Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption

Cognitive Change Clinical Trial

Official title:

Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177679
• Other study ID #: 21066
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2022
• Est. completion date: April 30, 2026

Study information

• Verified date: April 2023
• Source: University of Illinois at Urbana-Champaign
• Contact: Naiman Khan, PhD
• Phone: 217-300-2197
• Email: nakhan2[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: April 30, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Achievement
• Cognitive Change
• Macular Pigmentation

Intervention

Dietary Supplement:
• Active supplement
Carotenoid supplement comprised of 10mg lutein and 2mg zeaxanthin.
• Placebo control
Placebo control supplement

Locations

Country	Name	City	State
United States	University of Illinois Urbana-Champaign	Urbana	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	Northeastern University, University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attentional Accuracy	Changes in accuracy (%) between groups using a computerized flanker task.	9 months (Baseline vs Follow-up)
Primary	Attentional Reaction Time	Changes in reaction time (ms) between groups using a computerized flanker task.	9 months (Baseline vs Follow-up)
Primary	Hippocampal-dependent Relational memory	Spatial memory task accuracy	9 months (Baseline vs Follow-up)
Primary	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	Macular Pigment Optical Density	Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer.	9 months (Baseline vs Follow-up)
Secondary	Attentional Resource Allocation	Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task.	9 months (Baseline vs Follow-up)
Secondary	Attentional Processing Speed	Changes in P3 event related potential latency (ms) between groups using a computerized flanker task.	9 months (Baseline vs Follow-up)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)