New PKU protein drink shows promise in small study

NCT ID NCT04679467

First seen Apr 16, 2026 · Last updated May 17, 2026 · Updated 4 times

Summary

This study looked at how well people with phenylketonuria (PKU) tolerate a new protein substitute called PKU Sphere™. Thirteen participants gradually added PKU Sphere to their diet over up to 16 weeks, then continued for 4 more weeks while researchers tracked their blood amino acid levels, digestive comfort, and quality of life. The goal was to see if this glycomacropeptide-based formula is a practical and acceptable option for managing PKU long-term.

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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

Conditions

Explore the condition pages connected to this study.