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

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Modified Atkins Diet (MAD)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Epilepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institute of Neurology and Neurosurgery at Saint Barnabas
  • NYU Langone Epilepsy Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Modified Atkins Diet (MAD)

Normal Diet

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 30, 2015
Last Updated
January 16, 2020
Sponsor
NYU Langone Health
Collaborators
St. Barnabas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02565966
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
St. Barnabas Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified Atkins Diet (MAD)
Arm Type
Experimental
Arm Title
Normal Diet
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Modified Atkins Diet (MAD)
Intervention Description
For those in the MAD intervention group, the dietitian trains the patient and family in the preparation and management of this specialized therapy including sick-day guidelines, meal planning, carbohydrate counting and trouble-shooting. Written and verbal education including, but not limited to: recipes, education materials, sample meal plans and carbohydrate counters are provided to the patient during the initial education session. The caregiver/patient is trained in the outpatient setting and the diet is implemented at home with as much email/phone support from the dietician and ketogenic team as the patient needs to successfully maintain the diet. Medications are all changed over to the lowest carbohydrate forms to eliminate excess carbohydrate intake and all patients are started on vitamin supplements to maintain adequate nutrition.
Primary Outcome Measure Information:
Title
Neuroinflammation markers in blood
Description
As measured by level of cytokines IL-6, TNF alpha, and C-reactive protein in blood samples
Time Frame
At time of surgery (approximately 3-4 weeks after randomization)
Title
Metabolism
Description
As measured by level of fasting lipid profile, acylcarnitine profile, and beta-hydroxybutyrate in blood
Time Frame
At time of surgery (approximately 3-4 weeks after randomization)
Title
Neuroinflammation markers in brain tissue
Description
As measured by level of cytokines, IL6, TNF alpha, and microglial activation and proliferation in brain tissue obtained during durgery
Time Frame
At time of surgery (approximately 3-4 weeks after randomization)
Title
Levels of leptin in brain tissue
Time Frame
At time of surgery (approximately 3-4 weeks after randomization)
Title
Levels of adenosine in brain tissue
Time Frame
At time of surgery (approximately 3-4 weeks after randomization)
Title
Levels of adenosine kinase in brain tissue
Time Frame
At time of surgery (approximately 3-4 weeks after randomization)
Title
Levels of adenosite-1 (A1) receptors in brain tissue
Time Frame
At time of surgery (approximately 3-4 weeks after randomization)
Title
Levels of enzymes that synthesize glutamate and GABA
Description
As measured in brain tissue obtained during surgery
Time Frame
At time of surgery (approximately 3-4 weeks after randomization)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orrin Devinsky, MD
Organizational Affiliation
NYU Langone Epilepsy Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Neurology and Neurosurgery at Saint Barnabas
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
NYU Langone Epilepsy Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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