KetoEasy meal plan for Ketogenic Diet Therapy in children 2-12 years with parmacoresistant epilepsy

General
According to RIVM (2015) every year 3.000 children are diagnosed with epilepsy
in the Netherlands. Response rates to standard treatment with anti-epileptic
drugs are 70% . For the Netherlands this means 2100 (70%) seizures adequately
respond to anti-epileptic drugs. However, in 900 (30%) children this is not the
case. For this group Ketogenic Diet Therapy (KDT) is an important treatment
option.
Ketogenic Diet Therapy (KDT) is a specialist medical diet for children with
pharmaco resistant (i.e.2-3 anti-epileptic drugs have failed) epilepsy. It is
an extremely high fat (71-90 en%), very low carbohydrate (5-19 en%) diet
without caloric restriction and normal protein. This situation mimics the
metabolic state of fasting and induces the production of ketone bodies. The
reaction of the body is based on the ratio between the ketone producing
nutrient (fat) and the non-ketone producing nutrients (carbohydrates plus
protein). A 4:1 ratio means 4 grams of fat is used opposite to 1 gram
carbohydrates plus protein which is the most strict version and known as the
Classic Diet. Lower dietary ratio's as 3:1 are recommended for (young) infants.
KDT requires major adjustments of the regular menu and side effects are
frequently seen
KDT nowadays is a well-established treatment option in both children and adults
with pharmaco resistant epilepsy, in case of severe side effects of AEDs or
while waiting for epilepsy surgery. KDT is a treatment option of first choice
in case of specific metabolic diseases as Glucose Transporter Deficiency type 1
(GLUT-1), Pyruvate Dehydrogenase Deficiency (PDHC) or mitochondrial diseases.
In clinical practice KDT is initiated in a step-wise manner which can be done
safe and effective both during a short hospital admission or outpatient .
Evaluation of efficacy is done after period of 3 months after dietinitiation is
completed. In case the diet is effective it will be maintained for 2 years

The Ketoteam of the Erasmus MC-Sophia Children*s hospital has initiated KDT in
>280 children both outpatient as well as inpatient. However, this successful
treatment has been hampered by several challenges. From both the parent and
team perspective, the application of the KDT is a resource-consuming and
time-intensive process.
Moreover, recent research among our parent group shows that calculation,
weighing and preparation of the daily ketogenic menu*s and snacks are a
significant barrier for them in daily practice. This might not only cause a lot
of stress but might also be reason for stopping KDT.
At the Erasmus MC-Sophia children*s hospital both parents and the Ketoteam
strongly feel the need to tackle these barriers and make application of KDT
less stressful by making it more easy. Therefore, the Ketoteam has developed a
simplified version of KDT: the Keto-Easy meal plan. Keto-Easy is a
well-structured meal plan that is based on Classic Ketogenic Diet with 3:1
ratio with recipes of the same nutritional composition which makes them
interchangeable. The application of KDT by the use of Keto-Easy requires no
calculation neither by the parents nor the dietitian.
A delegation of our parent support group has tested a selection of the
developed recipes. Their opinion and advices have been very valuable and has
contributed to improvement of the meal plan.

Primary Objective:
To evaluate whether KDT application as the KetoEasy meal plan induces ketosis
and leads to seizure reduction in children 2-12 years with refractory epilepsy.

Secondary Objective(s):
To evaluate
-Feasibility: application in daily practice
-Safety: occurrence of side effects
-Growth : parameters by anthropometrics
-Adherence: number of drop outs and reason for stopping
-Experience in daily practice by parents

Other objective(s)
To evaluate
-Experience in daily practice by parents and the ketoteam

This is a proof of concept study of 4 months.

Ketogenic Diet Therapy (KDT) is a specialist medical diet for children with
pharmaco resistant (i.e.2-3 anti-epileptic drugs have failed) epilepsy. It is
an extremely high fat (71-90 en%), very low carbohydrate (5-19 en%) diet
without caloric restriction and normal proteinIn this study patients eligible
for ketogenic diet therapy will follow the Classic version of KDT by the use of
the KetoEasy meal plan. The Keto-Easy meal plan requires NO calculation neither
by the parents nor the dietitian.
Keto-Easy is a well-structured meal plan that is based on Classic Ketogenic
Diet with 3:1 ratio. This ratio consists of number of grams of ketone producing
nutrient (fat) opposite to the number of grams of non-ketone producing
nutrients (carbohydrates plus protein). The higher the ratio, the stricter the
diet. The KD used in this diet is based on a moderate 3:1 diet ratio.
The Keto Easy meal plan:
- is suitable for children age 2-12 years,
- recipes are based on units (1, 1.5 and 2 units),
- the dietitian determines the units the patient needs to follow to match the
individual need,
- the parent follows the recipe by using the amounts of the ingredients noted
at the
corresponding unit,
- the recipes have the same nutritional composition which makes them
interchangeable,
- the accompanied keto-snacks and sweets are based on ratio 3:1 and 4:1,
- the dietitian is able to fine-tune the diet by the choice of units and ratio
of the keto-snacks
and sweets,
- there are > 100 recipes available of several categories that can be used
either as main
course or as a snack,
- the recipes contain as less ingredients as possible and are easy to prepare,
- the majority of the recipes can be stored in the freezer,
- a number of recipes are especially designed to be used by the total family
(family recipe).
- majority of the recipes is tested by parents of the parent support group of
the ketoteam.

The meal plan is available for parents as a word document. Majority of the
recipes are illustrated with a photo.

The extent of the burden of our study is considered low.The ketogenic diet have
been proven feasible and safe in previous studies. Side effects are well
described and can be resolved by close monitoring by the experienced
multidisciplinary ketoteam. No extra visits or checks are required in this
study as the routine of the regular KDT protocol will be followed. Outcomes of
this study give an opportunity to tackle barriers and make application of KDT
less stressful by making it more easy while using the KetoEasy meal plan.
Overall goal is to get this successful treatment more widely available for
children in the Netherlands.