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GMP Powdered Substitutes in PKU and TYR

RecruitingNAAges 3 Years - anyAllNutricia UK Ltd
NCT06941532 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Four new GMP-based protein substitutes have been developed to support the dietary management of PKU and TYR. These products are powdered protein substitutes, low in phenylalanine and low in phenylalanine and tyrosine respectively, with a mix of glycomacropeptide (GMP), essential and non-essential amino acids, carbohydrates, fibres, fats (including DHA) and micronutrients. The proteins in these new protein substitutes are based on GMP, a peptide isolated from milk during cheese manufacturing and the only known naturally derived protein source low in phenylalanine and tyrosine. The GMP is supplemented with other amino acids which are naturally low or not present in GMP, as well as carbohydrates, fats, fibre and micronutrients. Studies to date have illustrated that PKU patients who replace their regular phenylalanine-free amino acid-based formula with GMP-based foods may have better diet co

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📋 Eligibility rules (as published)
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
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What it tests

  • GMP Intervention Product
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Where

1 site
Birmingham Women and Children's Hospital
Birmingham, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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