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Intermittent Fasting in Refractory Epilepsy

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ClinicalTrials.gov Identifier: NCT02311023
Recruitment Status : Terminated (Difficulties recruiting)
First Posted : December 8, 2014
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Alan Wah Cheong Yuen, University College London Hospitals

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.

Condition or disease Intervention/treatment Phase
Epilepsy Other: Intermittent fasting Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Centre Open Six Months Study of Intermittent Fasting for the Treatment of People With Refractory Epilepsy.
Study Start Date : March 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: 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.
Other: Intermittent fasting



Primary Outcome Measures :
  1. Daily total number of seizures [ Time Frame: up to 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Current/previous eating disorder
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311023


Locations
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United Kingdom
UCLH , The Epilepsy Society
Chalfont St Peters, Buckinghamshire, United Kingdom, SL9 0RJ
Sponsors and Collaborators
University College London Hospitals

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Responsible Party: Dr Alan Wah Cheong Yuen, Honorary Research Associate, University College London Hospitals
ClinicalTrials.gov Identifier: NCT02311023     History of Changes
Other Study ID Numbers: UCLH 13/0389
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases