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 :
Completed
First Posted : October 1, 2015
Last Update Posted : January 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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Epilepsy | Other: Modified Atkins Diet (MAD) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 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 |
Actual Primary Completion Date : | October 1, 2019 |
Actual Study Completion Date : | October 1, 2019 |

Arm | Intervention/treatment |
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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.
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- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, New Jersey | |
Institute of Neurology and Neurosurgery at Saint Barnabas | |
Livingston, New Jersey, United States, 07039 | |
United States, New York | |
NYU Langone Epilepsy Center | |
New York, New York, United States, 10016 |
Principal Investigator: | Orrin Devinsky, MD | NYU Langone Epilepsy Center |
Responsible Party: | NYU Langone Health |
ClinicalTrials.gov Identifier: | NCT02565966 |
Other Study ID Numbers: |
14-01069 |
First Posted: | October 1, 2015 Key Record Dates |
Last Update Posted: | January 18, 2020 |
Last Verified: | January 2020 |
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |