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New PKU food shows promise in small trial

NCT ID NCT05487378

Disease control Sponsor: APR Applied Pharma Research s.a. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed trial tested whether PKU GOLIKE, a special food for managing PKU, works better than standard amino acid protein substitutes at controlling blood phenylalanine levels. Sixteen children with PKU, aged 5 to 16, took part in a crossover study where they tried both products for 7 days each. Researchers measured blood phenylalanine and tyrosine levels, sleep quality, and diet to see if PKU GOLIKE offers smoother control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PKU GOLIKE (a food for special medicinal purposes for dietary management of PKU)
What this could lead to
If it works, this could show that PKU GOLIKE helps control blood phenylalanine levels more smoothly than standard protein substitutes.
What could go wrong
This is a small, early-stage trial with only 16 children, so results may not apply to everyone. It's a dietary supplement study, not a treatment, so it won't cure PKU.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

16 people

The number who actually took part.

Started

Jun 2023

Finished

May 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 16 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female PKU patients ≥5 years and ≤16 years of age. 2. Patients diagnosed with PKU via new born screening. 3. Taking a Phe free/low Phe protein substitute 4. On a low phenylalanine diet . 5. Absence of neurological deficiencies. 6. Adherence with dietary management and protein substitute. 7. Able to understand and comply with the requirements of the investigation and sign the Informed Consent Form/Assent form. Exclusion Criteria: 1. Age \<5 years old and \>16 years old. 2. Patients with mild PKU or HPA. 3. On sapropterin therapy. 4. Patients with late diagnosis of PKU and neurological problems. 5. History of hypersensitivity to any excipients/components of the investigational product. 6. Pregnancy or breastfeeding during the study. 7. Any moderate to severe acute illness which in the opinion of the Investigator would interfere with the study procedures or study outcome. 8. History of poor co-operation, non-adherence with dietary management, or poor adherence to investigation procedures. 9. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

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Conditions

The condition(s) this trial relates to.

phenylketonuria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Phenylketonurias

Contacts and locations

Locations

  • Birmingham Children's Hospital Steelhouse Lane

    Birmingham, B4 6NH, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.