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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
Sponsor:
Collaborator:
Egg Nutrition Center
Information provided by (Responsible Party):
Naiman Khan, University of Illinois at Urbana-Champaign

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diet Habit Cognitive Control Other: Whole Egg Intervention Other: Egg White Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Cognitive control [ Time Frame: 1 month ]
    Changes in Cognitive Task Performance between Groups


Secondary Outcome Measures :
  1. Macular Pigment Optical Density (MPOD) [ Time Frame: 1 month ]
    Changes in MPOD between Groups


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Ginger Reeser, MS, RD 217-244-8442 reeser2@illinois.edu
Contact: Caitlyn Edwards, BS 217-300-1667 cgedwar2@illinois.edu

Locations
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United States, Illinois
University of Illinois Recruiting
Urbana, Illinois, United States, 61801
Contact: Ginger Reeser, MS, RD       reeser2@illinois.edu   
Contact: Caitlyn Edwards, BS       cgedwar2@illinois.edu   
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Egg Nutrition Center
Investigators
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Principal Investigator: Naiman Khan, PhD, RD University of Illinois at Urbana-Champaign
More Information
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Responsible Party: Naiman Khan, Naiman Khan, PhD, RD, University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT03521349    
Other Study ID Numbers: SHELL
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Naiman Khan, University of Illinois at Urbana-Champaign:
Electroencephalography
Executive Function
Egg
Diet