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Evaluation of Low Phenylalanine Formulas

NCT06332105 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-04-15

No results posted yet for this study

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.

Conditions

  • Phenylketonurias

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

Sponsors & Collaborators

  • Birmingham Children's Hospital

    collaborator OTHER

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER

  • Ajinomoto Co., Inc.

    lead INDUSTRY

Principal Investigators

  • Anita MacDonald, BSc PhD · Birmingham Women and Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-30
Primary Completion
2025-01-31
Completion
2025-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06332105 on ClinicalTrials.gov