Modified Atkins Diet Plus KetoCal for Adult Epilepsy

Not Applicable

Completed

• Conditions: Epilepsy; Seizure; Medically Resistant Epilepsy; Medically Resistant Seizures
• Interventions: Dietary Supplement: Modified Atkins diet; Dietary Supplement: KetoCal

• Registration Number: NCT01834482
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-18
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-29
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Atkins diet	Modified Atkins diet	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.
Modified Atkins diet plus KetoCal	Modified Atkins diet	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.
Modified Atkins diet plus KetoCal	KetoCal	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Study completion rate	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.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States