[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609321":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":35,"locations":42,"responsibleParty":60,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":26,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Universidad de Burgos","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","ACTIVE_COMPARATOR","Participants will receive placebo supplementation",[13,14],"Other: Nutrition education","Dietary Supplement: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Supplementation","EXPERIMENTAL","Participants will receive creatine monohydrate and beta-hydroxy-beta-methylbutyrate supplementation",[13,20],"Dietary Supplement: Supplement",[22,27,32],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"Nutrition education","Participants and their families will also take part in nutrition education sessions to promote healthy eating and lifestyle habits.",[9,16],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DIETARY_SUPPLEMENT","Supplement","Supplementation with 3 g\u002Fday of creatine monohydrate abd 3 g\u002Fday of beta-hydroxy-beta-methylbutyrate for 8 weeks",[16],{"type":28,"name":9,"description":33,"armGroupLabels":34,"otherNames":26},"Supplementation with 6 g\u002Fday of inulin orally for 8 weeks",[9],[36],{"name":37,"role":38,"phone":39,"phoneExt":40,"email":41},"Alba Abia Heras, Nutrition and Dietetics","CONTACT","615 18 16 15","+34","aheras@uemc.es",[43],{"facility":5,"status":44,"city":45,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Burgos","09003","Spain","ES",{"type":50,"coordinates":51},"Point",[52,53],-3.70184,42.34106,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":58,"phoneExt":26,"email":59},"Juan Mielgo Ayuso, Nutrition and Dietetics","947 49 91 10","jfmielgo@ubu.es",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","MARIA MARTINEZ","Principal Investigator",[65],{"name":66,"class":6},"European University Miguel de Cervantes","100609321","effects-of-chronic-creatine-and-beta-hydroxy-beta-methylbutyrate-supplementation-on-oxidative-stress-inflammation-muscle-strength-and-body-composition-in-individuals-with-down-syndrome-100609321",false,"NCT07213063","Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome","Inclusion Criteria:\n\n* Diagnosis: Medical confirmation of Down syndrome (trisomy of chromosome 21).\n* Physical capacity: Ability to perform basic physical tests (e.g., standing up from a chair or walking without assistance).\n* Informed consent: Informed consent will be obtained from both the participant and their legal representative, in compliance with current legislation for individuals requiring support measures.\n\nExclusion Criteria:\n\n* Chronic kidney disease: Diagnosis of chronic kidney disease.\n* Severe motor limitations: Inability to perform the required physical tests (e.g., paralysis or mobility impairments preventing the execution of muscle strength assessments).\n* Participation in other studies: Participation in another nutritional or supplementation intervention study within the last 6 months.\n* Allergies or intolerances: Known allergy to creatine or to components of the placebo (inulin).","ALL","18 Years",{"count":76,"type":77},50,"ESTIMATED","INTERVENTIONAL",[80],"NA","Purpose:\n\nThis study will test whether 8 weeks of creatine and HMB supplementation can improve muscle strength, body composition, balance, and overall health in people with Down syndrome. Participants will also receive nutrition tips during the study.\n\nWho can participate:\n\nPeople with Down syndrome who can perform basic physical tasks. Must provide consent from the participant and legal guardian.\n\nWhat participants will do:\n\nTake creatine (3 g\u002Fday) and HMB (3 g\u002Fday) or placebo for 8 weeks. Complete tests for muscle strength, balance, and cognitive function. Undergo body composition scans and give blood samples for health markers.\n\nTiming:\n\nAll tests and blood samples are taken before and after each 8-week period.\n\nImportance:\n\nResults will help determine if creatine and HMB can safely improve strength, balance, and overall health in people with Down syndrome.",[83,16],"Down Syndrome (DS)",[85,86,87],"creatine","down syndrome","bone mineral health","2026-01-12",{"date":90,"type":91},"2026-01-14","ACTUAL",{"date":93,"type":91},"2025-09-15",{"date":95,"type":77},"2026-05-30",{"name":5,"class":6},1]