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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 : Recruiting
First Posted : April 24, 2015
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Vitaflo International, Ltd
Information provided by (Responsible Party):
Johns Hopkins University

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.

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)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 (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

Information from the National Library of Medicine

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


Contacts
Contact: Mackenzie C. Cervenka, M.D. 443-287-0423 ext 3 mcerven1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Mackenzie C. Cervenka, M.D.    443-287-0423 ext 3    mcerven1@jhmi.edu   
Sub-Investigator: Elizabeth A. Felton, M.D., Ph.D.         
Sub-Investigator: Eric H. Kossoff, M.D.         
Sub-Investigator: Bobbie J. Henry, R.D.         
United States, Wisconsin
University of Wisconsin Hospital & Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Elizabeth Felton, M.D.,Ph.D.    608-263-9578    felton@neurology.wisc.edu   
Sponsors and Collaborators
Johns Hopkins University
Vitaflo International, Ltd
Investigators
Principal Investigator: Mackenzie C Cervenka, M.D. Johns Hopkins University

Additional Information:
Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02426047     History of Changes
Other Study ID Numbers: CIR00007655
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

Keywords provided by Johns Hopkins University:
seizures
epilepsy
catamenial
ketogenic diet
modified Atkins diet
intractable epilepsy
medically refractory epilepsy
adult
medium chain triglyceride

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms