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PKU Protein Requirements

NCT07194993 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-14

No results posted yet for this study

Summary

The objective of this research is to determine the protein requirements based on genotype and medical food consumption in a sample of adults with Phenylketonuria (PKU) using the indicator amino acid oxidation (IAAO) method.

Conditions

  • PKU

Interventions

OTHER

Nonradioactive stable oral isotope

NaH13CO3 \[99% atom percent excess (APE) and L-\[1-13C\]Leu (99% APE) will be given orally. Isotope administration will begin with the fifth meal on each study day with each remaining meal. The nonradioactive stable oral isotope is being administered to study the physiological process of amino acid oxidation.

OTHER

Test diet

Test diets will be provided on study days in 8 hourly isocaloric and isonitrogenous meals to maintain a metabolic steady state. Each meal will provide one-twelfth of the participant's daily needs to model a 12-hour fasted and 12-hour fed feeding pattern. The diet will be composed of PFD2 (Mead Johnson), Tang and Kool-Aid (Kraft), corn oil, and protein-free wheat starch cookies. Each participant will receive 1 of 7 test protein intakes (0.2-3.2 g ⋅ kg-1 ⋅ d-1) on each study day. Protein will be provided as a crystalline L-amino acid mixture based on an egg protein pattern. Phe will be provided separately based on the Phe tolerance for each patient established by the metabolic dietitian listed on the IRB protocol. Leucine will be provided at a constant amount of 82.6 mg/kg/day as it is used as the indicator amino acid. The medical food used in this study is being fed to subjects for nutritional purposes to study the oxidation of the nonradioactive oral isotope.

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-16
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07194993 on ClinicalTrials.gov