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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

Tracking Information
First Submitted Date  ICMJE September 30, 2015
First Posted Date  ICMJE October 1, 2015
Last Update Posted Date January 29, 2019
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
  • 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
  • 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
  • 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
  • Levels of leptin in brain tissue [ Time Frame: At time of surgery (approximately 3-4 weeks after randomization) ]
  • Levels of adenosine in brain tissue [ Time Frame: At time of surgery (approximately 3-4 weeks after randomization) ]
  • Levels of adenosine kinase in brain tissue [ Time Frame: At time of surgery (approximately 3-4 weeks after randomization) ]
  • Levels of adenosite-1 (A1) receptors in brain tissue [ Time Frame: At time of surgery (approximately 3-4 weeks after randomization) ]
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02565966 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues
Official Title  ICMJE Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Epilepsy
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Modified Atkins Diet (MAD)
    Intervention: Other: Modified Atkins Diet (MAD)
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2015)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Orrin Devinsky, MD (646) 558-0801 Od4@nyu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02565966
Other Study ID Numbers  ICMJE 14-01069
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE St. Barnabas Medical Center
Investigators  ICMJE
Principal Investigator: Orrin Devinsky, MD NYU Langone Epilepsy Center
PRS Account NYU Langone Health
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP