Phe and tyr concentrations over 24hrs GMP vs L amino acids
Research type
Research Study
Full title
A four week randomisation crossover prospective study investigating the 48 hour blood phenylalanine and tyrosine profiles of Glycomacropeptide (GMP) compared with phenylalanine-free L-amino acid supplements in PKU
IRAS ID
188162
Contact name
Anne Daly
Contact email
Sponsor organisation
Birmingham Children's Hospital
Duration of Study in the UK
0 years, 0 months, 31 days
Research summary
The main treatment for PKU is a low phenylalanine diet. Part of this treatment involves taking a phenylalanine-free protein substitute. This is essential for normal growth and development. Conventional protein substitutes are made from individual amino acids, these are called phenylalanine-free L-amino acid protein substitutes. A protein substitute containing GMP has been developed. GMP is different from protein substitutes made only with amino acids, because it is made from a peptide and some free amino acids (about 60% peptide and 40% free amino acids). GMP does contain a little phenylalanine but the amount is very small in comparison to the phenylalanine intake in the rest of the diet The children who will be recruited to this study, will already be taking GMP as part of a longer term study. We will look at how phenylalanine and tyrosine concentrations change over 2 consecutive days. We will aim to recruit 15- 18 children
The study will take place over 4 weeks. week 1 is a control week in which they take the usual substiute , week 2 and 4 subjects will take 100% GMP or amino acid substitute in random order.Week 3 is a washout period back to usual substitute. A standard meal plan is taken on days 5,6,7, 12.13,14 and 19,20,21 all food intake will be recorded. Finger prick blood spots will be collected 4 hrly over 48hrs on days 6,7, 13,14, 20,21. Week 2 and 4 protein substitute will be taken at set times. Week 1 protein substitute will be taken as per usual routine.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
15/WM/0335
Date of REC Opinion
17 Nov 2015
REC opinion
Further Information Favourable Opinion