Correlational and Intervention Effects of Egg Consumption on Macular Carotenoids, Cognition, and Achievement During Childhood (SHELL)
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|ClinicalTrials.gov Identifier: NCT03521349|
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : April 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diet Habit Cognitive Control||Other: Whole Egg Intervention Other: Egg White Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Correlational and Intervention Effects of Egg Consumption on Macular Carotenoids, Cognition, and Achievement During Childhood|
|Actual Study Start Date :||March 21, 2018|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
Placebo Comparator: Egg White Snacks
Egg white-based snacks
Other: Egg White Control
Participants will consume an isocaloric muffin containing egg white, lacking important bioactives from whole eggs.
Experimental: Whole Egg Snacks
Whole egg-based snacks
Other: Whole Egg Intervention
Participants will consume an isocaloric muffin containing important bioactives from whole eggs.
- Cognitive control [ Time Frame: 1 month ]Changes in Cognitive Task Performance between Groups
- Macular Pigment Optical Density (MPOD) [ Time Frame: 1 month ]Changes in MPOD between Groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521349
|Contact: Ginger Reeser, MS, RDemail@example.com|
|Contact: Caitlyn Edwards, BSfirstname.lastname@example.org|
|Principal Investigator:||Naiman Khan, PhD, RD||University of Illinois at Urbana-Champaign|