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Evaluation of Low Phenylalanine Formulas
Sponsor: Ajinomoto Co., Inc.
Summary
Ajinomoto Cambrooke has developed a PKU protein substitute that is a proprietary blend of purified Glycomacropeptide (GMP) and essential amino acids, under the brand name Glytactin®. One serving of such Glytactin® products contains 20mg or less of Phenylalanine (Phe). The aim of the proposed study is to use this purified GMP-AA-based protein substitute, with less Phe per gram of protein equivalent than other commercially available products, in children with PKU at 100% of their protein substitute intake and evaluate its efficacy and the change in blood Phe in comparison to Phe-free L-AA-based protein substitutes.
Official title: The Effects of an Innovative Glycomacropeptide Based Protein Supplement Purified to Lower the Phenylalanine Content for the Treatment of Paediatric Patients With Phenylketonuria
Key Details
Gender
All
Age Range
3 Years - 16 Years
Study Type
INTERVENTIONAL
Enrollment
19
Start Date
2023-01-30
Completion Date
2025-04
Last Updated
2024-04-15
Healthy Volunteers
No
Conditions
Interventions
Glytactin
Glycomacropeptide based protein substitute for dietary treatment of PKU
L-AA
Amino acid based protein substitute for dietary treatment of PKU
Locations (2)
Birmingham Women and Children's Hospital
Birmingham, West Midlands, United Kingdom
Great Ormond Street Hospital for Children
London, United Kingdom