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出境医 / 临床实验 / A Pilot Study of the Low Glycaemic Index Diet in Adults With Epilepsy

A Pilot Study of the Low Glycaemic Index Diet in Adults With Epilepsy

Study Description
Brief Summary:

Many persons with epilepsy have seizures which remain uncontrolled by anti-epilepsy medications and are unsuitable for or unwilling to undergo surgical treatments for their epilepsy, or have undergone such treatments and continue to have seizures. Dietary treatments for epilepsy have been shown to be effective in children, and are probably effective in adults, but compliance with the classic ketogenic diet (KD) and to some degree also the modified Atkins diet (MAD) seems difficult for many adults.

The LGI diet may be easier and in children appears to be of comparable efficacy to other dietary treatments (KD and MAD), but has been little studied in adults.

This is a randomised study of immediate versus deferred LGI diet in adults with seizures incompletely controlled by anti-epilepsy medications. 12 weeks of dietary treatment in those randomised to LGI will be followed by the opportunity for the control group to undertake 12 weeks of the LGI diet.


Condition or disease Intervention/treatment Phase
Epilepsy Other: Low Glycaemic Index Diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study of the Low Glycaemic Index Diet in Adults With Epilepsy
Actual Study Start Date : March 19, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : November 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Immediate Diet Group
Adhere to Low Glycaemic Index diet for 52 weeks, beginning immediately after randomisation.
Other: Low Glycaemic Index Diet
Adherence to a diet which limits carbohydrate intake to 40-60 g/day, but carbohydrates must have a glycaemic index of less than 50. Fat and protein intake is encouraged, with approximately 60% of calorie intake as fat.
Other Name: LGI Diet

Active Comparator: Delayed Diet Group
Adhere to Low Glycaemic Index diet for 52 weeks, beginning 12 weeks after randomisation.
Other: Low Glycaemic Index Diet
Adherence to a diet which limits carbohydrate intake to 40-60 g/day, but carbohydrates must have a glycaemic index of less than 50. Fat and protein intake is encouraged, with approximately 60% of calorie intake as fat.
Other Name: LGI Diet

Outcome Measures
Primary Outcome Measures :
  1. % of patients who adhere to the diet as recorded in food diaries [ Time Frame: 52 weeks ]
    Adherence to the diet will be assessed by self report food diaries which patients will keep. These will be assessed at 12 weeks and 52 weeks after beginning the diet.

  2. Score on diet adherence likert scale questionnaire [ Time Frame: 52 weeks ]
    Adherence to the diet will be assessed by patients scores on a self report likert scale, ranging from 1 (follow the diet all the time) to 5 (follow the diet none of the time), at 12 weeks and 52 weeks after beginning the diet.

  3. Score on diet acceptability likert scale questionnaire [ Time Frame: 52 weeks ]
    Acceptability of the diet will be assessed by patients scores on a self report likert scale, ranging from 1 (the diet is acceptable all of the time) to 5 (the diet is acceptable none of the time), at 12 weeks and 52 weeks after beginning the diet.


Secondary Outcome Measures :
  1. Proportion of patients showing a 50% or greater reduction in seizure frequency from baseline [ Time Frame: 52 weeks ]
    Seizure frequency will be assessed through patient completion of seizure diaries throughout the study. This will be assessed at baseline and 12 weeks, 24 weeks and 52 weeks after beginning the diet.

  2. Change from baseline in QOLIE-31 score [ Time Frame: 52 weeks ]
    Epilepsy related quality of life will be measured using the Quality of Life in Epilepsy Inventory-31 (QOLIE-31), a self report questionnaire comprising two factors (emotional and psychological effects, and medical and social effects), eight sub-scales, and 39 items. Items are measured on 4- to 6- point Likert scales, with a maximum total score of 100. Higher scores indicate a better QoL. Change in QOLIE-31 score from baseline to 12 week and 52 weeks after beginning the diet will be assessed.


Eligibility Criteria
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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:

  • adults (>18 years)
  • epilepsy refractory to at least two appropriate first line anti-epileptic drugs in adequate dose, unsuitable for or unwilling to undergo surgery for epilepsy.
  • At least 1 seizure per week.
  • BMI >18

Exclusion Criteria:

  • unable to give informed consent
  • unable to comply with diet
  • surgery for epilepsy or VNS within the last 12 months
  • non-epileptic seizures
  • pregnant or planning pregnancy
  • significant renal impairment
  • history of renal stones
Contacts and Locations

Contacts
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Contact: Stephen Howell, MD 0114 2713669 Stephen.Howell@sth.nhs.uk
Contact: Rowan Sutherill, RD 0114 2712617 Rowan.Sutherill@sth.nhs.uk

Locations
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United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital Recruiting
Sheffield, United Kingdom, S10 2JF
Contact: Stephen Howell, MD    0114 2713669    Stephen.Howell@sth.nhs.uk   
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Stephen Howell, MD Sheffield Teaching Hospitals NHS Foundation Trust
Tracking Information
First Submitted Date  ICMJE June 24, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date June 27, 2019
Actual Study Start Date  ICMJE March 19, 2019
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • % of patients who adhere to the diet as recorded in food diaries [ Time Frame: 52 weeks ]
    Adherence to the diet will be assessed by self report food diaries which patients will keep. These will be assessed at 12 weeks and 52 weeks after beginning the diet.
  • Score on diet adherence likert scale questionnaire [ Time Frame: 52 weeks ]
    Adherence to the diet will be assessed by patients scores on a self report likert scale, ranging from 1 (follow the diet all the time) to 5 (follow the diet none of the time), at 12 weeks and 52 weeks after beginning the diet.
  • Score on diet acceptability likert scale questionnaire [ Time Frame: 52 weeks ]
    Acceptability of the diet will be assessed by patients scores on a self report likert scale, ranging from 1 (the diet is acceptable all of the time) to 5 (the diet is acceptable none of the time), at 12 weeks and 52 weeks after beginning the diet.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Proportion of patients showing a 50% or greater reduction in seizure frequency from baseline [ Time Frame: 52 weeks ]
    Seizure frequency will be assessed through patient completion of seizure diaries throughout the study. This will be assessed at baseline and 12 weeks, 24 weeks and 52 weeks after beginning the diet.
  • Change from baseline in QOLIE-31 score [ Time Frame: 52 weeks ]
    Epilepsy related quality of life will be measured using the Quality of Life in Epilepsy Inventory-31 (QOLIE-31), a self report questionnaire comprising two factors (emotional and psychological effects, and medical and social effects), eight sub-scales, and 39 items. Items are measured on 4- to 6- point Likert scales, with a maximum total score of 100. Higher scores indicate a better QoL. Change in QOLIE-31 score from baseline to 12 week and 52 weeks after beginning the diet will be assessed.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of the Low Glycaemic Index Diet in Adults With Epilepsy
Official Title  ICMJE A Pilot Study of the Low Glycaemic Index Diet in Adults With Epilepsy
Brief Summary

Many persons with epilepsy have seizures which remain uncontrolled by anti-epilepsy medications and are unsuitable for or unwilling to undergo surgical treatments for their epilepsy, or have undergone such treatments and continue to have seizures. Dietary treatments for epilepsy have been shown to be effective in children, and are probably effective in adults, but compliance with the classic ketogenic diet (KD) and to some degree also the modified Atkins diet (MAD) seems difficult for many adults.

The LGI diet may be easier and in children appears to be of comparable efficacy to other dietary treatments (KD and MAD), but has been little studied in adults.

This is a randomised study of immediate versus deferred LGI diet in adults with seizures incompletely controlled by anti-epilepsy medications. 12 weeks of dietary treatment in those randomised to LGI will be followed by the opportunity for the control group to undertake 12 weeks of the LGI diet.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Epilepsy
Intervention  ICMJE Other: Low Glycaemic Index Diet
Adherence to a diet which limits carbohydrate intake to 40-60 g/day, but carbohydrates must have a glycaemic index of less than 50. Fat and protein intake is encouraged, with approximately 60% of calorie intake as fat.
Other Name: LGI Diet
Study Arms  ICMJE
  • Experimental: Immediate Diet Group
    Adhere to Low Glycaemic Index diet for 52 weeks, beginning immediately after randomisation.
    Intervention: Other: Low Glycaemic Index Diet
  • Active Comparator: Delayed Diet Group
    Adhere to Low Glycaemic Index diet for 52 weeks, beginning 12 weeks after randomisation.
    Intervention: Other: Low Glycaemic Index Diet
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 24, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2020
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adults (>18 years)
  • epilepsy refractory to at least two appropriate first line anti-epileptic drugs in adequate dose, unsuitable for or unwilling to undergo surgery for epilepsy.
  • At least 1 seizure per week.
  • BMI >18

Exclusion Criteria:

  • unable to give informed consent
  • unable to comply with diet
  • surgery for epilepsy or VNS within the last 12 months
  • non-epileptic seizures
  • pregnant or planning pregnancy
  • significant renal impairment
  • history of renal stones
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 NCT03999827
Other Study ID Numbers  ICMJE STH20468
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sheffield Teaching Hospitals NHS Foundation Trust
Study Sponsor  ICMJE Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Howell, MD Sheffield Teaching Hospitals NHS Foundation Trust
PRS Account Sheffield Teaching Hospitals NHS Foundation Trust
Verification Date June 2019

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