Epilepsy, Medically Resistant Epilepsy, Medically Resistant Seizures, Seizure
Conditions
Keywords
seizures, epilepsy, adult, intractable, medically refractory, Atkins, ketogenic, diet
Brief summary
The modified Atkins diet (MAD) has been shown to be effective in treating children and adults with medically resistant seizures. A recent study in children showed that the use of KetoCal® once per day in addition to the MAD appeared to be beneficial when used during the first month. The investigators hypothesize that including a daily KetoCal® liquid tetrapak with one meal during the initial month of the MAD will produce urinary ketosis in more adult patients than the MAD alone and will lead to greater seizure reduction.
Interventions
DIETARY_SUPPLEMENTModified Atkins diet
Patients will receive the modified Atkins diet with a 20 gram per day carbohydrate limit and encouragement to consume plenty of fat and eat to satiety.
DIETARY_SUPPLEMENTKetoCal
Patients will receive a KetoCal 4:1 ratio (fat: carbohydrates and protein) liquid daily for the first month (if randomized to this arm of the study). They will also be started on the modified Atkins diet.
Sponsors
Nutricia Liverpool
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Adults ages \>17 years. * At least weekly seizures (or 4 per month). All seizure types allowed. * Tried at least two anticonvulsants.
Exclusion criteria
* Unwilling to restrict carbohydrates * Significantly underweight (Body Mass Index \<18.5) * Prior use of the modified Atkins diet for ≥ 2 days * Prior use of KetoCal® at any time for any duration * Use of the ketogenic diet within the past year * Kidney disease * History of hypercholesterolemia (total cholesterol \> 300 mg/dl) or hypertriglyceridemia (triglycerides \> 200 mg/dl) * Metabolic or mitochondrial disorder * Pregnancy or breastfeeding * Lactose intolerance or milk allergy * Aversion to liquids or inability to eat solid food
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ketosis | 1 month | Time to urinary ketosis in days will be recorded and whether or not patients achieve serum ketosis at 1 month and 2 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seizure reduction | 2 months | The percent seizure reduction compared to baseline (1 month before beginning the diet) will be recorded at 1 month and 2 months. |
| Tolerability and taste | 2 months | Patients will be asked to rank convenience, taste, texture, and tolerability of the liquid on a 10 point scale (1 = poor, 10 = excellent). |
| Side effects | 2 months | Patients will be screened for constipation and asked if they have experienced any side effects related to use of the modified Atkins diet and KetoCal® at 1 and 2 months. |
| Study completion rate | 2 months | — |
Countries
United States
Outcome results
None listed