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Impact of Fruit and Vegetables in PKU

NCT05249218 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-02-21

No results posted yet for this study

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. The investigators 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.

Conditions

  • Phenylketonurias

Interventions

OTHER

Phase B - Extra 1 Phe exchange from fruits/vegetables containing Phe from 76-100mg/100g

Usual low Phe diet + 60g fruits/vegetables containing Phe from 76-100mg/100g

OTHER

Phase C - Extra 2 Phe exchanges from fruits/vegetables containing Phe from 76-100mg/100g

Usual low Phe diet + 120g fruits/vegetables containing Phe from 76-100mg/100g

OTHER

Phase D - Extra 1 Phe exchange from milk or yoghurt

Usual low Phe diet but 1 x 50 mg extra Phe exchange from milk or yoghurt

OTHER

Phase E - Extra 2 Phe exchanges from milk or yoghurt

Usual low Phe diet but 2 x 50 mg extra Phe exchange from milk or yoghurt eaten daily

Sponsors & Collaborators

  • Alex Pinto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-20
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05249218 on ClinicalTrials.gov