Modified Atkins Diet Plus KetoCal for Adult Epilepsy

Johns Hopkins University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Epilepsy Seizure Medically Resistant Epilepsy Medically Resistant Seizures

Interventions

Modified Atkins dietDIETARY_SUPPLEMENT

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.

KetoCalDIETARY_SUPPLEMENT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Ketosis

Time to urinary ketosis in days will be recorded and whether or not patients achieve serum ketosis at 1 month and 2 months.

Time frame: 1 month

Secondary Outcomes

Seizure reduction

The percent seizure reduction compared to baseline (1 month before beginning the diet) will be recorded at 1 month and 2 months.

Time frame: 2 months

Tolerability and taste

Patients will be asked to rank convenience, taste, texture, and tolerability of the liquid on a 10 point scale (1 = poor, 10 = excellent).

Time frame: 2 months

Side effects

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.

Time frame: 2 months

Study completion rate

Time frame: 2 months

Modified Atkins Diet Plus KetoCal for Adult Epilepsy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes