Abstracts

Rationale: Ketogenic diets (KDs) are an effective option for drug-resistant epilepsy, although they are often associated with poor compliance and dissatisfaction. Medium chain triglycerides (MCT) can improve the palatability of KDs, but their use is limited due to poor acceptability, taste and lack of convenience. Betashot, a ready-to-use, palatable emulsion of a unique blend of specific MCTs, aims to address these issues and improve tolerability of dietary treatment by avoiding the need to follow a ketosis-inducing KD.This study evaluates the compliance, tolerability and acceptability of Betashot in individuals with epilepsy. Seizure frequency was also noted. Methods: Children aged over 3 years and adults with epilepsy took Betashot daily for 12 weeks whilst consuming their usual diets, but limiting intake of high refined-sugar foods. Betashot was built up incrementally, according to individual tolerance, with the aim of achieving a maximum daily intake of 35% energy requirements for children or two pouches daily (2 x 120ml) for adults. Study visits were conducted at baseline (visit A), 5 weeks (visit B) and 12 weeks (visit C); visits included dietetic and medical assessment, quality of life questionnaires and biochemical investigations. Number of reported seizures were compared from the first three weeks of the study to the last three weeks. Results: 35 children (51% male, mean age 10.8 years) and 26 adults (20% male, mean age 36.4 years) commenced Betashot. 23(66%) children and 18(69%) adults completed the 12-week study. 76% participants who completed the study complied with their prescribed daily amount of Betashot. Adults achieved a median intake of 240ml Betashot by visit C, the target daily amount. For children, the median intake of Betashot by visit C was 120ml, or 18.7% total daily energy.The most frequently reported gastrointestinal symptoms were excessive flatulence, abdominal bloating or feeling full, and abdominal pain or discomfort. Overall, gastrointestinal symptoms decreased throughout the study period, following a peak during the initial introduction of Betashot.There was a statistically significant reduction in mean estimated number of seizures at visit C compared to visit A (P<0.001).The most common known reason for discontinuation prior to visit C was gastrointestinal side effects (abdominal pain/discomfort, diarrhoea and/or vomiting) in both children and adults. 21(91%) children and 10(56%) adults remained on Betashot after the study end point. Conclusions: Adult and child participants with epilepsy who completed the study were able to comply with intakes of Betashot, and it was reported as acceptable when taken alongside their usual diet with minimal modifications. This is reflected by attrition rates and the proportion of participants remaining on Betashot past the study end point. In general, tolerance-related adverse gastrointestinal side effects, all of which are associated with MCT and could therefore be anticipated, were predominantly mild and resolved satisfactorily with appropriate dietetic support. Dietary modification with Betashot had a beneficial effect on mean seizure frequency. Further study is warranted to determine the role of Betashot as a possible alternative or adjunct to the KD for individuals with drug-resistant epilepsy. Funding: Vitaflo (International) Ltd.