Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy - a Controlled, Randomized Trial

In Oslo University Hospital, department of complex epilepsy, offer ketogenic diet to treat children with medically intractable epilepsy. From 2009 we added modified Atkins diet as a treatment option for children up to 18 years.

We now initiate an open, prospective, randomized and controlled study with the aim to test the efficacy of treatment with modified Atkins diet in adults with focal and generalized epilepsy diagnoses, in order to evaluate whether this treatment should be offered to patients on a permanent basis.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Generalized Epilepsy; Focal Epilepsy
• Intervention / Treatment: Other: Modified Atkins diet treatment

Detailed Description

Poorly controlled epilepsy in adults affects health and quality of life in many ways. Within this heterogenous population there are individuals who are motivated for a very strict diet in order to reduce seizures.

Among adults with epilepsy 75 - 80 % are diagnosed with focal epilepsy, while 20 - 25 % have generalized onset of seizures.

We plan to include 92 patients with focal epilepsy diagnosis. Those are randomized into diet and control groups.

During the inclusion period we also treat patients with generalized epilepsy that qualify for participation, but these are not to be randomized, rather they will follow the diet group course. We assume 18 - 23 patients with generalized epilepsy will be included in the project.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bærum Postterminal
    • Sandvika, Bærum Postterminal, Norway, 1306
      • Oslo University Hospital, The national Centre for epilepsy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Focal or generalized epilepsy diagnosis
• More than 3 recordable seizures per month
• BMI > 18,5
• Not responded to at least three 3 AEDs
• 16 years or older
• Motivated to complete the diet after thorough information
• Capable of recording seizures
• Capable of preparing the diet

Exclusion Criteria:

• Hypercholesterolemia, cardiovascular disease or kidney disease
• Been on modified Atkins diet for more than one week during the last year
• Status epilepticus last six months
• epilepsy surgery or VNS implant last year
• 4 weeks continuous seizure freedom last 2 months
• PNES seizures
• other disease where dietary treatment is contraindicated
• usage of drugs or supplements that may interfere with diet or AED
• being pregnant or planning pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Modified Atkins diet treatment; 12 weeks of Modified Atkins diet treatment, recording seizures	Other: Modified Atkins diet treatment; Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.
NO_INTERVENTION: No intervention; 12 weeks seizure record

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in seizure frequency	All participants record detailed seizure records for 12 weeks prior to the control/diet period. The diet group participants are subsequently treated with modified Atkins diet for 12 weeks, while the control group continue their normal diet and record seizures for another 12 weeks. Seizure records for each participant before and during intervention are compared.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in body weight	12 weeks
Change in standard 3-hrs EEG	12 weeks
Change in life quality measured by validated questionnaire	12 weeks
Change in various blood and serum measures	12 weeks
Change in executive functions measured with validated questionnaire	12 weeks
Change in seizure strength and severity measured by validated questionnaire	12 weeks

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Karl Otto Nakken, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2011
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: March 7, 2011
• First Submitted That Met QC Criteria: March 7, 2011
• First Posted (ESTIMATE): March 9, 2011

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: epilepsy; RCT; ketogenic diet; adults; modified Atkins diet
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial; Epilepsy, Generalized; Drug Resistant Epilepsy
• Other Study ID Numbers: 2010/2326 (REK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED