A Pilot Study of the Low Glycaemic Index Diet in Adults With Epilepsy
Primary Purpose
Epilepsy
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Low Glycaemic Index Diet
Sponsored by
About this trial
This is an interventional other trial for Epilepsy
Eligibility 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
Sites / Locations
- Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate Diet Group
Delayed Diet Group
Arm Description
Adhere to Low Glycaemic Index diet for 52 weeks, beginning immediately after randomisation.
Adhere to Low Glycaemic Index diet for 52 weeks, beginning 12 weeks after randomisation.
Outcomes
Primary Outcome Measures
% of patients who adhere to the diet as recorded in food diaries
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
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
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
Proportion of patients showing a 50% or greater reduction in seizure frequency from baseline
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
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.
Full Information
NCT ID
NCT03999827
First Posted
June 24, 2019
Last Updated
June 24, 2019
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03999827
Brief Title
A Pilot Study of the Low Glycaemic Index Diet in Adults With Epilepsy
Official Title
A Pilot Study of the Low Glycaemic Index Diet in Adults With Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 19, 2019 (Actual)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
November 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate Diet Group
Arm Type
Experimental
Arm Description
Adhere to Low Glycaemic Index diet for 52 weeks, beginning immediately after randomisation.
Arm Title
Delayed Diet Group
Arm Type
Active Comparator
Arm Description
Adhere to Low Glycaemic Index diet for 52 weeks, beginning 12 weeks after randomisation.
Intervention Type
Other
Intervention Name(s)
Low Glycaemic Index Diet
Other Intervention Name(s)
LGI Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
% of patients who adhere to the diet as recorded in food diaries
Description
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.
Time Frame
52 weeks
Title
Score on diet adherence likert scale questionnaire
Description
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.
Time Frame
52 weeks
Title
Score on diet acceptability likert scale questionnaire
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients showing a 50% or greater reduction in seizure frequency from baseline
Description
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.
Time Frame
52 weeks
Title
Change from baseline in QOLIE-31 score
Description
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.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Howell, MD
Phone
0114 2713669
Email
Stephen.Howell@sth.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Rowan Sutherill, RD
Phone
0114 2712617
Email
Rowan.Sutherill@sth.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Howell, MD
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Howell, MD
Phone
0114 2713669
Email
Stephen.Howell@sth.nhs.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Study of the Low Glycaemic Index Diet in Adults With Epilepsy
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