[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656400":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":38,"studyPopulation":25,"armGroups":39,"interventions":52,"overallOfficials":25,"centralContacts":62,"locations":68,"responsibleParty":82,"collaborators":86,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":25,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":117,"overallStatus":124,"whyStopped":25,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Universidad Pablo de Olavide","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in Heart Rate Variability (rMSSD)","Autonomic recovery assessed as Root Mean Square of Successive Differences (rMSSD) during nocturnal sleep via Garmin wearable devices. Higher values indicate better parasympathetic recovery.","Baseline and daily for 8 weeks.",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Change from Baseline in Sleep Score","Overall sleep quality score calculated by Garmin's proprietary algorithm based on sleep duration, REM, and deep sleep cycles.","Daily for 8 weeks.",{"measure":19,"description":20,"timeFrame":17},"Change from Baseline in Recovery Readiness Index","Daily readiness score (Body Battery) obtained via Garmin wearable algorithm. Scores range from 0 to 100; higher scores indicate greater physical readiness for training.",{"measure":22,"description":23,"timeFrame":24},"Body Composition","Body composition assessed at week 8. Lower values indicate reduction","8 weeks.",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","Participants are randomly assigned to one of two groups (KA-EX or Placebo) for the entire 2-month duration of the intervention to compare between-group differences in recovery parameters.","SUPPORTIVE_CARE",{"masking":32,"maskingDescription":33,"whoMasked":34},"TRIPLE","Both KA-EX and Placebo are provided in sensory-matched packaging (same taste, texture, and appearance) to ensure neither the athletes nor the researchers collecting Garmin and BIA data know the allocation",[35,36,37],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Background and Rationale: Post-exercise recovery is a critical determinant of performance and adaptation in high-level football players. Insufficient recovery can lead to decreased physical readiness and increased risk of injury. KA-EX is a nutritional supplement containing a complex of amino acids, electrolytes, and functional sugars designed to support metabolic and physiological recovery. This study aims to investigate its efficacy in a real-world elite training environment.\n\nStudy Objectives: The primary objective is to evaluate the effect of KA-EX supplementation on physiological recovery parameters (HRV). Secondary objectives include assessing the impact on sleep recovery indices, changes in body composition (via DEXA), and cellular health parameters (via BIA).\n\nMethodology and Design: This is an experimental, randomized, double-blind, placebo-controlled study.\n\nParticipants: 25 male players from the Udine Primavera team (Italy). Intervention: Participants will be randomly assigned to an experimental group (KA-EX) or a control group (placebo). The products will be identical in appearance, taste, and packaging to ensure blinding.\n\nDuration: The intervention will last for 2 months, typically following the pre-season period.\n\nProcedures:\n\nBaseline Assessment: Participants will undergo initial DEXA scans, bioelectrical impedance analysis (BIA 101), and anthropometric measurements. Monitoring with Garmin devices will be initiated.\n\nIntervention Phase: Supplements or placebos will be administered immediately after every training session. Recovery variables (HRV and sleep) will be continuously monitored using Garmin algorithms.\n\nFinal Assessment: At the end of the 2-month period, DEXA, BIA, and anthropometric measurements will be repeated to evaluate longitudinal changes.\n\nStatistical Analysis: Within-group and between-group differences will be analyzed to compare the magnitude of change from baseline to post-intervention. Temporal evolution of recovery metrics throughout the 8-week period will also be assessed.",[40,47],{"label":41,"type":42,"description":43,"interventionNames":44},"KA-EX Group y Placebo Group.","EXPERIMENTAL","Participants in this arm will receive the KA-EX supplement immediately after each training session during the 2-month intervention period. KA-EX is a dietary supplement containing a complex of amino acids, electrolytes and functional sugars designed to support physiological recovery.",[45,46],"Dietary Supplement: KA-EX","Dietary Supplement: Experimental: KA-EX Supplement",{"label":48,"type":49,"description":50,"interventionNames":51},"Placebo Group.","PLACEBO_COMPARATOR","Participants in this arm will receive a placebo supplement immediately after each training session during the 2-month intervention period. The placebo is organoleptically identical to the experimental supplement in terms of appearance, taste, texture and packaging to ensure double-blinding.",[45,46],[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":25},"DIETARY_SUPPLEMENT","KA-EX","Powder sachet to be dissolved in water. Contains a patented complex of amino acids, electrolytes, and carbohydrates designed to normalize cortisol and support recovery.",[41,48],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":25},"Experimental: KA-EX Supplement","Powder sachet with identical organoleptic characteristics but without the active recovery ingredients of KA-EX.",[41,48],[63],{"name":64,"role":65,"phone":66,"phoneExt":25,"email":67},"Francisco J. Berral de la Rosa, PhD","CONTACT","+34672781737","nutrifarma@centrosnutrifarma.es",[69],{"facility":70,"status":25,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":25},"Stadio BlueEnergy","Udine","Friuli Venecia","3310'","Italy","IT",{"type":77,"coordinates":78},"Point",[79,80],13.23715,46.0693,{"lat":80,"lon":79},{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Antonio Molina Lopez","Profesor",[87,89,91],{"name":88,"class":6},"Universidad Europea de Madrid",{"name":90,"class":6},"University of Udine",{"name":5,"class":6},"100656400","effect-of-ka-ex-supplementation-on-recovery-parameters-in-high-level-young-football-players-100656400",false,"NCT07824752","Effect of KA-EX Supplementation on Recovery Parameters in High-Level Young Football Players","Effect of KA-EX Supplementation on Recovery Parameters in High-Level Young Football Players: A Randomised, Double-Blind, Placebo-Controlled Study","Effect of KA-E","Inclusion Criteria:\n\n* Membership of the Udine Primavera team at the time of the study. Regular participation in the training programme during the intervention period (September).\n\nProvision of written informed consent to participate in the study. Willingness to use a Garmin wearable device for continuous monitoring of recovery variables.\n\nExclusion Criteria:\n\n* Presence of any injury or medical condition that limits normal participation in team training sessions.\n\nUse of any other recovery supplements or ergogenic aids outside of the study protocol during the intervention period.\n\nFailure to comply with the daily supplementation protocol or the scheduled assessment sessions (DEXA\u002FBIA).",true,"MALE","17 Years","20 Years",{"count":105,"type":106},25,"ESTIMATED","INTERVENTIONAL",[109],"NA","The purpose of this study is to evaluate the effects of KA-EX supplementation on recovery parameters in elite young football players. Athletes from the Udine Primavera team will be randomly assigned to receive either the KA-EX supplement or a sensory-matched placebo immediately following their training sessions for a period of two months.\n\nThe researchers will monitor heart rate variability (HRV) and sleep quality using Garmin wearable devices, and assess changes in body composition using Dual-energy X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA). The goal of the study is to determine if post-training KA-EX administration improves physiological recovery, sleep quality, and physical readiness in high-performance athletes during a competitive season.",[112,113,114,115,116],"Sport","Muscle Fatigue","Recovery of Function (G11.427.698.620)","Athletic Performance","Sleep Quality",[118,119,120,22,121,122,123],"Heart Rate Variability","Soccer","Amino Acids","Garmin Wearables","DEXA","Post-Exercise Recovery","NOT_YET_RECRUITING","2026-09-13",{"date":127,"type":128},"2026-09-17","ACTUAL",{"date":130,"type":106},"2026-09-05",{"date":132,"type":106},"2026-12-01",{"name":84,"class":6},1]