None listed
Conditions
Brief summary
Epilepsy affects an estimated 225,000 Australians. Approximately one-third of people with epilepsy still experience seizures whilst on medications. They may be on maximum therapy or are unable to tolerate the side-effects of anti-seizure medications. There is emerging evidence to show a very low carbohydrate diet, known as the Modified Atkins Diet for Epilepsy (MADE), may improve seizure control, with relatively low side-effects. The use of this dietary therapy has not previously been studied in Australian adults. This research aims to investigate if Australian adults with epilepsy are able to comply with the dietary modifications of the MADE and to assess if participants experience a reduction in the number of seizures whilst on the diet. Participants will be seen regularly during the study by a Neurologist to monitor for any side-effects of the diet. A Dietitian will provide education, support and resources for those participating in the study on a regular basis. We anticipate most participants will be able to implement the dietary modification of the MADE. It is expected participants will experience up to half the number of seizures than normal whilst on the diet with minimal side-effects. A reduction in seizures can significantly improve the quality of life and overall health status of people with epilepsy who do not respond to medication management.
Interventions
After a four week, prospective baseline screening period, participants will be randomised to immediate or delayed commencement of the modified atkins diet for epilepsy (MADE). The MADE is a low carbohydrate, high fat diet. Total carbohydrate intake is limited to 15-20g per day, added fats are encouraged and intake for carbohydrate-free food and fluids is allowed. Participants will be instructed by a dieititian on the dietary modifications and will be given an information booklet including carboh
After a four week, prospective baseline screening period, participants will be randomised to immediate or delayed commencement of the modified atkins diet for epilepsy (MADE). The MADE is a low carbohydrate, high fat diet. Total carbohydrate intake is limited to 15-20g per day, added fats are encouraged and intake for carbohydrate-free food and fluids is allowed. Participants will be instructed by a dieititian on the dietary modifications and will be given an information booklet including carbohydrate counting, meal and recipe ideas and label reading. The participants will follow the diet a period of three months and record the number of seizures they have per month compared to the baseline period. Participants will then have the option to continue on the diet for up to twelve months with regular follow up. During the trial participants will be reviewed regularly through face-to-face 30-60 minute consultations by the dietitian and a Neurologist and monitored for adverse events. The visits will occur at baseline, at the commencement of the diet, two weeks after starting the diet and at one month and three months after commencing the diet. Participants choosing to remain on the diet for longer than three months, will be followed up everyone three months for one year. Monitoring will include blood tests, urine ketone testing and food and seizure diaries.
Sponsors
Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Aged 18-75 years Diagnosed epilepsy, whether taking AEDs or not, experiencing two or more seizures in four weeks of one or more of the following types of seizures: complex partial seizures (focal dyscognitive seizures) secondary generalised tonic clonic seizures simple partial seizures with motor features primary generalised tonic clonic seizures tonic seizures atonic seizures No changes in AEDs or vagus nerve stimulation (VNS) settings for one month prior to enrolment
Exclusion criteria
Under 18 years of age Body mass index < 18.5kg/m2 Patients with cluster seizures or who are unable to count or describe their seizures Patients experiencing myoclonic or absence seizures only Patients experiencing non-epileptic seizures Diabetes Mellitus Fatty acid or amino acid oxidation disorders Pre-existing renal and/or liver failure Currently on the ketogenic diet Prior history of eating disorders Females who are pregnant or breastfeeding
Outcome results
None listed