Medium Chain Triglycerides as an Adjunct to the Modified Atkins Diet for Women With Catamenial Epilepsy
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|ClinicalTrials.gov Identifier: NCT02426047|
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : April 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Seizure Catamenial Epilepsy Medically Resistant Epilepsy Medically Resistant Seizures||Dietary Supplement: betaquik®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||January 2020|
|Actual Study Completion Date :||January 2020|
Experimental: 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).
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 Name: betaquik
- 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.
- Tolerability (10 point tolerance scale) [ Time Frame: 6 months ]Secondary outcome measures will be tolerability of betaquik® based on a 10 point tolerance scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426047
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|United States, Wisconsin|
|University of Wisconsin Hospital & Clinics|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Mackenzie C Cervenka, M.D.||Johns Hopkins University|