An interventional study of PKU express plus in Phenylketonurias, PKU and Homocystinuria, sponsored by Vitaflo International, Ltd. Completed at 6 sites in United Kingdom. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Vitaflo International, Ltd (part of Nestlé S.A.) · Not applicable, Interventional, and Supportive care
A prospective, open label, acceptability study to evaluate PKU, MSUD, HCU, TYR and GA express plus in the dietary management of 40 patients with IEM. The following parameters will be assessed: adherence to prescribed dietary intakes, palatability, usability, gastrointestinal tolerance, clinically relevant routine biochemical parameters, timeframe to transition and contribution of the express plus range to overall protein substitute intake over a 28 day period.
This is a prospective acceptability study of the express plus range in 40 participants aged at least three years of age for the dietary management of IEM (PKU, MSUD, HCU, TYR and GA ).
The study will involve a Transition Period where patients will build-up to at least one sachet of express plus per day. During the Transition Period, daily intake of express plus and the patient's other PS will be recorded, including the time taken to consume.
The Transition Period will last a maximum of 6 weeks, after which the patient will enter a 28-day Evaluation Period. During the Evaluation Period, patients will continue to record intakes, as well as GI tolerance and a final evaluation of the product's palatability and usability. Some patients, likely adults, will not require a transition from their original protein substitute to at least one sachet of express plus. These patients can enter the Evaluation Period directly.
The end of the 4-week Evaluation Period is defined as the participant's End of Study. Following this, participants will be followed up as per standard of care. Some of this standard of care data may be relayed to the sponsor for a maximum of 26 weeks. This will last for a maximum of 26 weeks and will involve the collection of routine phe and tyrosine levels, as well as amount of PS prescribed and taken. Information will also be collected from patients regarding the reasons for the success or indeed failure of transition to PKU express plus. This data will come from routine clinical contact and will be recorded by the HCP, rather than by the patient.
191 studies on the registry are indexed under Phenylketonurias; 40 are open to participants now.
This study's enrollment of 28 is close to 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..
Counted across the registry records on this site, refreshed daily.
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.
In the opinion of the study investigator, the participant is able to take the study product and meets at least one of the following criteria:
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.
express plus to be transitioned onto over a maximum of 6 weeks and then incorporated into each participants usual diet for 28 days. Amount taken and frequency to be determined by dietitian.
Dietary Supplement: PKU express plus
PKU express plus is a powdered protein substitute for the dietary management of PKU. It is formulated in a variety of flavours to provide a convenient, low volume, lower calorie, pre-measured protein substitute, containing a full micronutrient profile.
Questionnaire of self-reported adherence to the prescribed amount of study product
Participants will record the amount of PKU express taken each day compared to the amount recommended by their dietitian
Time frame: Days 1-28
Transition time
Time taken for participants to transition from their current diet to the inclusion of one sachet of PKU express plus per day
Time frame: Transition period Weeks 1-6 (maximum)
Change in gastrointestinal tolerance from week 1 to week 4
Participants will self-report any gastrointestinal symptoms experience over the course of the study in daily study diaries
Time frame: Days 1-7 and days 21-28
Product acceptability rated on a Likert scale by the patient after 28-day intake
Participants will answer questions relating to PKU express plus' palatability and ease of use following the end of study
Time frame: Visit 2 (end of 28 day evaluation period)
Change in general neophobia
Participants to complete general neophobia questionnaire at baseline and end of study to compare results
Time frame: Visit 1 (Day 1) and Visit 2 (end of 28 day evaluation period)
Change in food neophobia
Participants to complete food neophobia questionnaire at baseline and end of study to compare results
Time frame: Visit 1 (Day 1) and Visit 2 (end of 28 day evaluation period)
Nutritional suitability: change Phenylalanine levels
PKU express plus' nutritional suitability will be assessed by evaluating Phenylalanine levels recorded as part of routine care
Time frame: Visit 1 until visit 2 (day 28)
Nutritional suitability: change Tyrosine levels
PKU express plus' nutritional suitability will be assessed by evaluating Tyrosine levels recorded as part of routine care
Time frame: Visit 1 until visit 2 (day 28)
Plan to share: No — No plans to share IPD
No publications or documents are linked to this record.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.