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Completed

NCT Number: NCT02426047

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Catamenial Epilepsy Central Nervous System Diseases Drug Resistant Epilepsy Medically Resistant Epilepsy Medically Resistant Seizures Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizure Seizures Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

betaquik®

Dietary Supplement

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

Primary outcomes

  1. Compliance as measured by the percent of time the participants drinks betaquik® averaged over 3 months

    Time frame: 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 outcomes

  1. Tolerability (10 point tolerance scale)

    Time frame: 6 months

    Secondary outcome measures will be tolerability of betaquik® based on a 10 point tolerance scale.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Vitaflo International, Ltd

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2015
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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