Medium Chain Triglycerides as an Adjunct to the Modified Atkins Diet for Women With Catamenial Epilepsy

Not Applicable

Completed

• Conditions: Medically Resistant Epilepsy; Catamenial Epilepsy; Epilepsy; Seizure; Medically Resistant Seizures
• Interventions: Dietary Supplement: betaquik®

• Registration Number: NCT02426047
• Lead Sponsor: Johns Hopkins University

Brief Summary

The modified Atkins diet (MAD) has been shown to be effective in treating intractable epilepsy. Approximately 55% of the patients started on the diet are women of childbearing age and women with epilepsy often have a pattern of seizures that correlates with their menstrual cycle, called catamenial epilepsy. The investigators have observed that despite an overall reduction in seizure frequency, some women on the MAD continue to have breakthrough seizures in a catamenial pattern. The investigators hypothesize that women with a history of intractable epilepsy who have been on the modified Atkins diet for at least 3 months and have a catamenial seizure pattern will tolerate and be compliant with the addition of a daily amount of betaquik® (a liquid emulsion of medium chain triglycerides) for a 10 day time interval starting 2 days prior to and encompassing the primary catamenial pattern.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-10
• Study First Submitted QC: 2015-04-23
• Study First Posted: 2015-04-24
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

• Adult women ≥ 18 years
• Already on the modified Atkins diet for at least 3 months and compliant with treatment
• Catamenial seizure pattern (by Herzog criteria) for at least 2 of the past 3 months (as documented by calendars provided with annotations for seizures and menstrual cycle start and end dates)

Exclusion Criteria (basic exclusion criteria for the modified Atkins diet, so patients should have already been screened for these factors):

• Unwilling to restrict carbohydrates
• Significantly underweight (BMI <18.5)
• Kidney disease
• History of hypercholesterolemia (>300 mg/dl) or hypertriglyceridemia (>200 mg/dl)
• Metabolic or mitochondrial disorder
• Pregnancy
• Lactose intolerance or milk allergy
• Aversion to liquids or inability to eat solid food

Exclusion Criteria (specific to this study):

• Men
• Women who are menopausal or peri-menopausal
• Prior use of betaquik® at any time for any duration
• Already using another ketogenic diet supplement on a sporadic basis (unless the patient is using one daily and is willing to continue doing so for the duration of this study)
• Already using coconut oil specifically for catamenial epilepsy within the month prior to enrollment (okay if patient only using for cooking throughout the month)
• Taking a hormonal contraceptive so that they do not menstruate (e.g. taking active instead of placebo oral contraceptive pills to avoid having a period)
• Anticipated need to adjust anti-epileptic medications within the next 6 months
• Anticipated initiation, change, or discontinuation of a hormonal contraceptive within the next 6 months
• Pregnant or anticipated pregnancy within the next 6 months

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modified Atkins diet plus betaquik®	betaquik®	Participants will continue on the modified Atkins diet (with a 20 net grams carbohydrate per day limit) and add betaquik® (a liquid emulsion of medium chain triglycerides) for 10 days per month for 5 months. The days chosen are based on their particular catamenial pattern (there are 3 types that have been identified in the literature).

Primary Outcome Measures

Name	Time	Method
Compliance as measured by the percent of time the participants drinks betaquik® averaged over 3 months	6 months	The primary outcome measure will be compliance with betaquik® (compared to published compliance of MAD and medium chain triglyceride diets) to demonstrate feasibility. The participant will be considered compliant if they drink the required amount of betaquik® on more than 80% of the prescribed days.

Secondary Outcome Measures

Name	Time	Method
Tolerability (10 point tolerance scale)	6 months	Secondary outcome measures will be tolerability of betaquik® based on a 10 point tolerance scale.

Trial Locations

Locations (2)

University of Wisconsin Hospital & Clinics; 🇺🇸 Madison, Wisconsin, United States

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