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

NCT ID: NCT03521349

Last Updated: 2020-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-21

Study Completion Date

2020-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diet Habit Cognitive Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Egg White Snacks

Egg white-based snacks

Group Type PLACEBO_COMPARATOR

Egg White Control

Intervention Type OTHER

Participants will consume an isocaloric muffin containing egg white, lacking important bioactives from whole eggs.

Whole Egg Snacks

Whole egg-based snacks

Group Type EXPERIMENTAL

Whole Egg Intervention

Intervention Type OTHER

Participants will consume an isocaloric muffin containing important bioactives from whole eggs.

Interventions

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Whole Egg Intervention

Participants will consume an isocaloric muffin containing important bioactives from whole eggs.

Intervention Type OTHER

Egg White Control

Participants will consume an isocaloric muffin containing egg white, lacking important bioactives from whole eggs.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Egg Nutrition Center

OTHER

Sponsor Role collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Naiman Khan

Naiman Khan, PhD, RD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Naiman Khan, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Urbana-Champaign

Locations

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University of Illinois

Urbana, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ginger Reeser, MS, RD

Role: CONTACT

217-244-8442

Caitlyn Edwards, BS

Role: CONTACT

217-300-1667

Facility Contacts

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Ginger Reeser, MS, RD

Role: primary

Caitlyn Edwards, BS

Role: backup

References

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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.

Reference Type DERIVED
PMID: 33758790 (View on PubMed)

Other Identifiers

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SHELL

Identifier Type: -

Identifier Source: org_study_id

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