The first clinical trial of a new dietary treatment for children and
adults with severe forms of epilepsy, co-developed by UCL researchers
and based on the ketogenic diet, has been successfully completed.
For the study, published in Brain Communications,
clinicians evaluated the use of K.Vita®, (also known as Betashot), an
oral liquid dietary supplement developed by UCL in collaboration with
Royal Holloway, University of London, and Vitaflo International Ltd.
The ketogenic diet consists of high-fat, low-carbohydrate and
adequate protein consumption and mimics the fasting state, 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.
It is widely used to treat drug-resistant epilepsies. However, the
highly restrictive diet, which can cause constipation, low blood sugar,
and stomach problems, can have poor compliance and is not suitable for
everyone. Some ketogenic diet supplements are also known to be unappetizing.
K.Vita is based on novel findings by UCL researchers*, who
discovered a different underlying mechanism to explain why the ketogenic diet is
effective against epilepsy; in developing a new treatment, researchers
also sought to reduce the adverse side effects caused by ketogenic diet.
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
"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 antiseizure 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."
For the feasibility trial, researchers wanted to establish
participants' tolerance (side effects such as bloating or cramps) to the
treatment, acceptability (flavor, texture, taste), and compliance (how
easy it is to use K.Vita at the advised quantity, as part of their daily
As secondary outcomes, they also monitored the frequency of
epileptic seizures or paroxysmal events (fits, attacks, convulsions) and
whether ketone production was decreased.
In total, 35 children (aged 3 to 18) with genetically caused
epilepsy and known to be unresponsive to drugs, and 26 adults with
drug-resistant epilepsy*** (DRE), were given K.Vita liquid supplements
(a drink), to be taken with meals. They were also asked to limit
high-refined sugary food and beverages from their diets.
The trial lasted 12 weeks with K.Vita treatments increasing
incrementally over time, taking into account individuals' tolerance to
In total, 23/35 (66%) children and 18/26 (69%) adults completed the
trial i.e they were continuing to take K.Vita at 12 weeks.
Gastrointestinal disturbances were the primary reason for
discontinuation, and their incidence decreased over time
Over three-quarters of participants/caregivers reported favorably
on sensory attributes, such as taste, texture and appearance, and ease
In regards to the secondary outcomes, there was a mean 50% reduction
in seizures or paroxysmal events, and fewer than 10% of people on the
diet produced significant ketones.
Commenting on the findings, Professor Walker, who is also a
consultant neurologist at the National Hospital for Neurology and
Neurosurgery, said: "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 added: "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
"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
First author, Dr. Natasha Schoeler, Research Dietitian at UCL Great
Ormond Street Institute of Child Health commented: "This novel dietary
approach for epilepsy management involves following the principles of a
healthy balanced diet alongside use of K.Vita, allowing greater dietary
freedom compared to ketogenic diets. Our approach also requires much
less input from a specialist dietician than is required by traditional
ketogenic diets, and so may allow more widespread access to people with
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.
Source: News Release
University College London
July 22, 2021