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Intermittent Fasting in Refractory Epilepsy

Primary Purpose

Epilepsy

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Intermittent fasting
Sponsored by
University College London Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 4, 2014
Last Updated
November 3, 2016
Sponsor
University College London Hospitals
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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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