Evaluation of PKU express plus
Research type
Research Study
Full title
A STUDY TO EVALUATE THE ACCEPTABILITY OF PKU EXPRESS PLUS, A FOOD FOR SPECIAL MEDICAL PURPOSES (FSMP), IN CHILDREN AND ADULTS WITH PHENYLKETONURIA (PKU).
IRAS ID
281995
Contact name
Anita MacDonald
Contact email
Sponsor organisation
Vitaflo
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Establishing good practices with protein substitute administration in childhood is essential so this may continue into adulthood. When choosing an appropriate protein substitute (PS), it is always important to consider the age and development needs of the individual.
Vitaflo International has renovated PKU express (introduced in the UK in 2002 as the first low volume, concentrated, protein substitute for children and adults), now PKU express plus, for the purpose of updating both its nutritional formulation, texture and packaging. To improve the texture of the product Vitaflo is using the same starch in PKU express plus as in PKU explore, a recently launched second stage protein substitute. It is anticipated that this will lead to an easier transition for patients as there will be comparable sensory properties between these products when taken as a semi-solid consistency. PKU express plus can also be taken as a low volume drink. It is anticipated an improvement in texture and mouthfeel will assist the transition of those individuals with PKU who are on a nutritionally age inappropriate PS.
This is a prospective study to evaluate the acceptability in terms of gastrointestinal tolerance, palatability and adherence in individuals with PKU aged 3 years and over. For children up to the age of 13, neophobia scores and transition rates from existing product to PKU express plus will also be assessed.
The outcome of this assessment will be used in a submission by Vitaflo (International) Ltd to the Advisory Committee on Borderline Substances (ACBS) for PKU express plus to become reimbursable on prescription in the UK.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
20/YH/0248
Date of REC Opinion
17 Sep 2020
REC opinion
Favourable Opinion