Market research - acceptability study for a range of MCT products
Research type
Research Study
Full title
Market research - acceptability study for a range of new MCT based products (Dr Schär - Kanso MCT) Kanso MCT 100% oil Kanso MCT 77% oil Kanso MCT 83% margarine
IRAS ID
234937
Contact name
Maryann McLees
Contact email
Sponsor organisation
Dr Schar
Duration of Study in the UK
0 years, 1 months, 2 days
Research summary
An acceptability study for a new range of MCT based products. Medium Chain Triglycerides (MCT) are effective in a variety of dietary treatments for epilepsy and inborn errors of metabolism and patients with malabsoprtion. Products containing MCT are an integral part of the dietary management of epilepsy, glucose transporter type 1 (GLUT-1) deficiency syndrome and those with malabsoption. Some Fatty Acid Oxidation Disorders (FAODs), which are an inborn errors of metabolism are treated with a specialist diet, which includes MCT. This study will ascertain whether they are palatable, tolerable and seeks to identify if there are any side effects such as vomiting, tummy aches or diarrhoea (common side effects in already Advisory Committee on Borderline Substances (ACBS) approved products of this nature). Practicality for daily use will also be evaluated e.g. how easy/difficult are they to consume and administer. Patients from 3 years of age to adulthood will be included in the study. 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 to be on prescription. An acceptability study is obligatory for the ACBS application. Participants will be asked to take 3 new fat supplements over a 25 day period (7 days per product with 2 days "rest" between products weeks after each product). 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 issues observed.The questionnaire should take 30 minutes to complete.
REC name
North West - Preston Research Ethics Committee
REC reference
18/NW/0653
Date of REC Opinion
9 Oct 2018
REC opinion
Favourable Opinion