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

Primary Purpose

Epilepsy, Seizure, Catamenial Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
betaquik®
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring seizures, epilepsy, catamenial, ketogenic diet, modified Atkins diet, intractable epilepsy, medically refractory epilepsy, adult, medium chain triglyceride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Hospital
  • University of Wisconsin Hospital & Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Modified Atkins diet plus betaquik®

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Tolerability (10 point tolerance scale)
Secondary outcome measures will be tolerability of betaquik® based on a 10 point tolerance scale.

Full Information

First Posted
March 10, 2015
Last Updated
April 13, 2020
Sponsor
Johns Hopkins University
Collaborators
Vitaflo International, Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02426047
Brief Title
Medium Chain Triglycerides as an Adjunct to the Modified Atkins Diet for Women With Catamenial Epilepsy
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 Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Vitaflo International, Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Atkins diet plus betaquik®
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
betaquik®
Other Intervention Name(s)
betaquik
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compliance as measured by the percent of time the participants drinks betaquik® averaged over 3 months
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Tolerability (10 point tolerance scale)
Description
Secondary outcome measures will be tolerability of betaquik® based on a 10 point tolerance scale.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mackenzie C Cervenka, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Wisconsin Hospital & Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17919301
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. doi: 10.1111/j.1528-1167.2007.01256.x. Epub 2007 Oct 5.
Results Reference
background
PubMed Identifier
9579954
Citation
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.
Results Reference
background

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

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