Completed

Acceptability and Tolerance of New PKU Protein Substitute in Children

What is being tested

Motion

Dietary Supplement

Who is being recruted

Amino Acid Metabolism, Inborn Errors+9

+ Brain Diseases

+ Brain Diseases, Metabolic

From 3 to 16 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Other Study

Interventional

Study Start: July 2018

See protocol details

Summary

Principal SponsorDr. Schär AG / SPA

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2018

Actual date on which the first participant was enrolled.

This study focuses on children with PKU, a condition where the body can't break down a specific amino acid. The main goal is to test a new protein substitute, Mevalia Amino Acids, and see if it's acceptable and well-tolerated by these children. The importance of this study lies in potentially improving the dietary options for children with PKU, making their daily lives easier and more enjoyable. During the study, participants will consume the new protein substitute and provide feedback. The study measures four main aspects: gastrointestinal tolerance, product acceptability, product compliance, and product palatability. Participants will fill out daily questionnaires about any gastrointestinal symptoms, the overall liking and acceptability of the product, the amounts consumed compared to the recommended amount, and the taste of the product. This feedback will help determine the effectiveness and acceptability of the new protein substitute.

Official TitleMarket Research - Acceptability Trial for a New PKU Amino Acid Based Protein Substitute (Dr Schär Medical Nutrition - Mevalia Amino Acids) Mevalia PKU Motion 10 - Tropical or Red Fruits Mevalia PKU Motion 20 - Tropical or Red Fruits

NCT04309331

Principal SponsorDr. Schär AG / SPA

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 3 to 16 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Amino Acid Metabolism, Inborn ErrorsBrain DiseasesBrain Diseases, MetabolicCentral Nervous System DiseasesMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNutritional and Metabolic DiseasesPhenylketonuriasBrain Diseases, Metabolic, InbornGenetic Diseases, Inborn

Criteria

4 inclusion criteria required to participate

Diagnosis of PKU or PKU variant requiring a phenylalanine-free protein substitute

Subjects who are already taking a phenylalanine-free protein substitute and are willing to try the study product for 7 days

Patients aged 3 years of age to adulthood

Written informed consent obtained from parental caregiver

5 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

amino acid based protein substitute

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Birmingham Children's Hospital

Birmingham, United KingdomOpen Birmingham Children's Hospital in Google Maps

CompletedOne Study Center