- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02565966
Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues
January 16, 2020 updated by: NYU Langone Health
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Livingston, New Jersey, United States, 07039
- Institute of Neurology and Neurosurgery at Saint Barnabas
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New York
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New York, New York, United States, 10016
- NYU Langone Epilepsy Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Modified Atkins Diet (MAD)
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuroinflammation markers in blood
Time Frame: At time of surgery (approximately 3-4 weeks after randomization)
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As measured by level of cytokines IL-6, TNF alpha, and C-reactive protein in blood samples
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At time of surgery (approximately 3-4 weeks after randomization)
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Metabolism
Time Frame: At time of surgery (approximately 3-4 weeks after randomization)
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As measured by level of fasting lipid profile, acylcarnitine profile, and beta-hydroxybutyrate in blood
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At time of surgery (approximately 3-4 weeks after randomization)
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Neuroinflammation markers in brain tissue
Time Frame: At time of surgery (approximately 3-4 weeks after randomization)
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As measured by level of cytokines, IL6, TNF alpha, and microglial activation and proliferation in brain tissue obtained during durgery
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At time of surgery (approximately 3-4 weeks after randomization)
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Levels of leptin in brain tissue
Time Frame: At time of surgery (approximately 3-4 weeks after randomization)
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At time of surgery (approximately 3-4 weeks after randomization)
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Levels of adenosine in brain tissue
Time Frame: At time of surgery (approximately 3-4 weeks after randomization)
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At time of surgery (approximately 3-4 weeks after randomization)
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Levels of adenosine kinase in brain tissue
Time Frame: At time of surgery (approximately 3-4 weeks after randomization)
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At time of surgery (approximately 3-4 weeks after randomization)
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Levels of adenosite-1 (A1) receptors in brain tissue
Time Frame: At time of surgery (approximately 3-4 weeks after randomization)
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At time of surgery (approximately 3-4 weeks after randomization)
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Levels of enzymes that synthesize glutamate and GABA
Time Frame: At time of surgery (approximately 3-4 weeks after randomization)
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As measured in brain tissue obtained during surgery
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At time of surgery (approximately 3-4 weeks after randomization)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Orrin Devinsky, MD, NYU Langone Epilepsy Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
October 1, 2019
Study Registration Dates
First Submitted
September 30, 2015
First Submitted That Met QC Criteria
September 30, 2015
First Posted (Estimate)
October 1, 2015
Study Record Updates
Last Update Posted (Actual)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 16, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-01069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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