Trial | NCT02426047  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    16
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.
Study Started
Mar 31
2015
Primary Completion
Jan 31
2020
Study Completion
Jan 31
2020
Last Update
Apr 15
2020

Dietary Supplement betaquik®

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.

  • Other names: betaquik

Modified Atkins diet plus betaquik® Experimental

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).

Criteria 

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
No Results Posted