restriction to induce dehydration\n* Subject is willing to wear a wrist worn wearable device for the duration of the study\n\nExclusion Criteria:\n\n* Subject has participated or currently enrolled in a clinical trial within the past 30 days\n* Subject has participated in any PepsiCo trial within the past 3 months\n* Subject has a condition or is taking medication that the investigator believes would interfere with his\u002Fher 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, as indicated on the GHQ\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.\n* Subject has a health condition or is taking medication that can be worsened by fluid restriction, as indicated on the GHQ",[116],"ADULT",[118,133],{"facility":119,"status":7,"city":120,"state":121,"zip":122,"country":123,"contacts":124,"geoPoint":130},"PepsiCo R&D","Frisco","Texas","75034","United States",[125],{"name":126,"role":127,"phone":128,"email":129},"Anthony Wolfe","CONTACT","574-315-5901","anthony.wolfe@pepsico.com",{"lat":131,"lon":132},33.15067,-96.82361,{"facility":119,"status":7,"city":134,"state":121,"zip":135,"country":123,"contacts":136,"geoPoint":138},"Plano","75024",[137],{"name":126,"role":127,"phone":128,"email":129},{"lat":139,"lon":140},33.01984,-96.69889,[142],{"name":126,"role":127,"phone":128,"email":129},[],[],[],{"nct_id":4,"conditions":147,"biomarkers":149},[148],"Hydration status",[],{"nct_id":4,"found":92,"summary":151,"prompt_version":160},{"design":152,"status":153,"heading":6,"summary":154,"follow_up":155,"word_count":156,"commitments":157,"compensation":158,"drugs_mentioned":159},"This interventional study plans to enroll 30 participants to test a new method for assessing hydration.","completed","This study is exploring a new way to measure hydration using wearable devices. Currently, hydration is often checked by measuring body weight changes, fluid intake, and urine, which can be time-consuming. Researchers believe that wearable devices, which use light to detect blood flow patterns just under your skin, might offer a simpler, non-invasive method. The study will involve 30 participants, aged 18 to 45, who will perform stationary cycling exercise. The main goals are to see how well data from wearable sensors and changes in body mass during and after exercise can help understand hydration status. The current status of this study is unclear.","Wearable sensor data will be collected continuously for 24 hours from the start of exercise through the completion of Day 2 measurements.",104,"You would perform two 30-minute sessions of stationary cycling exercise and have wearable sensor data collected continuously for 24 hours.","Not stated in the trial record.",[29],"v2"]