Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Epilepsy, Focal Epilepsy, Generalized Epilepsy

Intervention / Treatment
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* Other: Modified Atkins diet treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Atkins diet treatment<br>12 weeks of Modified Atkins diet treatment, recording seizures | Other: Modified Atkins diet treatment<br>* Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.<br>|
| No Intervention: No intervention<br>12 weeks seizure record | |

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, modified Atkins diet, epilepsy, adults, ketogenic diet