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Modified Atkins Diet Plus KetoCal for Adult Epilepsy

Primary Purpose

Epilepsy, Seizure, Medically Resistant Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Atkins diet
KetoCal
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, adult, intractable, medically refractory, Atkins, ketogenic, diet

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults ages >17 years.
  • At least weekly seizures (or 4 per month). All seizure types allowed.
  • Tried at least two anticonvulsants.

Exclusion Criteria:

  • Unwilling to restrict carbohydrates
  • Significantly underweight (Body Mass Index <18.5)
  • Prior use of the modified Atkins diet for ≥ 2 days
  • Prior use of KetoCal® at any time for any duration
  • Use of the ketogenic diet within the past year
  • Kidney disease
  • History of hypercholesterolemia (total cholesterol > 300 mg/dl) or hypertriglyceridemia (triglycerides > 200 mg/dl)
  • Metabolic or mitochondrial disorder
  • Pregnancy or breastfeeding
  • Lactose intolerance or milk allergy
  • Aversion to liquids or inability to eat solid food

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Modified Atkins diet plus KetoCal

Modified Atkins diet

Arm Description

Patients will receive the modified Atkins diet in combination with a KetoCal tetrapak daily for the first month. The second month, no tetrapaks will be given.

Patients will receive the modified Atkins diet for the first month. The second month, they will be given the choice to also use KetoCal in addition to the modified Atkins diet if they choose to do so.

Outcomes

Primary Outcome Measures

Ketosis
Time to urinary ketosis in days will be recorded and whether or not patients achieve serum ketosis at 1 month and 2 months.

Secondary Outcome Measures

Seizure reduction
The percent seizure reduction compared to baseline (1 month before beginning the diet) will be recorded at 1 month and 2 months.
Tolerability and taste
Patients will be asked to rank convenience, taste, texture, and tolerability of the liquid on a 10 point scale (1 = poor, 10 = excellent).
Side effects
Patients will be screened for constipation and asked if they have experienced any side effects related to use of the modified Atkins diet and KetoCal® at 1 and 2 months.
Study completion rate

Full Information

First Posted
April 1, 2013
Last Updated
August 29, 2018
Sponsor
Johns Hopkins University
Collaborators
Nutricia Liverpool
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1. Study Identification

Unique Protocol Identification Number
NCT01834482
Brief Title
Modified Atkins Diet Plus KetoCal for Adult Epilepsy
Official Title
A Randomized, Open-label Evaluation of KetoCal® in Initial Combination With the Modified Atkins Diet for the Dietary Management of Intractable Adult Epilepsy.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Nutricia Liverpool

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The modified Atkins diet (MAD) has been shown to be effective in treating children and adults with medically resistant seizures. A recent study in children showed that the use of KetoCal® once per day in addition to the MAD appeared to be beneficial when used during the first month. The investigators hypothesize that including a daily KetoCal® liquid tetrapak with one meal during the initial month of the MAD will produce urinary ketosis in more adult patients than the MAD alone and will lead to greater seizure reduction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Seizure, Medically Resistant Epilepsy, Medically Resistant Seizures
Keywords
seizures, epilepsy, adult, intractable, medically refractory, Atkins, ketogenic, diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Atkins diet plus KetoCal
Arm Type
Active Comparator
Arm Description
Patients will receive the modified Atkins diet in combination with a KetoCal tetrapak daily for the first month. The second month, no tetrapaks will be given.
Arm Title
Modified Atkins diet
Arm Type
Active Comparator
Arm Description
Patients will receive the modified Atkins diet for the first month. The second month, they will be given the choice to also use KetoCal in addition to the modified Atkins diet if they choose to do so.
Intervention Type
Dietary Supplement
Intervention Name(s)
Modified Atkins diet
Intervention Description
Patients will receive the modified Atkins diet with a 20 gram per day carbohydrate limit and encouragement to consume plenty of fat and eat to satiety.
Intervention Type
Dietary Supplement
Intervention Name(s)
KetoCal
Other Intervention Name(s)
KetoCal 4:1 liquid, KetoCal tetrapak
Intervention Description
Patients will receive a KetoCal 4:1 ratio (fat: carbohydrates and protein) liquid daily for the first month (if randomized to this arm of the study). They will also be started on the modified Atkins diet.
Primary Outcome Measure Information:
Title
Ketosis
Description
Time to urinary ketosis in days will be recorded and whether or not patients achieve serum ketosis at 1 month and 2 months.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Seizure reduction
Description
The percent seizure reduction compared to baseline (1 month before beginning the diet) will be recorded at 1 month and 2 months.
Time Frame
2 months
Title
Tolerability and taste
Description
Patients will be asked to rank convenience, taste, texture, and tolerability of the liquid on a 10 point scale (1 = poor, 10 = excellent).
Time Frame
2 months
Title
Side effects
Description
Patients will be screened for constipation and asked if they have experienced any side effects related to use of the modified Atkins diet and KetoCal® at 1 and 2 months.
Time Frame
2 months
Title
Study completion rate
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults ages >17 years. At least weekly seizures (or 4 per month). All seizure types allowed. Tried at least two anticonvulsants. Exclusion Criteria: Unwilling to restrict carbohydrates Significantly underweight (Body Mass Index <18.5) Prior use of the modified Atkins diet for ≥ 2 days Prior use of KetoCal® at any time for any duration Use of the ketogenic diet within the past year Kidney disease History of hypercholesterolemia (total cholesterol > 300 mg/dl) or hypertriglyceridemia (triglycerides > 200 mg/dl) Metabolic or mitochondrial disorder Pregnancy or breastfeeding Lactose intolerance or milk allergy Aversion to liquids or inability to eat solid food
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 University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20833798
Citation
Kossoff EH, Dorward JL, Turner Z, Pyzik PL. Prospective study of the modified atkins diet in combination with a ketogenic liquid supplement during the initial month. J Child Neurol. 2011 Feb;26(2):147-51. doi: 10.1177/0883073810375718. Epub 2010 Sep 10.
Results Reference
background
PubMed Identifier
22332768
Citation
Cervenka MC, Terao NN, Bosarge JL, Henry BJ, Klees AA, Morrison PF, Kossoff EH. E-mail management of the modified Atkins Diet for adults with epilepsy is feasible and effective. Epilepsia. 2012 Apr;53(4):728-32. doi: 10.1111/j.1528-1167.2012.03406.x. Epub 2012 Feb 14.
Results Reference
background
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
Links:
URL
http://www.hopkinsmedicine.org/neurology_neurosurgery/specialty_areas/epilepsy/adult/adult-epilepsy-diet-center/
Description
Adult Epilepsy Diet Center at Hopkins website

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Modified Atkins Diet Plus KetoCal for Adult Epilepsy

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