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

NCT02426047 | Completed

• 1 other identifier: IRB00038562
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Epilepsy; Seizure; Catamenial Epilepsy; Medically Resistant Epilepsy; Medically Resistant Seizures

Keywords

seizures; epilepsy; catamenial; ketogenic diet; modified Atkins diet; intractable epilepsy; medically refractory epilepsy; adult; medium chain triglyceride

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tolerability (10 point tolerance scale)

  6 months

Study Arms (1)

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).

Dietary Supplement: betaquik®

Interventions

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.

Also known as: betaquik

Modified Atkins diet plus betaquik®

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Vitaflo International, Ltd: collaborator

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Kossoff EH, Rowley H, Sinha SR, Vining EP. A prospective study of the modified Atkins diet for intractable epilepsy in adults. Epilepsia. 2008 Feb;49(2):316-9. doi: 10.1111/j.1528-1167.2007.01256.x. Epub 2007 Oct 5.

  PMID: 17919301 BACKGROUND

• Herzog AG, Klein P, Ransil BJ. Three patterns of catamenial epilepsy. Epilepsia. 1997 Oct;38(10):1082-8. doi: 10.1111/j.1528-1157.1997.tb01197.x.

  PMID: 9579954 BACKGROUND

MeSH Terms

Conditions

Epilepsy; Seizures; Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mackenzie C Cervenka, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: April 24, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

US (2)