An interventional study of Glytactin and L-AA in Phenylketonurias, sponsored by Ajinomoto Co., Inc.. Status unknown at 2 sites in United Kingdom. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by Ajinomoto Co., Inc. · Not applicable, Interventional, and Treatment
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.
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.
187 studies on the registry are indexed under Phenylketonurias; 38 are open to participants now.
This study's planned enrollment of 19 is below the median of 25 across 117 interventional studies indexed under Phenylketonurias.
Browse Phenylketonurias studies →Ajinomoto Co., Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Patients with PKU, aged 5 to 16 years of age, currently compliant with protein restricted diet and L-AA- and/or GMP-AA-based protein substitute willing to switch to a GMP-AA-based only product for 4 weeks.
Exclusion Criteria:
Milk protein allergy
After an initial washout period of 2 weeks, participants randomised to Sequence AB will consume GMP-AA for 3 months whilst keeping a food diary and sending blood spots for twice weekly analysis. At the end of 3 months there is a further 2 week washout period with L-AA, after which the participant will consume L-AA for 3 months whilst keeping a food diary and sending blood spots for twice weekly analysis.
Dietary Supplement: Glytactin
After an initial washout period of 2 weeks, participants randomised to Sequence BA will consume L-AA for 3 months whilst keeping a food diary and sending blood spots for twice weekly analysis. At the end of 3 months there is a further 2 week washout period with L-AA, after which the participant will consume GMP-AA for 3 months whilst keeping a food diary and sending blood spots for twice weekly analysis.
Dietary Supplement: L-AA
Glycomacropeptide based protein substitute for dietary treatment of PKU
Also known as: Glytactin Build 20 Flavours, Glytactin Ready To Drink (RTD) 15 Lite, Glytactin Build 10
Amino acid based protein substitute for dietary treatment of PKU
Change in blood Phe in
Change in blood Phe in subjects ingesting purified GMP-AA-protein substitute compared with the change when ingesting L-AA-protein substitute
Time frame: 16 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Jan 2025, 24 months after the start.
Of 32 interventional studies with no phase under Phenylketonurias, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's planned 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Ajinomoto Co., Inc.