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

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.

Study Overview

• Status: Unknown
• Conditions: Diet Habit; Cognitive Control
• Intervention / Treatment: Other: Egg White Control; Other: Whole Egg Intervention

Detailed Description

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
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ginger Reeser, MS, RD; Phone Number: 217-244-8442; Email: reeser2@illinois.edu
• Study Contact Backup: Name: Caitlyn Edwards, BS; Phone Number: 217-300-1667; Email: cgedwar2@illinois.edu

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Recruiting
      • University of Illinois
      • Contact: Ginger Reeser, MS, RD; Email: reeser2@illinois.edu
      • Contact: Caitlyn Edwards, BS; Email: cgedwar2@illinois.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive control	Changes in Cognitive Task Performance between Groups	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular Pigment Optical Density (MPOD)	Changes in MPOD between Groups	1 month

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Collaborators: Egg Nutrition Center
• Investigators: Principal Investigator: Naiman Khan, PhD, RD, University of Illinois at Urbana-Champaign

Publications and helpful links

General Publications

• Liu R, Edwards CG, Cannavale CN, Flemming IR, Chojnacki MR, Reeser GE, Iwinski SJ, Renzi-Hammond LM, Khan NA. Weight Status and Visceral Adiposity Mediate the Relation between Exclusive Breastfeeding Duration and Skin Carotenoids in Later Childhood. Curr Dev Nutr. 2021 Feb 15;5(3):nzab010. doi: 10.1093/cdn/nzab010. eCollection 2021 Mar.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2018
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: April 28, 2018
• First Submitted That Met QC Criteria: April 28, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Diet; Executive Function; Electroencephalography; Egg
• Other Study ID Numbers: SHELL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Results will be disseminated by journal articles, thesis or academic papers, conference presentations, and sharing with the funding organization. No subject's identity will be disclosed in any presentation or released without their written permission.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No