Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption

Sponsor
University of Illinois at Urbana-Champaign (Other)
Overall Status
Recruiting
CT.gov ID
NCT05177679
Collaborator
Northeastern University (Other), University of Georgia (Other)
288
1
2
46
6.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Active supplement
  • Dietary Supplement: Placebo control
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
288 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, placebo-controlled, double-blind trial.Randomized, placebo-controlled, double-blind trial.
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Apr 1, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Attentional Accuracy [9 months (Baseline vs Follow-up)]

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

  2. Attentional Reaction Time [9 months (Baseline vs Follow-up)]

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

  3. Hippocampal-dependent Relational memory [9 months (Baseline vs Follow-up)]

    Spatial memory task accuracy

  4. 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.

Secondary Outcome Measures

  1. Macular Pigment Optical Density [9 months (Baseline vs Follow-up)]

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

  2. Attentional Resource Allocation [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 [9 months (Baseline vs Follow-up)]

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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Illinois Urbana-Champaign Urbana Illinois United States 61801

Sponsors and Collaborators

  • University of Illinois at Urbana-Champaign
  • Northeastern University
  • University of Georgia

Investigators

  • Principal Investigator: Naiman Khan, PhD, University of Illinois Urbana-Champaign

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT05177679
Other Study ID Numbers:
  • 21066
First Posted:
Jan 4, 2022
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Illinois at Urbana-Champaign

Study Results

No Results Posted as of May 20, 2022