Achievement, Cognitive Change, Macular Pigmentation
Conditions
Keywords
Lutein, Zeaxanthin, Carotenoids, Child, Spatial memory, Hippocampus, Academic success, Cognition
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.
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).
Interventions
DIETARY_SUPPLEMENTActive supplement
Carotenoid supplement comprised of 10mg lutein and 2mg zeaxanthin.
DIETARY_SUPPLEMENTPlacebo control
Placebo control supplement
Sponsors
University of Illinois at Urbana-Champaign
Northeastern University
University of Georgia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized, placebo-controlled, double-blind trial.
Eligibility
Sex/Gender
ALL
Age
8 Years to 10 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNaiman Khan, PhD
University of Illinois Urbana-Champaign
Outcome results
None listed