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PKU Protein Requirements Study

This study is looking for adults with Phenylketonuria (PKU) to help researchers understand their protein needs better. Current guidelines for protein intake in PKU might not be accurate for everyone, especially considering different genetic backgrounds and how much medical formula people use. This research aims to find more personalized protein requirements. You would receive a special diet and an oral tracer called NaH13CO3 and L-[1-13C]Leu, which are non-radioactive substances used to safely measure how your body uses protein. The main goal is to see how your body processes these tracers in your breath, which helps determine protein needs. This study is recruiting 18 participants and is currently unclear on its status.

Study design
This is an interventional study planning to enroll 18 adult participants with PKU. It will use a direct method called indicator amino acid oxidation technique.
What's involved
You would attend one preliminary visit and 7 study days, each lasting 8 hours. The total study participation is expected to be about 4-6 months, and includes surveys, body measurements, diet history, and collection of blood, urine, and breath samples.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in breath samples between 3 and 8 hours after the intervention.

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NCT07194993

PKU Protein Requirements

Recruiting
NAAges 18+Interventional
Emory University
~18 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Nonradioactive stable oral isotopeTest diet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in rate of oxidation of tracer in the expired breath
Measured over Baseline, post-intervention (3-8 hours post-baseline)

Conditions

PKU

Explore related trials

PhenylketonuriaGenotyping

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Rani Singh, PhD, RDN, LD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Jessica Strosahl, PhD, RDN, LD
[email protected]
404-727-1528
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

will be males and females (50:50) 18 years and older who were diagnosed with PKU through newborn screening or diagnosis later in life, capable of providing consent, and have previously had mutation testing

Exclusion

include concurrent illness, recent history of weight loss or acute illness during the past 6 months that could affect protein metabolism, pregnancy, lack of regular menstruation, implantable electronic devices or pacemakers, history of claustrophobia, and inability to provide consent. In addition, participants will be excluded if their genotype subgroup has already reached its predefined maximum enrollment (n=4)

What this trial measures

  • Change in rate of oxidation of tracer in the expired breathBaseline, post-intervention (3-8 hours post-baseline)

    The rate of oxidation of tracer in the expired breath will be measured in each study day.