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

Study Overview
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Brief Summary
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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.

Official Title
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The Feasibility and Tolerability of Medium Chain Triglycerides as an Adjunct to the Dietary Management of Epilepsy in Women With a Catamenial Seizure Pattern on the Modified Atkins Diet

Conditions
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Epilepsy, Seizure, Catamenial Epilepsy, Medically Resistant Epilepsy, Medically Resistant Seizures

Intervention / Treatment
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* Dietary Supplement: betaquik®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Atkins diet plus betaquik®<br>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). | Dietary Supplement: betaquik®<br>* Participants will add 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.<br>* Other names: betaquik;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance as measured by the percent of time the participants drinks betaquik® averaged over 3 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability (10 point tolerance scale) | Secondary outcome measures will be tolerability of betaquik® based on a 10 point tolerance scale. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medium chain triglyceride, seizures, epilepsy, catamenial, ketogenic diet, modified Atkins diet, intractable epilepsy, medically refractory epilepsy, adult