Status:
NOT_YET_RECRUITING
PKU Protein Requirements
Lead Sponsor:
Emory University
Conditions:
PKU
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 o...
Detailed Description
Current phenylketonuria (PKU) protein guidelines are based on outdated methods and do not account for differences in genetics or how much medical formula an individual consumes. This research aims to ...
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)
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07194993
Start Date
November 1 2025
End Date
August 1 2027
Last Update
September 26 2025
Active Locations (1)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322