Trial | NCT04318509  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    8
The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.
Study Started
Feb 04
2019
Primary Completion
May 19
2019
Study Completion
May 19
2019
Last Update
Mar 24
2020

Dietary Supplement GMPOWER

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

PKU GMPOWER Experimental

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

Criteria 

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.
No Results Posted