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

NCT03999827 | Completed

• 1 other identifier: STH20468
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

• % 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.

  52 weeks

• 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.

  52 weeks

• 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.

  52 weeks

Secondary Outcomes (2)

• Proportion of patients showing a 50% or greater reduction in seizure frequency from baseline

  52 weeks

• Change from baseline in QOLIE-31 score

  52 weeks

Study Arms (2)

Immediate Diet Group

EXPERIMENTAL

Adhere to Low Glycaemic Index diet for 52 weeks, beginning immediately after randomisation.

Other: Low Glycaemic Index Diet

Delayed Diet Group

ACTIVE COMPARATOR

Adhere to Low Glycaemic Index diet for 52 weeks, beginning 12 weeks after randomisation.

Other: Low Glycaemic Index Diet

Interventions

Low Glycaemic Index Diet OTHER

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.

Also known as: LGI Diet

Delayed Diet Group; Immediate Diet Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Stephen Howell, MD

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 27, 2019
• Study Start: March 19, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)