Modified Atkins Diet Plus KetoCal for Adult Epilepsy
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ClinicalTrials.gov Identifier: NCT01834482 |
Recruitment Status
:
Completed
First Posted
: April 18, 2013
Last Update Posted
: January 23, 2018
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Condition or disease | Intervention/treatment | Phase |
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Epilepsy Seizure Medically Resistant Epilepsy Medically Resistant Seizures | Dietary Supplement: Modified Atkins diet Dietary Supplement: KetoCal | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | March 2013 |
Actual Primary Completion Date : | September 2017 |
Actual Study Completion Date : | September 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Modified Atkins diet plus KetoCal
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.
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Dietary Supplement: Modified Atkins diet
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.
Dietary Supplement: KetoCal
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.
Other Names:
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Active Comparator: Modified Atkins diet
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.
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Dietary Supplement: Modified Atkins diet
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.
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- Ketosis [ Time Frame: 1 month ]Time to urinary ketosis in days will be recorded and whether or not patients achieve serum ketosis at 1 month and 2 months.
- Seizure reduction [ Time Frame: 2 months ]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 [ Time Frame: 2 months ]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 [ Time Frame: 2 months ]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 [ Time Frame: 2 months ]

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT01834482
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Mackenzie C. Cervenka, M.D. | Johns Hopkins University |
Additional Information:
Publications:
Responsible Party: | Mackenzie Cervenka, Assistant Professor of Neurology, Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT01834482 History of Changes |
Other Study ID Numbers: |
NA_00068726 |
First Posted: | April 18, 2013 Key Record Dates |
Last Update Posted: | January 23, 2018 |
Last Verified: | January 2018 |
Keywords provided by Mackenzie Cervenka, Johns Hopkins University:
seizures epilepsy adult intractable |
medically refractory Atkins ketogenic diet |
Additional relevant MeSH terms:
Epilepsy Seizures Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms |