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临床试验/NCT03521349
NCT03521349Unknown不适用

Correlational and Intervention Effects of Egg Consumption on Macular Carotenoids, Cognition, and Achievement During Childhood

University of Illinois at Urbana-Champaign1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年3月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Cognitive control

研究概览

简要总结

The aim of this study is to examine the correlational and intervention effects of egg consumption on macular carotenoids, cognition, and achievement during childhood. Initially, this will be done with correlational examination of egg consumption and macular carotenoids. Individuals with low carotenoid status will be invited to participant in a month-long egg-based dietary intervention aimed at improving carotenoid status.

详细描述

Identification of foods that promote childhood cognitive function has the potential to have a lasting impact on children's long-term cognitive well-being. The nutrient profile in egg yolks, particularly the xanthophyll lutein, may be uniquely suitable for supporting important cognitive processes including attention, memory, and academic achievement. Lutein is the predominant carotenoid in the brain, comprising up to 77% of carotenoids in the brain. Further, lutein is among three xanthophylls that accumulate as macular pigment and protect the eye against photooxidative damage.

Accordingly, this work aims to: 1) assess the correlational relationship between habitual egg consumption, macular pigment optical density (MPOD), neurocognitive function and achievement among 7-12-years-olds; and 2) conduct a 4-week egg intake randomized controlled intervention (7 whole eggs/week vs 7 egg whites/week) to investigate the effects of regular egg consumption on changes in MPOD and behavioral and neuroelectric measures of cognitive control and relational memory, and academic achievement among school-aged children. Male and female children between 7-12 years (n=240) will be recruited. All children will be allowed (i.e., regardless of level of MPOD) to participate to address aim 1. A subsample of participants (n=80 [40 per group]) with lower MPOD (i.e., ≤0.40) will be invited to enroll in a 4-week egg intake randomized controlled trial. Following baseline testing, participants will be randomly assigned to one of two intervention groups (7 whole eggs/week vs 7 egg whites/week) for a 4- week period.

The investigators hypothesize that greater habitual egg consumption will be positively associated with MPOD and attention and memory and neural efficiency, and academic achievement. Further, the investigators anticipate that consuming whole eggs - via a 4-week intervention - will result in greater gains in behavioral and ERP cognitive measures and academic achievement, relative to egg white consumption. Finally, it is expected that cognitive benefits will correlate with change in MPOD, thereby establishing the importance of whole eggs for cognitive function and academic achievement in childhood.

The successful completion of the proposed work is expected to generate new knowledge establishing the importance of regular whole egg consumption, specifically lutein induced changes in macular carotenoids, for improving performance in cognitive processes vital for learning and long-term scholastic success among school-aged children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •a. Parental/guardian consent b. Between 7-12 years c. Absence of physician diagnosis of autism spectrum disorder d. Normal or corrected-to-normal vision based on the minimal 20/20 standard f. Intervention Only: Absence of food allergies

排除标准

  • •a. Parental/guardian non-consent b. Younger than 7 years or older than 12 years c. Physician diagnosis of autism spectrum disorder d. Uncorrected vision f. Intervention Only: Presence of food allergies

研究组 & 干预措施

Egg White Snacks

Placebo Comparator

Egg white-based snacks

干预措施: Egg White Control (Other)

Whole Egg Snacks

Experimental

Whole egg-based snacks

干预措施: Whole Egg Intervention (Other)

结局指标

主要结局

Cognitive control

时间窗: 1 month

Changes in Cognitive Task Performance between Groups

次要结局

  • Macular Pigment Optical Density (MPOD)(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Naiman Khan

Naiman Khan, PhD, RD

University of Illinois at Urbana-Champaign

研究点 (1)

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