Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 8 Years and 10 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized, placebo-controlled, double-blind trial.
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
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

Recruiting Locations

University of Illinois Urbana-Champaign
Urbana, Illinois 61801
Contact:
Naiman Khan, PhD
217-300-2197
nakhan2@illinois.edu

More Details

Status
Recruiting
Sponsor
University of Illinois at Urbana-Champaign

Study Contact

Naiman Khan, PhD
217-300-2197
nakhan2@illinois.edu

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.