New PKU drink passes small taste and tolerance test

NCT ID NCT04679467

Completed Disease control Sponsor: Vitaflo International, Ltd Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether people with phenylketonuria (PKU) can tolerate and stick with a new protein substitute called PKU Sphere. Thirteen participants gradually increased their intake over up to 16 weeks, then continued for 4 more weeks while researchers tracked their blood levels, gut symptoms, and how much they liked the product. The goal was to see if PKU Sphere is a practical option for managing PKU.

What this could mean

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

Active substance: PKU Sphere (a protein substitute made from glycomacropeptide)
What this could lead to: If successful, this could provide a more acceptable and easier-to-use protein substitute for people with PKU, helping them manage their condition better.
What could go wrong: This is a very small study (13 participants) with no control group, so results may not apply to everyone. It only looks at short-term tolerance and adherence, not long-term health outcomes.

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

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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 PKU

Contacts and locations

Locations

A.O.R.N. Santobono-Pausilipon - Ospedale Santobono

Naples, Italy
Ospedale San Paolo

Milan, Italy
Sant'Orsola-Malpighi Polyclinic (adults)

Bologna, Italy
Sant'Orsola-Malpighi Polyclinic (paediatrics)

Bologna, Italy

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