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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

Tracking Information
First Submitted Date  ICMJE December 4, 2014
First Posted Date  ICMJE December 8, 2014
Last Update Posted Date November 4, 2016
Study Start Date  ICMJE March 2014
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
Daily total number of seizures [ Time Frame: up to 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02311023 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intermittent Fasting in Refractory Epilepsy
Official Title  ICMJE A Single Centre Open Six Months Study of Intermittent Fasting for the Treatment of People With Refractory Epilepsy.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Other: Intermittent fasting
Study Arms  ICMJE 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.
Intervention: Other: Intermittent fasting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 3, 2016)
4
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2014)
20
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Current/previous eating disorder
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02311023
Other Study ID Numbers  ICMJE UCLH 13/0389
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Alan Wah Cheong Yuen, University College London Hospitals
Study Sponsor  ICMJE University College London Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University College London Hospitals
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP