Evaluation of Keyo in children with epilepsy
Research type
Research Study
Full title
A feasibility study to evaluate the acceptability of Keyo, a food for special medical purposes (FSMP) for use in the ketogenic diet (KD) with regard to product tolerance, compliance and acceptability
IRAS ID
196542
Contact name
Tom Barker
Contact email
Sponsor organisation
Vitaflo (International) Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
In brief, this research is a to evaluate the tolerance, acceptability and compliance of Keyo in 20 subjects aged 3 years and over, with intractable epilepsy or Glut-1 DS on a KD.\n\nKeyo (Vitaflo International Ltd) is a new, nutritionally complete FSMP designed to meet the nutritional requirements of children aged over 3 years and adults requiring a KD. It can be given orally, either as a sole source of nutrition to supply either 100% of an individual’s dietary requirements or as a supplement, e.g. as a meal replacement or in-between meal snack. The currently available FSMP products used in the dietary management of intractable epilepsy and Glut-1 DS are either powdered products, reconstituted as a liquid or as a ready to use liquid feed. \nKeyo has been designed as an alternative, it has a unique, pre-thickened texture and consistency which is achieved via the manufacturing technique without the addition of carbohydrates such as starches, fibres or gums as a thickening agents. This attribute potentially makes it very acceptable to those with epilepsy.\n\nParticipants will take Keyo for seven days and the following information will be collected:\n\n- Tolerance- any gastrointestinal side effects such as bloating and cramps \n- Compliance- how easy it is to take advised intake of Keyo \n- Acceptability of Keyo (flavour, taste, texture) \n \n\n
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0068
Date of REC Opinion
15 Feb 2016
REC opinion
Further Information Favourable Opinion