Comparison of Atherogenic Risk Factors and Efficacy of Nutritional Treatment Among Adult Phenylketonuria Patients
Launched by UNIVERSITY MEDICAL CENTRE LJUBLJANA · Jul 9, 2021
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how proper nutritional treatment can help adults with a rare metabolic disorder called phenylketonuria (PKU). PKU occurs when the body cannot break down a substance called phenylalanine, which can build up and cause serious brain damage and other health problems. The trial aims to see if a low-protein diet, along with special dietary supplements, can improve the well-being, blood results, and overall lifestyle of adults living with PKU.
To participate in this study, individuals must be over 18 years old and diagnosed with PKU or a related condition. They should be able to manage their own diet and understand the study's requirements. Participants will engage in a comprehensive treatment plan that includes both medical and nutritional support. Throughout the trial, they will fill out questionnaires and keep food diaries to help researchers analyze how different factors affect their health outcomes. The hope is that this research will lead to better dietary guidelines and reduced health complications for adults with PKU in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
About University Medical Centre Ljubljana
University Medical Centre Ljubljana (UMCL) is a leading academic medical institution in Slovenia, dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, UMCL integrates cutting-edge medical practices with comprehensive patient care, fostering an environment of collaboration among healthcare professionals, researchers, and patients. With a strong emphasis on ethical standards and scientific integrity, UMCL aims to contribute to the global body of medical knowledge while improving treatment outcomes in various therapeutic areas.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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