Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Recognition Memory in an Oddball Task
研究概览
简要总结
Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal.
Mothers will be randomized to a whole egg or egg white (due to lack of an appropriate control food). Initial diet intake will be screened using the NDSR. Participants will come to the lab 3 times across 3 months (age 3 months, 4.5 months, and 6 months). Milk, saliva, and plasma will be collected from the mother, while saliva and plasma (heel stick) are collected from the infant. Diet data will be collected at each visit. The infant will complete a recognition memory test using electrophysiology at 6 months as well as the Bayley Scales of Infant Development at 4.5 months. The mother will complete a temperament questionnaire at 3 months and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
The participants will be given a jar of egg powder without labeling and they will not be aware of which they receive (egg white or whole egg).
入排标准
- 年龄范围
- 3 Months 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infant is 12-15 weeks of age at enrollment
- •healthy, lactating mother age 18-35
- •gave birth at >38 weeks gestation without remarkable incident
- •consuming <=50% of the recommended amounts of 2 of the 3, DHA, choline, and lutein
排除标准
- •infant with diagnosis or documented suspicion of developmental delay
- •egg allergy or family history of egg allergy
- •gestational diabetes
- •any documented seizure activity
研究组 & 干预措施
Whole egg powder
Participants are given whole egg powder which contains high levels of the nutrients choline, lutein, and docosahexaenoic acid.
干预措施: Whole Egg Powder (Dietary Supplement)
Egg white powder
The participants are given an egg white powder that does not contain the target nutrients (choline, lutein, and docosahexaenoic acid).
干预措施: Egg White Powder (Dietary Supplement)
结局指标
主要结局
Recognition Memory in an Oddball Task
时间窗: 13 weeks (at 6 months of age)
The difference in microvolts between the negative deflection to novel pictures and the negative deflection to familiar pictures at approximately 100-400ms after the pictures come on the screen will be measured in an event-related potentials (ERP) paradigm. The investigators hypothesize that the whole egg group will have better memory for the familiar pictures than the egg white group.
次要结局
未报告次要终点