Impact of fruit and vegetables in PKU
Research type
Research Study
Full title
Impact of fruits and vegetables on metabolic control in children with PKU
IRAS ID
252561
Contact name
Anita MacDonald
Contact email
Sponsor organisation
Birmingham Women's and Children's Hospital
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
In the UK, some fruits and vegetables are permitted without measurement in the diets of people with phenylketonuria (PKU). It is proven that fruits and vegetables containing phenylalanine (Phe) up to 75mg/100g (e.g. carrots, sweet potato, tomatoes) do not affect blood Phe control but it is unknown to what extent fruits and vegetables containing Phe from 76-100mg/100g (e.g. cauliflower, broccoli, beansprouts and asparagus) increase blood Phe levels. In addition, there is very little information about how differently animal and vegetable protein affect blood Phe levels. It is believed that plant protein may have less bioavailability and therefore have less impact on blood Phe control. Our aim is to perform a randomized controlled study over 21 weeks in children (5-12y) with PKU. Children will be studied during five different time periods, examining the effect on blood Phe control when increasing Phe intake from vegetables/fruits containing Phe from 76-100 mg/100g vs. animal sources. At the end of the study, fruits and vegetables containing 76-100mg Phe/100g will continue to be given as “exchange-free” for 6 months. This is a practical, cost effective study and should bring benefit to all people with PKU following a very restrictive diet both within the UK and throughout the world.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0073
Date of REC Opinion
26 Apr 2019
REC opinion
Further Information Favourable Opinion