NCT07220265 Impact of Phenylalanine Elevations on Brain and Cognition in Adult PKU Carriers
| NCT ID | NCT07220265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Missouri-Columbia |
| Condition | Carrier of Phenylketonuria |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-12-19 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2025-12-19 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to advance our understanding of the cognitive and neurophysiologic sequelae associated with suboptimal phenylalanine (Phe) metabolism in heterozygous carriers of phenylketonuria (PKU). The main questions it aims to answer are: * Do PKU carriers experience prolonged elevations in brain Phe levels following oral ingestion of dietary Phe? * Do PKU carriers experience disruptions in cognitive functioning following oral ingestion of dietary Phe? * Do PKU carriers experience atypical brain activity following oral ingestion of dietary Phe? Researchers will compare PKU carriers and non-carriers following oral ingestion of dietary Phe and a placebo. Participants will: * Consume Phe or a placebo at two separate visits to our facility * At each visit, they will complete a series of MRIs and cognitive tests throughout the day
Eligibility Criteria
Inclusion Criteria: * Age 18-60 years * For the PKU carrier group: Individuals who are the parent of an individual with PKU or who are otherwise have confirmed PKU carrier status (e.g., a sibling of someone with PKU who has had genetic testing done) * For the non-carrier group: Individuals who do not have PKU or a family history of PKU Exclusion Criteria: * Obesity as defined by a body mass index (BMI) over 30\* * Taking oral contraceptives on the day of testing session\* * Positive cotinine urine test showing nicotine use * History of major neurologic condition (e.g., multiple sclerosis, severe closed head injury, Parkinson's disease)) unrelated to PKU and known to adversely impact brain health and function * Contraindications for safe MRI participation such as (a) pregnancy or plans to become pregnant during period of study enrollment; or (b) metallic objects inside the body (e.g., surgical staples left in the body following surgery, middle ear prosthesis, metal foreign objects lodged inside the eye, heart pacemakers).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07220265 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Carrier of Phenylketonuria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07220265 currently recruiting?
Yes, NCT07220265 is actively recruiting participants. Contact the research team at christse@missouri.edu for enrollment information.
Where is the NCT07220265 trial being conducted?
This trial is being conducted at Columbia, United States.
Who is sponsoring the NCT07220265 clinical trial?
NCT07220265 is sponsored by University of Missouri-Columbia. The trial plans to enroll 36 participants.