PKU Explore
Research type
Research Study
Full title
A study to evaluate the acceptability of PKU explore, a renovated phenylalanine free second stage protein substitute for use in the dietary management of Phenylketonuria in infants from 6 months to 5 years of age with regard to product tolerance and adherence.
IRAS ID
219119
Contact name
Anita MacDonald
Contact email
Sponsor organisation
Vitaflo International Ltd
Duration of Study in the UK
0 years, 1 months, 15 days
Research summary
During their first year, infants grow rapidly and so protein and energy needs are constantly increasing. As the first developmental milestones are reached complementary feeding begins. This leads to a reduction in the volume of breast milk/standard infant formula, reliance on liquids/a bottle is reduced and an appetite for solid food is established.\n\nWeaning is challenging in PKU and the nutritional requirements require attention. Care-givers of infants with PKU may be uncertain about introducing new foods for fear of food refusal and subsequently poor blood phenylalanine control, and this may delay developmental progress through the normal weaning stages.\n\nIn PKU as the daily amount of protein needed increases, so too does the volume of Phe-free formula taken. It is difficult to meet the recommended daily protein needs of many infants on formula feeds alone. One of the challenges is to find a balance between giving appropriate solid foods and maintaining sufficient intake of Phe-free protein substitute to meet protein requirements.\n\nSmall quantities of a concentrated second stage protein substitute in the form of a paste can be gradually introduced in the second 6 months of life. This replaces the liquid phe-free formula, providing a major source of non-phenylalanine protein by one year.\n\nSystematically introducing a concentrated second stage protein substitute at around 6 months allows Phe-free infant formula volumes to not exceed around 500 - 600ml/day between 6 and 12 months of age. It provides Phe-free protein equivalent in a much lower volume than infant formula.\n\nThis low volume, encourages normal feeding development by decreasing reliance on bottles and allowing appetite for foods. It helps ensure that the necessary amount of protein equivalent is consumed. This aids growth and metabolic control.\n\nThe purpose of the study is to determine the gastrointestinal tolerance, palatability and participant adherence with PKU Explore.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0223
Date of REC Opinion
12 Apr 2017
REC opinion
Favourable Opinion