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

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Other: Modified Atkins Diet (MAD)

• Registration Number: NCT02565966
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Atkins Diet (MAD)	Modified Atkins Diet (MAD)	-

Primary Outcome Measures

Name	Time	Method
Neuroinflammation markers in blood	At time of surgery (approximately 3-4 weeks after randomization)	As measured by level of cytokines IL-6, TNF alpha, and C-reactive protein in blood samples
Levels of leptin in brain tissue	At time of surgery (approximately 3-4 weeks after randomization)
Neuroinflammation markers in brain tissue	At time of surgery (approximately 3-4 weeks after randomization)	As measured by level of cytokines, IL6, TNF alpha, and microglial activation and proliferation in brain tissue obtained during durgery
Levels of adenosine kinase in brain tissue	At time of surgery (approximately 3-4 weeks after randomization)
Levels of enzymes that synthesize glutamate and GABA	At time of surgery (approximately 3-4 weeks after randomization)	As measured in brain tissue obtained during surgery
Metabolism	At time of surgery (approximately 3-4 weeks after randomization)	As measured by level of fasting lipid profile, acylcarnitine profile, and beta-hydroxybutyrate in blood
Levels of adenosine in brain tissue	At time of surgery (approximately 3-4 weeks after randomization)
Levels of adenosite-1 (A1) receptors in brain tissue	At time of surgery (approximately 3-4 weeks after randomization)

Trial Locations

Locations (2)

NYU Langone Epilepsy Center; 🇺🇸 New York, New York, United States

Institute of Neurology and Neurosurgery at Saint Barnabas; 🇺🇸 Livingston, New Jersey, United States