Clinical trial NCT05177679: Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption
Official title: Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Change
Achievement
Macular Pigmentation
Keywords: Lutein
Zeaxanthin
Carotenoids
Child
Spatial memory
Hippocampus
Academic success
Cognition
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: Northeastern University
name: University of Georgia
First posted: 2022-01-04
Enrollment: 288
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, double-blind trial.
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Attentional Accuracy
timeFrame: 9 months (Baseline vs Follow-up)
measure: Attentional Reaction Time
timeFrame: 9 months (Baseline vs Follow-up)
measure: Hippocampal-dependent Relational memory
timeFrame: 9 months (Baseline vs Follow-up)
measure: Composite Academic Achievement
timeFrame: 9 months (Baseline vs Follow-up)
Secondary outcomes:
measure: Macular Pigment Optical Density
timeFrame: 9 months (Baseline vs Follow-up)
measure: Attentional Resource Allocation
timeFrame: 9 months (Baseline vs Follow-up)
measure: Attentional Processing Speed
timeFrame: 9 months (Baseline vs Follow-up)
measure: Math
timeFrame: 9 months (Baseline vs Follow-up)
measure: Reading
timeFrame: 9 months (Baseline vs Follow-up)
measure: Written Language
timeFrame: 9 months (Baseline vs Follow-up)
measure: Reading Fluency
timeFrame: 9 months (Baseline vs Follow-up)
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois Urbana-Champaign
name: Naiman Khan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.