[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539011":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":10,"responsibleParty":44,"collaborators":46,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":10,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":10,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":10},{"fullName":5,"class":6},"metaX Institut fuer Diatetik GmbH","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"ZeroTP minis",null,"Intervention: Tyrosine-free and Phenylalanine-free protein substitute in tablet form. Subjects who currently take a protein substitute for the dietary management of either tyrosinaemia I, II, III or alkaptonuria will be recruited. Subjects will take the study product for 7 days. Subjects will replace some or their entire usual protein substitute with the new product. The amount of tablets prescribed will be calculated to provide the same amount of protein as their usual protein substitute.",[13],"Dietary Supplement: Zero minis (range of protein substitutes in tablet form)",{"label":15,"type":10,"description":16,"interventionNames":17},"ZeroMet minis","Intervention: Methionine-free and Cystine-enriched protein substitute in tablet form. Subjects who currently take a protein substitute for the dietary management of homocystinuria will be recruited. Subjects will take the study product for 7 days. Subjects will replace some or their entire usual protein substitute with the new product. The amount of tablets prescribed will be calculated to provide the same amount of protein as their usual protein substitute.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"ZeroVIL minis","Intervention: Valine-, Isoleucine- and Leucine-free protein substitute in tablet form. Subjects who currently take a protein substitute for the dietary management of MSUD will be recruited. Subjects will take the study product for 7 days. Subjects will replace some or their entire usual protein substitute with the new product. The amount of tablets prescribed will be calculated to provide the same amount of protein as their usual protein substitute.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DIETARY_SUPPLEMENT","Zero minis (range of protein substitutes in tablet form)","Intervention: range of protein substitute tablets. Subjects who currently take a protein substitute for the dietary management of either tyrosinaemias or alkaptonuria, homocystinuria, or MSUD will be recruited. Subjects will take the study product for 7 days. Daily questionnaires will be completed (ease of preparation,administration; any problems or gastrointestinal effects). Subjects will replace some or their entire usual protein substitute with the new product suitable for their diagnosed rare metabolic disease. The amount of tablets prescribed will be calculated to provide the same amount of protein as their usual protein substitute. Additional questions at the beginning and end of the study will record information on organoleptic properties, presentation and packaging of the product. Routine weekly blood samples will be collected and analysed for amino acids typically for the metabolic control of the individual specified metabolic disorders as is usual clinical practice.",[15,9,19],[9,15,19],[30],{"name":31,"affiliation":32,"role":33},"Anita MacDonald, Professor","Birmingham Children´s Hospital","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Bernhard Hoffmann, PhD","CONTACT","+49 6031 166 72 71","behoffmann@metax.org",{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},"Yvonne Mücke, PhD","+49 6031 166 72 79","yvonne.muecke@metax.org",{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[47,50],{"name":48,"class":49},"Birmingham Women's and Children's NHS Foundation Trust","OTHER",{"name":51,"class":49},"Great Ormond Street Hospital for Children NHS Foundation Trust","100539011","acceptabilitytolerance-of-protein-substitutes-in-tablet-form-for-the-dietary-management-of-rare-aminoacidopathies-100539011",false,"NCT06298292","Acceptability\u002FTolerance of Protein Substitutes in Tablet Form for the Dietary Management of Rare Aminoacidopathies","Zero Minis - Acceptability and Tolerance Market Research","ZeroMinisMR","Inclusion Criteria:\n\n* Diagnosis of Tyrosinaemia type I, II III or Alkaptonuria requiring a tyrosine- and phenylalanine-free protein substitute.\n* Diagnosis of Homocystinuria requiring a methionine-free, cystine-enriched protein substitute.\n* Diagnosis of MSUD requiring a valine-, leucine- and isoleucine-free protein substitute.\n* Subjects who are already taking a protein substitute for one of the specified rare metabolic disorders and are willing to try the study product for 7 days.\n* Children aged 7 years and over.\n* Written informed consent obtained from parental caregiver.\n\nExclusion Criteria:\n\n* Presence of serious concurrent illness\n* Lead Dietitian's uncertainty about the willingness or ability of the patient to comply with the protocol requirements\n* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.\n* Any children having taken antibiotics over the previous 2 weeks leading up to the study.\n* Children less than 7 years of age.","ALL","7 Years","18 Years",{"count":64,"type":65},15,"ESTIMATED","OBSERVATIONAL","The purpose of this prospective, observational study is to evaluate the tolerability and acceptability of Zero minis, a range of protein substitute tablets for use in the dietary management of children with either TYROSINAEMIA Type I, II, III or ALKAPTONURIA, HOMOCYSTINURIA, or MAPLE SYRUP URINE DISEASE (MSUD) over the age of 7 years.",[69,70,71,72,73,74],"Tyrosinemia, Type I","Tyrosinemia, Type II","Tyrosinemia, Type III","Alkaptonuria","Homocystine; Metabolic Disorder","MSUD (Maple Syrup Urine Disease)","NOT_YET_RECRUITING","2024-03-01",{"date":78,"type":79},"2024-03-07","ACTUAL",{"date":81,"type":65},"2024-04-01",{"date":83,"type":65},"2026-06-30",{"name":5,"class":6}]