Protein needs in PKU adults by genotype and formula use
Official title: Defining Protein Requirements in Adults With PKU: Impact of Genotype and Medical Food Intake
Run by Emory University · NCT07194993 · Data updated 2026-11-12
This study tests personalized protein needs in adults with PKU using a safe isotope method to see if genetics and how much medical formula they use change how much protein they need.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Status | Recruiting |
| Started | February 16, 2026 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07194993 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with PKU (18+ years) who have known PKU mutations, are able to consent, and are not pregnant or otherwise excluded.
✕Probably not a fit
Participants with conditions or circumstances that significantly alter protein metabolism beyond PKU, or those with contraindications to study procedures, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will determine protein requirements in adults with PKU using the indicator amino acid oxidation technique. The study considers genetic differences and the mix of natural protein versus medical formula. It involves one preliminary visit and seven 8-hour study days with diet control, biosample collection, and indirect calorimetry at Emory University. Participants may opt to bank blood and urine samples for future research, and enrollment is expected to take 4–6 months. The trial excludes vulnerable populations and other conditions that could affect protein metabolism.
Why it matters
Potential benefit: If successful, results could lead to more precise, genotype-based protein guidelines for adults with PKU.
How similar studies have gone: Prior work using similar isotope methods has shown promise in personalizing nutrient needs, though this exact genotype-stratified approach is relatively novel in PKU.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where it's running
-
Emory University Hospital
Atlanta, Georgia, United States Recruiting
Study contacts
- Principal investigator: Rani Singh, PhD, RDN, LD — Emory University
- Study coordinator: Jessica Strosahl, PhD, RDN, LD
- Email: jessica.nash.strosahl@emory.edu
- Phone: 404-727-1528
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.