Clinical trial NCT02565966: Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues
Official title: Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: St. Barnabas Medical Center
First posted: 2015-10-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Neuroinflammation markers in blood
timeFrame: At time of surgery (approximately 3-4 weeks after randomization)
measure: Metabolism
timeFrame: At time of surgery (approximately 3-4 weeks after randomization)
measure: Neuroinflammation markers in brain tissue
timeFrame: At time of surgery (approximately 3-4 weeks after randomization)
measure: Levels of leptin in brain tissue
timeFrame: At time of surgery (approximately 3-4 weeks after randomization)
measure: Levels of adenosine in brain tissue
timeFrame: At time of surgery (approximately 3-4 weeks after randomization)
measure: Levels of adenosine kinase in brain tissue
timeFrame: At time of surgery (approximately 3-4 weeks after randomization)
measure: Levels of adenosite-1 (A1) receptors in brain tissue
timeFrame: At time of surgery (approximately 3-4 weeks after randomization)
measure: Levels of enzymes that synthesize glutamate and GABA
timeFrame: At time of surgery (approximately 3-4 weeks after randomization)
Secondary outcomes:
Other outcomes:
Locations:
city: Livingston
country: United States
facility: Institute of Neurology and Neurosurgery at Saint Barnabas
state: New Jersey
city: New York
country: United States
facility: NYU Langone Epilepsy Center
state: New York
Study officials:
affiliation: NYU Langone Epilepsy Center
name: Orrin Devinsky, MD
role: PRINCIPAL_INVESTIGATOR
References: