GMP Powdered Substitutes in PKU and TYR

Launched by NUTRICIA UK LTD · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying four new powdered protein substitutes designed to help people with phenylketonuria (PKU) or tyrosinemia (TYR) manage their diets. These substitutes are made from a special protein called glycomacropeptide (GMP), which is low in the amino acids phenylalanine and tyrosine. The trial aims to see how well these new products are tolerated by both adults and children, how much participants like them, and whether they can successfully stick to using them over a period of 28 days. Previous studies suggest that patients who use these GMP-based substitutes may find them tastier and easier to include in their diets, while still keeping their metabolic health in check.

To be eligible for this trial, participants need to be at least 3 years old and diagnosed with PKU or TYR. They should have been taking a protein substitute for at least a month before joining the study. Participants will be monitored for 29 days, including a day to establish a baseline before starting the new products. It’s important to know that the trial is not yet recruiting participants, and those who are pregnant, require certain medical treatments, or have allergies to the study products are not eligible to join. If you or someone you know might be interested, it's a good idea to talk to a healthcare provider about the details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female
• • Over 3 years of age
• • Patients diagnosed with any phenotype of PKU characterised by hyperphenylalaninaemia or patients diagnosed with tyrosinaemia
• • Have been compliant in taking at least one protein substitute, providing at least 15g protein equivalents, for at least 1 month prior to trial commencement
• • Have a prescribed daily phenylalanine or phenylalanine and tyrosine allowance for PKU or TYR respectively
• • Written or electronic informed consent from patient, and/or from parent/caregiver if applicable
• • Participants who are anticipated to be able to take at least one sachet of GMP Product per day
• Exclusion Criteria:
• • Pregnant or lactating
• • Requiring parenteral nutrition
• • Major hepatic or renal dysfunction
• • Participation in other studies within 1 month prior to entry of this study
• • Allergy to any of the study product ingredients
• • Investigator concern around willingness/ability of patient or parent/caregiver to comply with protocol requirement