Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues

NYU Langone Health

Status: Completed

Conditions: Epilepsy

Treatments: Other: Modified Atkins Diet (MAD)

Study type: Interventional

Funder types: Other

Identifiers

NCT02565966

14-01069

Details and patient eligibility

About

The purpose of this study is to better define the potential molecular and anti-inflammatory changes induced by the modified Atkins diet in the brains of patients with treatment resistant epilepsy. The investigators plan to enroll 30 subjects overall in this study to compare serologic and brain tissue specimens. At NYU, investigators plan to enroll 20 subjects; an estimated ten (10) subjects will consume a modified Atkins diet for 3-4 weeks prior to surgery and an estimated ten (10) subjects will consume a non-modified, higher carbohydrate diet. Investigators at Saint Barnabas Medical Center plan to enroll 10 subjects in this study to compare serologic and brain tissue specimens. Approximately five (5) subjects will consume a modified Atkins diet for 3-4 weeks prior to surgery and five (5) subjects will consume a non-modified, higher carbohydrate diet. Blood and brain tissue specimens will be obtained at the time of surgery and will be compared. The goal of this study is to identify whether or not there are changes in neuroinflammation or neuroexcitability in the human brain induced by the modified Atkins diet.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients scheduled for epilepsy surgery at New York Langone Medical Center or St Barnabas Medical Center will be eligible for enrollment.

• Patient is at least 18 years of age
• Patient is willing to participate by complying with the modified Atkins diet 3 - 4 weeks prior to surgery and maintain a thorough food diary (Intervention study group) or to continue their usual diet and maintain a thorough food diary (Nonintervention study group)
• Patient/ his/her parent, caregiver, or health care proxy is willing and able to provide consent or assent

Exclusion criteria

• Patients under the age of 18 will be excluded
• Patients in whom a two-stage surgery is planned without any resection of brain tissue during the initial craniotomy
• Patients unwilling to comply with modified Atkins diet 3 -4 weeks prior to surgery or unwilling to maintain a thorough food diary will be excluded.
• Patients who are currently on an Atkins or Low Glycemic Index Diet will not be eligible for inclusion in the nonintervention group.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 2 patient groups

Modified Atkins Diet (MAD)

Experimental group

Treatment:

Other: Modified Atkins Diet (MAD)

Normal Diet

No Intervention group

Description:

Those patients in the normal diet (no intervention) group will also meet with the epilepsy center nutritionist to review the food diary and completion of this document, similar to those in the intervention (MAD) group. No dietary restrictions will be made in this group.