[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657780":3},{"organization":4,"outcomesModule":7,"designInfo":60,"detailedDescription":63,"studyPopulation":63,"armGroups":70,"interventions":82,"overallOfficials":63,"centralContacts":92,"locations":63,"responsibleParty":98,"collaborators":63,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":63,"eligibilityCriteria":107,"healthyVolunteers":108,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":63,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":127,"whyStopped":63,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":63},{"fullName":5,"class":6},"Poznan University of Life Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"5-km Running Time-Trial Performance","Time required to complete a 5-km treadmill running time trial, expressed in seconds. Participants will be instructed to complete the distance as quickly as possible and will be allowed to adjust treadmill speed throughout the trial. Lower completion time indicates better performance.","During the 5-km treadmill time trial performed after the 60-minute running preload and a 5-minute recovery period in each experimental trial.",[14],{"measure":15,"description":16,"timeFrame":17},"Sweat rate","Whole-body sweat rate will be estimated from the change in body mass from immediately before exercise to completion of the 5-km time trial, adjusted for fluid intake and urine output, if applicable, and expressed as L\u002Fh. Body mass will be measured using the calibrated electronic scale integrated with the BOD POD system (COSMED, Italy) and expressed in kilograms (kg). Changes in body mass will also be calculated and reported as a percentage of pre-exercise body mass (%).","From immediately before the 60-minute running preload to completion of the subsequent 5-km time trial during each experimental trial.",[19,23,26,30,34,37,41,44,48,52,56],{"measure":20,"description":21,"timeFrame":22},"Sweat sodium concentration","Sodium concentration will be measured in sweat samples collected from standardized sites on the forearm and thigh during exercise. Sweat samples will be collected between minutes 30 and 60 of the 60-minute running preload. Sodium concentration will be analyzed using a HORIBA ion-selective electrode analyzer and reported in mmol\u002FL.","Between minutes 30 and 60 of the 60-minute running preload during each experimental trial.",{"measure":24,"description":25,"timeFrame":22},"Sweat Potassium Concentration","Potassium concentration will be measured in sweat samples collected from standardized sites on the forearm and thigh during exercise. Sweat samples will be collected between minutes 30 and 60 of the 60-minute running preload. Sweat potassium concentration will be analyzed using a HORIBA ion-selective electrode analyzer and reported in mmol\u002FL.",{"measure":27,"description":28,"timeFrame":29},"Blood lactate concentration","Blood lactate concentration will be measured using a portable Lactate Scout 4 analyzer. Measurements will be obtained immediately after completion of the 60-minute running preload and immediately after completion of the subsequent 5-km time trial. Blood lactate concentration will be reported in mmol\u002FL.","Immediately after the 60-minute running preload and immediately after the 5-km time trial during each experimental trial.",{"measure":31,"description":32,"timeFrame":33},"Heart rate","Heart rate will be monitored continuously using a Garmin chest-strap heart rate monitor with integrated electrodes throughout the 60-minute running preload and the subsequent 5-km time trial. Outcome variables will include mean heart rate during the 60-minute preload, mean heart rate during the 5-km time trial, and maximal heart rate achieved during the 5-km time trial. Heart rate will be reported in beats per minute (bpm).","Continuously during the 60-minute running preload and the subsequent 5-km time trial in each experimental trial.",{"measure":35,"description":36,"timeFrame":33},"Core Body Temperature","Core body temperature will be monitored continuously using a CORE body temperature sensor attached to the Garmin chest strap throughout the 60-minute running preload and the subsequent 5-km time trial. Outcome variables will include mean core body temperature during the exercise protocol and the highest core body temperature recorded during the exercise protocol. Temperature will be reported in degrees Celsius (°C).",{"measure":38,"description":39,"timeFrame":40},"Running Economy","Running economy will be assessed by breath-by-breath indirect calorimetry using a QUARK RMR metabolic system during the final 10 minutes (minutes 50-60) of the 60-minute running preload. Running economy will be quantified as mean oxygen consumption (VO₂) relative to body mass at the standardized running velocity and expressed as mL·kg-¹·min-¹. Lower oxygen consumption at the same running velocity indicates better running economy.","During the final 10 minutes (minutes 50-60) of the 60-minute running preload in each experimental trial.",{"measure":42,"description":43,"timeFrame":40},"Respiratory Exchange Ratio","Respiratory exchange ratio (RER) will be assessed by breath-by-breath indirect calorimetry using a QUARK RMR metabolic system during the final 10 minutes (minutes 50-60) of the 60-minute running preload. RER will be calculated as the ratio of carbon dioxide production (VCO₂) to oxygen consumption (VO₂) and expressed as a unitless value. The mean RER over the measurement period will be used for analysis.",{"measure":45,"description":46,"timeFrame":47},"Urine specific gravity","Urine specific gravity (USG) will be measured using a URIT-31 urine analyzer from urine samples collected immediately before the 60-minute running preload and after completion of the subsequent 5-km time trial. USG will be reported as a dimensionless value. Urine osmolality will also be estimated from USG using a predefined conversion equation and reported in mOsm\u002Fkg.","Immediately before the 60-minute running preload and immediately after completion of the 5-km time trial in each experimental trial.",{"measure":49,"description":50,"timeFrame":51},"Rating of Perceived Exertion (RPE)","Rating of perceived exertion will be assessed using the Borg 6-20 Rating of Perceived Exertion scale, ranging from 6 (\"no exertion at all\") to 20 (\"maximal exertion\"). RPE will be recorded at 15-minute intervals during the 60-minute running preload and immediately after completion of the 5-km time trial.","At minutes 30, and 60 of the 60-minute running preload and immediately after completion of the 5-km time trial during each experimental trial.",{"measure":53,"description":54,"timeFrame":55},"Thirst Sensation","Perceived thirst will be assessed using a 9-point categorical thirst sensation scale ranging from 1 (\"not thirsty at all\") to 9 (\"very, very thirsty\"). Participants will be asked to rate their current sensation of thirst at each measurement time point.","Immediately before the 60-minute running preload, at minutes 30,and 60 of the preload, and immediately after completion of the 5-km time trial during each experimental trial.",{"measure":57,"description":58,"timeFrame":59},"Thermal Sensation","Thermal sensation will be assessed using a 17-point thermal sensation scale ranging from 0 to 8 in 0.5-point increments, with 0 representing \"unbearably cold\", 4 representing \"neutral\", and 8 representing \"unbearably hot\". Participants will rate their whole-body thermal sensation at each measurement time point.","Immediately before the 60-minute running preload, at minutes 30 and 60 of the preload, and immediately after completion of the 5-km time trial during each experimental trial.",{"allocation":61,"interventionModel":62,"interventionModelDescription":63,"primaryPurpose":6,"observationalModel":63,"timePerspective":63,"maskingInfo":64},"RANDOMIZED","CROSSOVER",null,{"masking":65,"maskingDescription":63,"whoMasked":66},"TRIPLE",[67,68,69],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[71,78],{"label":72,"type":73,"description":74,"interventionNames":75},"Betaine → Placebo Sequence","EXPERIMENTAL","Participants will first complete the betaine-enriched hyperhydration condition. After the washout period, they will complete the placebo hyperhydration condition.",[76,77],"Dietary Supplement: Anhydrous Betaine","Other: Placebo",{"label":79,"type":73,"description":80,"interventionNames":81},"Placebo → Betaine Sequence","Participants will first complete the placebo hyperhydration condition. After the washout period, they will complete the betaine-enriched hyperhydration condition.",[76,77],[83,88],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":63},"DIETARY_SUPPLEMENT","Anhydrous Betaine","Anhydrous betaine (trimethylglycine) will be administered as a single dose of 0.07 g\u002Fkg body mass, dissolved in a commercially available sports drink (5 mL\u002Fkg body mass), 150 minutes before exercise. The betaine-containing drink will constitute the first bolus of a standardized pre-exercise hyperhydration protocol providing a total fluid intake of approximately 25 mL\u002Fkg body mass over 120 minutes.",[72,79],{"type":6,"name":89,"description":90,"armGroupLabels":91,"otherNames":63},"Placebo","Participants will receive the same commercially available sports drink (5 mL\u002Fkg body mass) without added betaine 150 minutes before exercise. This will be followed by four additional fluid boluses of mineral water (5 mL\u002Fkg each) administered at 120, 90, 60, and 30 minutes before exercise, for a total pre-exercise fluid intake of approximately 25 mL\u002Fkg body mass.",[72,79],[93],{"name":94,"role":95,"phone":96,"phoneExt":63,"email":97},"Emilia Zawieja","CONTACT","+48500415726","emilia.zawieja@up.poznan.pl",{"type":99,"investigatorFullName":94,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":63,"oldOrganization":63},"PRINCIPAL_INVESTIGATOR","PhD","100657780","betaine-addition-to-water-loading-prior-to-running-exercise-100657780",false,"NCT07840248","Betaine Addition to Water Loading Prior to Running Exercise","Effects of a Betaine-Supplemented Hydration Protocol on Sweat Rate and Exercise Performance in Runners","Inclusion Criteria:\n\n* Age 18-45 years\n* Sex: men and premenopausal women\n* Continuous running training for at least 12 months\n* At least 3 running training sessions per week\n* Willingness and ability to complete the treadmill exercise protocol: 60 minutes of running at 60% of the running velocity corresponding to VO₂max, followed by a 5-km running time trial\n* Medical clearance for participation in maximal and prolonged exercise testing\n\nExclusion Criteria:\n\n* Age \\\u003C18 or \\>45 years\n* Postmenopausal women\n* Use of betaine, choline, folic acid\u002Ffolate, or vitamin B12 supplements within 3 months prior to study participation\n* Current musculoskeletal injury or injury occurring within the previous 2 months\n* Uncontrolled arterial hypertension\n* Pregnancy or breastfeeding\n* Diabetes requiring insulin therapy or inadequately controlled diabetes\n* Active or severe liver disease, including ALT or AST \\>3× the upper limit of normal\n* Renal impairment, including eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m²\n* Untreated or unstable thyroid disease, including hypothyroidism or hyperthyroidism\n* Gastrointestinal disease that may affect nutrient absorption\n* Kidney disease, cardiovascular disease, irritable bowel syndrome, or adrenal disease\n* Use of diuretics, SGLT2 inhibitors, laxatives, or glucocorticoids\n* Any medical contraindication to physical exercise and\u002For failure to obtain medical clearance for exercise testing\n* Elevated body temperature at the time of testing\n* Cystic fibrosis",true,"ALL","18 Years","45 Years",{"count":113,"type":114},20,"ESTIMATED","INTERVENTIONAL",[117],"NA","This randomized, double-blind, placebo-controlled crossover study will investigate whether acute betaine ingestion as part of a pre-exercise hyperhydration strategy improves endurance running performance and influences hydration-related responses during prolonged exercise.\n\nApproximately 30 recreationally trained male and premenopausal female runners will complete two experimental trials: a betaine condition and a placebo\u002Fcontrol condition. In the betaine condition, participants will ingest anhydrous betaine at a dose of 0.07 g\u002Fkg body mass as part of a standardized pre-exercise hydration protocol providing a total fluid intake of approximately 25 mL\u002Fkg body mass.\n\nFollowing the hydration protocol, participants will complete 60 minutes of treadmill running at 60% of the running velocity corresponding to VO₂max, followed by a 5-minute recovery period and a 5-km treadmill time trial.\n\nThe primary outcome will be 5-km running time-trial performance. Secondary outcomes will include exercise-induced fluid and sweat loss, urinary hydration markers, sweat electrolyte concentrations, physiological responses, exercise economy, substrate utilization, blood lactate concentration, perceived exertion, thirst, and thermal sensation.",[120,121],"Exercise","Hydration",[123,124,125,126],"betaine","hydration","endurance","exercise","NOT_YET_RECRUITING","2026-09-18",{"date":130,"type":131},"2026-09-25","ACTUAL",{"date":133,"type":114},"2026-10-01",{"date":135,"type":114},"2027-12-30",{"name":5,"class":6}]