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

NCT ID: NCT03999827

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-19
• Study Completion Date: 2020-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Immediate Diet Group

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

Group Type: EXPERIMENTAL

Low Glycaemic Index Diet

Intervention Type: 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.

Delayed Diet Group

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

Group Type: ACTIVE_COMPARATOR

Low Glycaemic Index Diet

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

LGI Diet

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Howell, MD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital

Sheffield, , United Kingdom

Countries

United Kingdom

Other Identifiers

STH20468

Identifier Type: -

Identifier Source: org_study_id