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Completed

NCT Number: NCT02565966

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Neurology and Neurosurgery at Saint Barnabas, Livingston, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modified Atkins Diet (MAD)

Other

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • St. Barnabas Medical Center

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2015
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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