[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614871":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":46,"interventions":59,"overallOfficials":67,"centralContacts":72,"locations":80,"responsibleParty":101,"collaborators":34,"id":103,"slug":34,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":110,"sex":111,"minAge":112,"maxAge":34,"enrollmentInfo":113,"targetDuration":34,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":34,"overallStatus":83,"whyStopped":34,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Center for Health Sciences, Serbia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Hand-grip strength","Handgrip strength quantifies maximal voluntary force generated by the hand using a dynamometer, serving as a simple, reliable indicator of overall muscle function and sarcopenia severity.","Change from baseline hand-grip strength at 12 weeks",[14,18,22,26,30],{"measure":15,"description":16,"timeFrame":17},"Senior fitness test score","The Senior Fitness Test score reflects aggregated performance across multiple functional tasks, providing a quantifiable index of an older adult's overall physical capability, mobility, and age-related fitness status.","Change from baseline senior fitness test score at 12 weeks",{"measure":19,"description":20,"timeFrame":21},"Mini-Mental State Examination Score","The Mini-Mental State Examination score quantifies global cognitive function by assessing orientation, memory, attention, language, and visuospatial abilities, offering a validated measure for detecting cognitive decline in older adults.","Change from baseline Mini-Mental State Examination Score at 12 weeks",{"measure":23,"description":24,"timeFrame":25},"Appendicular muscle mass","Appendicular muscle mass quantifies lean soft tissue in arms and legs serving as a key indicator of skeletal muscle quantity and sarcopenia-related muscle depletion.","Change from baseline appendicular muscle mass at 12 weeks",{"measure":27,"description":28,"timeFrame":29},"Brain creatine","Magnetic resonance spectra for brain creatine concentrations","Change from baseline brain creatine concentrations at 12 weeks",{"measure":31,"description":32,"timeFrame":33},"Irisin","Serum levels of irisin","Change from baseline serum levels of irisin at 12 weeks",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":41},"QUADRUPLE",[42,43,44,45],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[47,53],{"label":48,"type":49,"description":50,"interventionNames":51},"Experimental 1","EXPERIMENTAL","2 capsules of creatine HCl per day",[52],"Dietary Supplement: Experimental 1",{"label":54,"type":55,"description":56,"interventionNames":57},"Experimental 2","PLACEBO_COMPARATOR","2 capsules of inulin HCl per day",[58],"Dietary Supplement: Experimental 2",[60,64],{"type":61,"name":48,"description":62,"armGroupLabels":63,"otherNames":34},"DIETARY_SUPPLEMENT","Creatine HCl",[48],{"type":61,"name":54,"description":65,"armGroupLabels":66,"otherNames":34},"Innulin (placebo)",[54],[68],{"name":69,"affiliation":70,"role":71},"Sergej Ostojic, MD, PhD","Center for Mitochondrial Medicine","STUDY_CHAIR",[73,77],{"name":69,"role":74,"phone":75,"phoneExt":34,"email":76},"CONTACT","+381112643242","sergej.ostojic@chess.edu.rs",{"name":78,"role":74,"phone":75,"phoneExt":34,"email":79},"Nikola Todorovic","nikola.todorovic@appliedbioenergetics.org",[81],{"facility":82,"status":83,"city":84,"state":34,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"Center for Health Sciences","RECRUITING","Belgrade","11000","Serbia","RS",{"type":89,"coordinates":90},"Point",[91,92],20.46513,44.80401,{"lat":92,"lon":91},[95,98],{"name":96,"role":74,"phone":97,"phoneExt":34,"email":76},"Sergej M Ostojic, MD, PhD","+381-11-2643-242",{"name":99,"role":100,"phone":34,"phoneExt":34,"email":34},"Nikola Todorovic, PhD","PRINCIPAL_INVESTIGATOR",{"type":102,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100614871",false,"NCT07285226","Creatine HCl Supplementation in Sarcopenia: A Randomized Controlled Study","Impact of 12-Week Creatine HCl Supplementation on Body Composition, Functional Muscle and Brain Performance, Blood Biomarkers, and Tissue Creatine Levels in Older Adults With Sarcopenia","SARCOPA","Inclusion Criteria:\n\n* Age \\> 60 years\n* Low muscle strength by handgrip (SDOC criteria for sarcopenia): \\\u003C 35.5 kg in men and \\\u003C 20 kg in women\n* Sign free and informed consent\n* Demonstrate interest, conditions and availability to participate\n\nExclusion Criteria:\n\n* Patients undergoing interventional treatment for sarcopenia\n* Physical amputation\n* Cognitive impairment (MSSE \\\u003C 25)\n* Unwillingness to return for follow-up analysis\n* Participation in other clinical trials",true,"ALL","60 Years",{"count":114,"type":115},30,"ESTIMATED","INTERVENTIONAL",[118],"NA","The CONCRET-SARCOPA trial is a 12-week, double-blind, randomized controlled study designed to evaluate the efficacy of creatine HCl supplementation in older adults with sarcopenia. The trial investigates whether daily creatine HCl improves body composition, enhances functional muscle and cognitive performance, and favorably alters key blood biomarkers associated with muscle health and metabolic status. Additionally, the study assesses changes in tissue creatine levels using non-invasive and biochemical methods to clarify mechanistic responses to supplementation. Findings from this trial will provide critical evidence on the therapeutic potential of creatine HCl as a targeted nutritional strategy for managing sarcopenia in the geriatric population.",[121],"Sarcopenia","2025-12-27",{"date":124,"type":125},"2026-01-02","ACTUAL",{"date":127,"type":125},"2025-12-01",{"date":129,"type":115},"2026-09-15",{"name":5,"class":6},1]