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Intermittent Fasting in Refractory Epilepsy

NCT ID: NCT02311023

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intermittent fasting

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.

Group Type EXPERIMENTAL

Intermittent fasting

Intervention Type OTHER

Interventions

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Intermittent fasting

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Experiencing at least 2 seizures per month
* .BMI of 25 or over

Exclusion Criteria

* Current/previous eating disorder
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College London Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Dr Alan Wah Cheong Yuen

Honorary Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCLH , The Epilepsy Society

Chalfont Saint Peters, Buckinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UCLH 13/0389

Identifier Type: -

Identifier Source: org_study_id