PhenylketonuriasNCT05249218
Impact of Fruit and Vegetables in PKU
A study testing Phase B - Extra 1 Phe exchange from fruits/vegetables containing Phe from 76-100mg/100g, Phase C - Extra 2 Phe exchanges from fruits/vegetables containing Phe from 76-100mg/100g and Phase D - Extra 1 Phe exchange from milk or yoghurt in people with Phenylketonurias, run by Alex Pinto at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Phenylketonurias
- What is being tested?
- Phase B - Extra 1 Phe exchange from fruits/vegetables containing Phe from 76-100mg/100g, Phase C - Extra 2 Phe exchanges from fruits/vegetables containing Phe from 76-100mg/100g and Phase D - Extra 1 Phe exchange from milk or yoghurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jul 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- PKU patients diagnosed by NBS and BH4 deficiencies;
- Early and continuously treated;
- Adherent to their prescribed PKU diet consisting of a protein-restricted diet and Phe-free amino acid based protein substitute;
- In good general health as evidenced by medical history;
- Able to provide written informed consent/assent (parent/child);
- Able to comply with the study protocol and take study product according to the opinion of the PI;
- Patients with good metabolic control (age 5-12y, 120-360μmol/L) with 3 out of 4 levels within range prior to consent (if 2 of 4 above target range but one close to the upper limit, PI to decide if patient can enter the study).
Who cannot join
- Concomitant diseases / disorders such as renal or gut disease / disorders and diabetes;
- Dislikes fruits and vegetables containing 76-100 mg of Phe/100g e.g.brocolli or cauliflower;
- Treated with BH4 (sapropterin);
- Presence of intercurrent infection;
- Patients with poor metabolic control (age 5-12y, >360μmol/L).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham Women's and Children's Hospital
Birmingham, West Midlands, B4 6NH
About this study
Official title: Impact of Fruits and Vegetables on Metabolic Control in Children With PKU
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
- Being tested
- Phase B - Extra 1 Phe exchange from fruits/vegetables containing Phe from 76-100mg/100g, Phase C - Extra 2 Phe exchanges from fruits/vegetables containing Phe from 76-100mg/100g, Phase D - Extra 1 Phe exchange from milk or yoghurt, Phase E - Extra 2 Phe exchanges from milk or yoghurt
- Keywords
- Fruit and vegetables, Phenylalanine, Animal protein, Vegetable protein
- Medical subject headings
- Phenylketonurias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase B - Extra 1 Phe exchange from fruits/vegetables containing Phe from 76-100mg/100gOther
Usual low Phe diet + 60g fruits/vegetables containing Phe from 76-100mg/100g
Phase C - Extra 2 Phe exchanges from fruits/vegetables containing Phe from 76-100mg/100gOther
Usual low Phe diet + 120g fruits/vegetables containing Phe from 76-100mg/100g
Phase D - Extra 1 Phe exchange from milk or yoghurtOther
Usual low Phe diet but 1 x 50 mg extra Phe exchange from milk or yoghurt
Phase E - Extra 2 Phe exchanges from milk or yoghurtOther
Usual low Phe diet but 2 x 50 mg extra Phe exchange from milk or yoghurt eaten daily
| Study group | Role | What they receive |
|---|---|---|
| Group starting intervention with vegetable protein | Active comparator | Phase A followed by Phases B, C, D, E. Receives: Other: Phase B - Extra 1 Phe exchange from fruits/vegetables containing Phe from 76-100mg/100g; Other: Phase C - Extra 2 Phe exchanges from fruits/vegetables containing Phe from 76-100mg/100g; Other: Phase D - Extra 1 Phe exchange from milk or yoghurt; Other: Phase E - Extra 2 Phe exchanges from milk or yoghurt |
| Group starting intervention with animal protein | Active comparator | Phase A followed by Phases D, E, B, C. Receives: Other: Phase B - Extra 1 Phe exchange from fruits/vegetables containing Phe from 76-100mg/100g; Other: Phase C - Extra 2 Phe exchanges from fruits/vegetables containing Phe from 76-100mg/100g; Other: Phase D - Extra 1 Phe exchange from milk or yoghurt; Other: Phase E - Extra 2 Phe exchanges from milk or yoghurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Phe levels three times a week of patients with PKU taking extra 1 or 2 exchanges of fruits and vegetables containing 76-100mg of Phe/100g during 4 weeks each.
Measured: 8 weeks
Blood Phe levels three times a week of patients with PKU taking extra 1 or 2 exchanges of animal protein during 4 weeks each.
Measured: 8 weeks
Secondary outcomes (1)
Blood Phe levels three times a week with PKU taking fruits and vegetables containing 76-100mg of Phe/100g without measurement during 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start20 Jul 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhenylketonuriasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a prospective, randomised controlled study over 21 weeks in children to assess how Phe intake from fruits and vegetables (containing 76-100 mg Phe/100g) vs. animal sources will impact on blood Phe control. This will be followed by a 6 months extension study examining the 'unlimited' use of fruits and vegetables containing Phe 76-100 mg/100g on blood Phe control.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alex Pinto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alex Pinto, Birmingham Children's Hospital, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249218
- Sponsor's protocol ID
- 18/BC/DTS/NO/215
- Status last verified
- Feb 2022
- First submitted
- 10 Jun 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fruits and Vegetables on Metabolic Control in Children With PKU
- ClinicalTrials.gov ID
- NCT05249218
- Acronym / sponsor ID
- 18/BC/DTS/NO/215
- Conditions
- Phenylketonurias
- Keywords
- Fruit and vegetables, Phenylalanine, Animal protein, Vegetable protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Alex PintoUniversity, hospital or other
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomised controlled study over 21 weeks in children to assess how Phe intake from fruits and vegetables (containing 76-100 mg Phe/100g) vs. animal sources will impact on blood Phe control. This will be followed by a 6 months extension study examining the 'unlimited' use of fruits and vegetables containing Phe 76-100 mg/100g on blood Phe control.
| Arm | Type | Receives |
|---|---|---|
| Group starting intervention with vegetable protein | Active comparator | Other: Phase B - Extra 1 Phe exchange from fruits/vegetables containing Phe from 76-100mg/100g, Other: Phase C - Extra 2 Phe exchanges from fruits/vegetables containing Phe from 76-100mg/100g, Other: Phase D - Extra 1 Phe exchange from milk or yoghurt, Other: Phase E - Extra 2 Phe exchanges from milk or yoghurtPhase A followed by Phases B, C, D, E. |
| Group starting intervention with animal protein | Active comparator | Other: Phase B - Extra 1 Phe exchange from fruits/vegetables containing Phe from 76-100mg/100g, Other: Phase C - Extra 2 Phe exchanges from fruits/vegetables containing Phe from 76-100mg/100g, Other: Phase D - Extra 1 Phe exchange from milk or yoghurt, Other: Phase E - Extra 2 Phe exchanges from milk or yoghurtPhase A followed by Phases D, E, B, C. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- PKU patients diagnosed by NBS and BH4 deficiencies;
- Early and continuously treated;
- Adherent to their prescribed PKU diet consisting of a protein-restricted diet and Phe-free amino acid based protein substitute;
- In good general health as evidenced by medical history;
- Able to provide written informed consent/assent (parent/child);
Key exclusion criteria (5 listed)
- Concomitant diseases / disorders such as renal or gut disease / disorders and diabetes;
- Dislikes fruits and vegetables containing 76-100 mg of Phe/100g e.g.brocolli or cauliflower;
- Treated with BH4 (sapropterin);
- Presence of intercurrent infection;
- Patients with poor metabolic control (age 5-12y, >360μmol/L).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase B - Extra 1 Phe exchange from fruits/vegetables containing Phe from 76-100mg/100gUsual low Phe diet + 60g fruits/vegetables containing Phe from 76-100mg/100g | Other | Group starting intervention with animal protein, Group starting intervention with vegetable protein |
| Phase C - Extra 2 Phe exchanges from fruits/vegetables containing Phe from 76-100mg/100gUsual low Phe diet + 120g fruits/vegetables containing Phe from 76-100mg/100g | Other | Group starting intervention with animal protein, Group starting intervention with vegetable protein |
| Phase D - Extra 1 Phe exchange from milk or yoghurtUsual low Phe diet but 1 x 50 mg extra Phe exchange from milk or yoghurt | Other | Group starting intervention with animal protein, Group starting intervention with vegetable protein |
| Phase E - Extra 2 Phe exchanges from milk or yoghurtUsual low Phe diet but 2 x 50 mg extra Phe exchange from milk or yoghurt eaten daily | Other | Group starting intervention with animal protein, Group starting intervention with vegetable protein |
Primary outcome
Blood Phe levels three times a week of patients with PKU taking extra 1 or 2 exchanges of fruits and vegetables containing 76-100mg of Phe/100g during 4 weeks each.
Time frame: 8 weeks
Blood Phe levels three times a week of patients with PKU taking extra 1 or 2 exchanges of animal protein during 4 weeks each.
Time frame: 8 weeks
1 secondary outcome
Blood Phe levels three times a week with PKU taking fruits and vegetables containing 76-100mg of Phe/100g without measurement during 6 months.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase B - Extra 1 Phe exchange from fruits/vegetables containing Phe from 76-100mg/100g, Phase C - Extra 2 Phe exchanges from fruits/vegetables containing Phe from 76-100mg/100g and Phase D - Extra 1 Phe exchange from milk or yoghurt in people with Phenylketonurias, run by Alex Pinto at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Phe levels three times a week of patients with PKU taking extra 1 or 2 exchanges of fruits and vegetables containing 76-100mg of Phe/100g during 4 weeks each. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.