Modified Atkins Diet Plus KetoCal for Adult Epilepsy

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-label Evaluation of KetoCal® in Initial Combination With the Modified Atkins Diet for the Dietary Management of Intractable Adult Epilepsy.

Conditions
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Epilepsy, Seizure, Medically Resistant Epilepsy, Medically Resistant Seizures

Intervention / Treatment
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* Dietary Supplement: Modified Atkins diet
* Dietary Supplement: KetoCal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Modified Atkins diet plus KetoCal<br>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<br>* 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.<br>Dietary Supplement: KetoCal<br>* 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.<br>* Other names: KetoCal tetrapak;|
| Active Comparator: Modified Atkins diet<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Study completion rate |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seizures, epilepsy, adult, intractable, medically refractory, Atkins, ketogenic, diet