Market Research - Acceptability Study for a New PKU Protein Substitute

March 20, 2020 updated by: Dr. Schär AG / SPA

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B4 6NH
        • Birmingham Children's Hospital
      • Bristol, United Kingdom, BS2 8BJ
        • Bristol Royal Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PKU GMPOWER
(casein) glycomacropeptide protein substitute for the dietary management of PKU from the age of 3 years
Dietary supplement: GMPOWER
(casein) glycomacropeptide protein substitute for the dietary management of PKU from the age of 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days
Product compliance
Time Frame: 7 days
Daily questionnaire on amounts offered and amounts actually consumed, compared to recommended amount.
7 days
Product palatability
Time Frame: 7 days
Questionnaire data captured to evaluate taste
7 days
Product acceptability
Time Frame: 7 days
Brief tick-box questionnaire on overall liking and acceptability of product
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Schär AG / SPA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2019

Primary Completion (Actual)

May 19, 2019

Study Completion (Actual)

May 19, 2019

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 20, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 20, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMPower1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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