Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption

Not Applicable

Recruiting

• Conditions: Macular Pigmentation; Cognitive Change; Achievement
• Interventions: Dietary Supplement: Placebo control; Dietary Supplement: Active supplement

• Registration Number: NCT05177679
• Lead Sponsor: University of Illinois at Urbana-Champaign

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-11-02
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-04
• Study Start: 2022-06-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27
• Primary Completion: 2025-05-31
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 288

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Control	Placebo control	The placebo control group participants will be asked to consume a placebo supplement for 9 months.
Active Supplement	Active supplement	The active supplementation group participants will be asked to consume a daily carotenoid supplement for 9 months.

Primary Outcome Measures

Name	Time	Method
Hippocampal-dependent Relational memory	9 months (Baseline vs Follow-up)	Spatial memory task accuracy
Attentional Accuracy	9 months (Baseline vs Follow-up)	Changes in accuracy (%) between groups using a computerized flanker task.
Composite Academic Achievement	9 months (Baseline vs Follow-up)	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.
Attentional Reaction Time	9 months (Baseline vs Follow-up)	Changes in reaction time (ms) between groups using a computerized flanker task.

Secondary Outcome Measures

Name	Time	Method
Macular Pigment Optical Density	9 months (Baseline vs Follow-up)	Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer.
Attentional Resource Allocation	9 months (Baseline vs Follow-up)	Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task.
Written Language	9 months (Baseline vs Follow-up)	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.
Reading Fluency	9 months (Baseline vs Follow-up)	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.
Attentional Processing Speed	9 months (Baseline vs Follow-up)	Changes in P3 event related potential latency (ms) between groups using a computerized flanker task.
Math	9 months (Baseline vs Follow-up)	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.
Reading	9 months (Baseline vs Follow-up)	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.

Trial Locations

Locations (1)

University of Illinois Urbana-Champaign; 🇺🇸 Urbana, Illinois, United States