Evaluation of Ketoflo
Research type
Research Study
Full title
A study to evaluate the acceptability of Ketoflo, a food for special medical purposes (FSMP) for use in the dietary management of epilepsy or neurometabolic conditions requiring a ketogenic diet (KD).
IRAS ID
232386
Contact name
Kathryn Lightfoot
Contact email
Sponsor organisation
Vitaflo (International) Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Around 25 - 30% of people with epilepsy fail to respond to anti-epileptic medications and the ketogenic diet can be highly effective in drug-resistant patients. However, a significant number of people who suffer with epilepsy also experience feeding problems. In such patients, tube feeding can be an effective way to administer the ketogenic diet.
To help to address this, Vitaflo (International) Ltd. has developed Ketoflo, a high fat, low carbohydrate ketogenic enteral feed which can be administered by tube or used as a sip feed.
The trial is being conducted to support an application to the UK Government’s Advisory Committee on Borderline Substances (ACBS) to make Ketoflo available on prescription within the NHS. The ACBS specify that the acceptability of new products must first be trialled in the population for whom they are designed – in this case, patients aged at least three years of age requiring a ketogenic diet (KD).
Acceptability is defined by the ACBS as comprising gastrointestinal tolerance, adherence to recommended intakes and palatability. These requirements have closely informed the design of the trial.
We are proposing to recruit 15 patients aged at least three years of age who will incorporate Ketoflo into their usual ketogenic diet. Participants will be recruited form three NHS centres in England.
Suitable participants are identified by their dietitian and once consented, they will be provided with a supply of Ketoflo. The product is incorporated into participants' usual ketogenic diet for 28 consecutive days. Data collection is by Baseline and End-of-Study CRFs completed by the Investigators as well as Diaries and Final Questionnaires completed by participants at home over the course of the study. Data will be transferred, pseudonymised, to the sponsor following review by the local Investigator.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0018
Date of REC Opinion
15 Mar 2019
REC opinion
Further Information Favourable Opinion