K.Vita: a feasibility study of a blend of medium chain triglycerides to manage drug-resistant epilepsy

Abstract

This prospective open-label feasibility study aimed to evaluate acceptability, tolerability and compliance with dietary intervention with K.Vita, a medical food containing a unique ratio of decanoic acid to octanoic acid, in individuals with drug-resistant epilepsy. Adults and children aged 3-18 years with drug-resistant epilepsy took K.Vita daily whilst limiting high-refined sugar food and beverages. K.Vita was introduced incrementally with the aim of achieving ≤35% energy requirements for children or 240 ml for adults. Primary outcome measures were assessed by study completion, participant diary, acceptability questionnaire and K.Vita intake. Reduction in seizures or paroxysmal events was a secondary outcome. 23/35 (66%) children and 18/26 (69%) adults completed the study; completion rates were higher when K.Vita was introduced more gradually. Gastrointestinal disturbances were the primary reason for discontinuation, but symptoms were similar to those reported from ketogenic diets and incidence decreased over time. At least three-quarters of participants/caregivers reported favourably on sensory attributes of K.Vita, such as taste, texture and appearance, and ease of use. Adults achieved a median intake of 240 ml K.Vita, and children 120 ml (19% daily energy). Three children and one adult had ß-hydroxybutyrate >1 mmol/l. There was 50% (95% CI 39-61%) reduction in mean frequency of seizures/events. Reduction in seizures or paroxysmal events correlated significantly with blood concentrations of medium chain fatty acids (C10 and C8) but not ß-hydroxybutyrate. K.Vita was well accepted and tolerated. Side effects were mild and resolved with dietetic support. Individuals who completed the study complied with K.Vita and additional dietary modifications. Dietary intervention had a beneficial effect on frequency of seizures or paroxysmal events, despite absent or very low levels of ketosis. We suggest that K.Vita may be valuable to those with drug-resistant epilepsy, particularly those who cannot tolerate or do not have access to ketogenic diets, and may allow for more liberal dietary intake compared to ketogenic diets, with mechanisms of action perhaps unrelated to ketosis. Further studies of effectiveness of K.Vita are warranted.

Keywords: C10; decanoic acid; ketogenic; seizure.

Graphical Abstract

Figure 1

Flowchart of participants.

Figure 2

Percentage energy from macronutrients and K.Vita at study visits. Mean percentage of daily energy from macronutrients (visit A, B and C) and K.Vita (visits B and C) (A in children; B in adults)

Figure 3

Beta-hydroxybutyrate and medium chain fatty acid levels at baseline and visit C. Plasma beta-hydroxybutyrate and medium chain fatty acid levels measured in participants at both baseline and at visit C: median, interquartile range and range (Left panels in children; Right panels in adults). **P < 0.01, ***P < 0.001, ****P < 0.0001 (Mann–Whitney test).

Figure 4

Seizures or paroxysmal events at visits A, B and C. Number of reported seizures or paroxysmal events at visits A, B and C, in 4-week epochs (A in all participants; B in children; C in adults). Analysis is based on n = 113 observations from 44 individuals, using linear mixed modelling, adjusting for data source (study diary or physician-documented count) and patient age (adult versus child) as fixed effects, and participant identifier as a random intercept. The reduction between baseline and visit B has a t-value of −3.255 (P = 0.0015) and the reduction between baseline and visit C has a t-value of −4.959 (P < 0.0001) (all participants).