Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption

Study Overview
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Brief Summary
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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
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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).

Official Title
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Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption

Conditions
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Cognitive Change, Achievement, Macular Pigmentation

Intervention / Treatment
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* Dietary Supplement: Active supplement
* Dietary Supplement: Placebo control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, placebo-controlled, double-blind trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Supplement<br>The active supplementation group participants will be asked to consume a daily carotenoid supplement for 9 months. | Dietary Supplement: Active supplement<br>* Carotenoid supplement comprised of 10mg lutein and 2mg zeaxanthin.<br>|
| Placebo Comparator: Placebo Control<br>The placebo control group participants will be asked to consume a placebo supplement for 9 months. | Dietary Supplement: Placebo control<br>* Placebo control supplement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attentional Accuracy | Changes in accuracy (%) between groups using a computerized flanker task. | 9 months (Baseline vs Follow-up) | 
| Attentional Reaction Time | Changes in reaction time (ms) between groups using a computerized flanker task. | 9 months (Baseline vs Follow-up) | 
| Hippocampal-dependent Relational memory | Spatial memory task accuracy | 9 months (Baseline vs Follow-up) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular Pigment Optical Density | Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer. | 9 months (Baseline vs Follow-up) | 
| Attentional Resource Allocation | Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task. | 9 months (Baseline vs Follow-up) | 
| Attentional Processing Speed | Changes in P3 event related potential latency (ms) between groups using a computerized flanker task. | 9 months (Baseline vs Follow-up) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lutein, Zeaxanthin, Carotenoids, Child, Spatial memory, Hippocampus, Academic success, Cognition