Low-Glycemic (LGI) Diet in Pregnant People With Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Tolerability of the low glycemic index diet in pregnant people with epilepsy
研究概览
简要总结
The goal of this clinical trial is to learn about the low glycemic index diet in pregnant people with epilepsy. The main questions it aims to answer are:
- Is the low glycemic index tolerable in pregnant people with epilepsy?
- Does the low glycemic index alter seizure frequency in pregnant people with epilepsy?
- Does the low glycemic index alter the gut bacteria & associated metabolic pathways in pregnant people with epilepsy? Participants will start the low glycemic index diet during pregnancy and will provide stool and blood samples a maximum of 3 times during study duration. Researchers will compare pregnant people with epilepsy on the diet to pregnant people with epilepsy not on a structured diet plan to see if tolerability, seizure frequency, and gut bacteria composition & metabolites differ.
详细描述
People with epilepsy who are planning for pregnancy or are pregnant have concerns about anti-seizure medication (ASM) treatment, as some ASMs increase the risk of major congenital malformations and can negatively influence cognitive outcomes in developing offspring (Tomson et al., 2018, Meador et al., 2021). Non-pharmacologic epilepsy treatments, such as specialized diets like the low glycemic diet or the modified Atkins diet, are not well studied in pregnant people with epilepsy but have proven to be effective in reducing seizures in the non-pregnant population. Dietary influence on seizure control is likely multifactorial, and recent studies have shown that one mechanism of action is to cause changes in the gut microbiome and alter neuroactive downstream bacterial metabolites, such as gamma-aminobutyric acid (Olson et al., 2018).
The low glycemic index (LGI) diet is one of the most flexible dietary therapies for epilepsy, and it appears to be safe in pregnancy with positive health outcomes for both the mother and baby (Walsh et al., 2012). Unfortunately, little is known about the effectiveness and mechanism of the LGI diet in pregnant patients with epilepsy. Therefore, the investigators propose this study in which the LGI diet will be initiated in the first half of pregnancy and explore LGI diet tolerability, seizure frequency, and potential underlying mechanisms in the pregnant epilepsy population.
Investigators will invite pregnant people with epilepsy up to 20 weeks gestation in the Brigham & Women's Epilepsy-Obstetrical clinic to participate in this study. Participants will choose to go on the low glycemic index diet or continue their standard diet, will a goal of enrolling 21 participants in a 1:2 intervention to control group ratio. Participants in the intervention group will meet will a dietician to initiate the diet and have ongoing dietician support and appointments. All participants will fill out diet questionnaires and provide a maximum of 3 stool samples and 3 blood samples. Dietary intervention will end when pregnancies end, and stool and blood samples will be collected up to 3 months postpartum. The main outcomes will be diet tolerability, seizure frequency, gut bacteria composition, and metabolite alterations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of focal or generalized epilepsy as defined by the International League Against Epilepsy
- •Pregnant up to 20 weeks gestational age
排除标准
- •Functional neurologic disorder
- •Primary gastrointestinal disease
- •Antibiotic use in past 3 months
- •Seizure freedom
结局指标
主要结局
Tolerability of the low glycemic index diet in pregnant people with epilepsy
时间窗: During the diet intervention and immediately after the diet intervention
Tolerability will be measured by the number of participants able to continue the diet in pregnancy with diet questionnaires + dietician follow up visits.
次要结局
- Seizure Frequency(Baseline pre-intervention, during the intervention, and through 3 months post-partum.)
- Gut Bacteria Composition(During the intervention until 3 months postpartum)
- Metabolic pathway alterations(During the intervention until 3 months postpartum)
研究者
Regan J. Lemley, MD
Instructor of Neurology, Division of Epilepsy
Brigham and Women's Hospital