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| Name | Class |
|---|---|
| Northeastern University | OTHER |
| University of Georgia | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Supplement | Experimental | The active supplementation group participants will be asked to consume a daily carotenoid supplement for 9 months. |
|
| Placebo Control | Placebo Comparator | The placebo control group participants will be asked to consume a placebo supplement for 9 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active supplement | Dietary Supplement | Carotenoid supplement comprised of 10mg lutein and 2mg zeaxanthin. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Naiman Khan, PhD | Contact | 217-300-2197 | nakhan2@illinois.edu | |
| Ginger Reeser, MS | Contact | 217-244-8442 | reeser2@illinois.edu |
| Name | Affiliation | Role |
|---|---|---|
| Naiman Khan, PhD | University of Illinois Urbana-Champaign | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Urbana-Champaign | Recruiting | Urbana | Illinois | 61801 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36252934 | Derived | Cannavale CN, Keye SA, Rosok L, Martell S, Holthaus TA, Reeser G, Raine LB, Mullen SP, Cohen NJ, Hillman CH, Hammond BR, Renzi-Hammond L, Khan NA. Enhancing children's cognitive function and achievement through carotenoid consumption: The Integrated Childhood Ocular Nutrition Study (iCONS) protocol. Contemp Clin Trials. 2022 Nov;122:106964. doi: 10.1016/j.cct.2022.106964. Epub 2022 Oct 15. |
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Randomized, placebo-controlled, double-blind trial.
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| Placebo control | Dietary Supplement | Placebo control supplement |
|
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) |