Intermittent Fasting in Refractory Epilepsy
Primary Purpose
Epilepsy
Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Intermittent fasting
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Experiencing at least 2 seizures per month
- .BMI of 25 or over
Exclusion Criteria:
- Current/previous eating disorder
- Pregnancy
Sites / Locations
- UCLH , The Epilepsy Society
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intermittent fasting
Arm Description
Patients consume their normal diet for 5 days in the week. On 2 days they only consume 500 Cals if female and 600 Cals if male.
Outcomes
Primary Outcome Measures
Daily total number of seizures
Secondary Outcome Measures
Full Information
NCT ID
NCT02311023
First Posted
December 4, 2014
Last Updated
November 3, 2016
Sponsor
University College London Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT02311023
Brief Title
Intermittent Fasting in Refractory Epilepsy
Official Title
A Single Centre Open Six Months Study of Intermittent Fasting for the Treatment of People With Refractory Epilepsy.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficulties recruiting
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College London Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open trial of intermittent fasting in a group of patients with refractory seizures. Patients will continue on the diet for 6 months to assess the impact of the diet on seizure frequency.
Detailed Description
A proportion of people with epilepsy continue to have seizures despite all conventional treatment options. The classical ketogenic diet and its variants have been shown to help some of these people. However, these diets require significant medical and dietician supervision,and is frequently not well tolerated. There is a need to develop other diet therapy that is easier to administer and more acceptable to the patient. This trial undertaken in adult overweight UCLH outpatients examines the effect of an intermittent fasting diet on seizures. Subjects may consume their normal diet for 5 days a week. On 2 days in a week, they consume only 25% of their daily calorie requirement. Subjects will continue on the diet for 6 months. Intermittent fasting has been shown in animal studies to activate a number of signalling pathways which are thought to reduce seizure thresholds. Has intermittent fasting in humans might be expected to reduce seizures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intermittent fasting
Arm Type
Experimental
Arm Description
Patients consume their normal diet for 5 days in the week. On 2 days they only consume 500 Cals if female and 600 Cals if male.
Intervention Type
Other
Intervention Name(s)
Intermittent fasting
Primary Outcome Measure Information:
Title
Daily total number of seizures
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Experiencing at least 2 seizures per month
.BMI of 25 or over
Exclusion Criteria:
Current/previous eating disorder
Pregnancy
Facility Information:
Facility Name
UCLH , The Epilepsy Society
City
Chalfont St Peters
State/Province
Buckinghamshire
ZIP/Postal Code
SL9 0RJ
Country
United Kingdom
12. IPD Sharing Statement
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Intermittent Fasting in Refractory Epilepsy
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