NCT06332105

Evaluation of Low Phenylalanine Formulas

The Effects of an Innovative Glycomacropeptide Based Protein Supplement Purified to Lower the Phenylalanine Content for the Treatment of Paediatric Patients With Phenylketonuria

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Ajinomoto Co., Inc. · Industry
• Sex: All
• Age: 3 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Design This is a 2-stage, 15-week randomized crossover trial. The randomized crossover design was chosen as it reduces the influence of differences among individuals; and it offers statistical efficiency (requires fewer subjects than non-crossover designs). In summary, 2 groups of 9 participants each will be assigned to either (1) sequence 1: take GMP-AA-based PS for the first 4 weeks and then take only L-AA-based Protein Substitute for 4 weeks, or (2) take only L-AA-based Protein Substitute for the first 4 weeks and then take GMP-AA-based PS for 4 weeks. At the end of the first 4 weeks, a 2-week washout period will follow with both groups only consuming L-AA-based PS. Randomization will be generated by a block randomization system and the random order will be kept within a sealed envelope. Primary research objective The principal research objective of this study is to evaluate the effect on Phe levels of a low-Phe diet combined with a purified GMP-AA-based protein substitute (containing 1 mg Phe/g Protein Equivalent), in the treatment of paediatric patients with PKU. Secondary research objectives The secondary objectives of the study aim to investigate whether there are any differences between the GMP-AA-based protein substitute and L-AA-based protein Substitute in the frequency and quantity of protein substitute intake, if any GI (gastrointestinal) symptoms occur with ingestion of the GMP-AA-based protein substitute, effect on satiety (hunger) and mood and any differences in anthropometric data.

Conditions

• Phenylketonurias

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-30
• Primary completion: 2025-01-01
• Completion: 2025-04-01
• First posted: 2024-03-27
• Last updated: 2024-04-15

Locations

2 sites across 1 country: United Kingdom