EpilepsyNCT02565966
Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues
A study testing Modified Atkins Diet (MAD) in people with Epilepsy, run by NYU Langone Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Modified Atkins Diet (MAD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute of Neurology and Neurosurgery at Saint Barnabas
Livingston, New Jersey, 07039
NYU Langone Epilepsy Center
New York, New York, 10016
About this study
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.
- Conditions
- Epilepsy
- Being tested
- Modified Atkins Diet (MAD)
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Modified Atkins Diet (MAD) | Experimental | Not described Receives: Other: Modified Atkins Diet (MAD) |
| Normal Diet | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroinflammation markers in blood
As measured by level of cytokines IL-6, TNF alpha, and C-reactive protein in blood samples
Measured: 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
Measured: 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
Measured: At time of surgery (approximately 3-4 weeks after randomization)
Levels of leptin in brain tissue
Measured: At time of surgery (approximately 3-4 weeks after randomization)
Levels of adenosine in brain tissue
Measured: At time of surgery (approximately 3-4 weeks after randomization)
Levels of adenosine kinase in brain tissue
Measured: At time of surgery (approximately 3-4 weeks after randomization)
Levels of adenosite-1 (A1) receptors in brain tissue
Measured: 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
Measured: At time of surgery (approximately 3-4 weeks after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startJun 2014
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- St. Barnabas Medical Center
- Responsible party
- Sponsor
- Investigators
- Orrin Devinsky, MD, Principal investigator, NYU Langone Epilepsy Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565966
- Sponsor's protocol ID
- 14-01069
- Status last verified
- Jan 2020
- First submitted
- 30 Sep 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
Publications
Leitner DF, Siu Y, Korman A, Lin Z, Kanshin E, Friedman D, Devore S, Ueberheide B, Tsirigos A, Jones DR, Wisniewski T, Devinsky O. Metabolomic, proteomic, and transcriptomic changes in adults with epilepsy on modified Atkins diet. Epilepsia. 2023 Apr;64(4):1046-1060. doi: 10.1111/epi.17540. Epub 2023 Feb 24.
PubMed 36775798
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues
- ClinicalTrials.gov ID
- NCT02565966
- Acronym / sponsor ID
- 14-01069
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- St. Barnabas Medical Center
- Study start
- Jun 2014
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Atkins Diet (MAD) | Experimental | Other: Modified Atkins Diet (MAD) |
| Normal Diet | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Modified Atkins Diet (MAD) |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 36775798Leitner DF, Siu Y, Korman A, Lin Z, Kanshin E, Friedman D, Devore S, Ueberheide B, Tsirigos A, Jones DR, Wisniewski T, Devinsky O. Metabolomic, proteomic, and transcriptomic changes in adults with epilepsy on modified Atkins diet. Epilepsia. 2023 Apr;64(4):1046-1060. doi: 10.1111/epi.17540. Epub 2023 Feb 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orrin Devinsky, MD principal investigator
NYU Langone Epilepsy Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Atkins Diet (MAD) in people with Epilepsy, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroinflammation markers in blood (time frame: At time of surgery (approximately 3-4 weeks after randomization)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.