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

Epilepsy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426047
• Other study ID #: IRB00038562
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: January 2020

Study information

• Verified date: April 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catamenial Epilepsy
• Epilepsy
• Medically Resistant Epilepsy
• Medically Resistant Seizures
• Seizure
• Seizures

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Wisconsin Hospital & Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Vitaflo International, Ltd

Country where clinical trial is conducted

United States, 

References & Publications (2)

Herzog AG, Klein P, Ransil BJ. Three patterns of catamenial epilepsy. Epilepsia. 1997 Oct;38(10):1082-8. — View Citation

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. Epub 2007 Oct 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tolerability (10 point tolerance scale)	Secondary outcome measures will be tolerability of betaquik® based on a 10 point tolerance scale.	6 months

External Links

•   Vitaflo International website information on betaquik®