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

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ClinicalTrials.gov Identifier: NCT03999827
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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




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.



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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

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): NCT03999827


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

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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03999827     History of Changes
Other Study ID Numbers: STH20468
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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