The Potential of a Low Glutamate Diet in Refractory Pediatric Epilepsy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in seizure frequency
研究概览
简要总结
The study is investigating if following the low glutamate diet for 1 month, as compared to care as usual, can improve seizure frequency, severity, and duration; cognitive functioning; and/or quality of life in children with epilepsy.
详细描述
Epilepsy is estimated to effect 470,000 children within the U.S. About a third of epilepsy patients are refractory. For these patients, dietary therapy is an alternative option. However, current dietary therapies present issues with compliance, palatability, adverse events, and providing necessary nutrients for brain growth and development during childhood. A dietary option that can improve tolerability, increase compliance, and reduce or eliminate adverse effects, while also optimizing nutrient intake, is critical for the advancement of dietary therapy options in epilepsy.
Glutamate is found in the diet as a flavor enhancer; and is also an important neurotransmitter in the body which mediates seizure activity. Dietary sources of free glutamate are common and include numerous food additives (including many hidden sources) and some items which naturally contain higher amounts of glutamate. The low glutamate diet reduces the consumption of free glutamate, while optimizing dietary micronutrient and antioxidant intake, which can protect against the negative effects caused by high glutamate concentrations in the brain. Additionally, the low glutamate diet is balanced, nutritious and palatable, with no side effects.
The study is investigating if following the low glutamate diet for 1 month can improve seizure frequency, severity, and duration; cognitive functioning; and/or quality of life, in children with epilepsy. Participation in the study will be done virtually and over a 2- or 3- month study period, depending on group randomization. All participants will have the opportunity to undergo dietary training and follow the diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4 or more seizures per month
- •Willing to keep all medications constant during the study.
- •All medications have remained constant for 30 days prior to study enrollment
- •Any previously attempted dietary therapies stopped before study enrollment
排除标准
- •Known or suspected inborn errors of metabolism
- •Non-English speaking households
结局指标
主要结局
Change in seizure frequency
时间窗: At 1 month post treatment
All families will keep a seizure diary recording the number of daily seizures. This will be used to accurately determine these variables for the last week, which will be recorded on seizure assessment forms.
Change in seizure severity
时间窗: At 1 month post treatment
. During the last week of each study period, families will be asked to complete a seizure assessment form. This will include a subjective rating scale for seizure severity with a minimum score of 0 (not severe) and a maximum score of 10 (very severe).
Change in seizure duration
时间窗: At 1 month post treatment
All families will keep a seizure diary recording the duration of seizures. This will be used to accurately determine these variables for the last week, which will be recorded on seizure assessment forms.
次要结局
- The effect of a 1-month low-glutamate diet on quality of life in children with epilepsy.(At 1 month post treatment)
- The effect of a 1-month low-glutamate diet on cognitive functioning in children with epilepsy.(At 1 month post treatment)
- Examine change in resting state brain waves after 1-month on the low glutamate diet(At 1 month post treatment)
研究者
Kathleen Holton
Associate Professor
American University