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NCT02565966 · ClinicalTrials.gov registry record · NA
Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
NCT02565966: Completed NA study, sponsored by NYU Langone Health.
NCT02565966 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 19 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02565966, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
Study 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.
Primary Outcome
As measured by level of cytokines IL-6, TNF alpha, and C-reactive protein in blood samples
Interventions
- OTHER Modified Atkins Diet (MAD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2014-06 |
| Est. Completion | 2019-10-01 |
| Phase | NA |
What the finished NCT02565966 record still lists
NCT02565966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Modified Atkins Diet (MAD) is the first listed.
NCT02565966 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02565966 about?
NCT02565966 is a clinical study titled "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 tissu...
What is the current status of trial NCT02565966?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2014-06. Estimated completion is 2019-10-01.
What interventions are being tested in trial NCT02565966?
The interventions under investigation include: Modified Atkins Diet (MAD) (OTHER).
Who is sponsoring clinical trial NCT02565966?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02565966's enrollment target sits among peer trials
19 1861st of 2000 higher than 138 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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