Modified Atkins Diet Plus KetoCal for Adult Epilepsy

NCT01834482 | Completed

• 1 other identifier: NA_00068726
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy; Seizure; Medically Resistant Epilepsy; Medically Resistant Seizures

Keywords

seizures; epilepsy; adult; intractable; medically refractory; Atkins; ketogenic; diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Seizure reduction

  2 months

• Tolerability and taste

  2 months

• Side effects

  2 months

• Study completion rate

  2 months

Study Arms (2)

Modified Atkins diet plus KetoCal

ACTIVE COMPARATOR

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; Dietary Supplement: KetoCal

Modified Atkins diet

ACTIVE COMPARATOR

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

Interventions

Modified Atkins diet DIETARY_SUPPLEMENT

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.

Modified Atkins diet; Modified Atkins diet plus KetoCal

KetoCal DIETARY_SUPPLEMENT

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.

Also known as: KetoCal 4:1 liquid, KetoCal tetrapak

Modified Atkins diet plus KetoCal

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Nutricia Liverpool: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (3)

• 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.

  PMID: 20833798 BACKGROUND

• 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.

  PMID: 22332768 BACKGROUND

• 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.

  PMID: 17919301 BACKGROUND

Related Links

• Adult Epilepsy Diet Center at Hopkins website

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Mackenzie C. Cervenka, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 18, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

US (1)