Randomised control trial of a ketogenic diet in adults with epilepsy – patient feasibility survey
University of Liverpool
About the study
The ketogenic diet is a specialist medical diet, which is much higher in fats and lower in carbohydrates than a typical diet. In the UK, it is a treatment option for children with epilepsy whose seizures can’t be reduced or stopped with epilepsy medicine. However, before the diet can be used for adults in the UK, well-controlled clinical trials are needed to research this more.
At Liverpool University, we are planning to apply for some funding to allow us to carry out this research. Before we do that, we want to involve people with epilepsy in how we will design the study. We would be very grateful for your help with this.
When will this study be recruiting?
Now until 15 July 2018
What will participants be asked to do?
We would like you to read some information about the ketogenic diet and also about how we plan to do the research.
We would then like you to answer 15 short questions about how acceptable you think the research trial would be to people with epilepsy.
The reading task and completing the survey might take you around 30 minutes to do.
Who can take part?
You can take part if you:
- Are an adult with epilepsy (over the age of 18)
- Are the carer of an adult (over the age of 18) with epilepsy
- Are a family member of an adult (over the age of 18) with epilepsy
- Live in the UK
Who is conducting the research?
Tony Marson, Professor of Neurology at the University of Liverpool
Who has reviewed this study?
The survey results will form part of a funding application which will be reviewed by National Institute for Health Research (NIHR). It does not need to be reviewed by an ethics committee at this stage.;
This research will help us design the study in a way that would be acceptable for people with epilepsy and make it more likely to succeed.
We are not asking you to take part in a the study - we'd just like to know your thoughts about how acceptable it would be, if you were asked to take part.
Please read the information below first and then complete a survey with 15 short questions
The ketogenic diet is a specialist medical diet, which is much higher in fats and lower in carbohydrates than a typical diet. In the UK, it is a treatment option for children with epilepsy whose seizures can’t be reduced or stopped with epilepsy medicine. Research suggests that about half of these children will see a 50% or more reduction in their seizures, when following a ketogenic diet.
A small number of research studies have shown that a 50-90% reduction in seizure activity is possible for adults who follow ketogenic diets. However, before the diet can be used for adults in the UK, well-controlled clinical trials are needed to research this more.
Researchers at Liverpool University are planning to apply for funding to carry out research. We want to involve people with epilepsy in the design of the study.
About the ketogenic diet
Usually, the body uses carbohydrate (sugary) foods for energy. When the person eats a ketogenic diet, their body uses fat for energy instead. These fats are broken down into ketones (hence the name of the diet). It is this switch in food that is thought to be how the diet works.
Committing to follow a ketogenic diet involves many lifestyle alterations, which can be challenging.
In the UK, a typical food intake is 50% carbohydrate, 15% protein and 35% fat. For ketogenic diets this is altered to about 5% carbohydrate, 15% protein and 80% fat. In terms of food for a person on the ketogenic diet, this means that:
- Carbohydrate foods are restricted, so foods like bread, pasta, rice, potatoes, crisps, sweets, cakes, milk and chocolate are not eaten
- Foods like fruit and vegetables can be eaten, but these are restricted, so they need to be counted or measured
- High fat foods are encouraged to be eaten. These include full-fat mayonnaise, double cream, butter, oils, nuts and cheese
- Protein foods like meats, fish and poultry remain the same as usual
Every person doing the ketogenic diet receives an individual plan containing menus and recipes from a dietician. This plan is very carefully worked out and needs to be followed closely. All meals need to be cooked from scratch. Ready meals, take away meals and convenience foods are not suitable for this diet.
The person must also see a dietician regularly, who will supervise them and monitor for side-effects. These can include altered cholesterol, constipation, loose stools and kidney stones.
A typical day on the ketogenic diet might look like this:
Breakfast - Eggs scrambled with double cream, fried bacon, fried mushrooms, spinach and half a mashed avocado
Lunch - Tuna mixed with plenty of mayonnaise, lettuce, cucumber, celery, half a pepper and grated cheese
Dinner - Salmon baked in pesto oil, 4 spoons of butternut squash mashed with butter, curly kale.
Snacks - Sugar free jelly, double cream, 10 strawberries and a handful of peanuts.
Designing a study to find out about the ketogenic diet in adults with difficult to control epilepsy
To see if ketogenic diets work for adults with epilepsy, researchers from the University of Liverpool would like to carry out a study. This will compare the results of adults eating a ketogenic diet and adults following a healthy eating plan.
Half the people who take part in the study will receive a ketogenic diet plan. The other half will receive a healthy eating advice from a dietitian. A computer will randomly decide which people receive which diet plan – the patient or their neurologist/dietician will not make this choice. This will allow for a fair comparison between the diet plans.
People following a ketogenic diet will be asked to do this for 6 months to begin with, and for up to 12 months in total. They will have regular meetings with a dietician and neurologist.
People following a healthy eating plan will have a single appointment with a dietitian. They will receive the same number of follow up appointments with a neurologist as the people on the ketogenic diet.
During the study people will be asked to complete food diaries, seizure diaries and questionnaires.