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.
Lay summary of study results: The main results from the study are summarised below:
Gastrointestinal (GI) Tolerance
• Ketoflo was well tolerated by most participants.
• Ketoflo was well tolerated by most participants, with 67% (14 of 24) experiencing no GI symptoms Palatability • 75% (15 of 20) of participants reported they either liked or loved the taste of Ketoflo.
• 86% (19 of 22) of respondents said Ketoflo was easy to use.
Adherence
• Most participants were able to stick to the recommended intakes of Ketoflo.
• 59% (14 of 24) of participants stated they would like to continue using Ketoflo.
Side Effects
• Side effects are undesired events that can happen afer taking any dietary or medical product. During this study some participants experienced side effects. There were 12 side effects reported. 10 were classed as mild and 2 were moderate.
6 of these were thought to be possibly related to the product.
• The study found that Ketoflo was safe to use.The results from this study found that:
• Ketoflo was well tolerated by most participants • Ketoflo was acceptable to most participants.
• Ketoflo is safe to use. Overall, Ketoflo offered participants an acceptable choice for the dietary management of epilepsy and other neurometabolic conditions needing a ketogenic diet.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