Market Research - Acceptability Study for a New PKU Protein Substitute

Market Research - Acceptability Study for a New PKU Glycomacropeptide Based Protein Substitute (Dr Schär- Mevalia Amino Acids) Mevalia PKU GMPower - Vanilla

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04318509

Enrollment

Registered

2020-03-24

Start date

2019-02-04

Completion date

2019-05-19

Last updated

2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inborn Errors of Metabolism, Metabolic Disease, Phenylketonurias, PKU

Brief summary

The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.

Interventions

DIETARY_SUPPLEMENTGMPOWER

(casein) glycomacropeptide protein substitute for the dietary management of PKU from the age of 3 years

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 16 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of PKU or PKU variant requiring a protein substitute. * Subjects who were already taking a phenylalanine-free/low phenylalanine protein substitute and were willing to try the study product for 7 days. * Patients aged 3 years of age to adulthood. * Written informed consent obtained from participant or parental caregiver (as appropriate).

Exclusion criteria

* Presence of serious concurrent illness * Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements * Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. * Any patients having taken antibiotics over the previous 2 weeks leading up to the study. * Patients less than 3 years of age.

Design outcomes

Primary

Measure	Time frame	Description
Gastrointestinal tolerance	7 days	Questionnaire detailing any GI symptoms, severity and change from usual • The collection of daily data about the gastro-intestinal tolerance of the protein substitute.
Product compliance	7 days	Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
Product palatability	7 days	Questionnaire data captured to evaluate taste
Product acceptability	7 days	Brief tick-box questionnaire on overall liking and acceptability of product

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026