Acceptability and Tolerance of a Ready-to-use Protein Substitute in Tablet Form for the Dietary Management of Phenylketonuria

CompletedOBSERVATIONAL
Enrollment

10

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

May 1, 2021

Study Completion Date

May 10, 2021

Conditions
PhenylketonuriasHyperphenylalaninaemiaTetrahydrobiopterin Deficiency
Interventions
DIETARY_SUPPLEMENT

Phenylalanine-free protein substitute in tablet form (XPhe minis)

Intervention is a Phenylalanine-free protein substitute in tablet form. Subjects who currently take a concentrated second stage phenylalanine-free protein substitute will be recruited. Subjects will take the study product for 7 days and daily questionnaires will be completed. Subjects will replace some or all of their usual protein substitute with the new product. The amount of study product prescribed will be calculated to provide the same amount of protein as their usual protein substitute. Daily acceptability and tolerance questionnaires will record information on ease of preparation and administration; how it is taken; and any problems or gastrointestinal effects. Additional questions at the beginning and end of the study will record information on taste, appearance, smell, presentation and packaging of the product. Routine weekly finger prick blood spots will be collected and analysed for phenylalanine and tyrosine as usual.

Trial Locations (1)

B4 6NH

Birmingham Children´s Hospital, Birmingham

All Listed Sponsors
collaborator

Birmingham Children's Hospital

OTHER

lead

metaX Institut fuer Diatetik GmbH

INDUSTRY

NCT04375592 - Acceptability and Tolerance of a Ready-to-use Protein Substitute in Tablet Form for the Dietary Management of Phenylketonuria | Biotech Hunter | Biotech Hunter