Not yet recruitingNAINTERVENTIONAL

Acceptability and Tolerance Market Research of a Slow Release, Phenylalanine-free Protein Substitute for the Dietary Management of Phenylketonuria

This study is exploring a new protein supplement called XPhe Piccos. It’s for children and adults who have a rare genetic condition called Phenylketonuria (PKU) or Hyperphenylalaninemia (HPA), which means they need to follow a special low-protein diet. This new supplement comes in tiny, slow-release tablets that don't contain phenylalanine (a substance people with PKU need to avoid). The main goal is to find out if people like taking these new tablets and if they cause any unwanted side effects. Having more choices for protein supplements can make it easier for people to stick to their special diet, which is important for their health and development. This small study involves 10 children aged three and over, trying the new tablets for 7 days.

At a glance

Status

Not yet recruiting

Phase

Sponsor

metaX Institut fuer Diatetik GmbH

Enrolment target

Start

01 Oct 2026

Estimated completion

01 Aug 2027

Phenylketonuria (PKU) and Hyperphenylalaninemia Brain Diseases, Metabolic, Inborn Brain Disorder, Metabolic Brain Diseases Central Nervous System Diseases Nervous System Diseases Amino Acid Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Disease, Inborn Genetic Diseases, Inborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Metabolic Diseases Nutritional and Metabolic Diseases

What is this study about?

If you or your child has Phenylketonuria (PKU) or Hyperphenylalaninemia (HPA), you'll know how important it is to stick to a special low-protein diet. A key part of this diet is taking a protein supplement to make sure you get enough nutrients for healthy growth and development. There are already different types of these supplements available, but sometimes it can be tricky to take them regularly, especially as this diet is often lifelong.

This study is looking at a new type of protein supplement called XPhe Piccos. It's designed to be a slow-release product, which means it releases its ingredients gradually over time. It comes in the form of very small tablets and doesn't contain phenylalanine, which is crucial for people with PKU/HPA. These tablets also have added vitamins and minerals. The aim is to see if this new option is a good alternative that people with PKU/HPA find easier to take and fit into their daily lives.

The researchers want to understand how people feel about taking these new tablets – whether they're easy to use, if they taste okay, and if they cause any tummy upsets or other side effects. By offering more choices in how these important supplements are taken, the hope is that it will be easier for people to manage their condition over the long term. This study will involve a small group of 10 children with PKU who are already taking a protein supplement.

Key takeaways

Looks at a new slow-release protein supplement for PKU/HPA.
Aims to find out if it's easy to take and well-tolerated.
Involves 10 children (aged 3+) trying it for 7 days.
Could offer more choices for managing PKU in the future.
No clinic visits, just daily questionnaires.

Who may be eligible?

To join this study, you or your child would need to have been diagnosed with PKU or HPA and currently use a protein supplement that doesn't contain phenylalanine. Participants must be at least 3 years old.

There are some reasons why someone might not be able to join. For example, if they have another serious illness, or if they have taken antibiotics in the two weeks before the study starts. Also, if someone is already taking part in another study involving new medicines or products, they won't be able to join this one.

Essentially, the study is looking for children aged 3 and over, who have PKU/HPA, are already on a special protein supplement, and are willing to try the new tablets for 7 days. Parents or guardians will need to give their permission (consent) for their child to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I/my child have PKU or HPA?
Do I/my child currently take a phenylalanine-free protein supplement?
Is my child aged 3 years or older?
Am I/my child generally well, without another serious illness?
Have I/my child avoided antibiotics in the last two weeks?
Am I/my child not currently in another medical research study?

Answer every question to see your result.

What does participation involve?

If you or your child decides to take part, you'll be asked to try the new XPhe Piccos tablets for 7 days. During this week, your child will replace some or all of their usual protein supplement with this new one. Each day, you or your child (if old enough) will fill out a short questionnaire. This questionnaire will ask about how easy the tablets were to take, whether your child took them as planned, and if they experienced any tummy upsets or other side effects. There are no clinic visits required; all information will be collected through the daily questionnaire over the 7 days.

Potential risks and benefits

Potential benefits of taking part include helping researchers develop new and potentially easier ways for people with PKU/HPA to manage their diet. This could lead to more choices in the future, making it simpler for patients to stick to their vital dietary plan. As with any new food product, there's a small chance of experiencing side effects, such as tummy upsets, though the study aims to monitor these carefully. You or your child can stop taking part in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Birmingham Children´s Hospital
Verified postcode
Birmingham, United Kingdom

Common questions

What is PKU?

PKU, or Phenylketonuria, is a rare inherited condition where the body can't break down an amino acid called phenylalanine. This means people with PKU need a special low-protein diet.

What are protein substitutes?

Protein substitutes are special food supplements that provide essential protein, vitamins, and minerals without the parts that people with PKU can't process, helping them grow and develop healthily.

How long does the study last?

The study itself lasts for 7 days, during which participants will try the new tablets and complete daily questionnaires.

Will I have to stop my usual medication?

No, you won't need to stop your usual medication. You will be replacing some or all of your usual protein substitute with the new study product.

Who is funding this study?

The information provided does not specify the funder, but it is a market research study evaluating a product called XPhe Piccos.

How to find out more

Bernhard Hoffmann, PhD

behoffmann@metax.org +49 6031 166 72 71 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.