A new dietary treatment for epilepsy based on a high fat, low carbohydrate diet was well tolerated and reduced seizures, study results have suggested.
The first clinical trial of a new oral liquid supplement for children and adults with severe forms of the condition is based on the ketogenic diet (KD).
It consists of high-fat, low-carbohydrate and adequate protein consumption and mimics fasting, altering the metabolism to use body fat as the primary fuel source.
This switch from carbohydrates to fat for body fuel is known as ketosis.
The diet, widely used to treat drug-resistant epilepsies, can cause constipation, low blood sugar and stomach problems, and can have poor compliance, experts say.
It is not suitable for everyone, and some KD supplements are also known to be unappetising.
Our study provides early evidence of the tolerability and effectiveness of a new dietary supplement in severe drug-resistant epilepsies in adults and children and provides a further treatment option in these devastating conditionsProfessor Matthew Walker
For the study clinicians evaluated the use of K.Vita (also known as Betashot), developed by UCL in collaboration with Royal Holloway, University of London, and Vitaflo International Ltd.
The dietary supplement is based on findings by UCL researchers who discovered a different underlying mechanism to explain why the KD is effective against epilepsy.
The researchers also sought to reduce the adverse side effects caused by KD.
Corresponding author Professor Matthew Walker, UCL Queen Square Institute of Neurology, said: “The ketogenic diet has been used for 100 years to treat epilepsy, helping reduce seizures in both children and adults.
“It has long been thought the diet was effective due to its production of ketones, however we now believe the increase in levels of the fatty acid, decanoic acid, also produced by the diet, may provide the powerful anti-seizure effects.
“In this study we evaluated a newly-developed medium chain triglyceride (type of dietary fat) supplement, designed to increase levels of decanoic acid, while also reducing the adverse side effects, and to be more palatable.”
Researchers wanted to establish participants’ tolerance (side effects such as bloating or cramps) to the treatment, acceptability (flavour, texture, taste) and compliance (how easy it is to use the supplement as part of their daily diet).
They also monitored the frequency of epileptic seizures or paroxysmal events (fits, attacks, convulsions) and whether ketone production was decreased.
Ketone is the chemical the liver produces when it breaks down fats.
The body uses ketones for energy typically during fasting, long periods of exercise, or when it is not getting as many carbohydrates.
In total, 23/35 (66%) children and 18/26 (69%) adults took the supplement for the 12-week trial.
Gastrointestinal disturbances were the primary reason for discontinuation, and their incidence decreased over time, the study found.
According to the research there was a mean 50% reduction in seizures or paroxysmal events, and less than than 10% of people on the diet produced significant ketones.
Professor Walker, who is also a consultant neurologist at the National Hospital for Neurology and Neurosurgery, added: “Our study provides early evidence of the tolerability and effectiveness of a new dietary supplement in severe drug-resistant epilepsies in adults and children and provides a further treatment option in these devastating conditions.
“It also offers an alternative, more liberal, diet for those who cannot tolerate or do not have access to ketogenic diets.”
He said: “While this study was not designed to include enough patients to fully assess the supplement’s effects on seizures, it is exciting to report that there was a statistically significant reduction in the number of seizures in the group overall after three months of treatment.
“Furthermore, high ketone levels were not observed in over 90% of the participants.
“This indicates that the effect of the diet was independent from ketosis; this is important because high ketone levels in the ketogenic diets contribute to both short- and longer-term side effects.”
Researchers say larger, controlled studies of K.Vita are now needed to determine the precise epilepsies and conditions in which the supplement is most effective.
The study is published in the journal Brain Communications.