Market research - acceptability trial of a new PKU protein substitute
Research type
Research Study
Full title
Market 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
IRAS ID
234819
Contact name
Anita MacDonald
Contact email
Sponsor organisation
Dr Schar Medical Nutrition
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
This is an acceptability trial for a new PKU amino acid based protein substitute product. These products are an integral part of the dietary management of Phenylketonuria (PKU), which is an inborn error of metabolism. This trial seeks to ascertain whether they are palatable for patients, and whether they are tolerated by patients, for example, whether there are any side effects such as vomiting, tummy aches or diarrhoea (these are common side effects in already Advisory Committee on Borderline Substances (ACBS) approved products of this nature). We are also looking to include whether they are practical for daily use, for example, how easy/difficult are they to consume and administer. Patients from 3 years of age to adulthood will be included in the trial. The products are suitable for this age range. The outcome of this market research will be included in our application to the ACBS in order to gain approval for us on prescription. An acceptability trial is obligatory for the ACBS application. The results of this trial will not be published or used in any medical texts. This is a market research exercise for our products, which have already been tested in patients with PKU and are currently available in other European countries (Germany and Italy). The composition of the new products are comparable to similar products currently available on the UK market, which are also approved by the ACBS. The ACBS guidelines advise that market research of this nature is required for this type of product. Long-term compliance with taking protein substitutes is an ongoing challenge in these patients and as a low phenylalanine diet is recommended for life, improving the choice in terms of new products may aid compliance.
Subjects will be asked to take the new product for 7 days. During this time parents/caregivers or the patient (where appropriate) will be asked to complete a daily questionnaire recording information on:
• Volume of product taken
• Ease and/or any issues with administration
• Any gastro-intestinal side-effects
A questionnaire will also be completed at the beginning and end of the study that will consider perceptions about taste, appearance, smell, presentation and packaging of the product; ease of administration; how it is taken; and any other problems or symptoms.The questionnaires should take a maximum of 30 minutes to complete.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0708
Date of REC Opinion
20 Mar 2018
REC opinion
Further Information Favourable Opinion