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

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ClinicalTrials.gov Identifier: NCT02565966
Recruitment Status : Recruiting
First Posted : October 1, 2015
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
St. Barnabas Medical Center
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Epilepsy Other: Modified Atkins Diet (MAD) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues
Study Start Date : June 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Modified Atkins Diet (MAD) Other: Modified Atkins Diet (MAD)
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.
No Intervention: Normal Diet
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.


Outcome Measures
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Primary Outcome Measures :
  1. Neuroinflammation markers in blood [ Time Frame: 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

  2. Metabolism [ Time Frame: 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

  3. Neuroinflammation markers in brain tissue [ Time Frame: 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

  4. Levels of leptin in brain tissue [ Time Frame: At time of surgery (approximately 3-4 weeks after randomization) ]
  5. Levels of adenosine in brain tissue [ Time Frame: At time of surgery (approximately 3-4 weeks after randomization) ]
  6. Levels of adenosine kinase in brain tissue [ Time Frame: At time of surgery (approximately 3-4 weeks after randomization) ]
  7. Levels of adenosite-1 (A1) receptors in brain tissue [ Time Frame: At time of surgery (approximately 3-4 weeks after randomization) ]
  8. Levels of enzymes that synthesize glutamate and GABA [ Time Frame: At time of surgery (approximately 3-4 weeks after randomization) ]
    As measured in brain tissue obtained during surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02565966


Contacts
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Contact: Orrin Devinsky, MD (646) 558-0801 Od4@nyu.edu

Locations
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United States, New Jersey
Institute of Neurology and Neurosurgery at Saint Barnabas Recruiting
Livingston, New Jersey, United States, 07039
Contact: Elaine DeCarlo, RN    973-322-7425    edecarlo@barnabashealth.org   
United States, New York
NYU Langone Epilepsy Center Recruiting
New York, New York, United States, 10016
Contact: Orrin Devinsky, MD    646-558-0801    Od4@nyu.edu   
Sponsors and Collaborators
NYU Langone Health
St. Barnabas Medical Center
Investigators
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Principal Investigator: Orrin Devinsky, MD NYU Langone Epilepsy Center
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02565966     History of Changes
Other Study ID Numbers: 14-01069
First Posted: October 1, 2015    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases