The Impact of Phenylalanine Elevations on Metabolic, Cognitive, and Neural Functioning in Adults Heterozygous for Phenylketonuria (PKU)

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 heterozygyous 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
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• 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

Locations
United States
Missouri
University of Missouri-Columbia
RECRUITING
Columbia
Contact Information
Primary
Shawn Christ
christse@missouri.edu
573-884-8140
Time Frame
Start Date: 2025-11
Estimated Completion Date: 2027-04
Participants
Target number of participants: 36
Treatments
Other: PKU Carriers
Heterzygous carriers of a pathogenic variant of the PAH gene associated with phenylketonuria (PKU)
Other: Non-Carriers
Individuals who do not carry a pathogenic variant of the PAH gene
Related Therapeutic Areas
Sponsors
Leads: University of Missouri-Columbia
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov