Maternal Intake of Eggs and Infant Neurodevelopment (MIND)
2026年5月6日 更新者：Danielle Christifano, PhD、University of Kansas Medical Center
The fetal brain requires DHA, choline, lutein, and zeaxanthin (L/Z) for development, dependent on maternal intake during pregnancy.
However, many pregnant women do not meet daily requirements through diet or prenatal vitamins.
Egg yolks are rich in choline, and women who consume eggs daily are more likely to meet the adequate intake of 450 mg/day.
A recent study by Christifano et al. found that maternal egg and neuroprotective nutrient intake predicted neurodevelopment at 32 and 36 weeks of gestation.
This study aims to determine if fetal neurodevelopment is enhanced among women who consume a prenatal diet emphasizing egg consumption (EGG) versus a healthy prenatal diet education control group (HPD).
Women between 12-20 weeks' gestation will be randomized into EGG and HPD groups.
The EGG group will receive education on the importance of prenatal choline and egg consumption and be encouraged to consume 10-14 eggs per week.
The HPD group will receive education on a healthy prenatal diet.
Both groups will be encouraged to take a DHA supplement, and dietary intake of choline, L/Z, and DHA will be collected.
Fetal heart rate variability will be measured at 36 weeks gestation and infant EEGs will be conducted postnatally to examine brain function.
Increasing prenatal egg consumption is both economical and feasible to boost prenatal choline intake, promote offspring neurodevelopment, and guide prenatal dietary recommendations.
研究概览
研究类型
介入性
注册 (估计的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Nicole Mathis, MS
- 电话号码：913-588-1906
- 邮箱：nmathis@kumc.edu
研究联系人备份
- 姓名：Lara Bennett, MS
- 电话号码：913-945-9149
- 邮箱：lbennett@kumc.edu
学习地点
-
-
Kansas
-
Kansas City、Kansas、美国、66160
- 招聘中
- The University of Kansas Medical Center
-
接触：
- Nicole Mathis, MS
- 电话号码：913-588-1906
-
接触：
- Lara Bennett, MS
- 电话号码：913-945-9149
-
首席研究员：
- Danielle Christifano, PhD
-
副研究员：
- Alexandra Brown, PhD
-
副研究员：
- Ke Liao, PhD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Pregnant females ≥18 years of age
- 12 to 20-weeks' gestation at enrollment
- No serious illnesses likely to confound study outcomes
- Consuming 3 eggs/week or less at enrollment and willing to increase consumption during the study
- Singleton gestation
- Available by telephone and text
Exclusion Criteria:
- Less than 18 years at enrollment
- Gestational age at enrollment <12 or >20 weeks
- Any serious illness likely to confound study outcomes
- Consuming more than 3 eggs per week at enrollment
- Unable/unwilling to consume eggs until delivery or egg allergy
- Expecting multiple infants
- No access to telephone or text
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：EGG Group
The EGG group will receive education on the importance of prenatal choline and egg consumption and be encouraged to consume 10-14 eggs per week.
|
Encouraged to consume 10-14 eggs per week.
|
|
安慰剂比较：HPD Group
The HPD group will receive education on a healthy prenatal diet
|
Educated on standard healthy prenatal diet and encouraged to follow recommendations.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fetal neurodevelopment as indexed by heart rate variability (HRV)
大体时间：36 weeks gestational age
|
Group comparisons will be made between time-domain metrics of fetal HRV (SDNN, RMSSD) between those in EEG vs. HPD groups using a dedicated fetal heart rate monitor.
|
36 weeks gestational age
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fetal neurodevelopment as indexed by heart rate variability (HRV)
大体时间：36 weeks gestational age
|
Relationship between intake of maternal neuroprotective nutrients, including choline, docosahexaenoic acid (DHA), lutein and zeaxanthin (L/Z) as measured by the Diet History Questionnaire-III and offspring neurodevelopment at 36 weeks gestation (fetal HRV).
|
36 weeks gestational age
|
|
Infant neurodevelopment as indexed by event-related potentials (ERP)
大体时间：1 month postnatal age
|
Brain neurophysiology will be measured at 1 month of age.
Assessments of band-limited spectral power during resting-state will be assessed.
Event-related potentials (ERP) to auditory stimuli will be recorded.
Group comparisons will be made between measures of resting state spectral power and auditory ERP components.
|
1 month postnatal age
|
|
Infant neurodevelopment as indexed by event-related potentials (ERP)
大体时间：1 month postnatal age
|
Relationship between intake of maternal neuroprotective nutrients, including choline, docosahexaenoic acid (DHA), lutein and zeaxanthin (L/Z) as measured by the Diet History Questionnaire-III and offspring neurodevelopment at 1 month postnatal age (infant ERP).
|
1 month postnatal age
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Danielle Christifano, PhD、University of Kansas Medical Center
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年1月1日
初级完成 (估计的)
2028年6月1日
研究完成 (估计的)
2028年6月1日
研究注册日期
首次提交
2026年4月30日
首先提交符合 QC 标准的
2026年5月6日
首次发布 (实际的)
2026年5月13日
研究记录更新
最后更新发布 (实际的)
2026年5月13日
上次提交的符合 QC 标准的更新
2026年5月6日
最后验证
2025年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.