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PKU Carriers' brains under the microscope: does phenylalanine cause hidden effects?

NCT ID NCT07220265

Knowledge-focused Sponsor: University of Missouri-Columbia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study examines how adults who carry the gene for phenylketonuria (PKU) but do not have the disease handle phenylalanine, a common amino acid. Researchers will give participants phenylalanine or a placebo and then use MRI scans and cognitive tests to measure brain activity, thinking skills, and blood levels. The goal is to understand if carriers experience subtle brain or cognitive changes after consuming phenylalanine.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Phenylalanine (Phe)
What this could lead to
If successful, this study could reveal whether PKU carriers face hidden cognitive or brain changes after eating phenylalanine, guiding future health advice.
What could go wrong
This is a small, early-stage observational study with only 36 participants. It looks at short-term effects, not long-term health outcomes, so results may not apply broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carrier of phenylketonuria Healthy

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Missouri-Columbia

    RECRUITING

    Columbia, Missouri, 65201, United States

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