NCT03521349

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

2.5 years

First QC Date

April 28, 2018

Last Update Submit

April 13, 2020

Conditions

Keywords

ElectroencephalographyExecutive FunctionEggDiet

Outcome Measures

Primary Outcomes (1)

  • Cognitive control

    Changes in Cognitive Task Performance between Groups

    1 month

Secondary Outcomes (1)

  • Macular Pigment Optical Density (MPOD)

    1 month

Study Arms (2)

Egg White Snacks

PLACEBO COMPARATOR

Egg white-based snacks

Other: Egg White Control

Whole Egg Snacks

EXPERIMENTAL

Whole egg-based snacks

Other: Whole Egg Intervention

Interventions

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

Whole Egg Snacks

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

Egg White Snacks

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois

Urbana, Illinois, 61801, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Naiman Khan, PhD, RD

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ginger Reeser, MS, RD

CONTACT

Caitlyn Edwards, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Naiman Khan, PhD, RD

Study Record Dates

First Submitted

April 28, 2018

First Posted

May 11, 2018

Study Start

March 21, 2018

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

April 15, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

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.

Locations