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Impact of Phenylalanine Elevations on Brain and Cognition in Adult PKU Carriers

University of Missouri-Columbia · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NCT07220265

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Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–60 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
36
US sites recruiting
1
Study start
December 19, 2025
Record last updated
October 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Phenylalanine (Phe); Placebo

Conditions: Carrier of Phenylketonuria; Healthy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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).

Recruiting US locations

  • University of Missouri-Columbia

    Columbia, MO 65201

    Site contact: Shawn Christ · 573-884-8140 · christse@missouri.edu

Study contacts (from the official record)

  • Shawn Christ · 573-884-8140 · christse@missouri.edu
All healthy volunteers studies in Missouri →
Impact of Phenylalanine Elevations on Brain and Cognition in Adult… (NCT07220265) | Bored Studies