An interventional study of PKU UP in PKU, sponsored by Vitaflo International, Ltd. Completed at 7 sites in United Kingdom. Open to participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Vitaflo International, Ltd (part of Nestlé S.A.) · Not applicable, Interventional, and Treatment
PKU UP is a prospective, single-arm, open-label, 26-week acceptability study to evaluate PKU UP for the dietary management of participants with phenylketonuria (PKU). Up to 15 participants aged 1 - 10 years old will be recruited and it is anticipated the study will open in at least three sites in the United Kingdom (UK) to recruit the target number of participants in the required timeframe.
PKU is a rare inborn error of metabolism with a prevalence of 1 in 10,000 in the UK population. The mainstay of treatment for most individuals is dietary therapy with a strict protein-restricted diet. We propose to recruit children with a diagnosis of PKU aged 1-10 years.
The study product, PKU UP, is a food for special medical purposes (FSMP), as defined by the Delegated Act EU 2016/128, used for the dietary management of Phenylketonuria (PKU).
The study will be investigating the acceptability of PKU UP, as defined by the Advisory Committee on Borderline Substances (ACBS). This includes the following:
Each participant will be on the study for 26 weeks. This includes evaluation part 1 and evaluation part 2:
Data collection will be performed using paper and/or electronic Case Report Forms completed by the investigators at the baseline, evaluation periods and end of study visits. There will also be three questionnaires completed by the parents/guardians over the course of the study, in relation to protein substitute intake, gastrointestinal tolerance, and product acceptability.
191 studies on the registry are indexed under Phenylketonurias; 40 are open to participants now.
This study's enrollment of 16 is below the median of 27 across 122 interventional studies indexed under Phenylketonurias.
Browse Phenylketonurias studies →Vitaflo International, Ltd is the lead sponsor of 23 studies on the registry; none are open to participants now.
First submitted after Vitaflo International, Ltd became part of Nestlé S.A..
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will be assessed by their dietitian and prescribed an appropriate amount of the study product, PKU UP, to manage their phenylketonuria.
Dietary Supplement: PKU UP
PKU UP is a food for special medical purposes (FSMP). This product is for use in the dietary management of Phenylketonuria (PKU) in children aged from one (1) to ten (10) years. PKU UP is a neutral-flavoured, ready-to-drink, low-phenylalanine protein substitute containing a blend of glycomacropeptide (GMP) isolate, essential and non-essential amino acids, fat, carbohydrate, vitamins, minerals and docosahexaenoic acid (DHA).
Change in phe level between baseline and visit 3
Change in phe level as measured by dried blood spot testing
Time frame: 26 weeks
Change in tyrosine level between baseline and visit 3
Change in tyrosine level as measured by dried blood spot testing
Time frame: 26 weeks
Change in PI impression of metabolic control
Assessment of the participant's metabolic control in the opinion of the investigator
Time frame: Week 0, week 6, week 12, week 26
Change in the growth of participants as measured by Height (length in under 2 years of age), Head circumference in under 2 years of age and Weight.
Assessed via anthropometry measurements. Participants will be weighed and measured for growth monitoring.
Time frame: Week 0, week 12, week 26
Change in GI tolerance (participant)
Gastrointestinal tolerance assessed using the PedsQL Gastrointestinal Symptoms Scale completed by the participants
Time frame: Week 0, week 6, week 12, week 26
Change in PI impression of GI tolerance
Assessment of the participant's GI tolerance in the opinion of the investigator
Time frame: Week 0, week 6, week 12, week 26
Change in compliance with study product consumption
Assessed via participant diary regarding study product intake
Time frame: Week 0, week 6, week 12, week 26
Change in PI impression of study product intake
Assessment of the participant's compliance in the opinion of the investigator
Time frame: Week 0, week 6, week 12, week 26
Change in product acceptability
Assessed via a product acceptability questionnaire completed by the participant/parent
Time frame: Week 0, week 12, week 26
Change in dietary intake
Assessed via 24-hour recall and low protein food frequency questionnaire
Time frame: Week 0, week 12, week 26
Change in nutritional biochemistry
Assessed via venous blood sample of approximately 10ml
Time frame: Week 0, week 26
Plan to share: No
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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