The modified Atkins diet for epilepsy: an RCT.

Epilepsy is one of the most common chronic neurological disorders. It affects approximately 14-44% of the people with intellectual disabilities (ID) and depending on the underlying etiology of the ID, the prevalence can be as high as 66%. Of all patients with epilepsy, approximately 30% will continue to have seizures and thus remain refractory to medical treatments. In patients with intellectual difficulties, this number is probably higher.
In children with refractory epilepsy, a beneficial effect of the ketogenic diet has been demonstrated. In adolescents and adults the ketogenic diet is less often used due to expected non- compliance to this very restricted diet. The last ten years, studies have been published evaluating the effect of the Modified Atkins diet (MAD) – a less restricted form of the ketogenic diet – on the seizure frequency in children and adults with refractory epilepsy. These studies showed a high tolerability and efficacy of the modified Atkins diet on seizure control in drug resistant epilepsy. So far, data on efficacy of the MAD in adult patients with ID and refractory epilepsy is lacking. We expect that, in this population the MAD will have a beneficial effect in reducing seizure frequency as well.



The main objective is to evaluate the effect of the modified Atkins diet on the seizure frequency of institutionalized adults with refractory epilepsy and severe intellectual disabilities.



This study will be a prospective open-label randomized controlled trial.



The study population includes adult patients (age >18 years) with severe intellectual disability and refractory epilepsy. Patients will be recruited from ‘Sherpa’ or ‘Amerpoort’, institutions for people with intellectual disabilities, in Baarn, the Netherlands.



The intervention group will be treated with the MAD for at least 4 months, with a total follow-up of at least 6 months. After the 4-month trial period, the control group can be started on the MAD as well.



To analyse the efficacy of the Modified Atkins diet (MAD), defined as 50% reduction in seizure frequency at 4 months, compared to a control group.



The secondary objectives are: to analyse retention rate of the MAD in this population, as a measure of overall effectiveness; to analyse the efficacy of the MAD, defined as improvement of daily functioning, studied with the Habilitative Improvement Scale (HIS); to assess the feasibility of the MAD in this population and this setting, with respect to logistics and adherence; to assess (serious) adverse events attributable to the MAD; to analyse which factors are associated with efficacy of the diet.

The MAD is effective in reducing seizure frequency in patients with refractory epilepsy and severe intellectual disabilities.

Patients will visit the outpatient department after 6 weeks and 4 months

The intervention group will be treated with the MAD for at least 4 months, with a total follow-up of at least 6 months. After the 4-month trial period, the control group can be started on the MAD as well, in which we will also evaluate efficacy, tolerability and safety.