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 |
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Epilepsy | Other: Low Glycaemic Index Diet | Not Applicable |
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 |
Arm | Intervention/treatment |
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Experimental: Immediate Diet Group
Adhere to Low Glycaemic Index diet for 52 weeks, beginning immediately after randomisation.
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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
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Active Comparator: Delayed Diet Group
Adhere to Low Glycaemic Index diet for 52 weeks, beginning 12 weeks after randomisation.
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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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephen Howell, MD | 0114 2713669 | Stephen.Howell@sth.nhs.uk | |
Contact: Rowan Sutherill, RD | 0114 2712617 | Rowan.Sutherill@sth.nhs.uk |
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 |
Principal Investigator: | Stephen Howell, MD | Sheffield Teaching Hospitals NHS Foundation Trust |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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 |
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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
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Sheffield Teaching Hospitals NHS Foundation Trust | ||||
Study Sponsor ICMJE | Sheffield Teaching Hospitals NHS Foundation Trust | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |