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OpenTrials
Completed

NCT Number: NCT05177679

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.

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Key information

Conditions

Cognitive Change Achievement Macular Pigmentation

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Urbana-Champaign

Urbana, Illinois, 61801, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active supplement

Dietary Supplement

Carotenoid supplement comprised of 10mg lutein and 2mg zeaxanthin.

Placebo Control

Dietary Supplement

Placebo control supplement

Primary outcomes

  1. Attentional Accuracy

    Time frame: 9 months (Baseline vs Follow-up)

    Changes in accuracy (%) between groups using a computerized flanker task.

  2. Attentional Reaction Time

    Time frame: 9 months (Baseline vs Follow-up)

    Changes in reaction time (ms) between groups using a computerized flanker task.

  3. Hippocampal-dependent Relational memory

    Time frame: 9 months (Baseline vs Follow-up)

    Spatial memory task accuracy

  4. Composite Academic Achievement

    Time frame: 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.

Secondary outcomes

  1. Macular Pigment Optical Density

    Time frame: 9 months (Baseline vs Follow-up)

    Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer.

  2. Attentional Resource Allocation

    Time frame: 9 months (Baseline vs Follow-up)

    Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task.

  3. Attentional Processing Speed

    Time frame: 9 months (Baseline vs Follow-up)

    Changes in P3 event related potential latency (ms) between groups using a computerized flanker task.

  4. Math

    Time frame: 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.

  5. Reading

    Time frame: 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.

  6. Written Language

    Time frame: 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.

  7. Reading Fluency

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • Northeastern University
  • University of Georgia

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 4, 2022
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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