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Completed

NCT Number: NCT04318509

Market Research - Acceptability Study for a New PKU Protein Substitute

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

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Key information

Conditions

PKU Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Inborn Errors of Metabolism Metabolic Disease Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Phenylketonurias

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham Children's Hospital, Birmingham, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GMPOWER

Dietary Supplement

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

Primary outcomes

  1. Gastrointestinal tolerance

    Time frame: 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.

  2. Product compliance

    Time frame: 7 days

    Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.

  3. Product palatability

    Time frame: 7 days

    Questionnaire data captured to evaluate taste

  4. Product acceptability

    Time frame: 7 days

    Brief tick-box questionnaire on overall liking and acceptability of product

Sponsors and collaborators

Lead sponsor

Dr. Schär AG / SPA

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 24, 2020
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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