跳至主要内容
临床试验/NCT03838536
NCT03838536
招募中
不适用

Synergistic Activity of Choline, Lutein, and Docosahexaenoic Acid in Human Milk in Support of Cognitive Development: An Egg Intervention Feasibility Study

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 84 人2019年2月5日

概览

阶段
不适用
干预措施
Whole Egg Powder
疾病 / 适应症
Breastfeeding, Exclusive
发起方
University of North Carolina, Chapel Hill
入组人数
84
试验地点
2
主要终点
Recognition Memory in an Oddball Task
状态
招募中
最后更新
12天前

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.

注册库
clinicaltrials.gov
开始日期
2019年2月5日
结束日期
2027年3月1日
最后更新
12天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

入排标准

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

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

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.

研究点 (2)

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