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

NCT ID: NCT02426047

Last Updated: 2020-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2020-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Modified Atkins diet plus betaquik®

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).

Group Type: EXPERIMENTAL

betaquik®

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

betaquik

Eligibility 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

• 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
• Anticipated initiation, change, or discontinuation of a hormonal contraceptive within the next 6 months
• Pregnant or anticipated pregnancy within the next 6 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vitaflo International, Ltd

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mackenzie C Cervenka, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17919301 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9579954 (View on PubMed)

Other Identifiers

IRB00038562

Identifier Type: -

Identifier Source: org_study_id