[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100436941":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":31,"locations":25,"responsibleParty":40,"collaborators":25,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":25,"eligibilityCriteria":49,"healthyVolunteers":46,"sex":50,"minAge":51,"maxAge":25,"enrollmentInfo":52,"targetDuration":25,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":67,"whyStopped":25,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":25},{"fullName":5,"class":6},"University Medical Centre Ljubljana","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients on diet","EXPERIMENTAL","We will invite approximately 50 adult patients with PKU who were or are still being managed in the PPB clinic of the Pediatric Clinic of the University Medical Center Ljubljana. It is estimated that half of the patients still fully or at least partially follow the dietary treatment.",[13,14],"Diagnostic Test: Ultrasound of the jugular veins","Dietary Supplement: addition of phenylalanine-free protein substitutes",{"label":16,"type":10,"description":17,"interventionNames":18},"patients without diet","Half of the patients have abandoned the diet treatment and mostly no longer come for outpatient examinations.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Ultrasound of the jugular veins","Ultrasound of the jugular veins to assess the thickness of the carotid intima media",[9,16],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DIETARY_SUPPLEMENT","addition of phenylalanine-free protein substitutes","addition of phenylalanine-free protein substitutes for sufficient daily intake of essential amino acids and other vitamins and minerals and nutritional plan",[9,16],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Ajda Mezek, master","CONTACT","0038640656109","ajda.mezek@gmail.com",{"name":38,"role":34,"phone":25,"phoneExt":25,"email":39},"Mojca Žerjav Tanšek, doctorate","mojca.zerjav-tansek@mf.uni-lj.si",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Ajda Mezek","mag.diet.","100436941","comparison-of-atherogenic-risk-factors-and-efficacy-of-nutritional-treatment-among-adult-phenylketonuria-patients-100436941",false,"NCT04969809","Comparison of Atherogenic Risk Factors and Efficacy of Nutritional Treatment Among Adult Phenylketonuria Patients","Inclusion Criteria:\n\n* The study will include subjects over the age of 18 who have PKU or hyperphenylalaninemia and are expected to have dietary treatment according to expert recommendations. A prerequisite for entering the investigation will be a signed consent to participate in the investigation and the ability of the participant to have a good understanding of the content of the research and to fully participate in the interventional dietary process.\n\nExclusion Criteria:\n\n* The investigators will not include adult patients who do not manage their diet on their own and need caregivers due to limited cognitive abilities (patients with late-diagnosed disease and neurological consequences of the disease) or who do not want to sign an informed consent.","ALL","18 Years",{"count":53,"type":54},50,"ESTIMATED","INTERVENTIONAL",[57],"NA","Phenylketonuria is a rare metabolic disease that results from the absence or near-absence activity of the enzyme phenylalanine hydroxylase, which metabolizes the amino acid phenylalanine to tyrosine in the body. Accumulation of phenylalanine in the brain causes brain damage that leads to mental retardation, neurological complications, and movement disorders.\n\nThe study is inherited autosomal recessively. The basis of treatment is a low-protein diet with dietary supplements of aminoxlin without phenylalanine and with appropriate substitutes for micro and macronutrients needed for different ages. A low-protein diet regulates the level of phenylalanine in the blood. This is especially important in childhood.\n\nIn the study, which will basically consist of theoretical, experimental and numerical work, the investigators will limit to a specific population, i.e. to adult patients with phenylketonuria. The research is intended to prove the hypothesis that with proper nutritional treatment of phenylketonuria in adulthood, we can have a positive effect on the patient's well-being, better blood results and improved lifestyle.\n\nThe investigators intend to test this hypothesis by implementing a complex, multidisciplinary project that will include a comprehensive treatment of adult PKU patients. This will be based on a multidisciplinary approach with the inclusion of medical and nutritional treatment. As part of the project, the investigators, among other things, create questionnaires and analyze food diaries related to the mentioned areas.\n\nUsing various statistical techniques, the investigators analyze the impact of individual factors on the success of achieving the objectives of the proposed study. The original contribution to science will be the nutritional treatment of adult patients with phenylketonuria in Slovenia and the consequent reduction of health complications in adulthood of patients with phenylketonuria.",[60,61],"Phenylketonurias","Nutritional and Metabolic Diseases",[63,64,65,66],"adult phenylketonuria","nutrition therapy","cardiovascular diseases","nutrition and metabolic diseases","NOT_YET_RECRUITING","2021-07-09",{"date":70,"type":71},"2021-07-21","ACTUAL",{"date":73,"type":54},"2021-09-01",{"date":75,"type":54},"2026-09-01",{"name":5,"class":6}]