Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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.
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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
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Outcome Measures
Primary Outcome Measures
- Attentional Accuracy [9 months (Baseline vs Follow-up)]
Changes in accuracy (%) between groups using a computerized flanker task.
- Attentional Reaction Time [9 months (Baseline vs Follow-up)]
Changes in reaction time (ms) between groups using a computerized flanker task.
- Hippocampal-dependent Relational memory [9 months (Baseline vs Follow-up)]
Spatial memory task accuracy
- 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
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Child assent and parent/guardian consent
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8-10 years of age
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No lutein supplementation within 6-months prior to enrollment (exception of multivitamins containing less than 1 mg lutein/day)
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Absence of learning disability (parent-reported)
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Tanner scale score ≤ 2
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20/20 or corrected vision
Exclusion Criteria:
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Non-assent of child or non-consent of guardian
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Above/below 8-10 years of age
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Lutein supplementation within 6-months prior to enrollment (including multivitamins containing more than 1 mg lutein/day)
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Identified learning disability (parent-reported)
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Tanner scale score > 2
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Not 20/20 or uncorrected vision
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- 21066