Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption

The aim of this study is to test the casual relationship between carotenoid supplementation, cognitive function, and achievement over a school-year. The central hypothesis is that, relative to the waitlist placebo group, children receiving the carotenoid supplement will exhibit greater gains in cognitive function and achievement.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Change; Achievement; Macular Pigmentation
• Intervention / Treatment: Dietary supplement: Active supplement; Dietary supplement: Placebo control

Detailed Description

This clinical trial will be a randomized placebo-controlled double-blind trial to examine the effects of carotenoid supplementation on cognitive control, hippocampal-dependent relational memory, and academic achievement among pre-adolescents over one school year (i.e. 9-months).

• Study Type: Interventional
• Enrollment (Anticipated): 288
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Naiman Khan, PhD; Phone Number: 217-300-2197; Email: nakhan2@illinois.edu
• Study Contact Backup: Name: Ginger Reeser, MS; Phone Number: 217-244-8442; Email: reeser2@illinois.edu

Study Locations

• United States
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Recruiting
      • University of Illinois Urbana-Champaign
      • Contact: Naiman Khan, PhD; Phone Number: 217-300-2197; Email: nakhan2@illinois.edu
      • Contact: Ginger Reeser, MS; Phone Number: 217-244-8442; Email: reeser2@illinois.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Child assent and parent/guardian consent
• 8-10 years of age
• No lutein supplementation within 6-months prior to enrollment (exception of multivitamins containing less than 1 mg lutein/day)
• Absence of learning disability (parent-reported)
• Tanner scale score ≤ 2
• 20/20 or corrected vision

Exclusion Criteria:

• Non-assent of child or non-consent of guardian
• Above/below 8-10 years of age
• Lutein supplementation within 6-months prior to enrollment (including multivitamins containing more than 1 mg lutein/day)
• Identified learning disability (parent-reported)
• Tanner scale score > 2
• Not 20/20 or uncorrected vision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Supplement; The active supplementation group participants will be asked to consume a daily carotenoid supplement for 9 months.	Dietary supplement: Active supplement; Carotenoid supplement comprised of 10mg lutein and 2mg zeaxanthin.
Placebo Comparator: Placebo Control; The placebo control group participants will be asked to consume a placebo supplement for 9 months.	Dietary supplement: Placebo control; Placebo control supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attentional Accuracy	Changes in accuracy (%) between groups using a computerized flanker task.	9 months (Baseline vs Follow-up)
Attentional Reaction Time	Changes in reaction time (ms) between groups using a computerized flanker task.	9 months (Baseline vs Follow-up)
Hippocampal-dependent Relational memory	Spatial memory task accuracy	9 months (Baseline vs Follow-up)
Composite Academic Achievement	Kaufman Test of Academic and Educational Achievement II (KTEA III) composite or comprehensive academic achievement score. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome.	9 months (Baseline vs Follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular Pigment Optical Density	Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer.	9 months (Baseline vs Follow-up)
Attentional Resource Allocation	Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task.	9 months (Baseline vs Follow-up)
Attentional Processing Speed	Changes in P3 event related potential latency (ms) between groups using a computerized flanker task.	9 months (Baseline vs Follow-up)
Math	Assessed as Mass subtest standard scores on the KTEA III. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome.	9 months (Baseline vs Follow-up)
Reading	Assessed as Reading subtest standard scores on the KTEA III. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome.	9 months (Baseline vs Follow-up)
Written Language	Assessed as Written Language subtest standard scores on the KTEA III. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome.	9 months (Baseline vs Follow-up)
Reading Fluency	Assessed as Reading Fluency subtest standard scores on the KTEA III. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome.	9 months (Baseline vs Follow-up)

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Collaborators: University of Georgia; Northeastern University
• Investigators: Principal Investigator: Naiman Khan, PhD, University of Illinois Urbana-Champaign

Publications and helpful links

General Publications

• Cannavale CN, Keye SA, Rosok L, Martell S, Holthaus TA, Reeser G, Raine LB, Mullen SP, Cohen NJ, Hillman CH, Hammond BR, Renzi-Hammond L, Khan NA. Enhancing children's cognitive function and achievement through carotenoid consumption: The Integrated Childhood Ocular Nutrition Study (iCONS) protocol. Contemp Clin Trials. 2022 Nov;122:106964. doi: 10.1016/j.cct.2022.106964. Epub 2022 Oct 15.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Anticipated): May 31, 2025
• Study Completion (Anticipated): April 30, 2026

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Child; Hippocampus; Cognition; Carotenoids; Lutein; Zeaxanthin; Spatial memory; Academic success
• Other Study ID Numbers: 21066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No