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ACTIVE NOT RECRUITING
NCT06332105
NA

Evaluation of Low Phenylalanine Formulas

Sponsor: Ajinomoto Co., Inc.

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Glytactin

Glycomacropeptide based protein substitute for dietary treatment of PKU

DIETARY_SUPPLEMENT

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