Modified Atkins Diet Plus KetoCal for Adult Epilepsy

Epilepsy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834482
• Other study ID #: NA_00068726
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: September 2017

Study information

• Verified date: August 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Medically Resistant Epilepsy
• Medically Resistant Seizures
• Seizure
• Seizures

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Nutricia Liverpool

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. Epub 2007 Oct 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ketosis	Time to urinary ketosis in days will be recorded and whether or not patients achieve serum ketosis at 1 month and 2 months.	1 month
Secondary	Seizure reduction	The percent seizure reduction compared to baseline (1 month before beginning the diet) will be recorded at 1 month and 2 months.	2 months
Secondary	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).	2 months
Secondary	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.	2 months
Secondary	Study completion rate		2 months

External Links

•   Adult Epilepsy Diet Center at Hopkins website
•   KetoCal 4:1 liquid (tetrapaks)