An interventional study of Modified Atkins Diet (MAD) in Epilepsy, sponsored by NYU Langone Health. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care
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.
1,804 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 19 is below the median of 50 across 1,205 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
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Patients scheduled for epilepsy surgery at New York Langone Medical Center or St Barnabas Medical Center will be eligible for enrollment.
Exclusion Criteria:
Other: Modified Atkins Diet (MAD)
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.
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.
Neuroinflammation markers in blood
As measured by level of cytokines IL-6, TNF alpha, and C-reactive protein in blood samples
Time frame: At time of surgery (approximately 3-4 weeks after randomization)
Metabolism
As measured by level of fasting lipid profile, acylcarnitine profile, and beta-hydroxybutyrate in blood
Time frame: At time of surgery (approximately 3-4 weeks after randomization)
Neuroinflammation markers in brain tissue
As measured by level of cytokines, IL6, TNF alpha, and microglial activation and proliferation in brain tissue obtained during durgery
Time frame: At time of surgery (approximately 3-4 weeks after randomization)
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
As measured in brain tissue obtained during surgery
Time frame: At time of surgery (approximately 3-4 weeks after randomization)
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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