Modified Atkins Diet Plus KetoCal for Adult Epilepsy

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01834482
• Collaborator: Nutricia Liverpool (Industry)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 54
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy; Seizure; Medically Resistant Epilepsy; Medically Resistant Seizures	Dietary Supplement: Modified Atkins diet; Dietary Supplement: KetoCal	N/A

Study Design

• Study Type: Interventional
• 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: Mar 1, 2013
• Actual Primary Completion Date: Sep 1, 2017
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

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.	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: KetoCal 4:1 liquid KetoCal tetrapak
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.	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.

Outcome Measures

Primary Outcome Measures

1. Ketosis [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.

Secondary Outcome Measures

1. Seizure reduction [2 months]

   The percent seizure reduction compared to baseline (1 month before beginning the diet) will be recorded at 1 month and 2 months.

2. Tolerability and taste [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).

3. Side effects [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.

4. Study completion rate [2 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21287

Sponsors and Collaborators

• Johns Hopkins University
• Nutricia Liverpool

Investigators

• Principal Investigator: Mackenzie C. Cervenka, M.D., Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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. Epub 2007 Oct 5.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01834482
• Other Study ID Numbers: NA_00068726
• First Posted: Apr 18, 2013
• Last Update Posted: Aug 31, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Johns Hopkins University: seizures; epilepsy; adult; intractable; medically refractory; Atkins; ketogenic; diet
• Additional relevant MeSH terms: Epilepsy; Seizures

Study Results

No Results Posted as of Aug 31, 2018