Use of Betashot in children and adults with epilepsy.
Research type
Research Study
Full title
A feasibility study of the use of Betashot, a medium chain triglyceride-based (MCT) food for special medical purposes (FSMP) in children and adults with epilepsy.
IRAS ID
181054
Contact name
Matthew Walker
Contact email
Sponsor organisation
Vitaflo International Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 21 days
Research summary
In brief, this research is a feasibility study to evaluate the use of Betashot, a medium chain triglyceride-based (MCT) food for special medical purposes (FSMP) in children and adults with epilepsy. \nMedium chain triglycerides (MCT) are a type of dietary fat used in the Ketogenic Diet. The ketogenic diet is a very high fat, low carbohydrate, adequate protein regime that has proven efficacy in the dietary management of drug resistant epilepsy. MCT is available as oil or emulsions. \nHowever, MCT can be difficult to consume orally. It has a distinctive mouth and throat feel, and users may experience mild gastrointestinal discomfort, such as a feeling of fullness. These factors in combination can result in high levels of dissatisfaction and poor dietary compliance with MCT and the ketogenic diet, despite its benefits. \nBetashot is a new nutritional preparation, developed by Vitaflo (International) Ltd, and is a ready to drink, flavoured, slightly thickened emulsion of MCT. In-house sensory trials indicate that the creamy texture and mouth feel of Betashot improves on the typical aftertaste and sensation of taking currently available MCT products orally.\nThis study explores the use of Betashot in a group of children and adults with epilepsy who are consuming their normal diets, but limiting intakes of foods high in carbohydrate and sugars, to assess the following concerning the product:\n1)\tTolerance – any side effects such as bloating and cramps\n2)\tAcceptability - flavour, texture, taste \n3)\tCompliance - how easy it is to Betashot daily and achieve the intake advised\n\n\n\n
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/1979
Date of REC Opinion
14 Jan 2016
REC opinion
Further Information Favourable Opinion