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A 16 Week Study Evaluating the Introduction of a GMP Based Protein Substitute in Participants With PKU

NCT03771391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-02-16

No results posted yet for this study

Summary

This study aims to measure changes in participants' blood phenylalanine (Phe) levels in participants with PKU when switching from a conventional amino acid based protein substitute to a GMP based protein substitute (PKU Sphere) over a 16 week period.

Conditions

  • Phenylketonurias

Interventions

DIETARY_SUPPLEMENT

PKU Sphere

PKU sphere is a powdered, low phenylalanine protein substitute containing a balanced mix of casein glycomacropeptide (GMP) isolate, essential and non-essential amino acids, carbohydrate, vitamins, minerals and docosahexaenoic acid (DHA). With sugar and sweetener.

Sponsors & Collaborators

  • Kreiskliniken Reutlingen

    collaborator OTHER

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • Vitaflo International, Ltd

    lead INDUSTRY

Principal Investigators

  • Peter Freisinger · Kreiskliniken Reutlingen GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2020-10-30
Completion
2023-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03771391 on ClinicalTrials.gov