Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption

University of Illinois at Urbana-Champaign

Status: Enrolling

Conditions: Cognitive Change; Achievement; Macular Pigmentation

Treatments: Dietary Supplement: Active supplement; Dietary Supplement: Placebo control

Study type: Interventional

Funder types: Other

Identifiers

NCT05177679

21066

Details and patient eligibility

About

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.

Full 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).

Enrollment: 288 estimated patients

Sex: All

Ages: 8 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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288 participants in 2 patient groups, including a placebo group

Active Supplement

Experimental group

Description:

The active supplementation group participants will be asked to consume a daily carotenoid supplement for 9 months.

Treatment:

Dietary Supplement: Active supplement

Placebo Control

Placebo Comparator group

Description:

The placebo control group participants will be asked to consume a placebo supplement for 9 months.

Treatment:

Dietary Supplement: Placebo control