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

NHS Foundation Trust

Status: Completed

Conditions: Epilepsy

Treatments: Other: Low Glycaemic Index Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03999827

STH20468

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Immediate Diet Group

Experimental group

Description:

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

Treatment:

Other: Low Glycaemic Index Diet

Delayed Diet Group

Active Comparator group

Description:

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

Treatment:

Other: Low Glycaemic Index Diet