Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Neuroinflammation markers in blood
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Neuroinflammation markers in blood
时间窗: 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
Levels of leptin in brain tissue
时间窗: At time of surgery (approximately 3-4 weeks after randomization)
Levels of enzymes that synthesize glutamate and GABA
时间窗: At time of surgery (approximately 3-4 weeks after randomization)
As measured in brain tissue obtained during surgery
Neuroinflammation markers in brain tissue
时间窗: 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 adenosine kinase in brain tissue
时间窗: At time of surgery (approximately 3-4 weeks after randomization)
Metabolism
时间窗: 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
Levels of adenosine in brain tissue
时间窗: At time of surgery (approximately 3-4 weeks after randomization)
Levels of adenosite-1 (A1) receptors in brain tissue
时间窗: At time of surgery (approximately 3-4 weeks after randomization)
次要结局
未报告次要终点