Modified Atkins Diet Plus KetoCal for Adult Epilepsy

Johns Hopkins University

Status: Completed

Conditions: Seizure; Epilepsy; Medically Resistant Epilepsy; Medically Resistant Seizures

Treatments: Dietary Supplement: KetoCal; Dietary Supplement: Modified Atkins diet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01834482

NA_00068726

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Modified Atkins diet plus KetoCal

Active Comparator group

Description:

Patients will receive the modified Atkins diet in combination with a KetoCal tetrapak daily for the first month. The second month, no tetrapaks will be given.

Treatment:

Dietary Supplement: Modified Atkins diet

Dietary Supplement: KetoCal

Modified Atkins diet

Active Comparator group

Description:

Patients will receive the modified Atkins diet for the first month. The second month, they will be given the choice to also use KetoCal in addition to the modified Atkins diet if they choose to do so.

Treatment:

Dietary Supplement: Modified Atkins diet