Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-23

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigating the Effects of Nutrition on the Maturation of Brain Networks Associated With Memory in Infants

NCT02457078

Healthy

UNKNOWN NA

Supplementation of Polyunsaturated Fatty Acids in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

NCT02114632

ADHD

COMPLETED PHASE1/PHASE2

The Cognitive Effects of 6- and 12-weeks Administration of a Food Supplement Containing Phosphatidylserine in Healthy Children Aged 8 to 12 Years

NCT05177978

Cognitive Change

COMPLETED NA

Cognitive Effects of Omega-3 Supplements in Children With Mild to Moderate Malnutrition

NCT01199120

Malnourishment

COMPLETED PHASE2

Effects of Omega-3 Fatty Acids Supplementation on Brain and Behaviour in Healthy Children.

NCT02346773

Behaviour

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cognitive Change Achievement Macular Pigmentation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, placebo-controlled, double-blind trial.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Supplement

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

Group Type EXPERIMENTAL

Active supplement

Intervention Type DIETARY_SUPPLEMENT

Carotenoid supplement comprised of 10mg lutein and 2mg zeaxanthin.

Placebo Control

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

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type DIETARY_SUPPLEMENT

Placebo control supplement

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Active supplement

Carotenoid supplement comprised of 10mg lutein and 2mg zeaxanthin.

Intervention Type DIETARY_SUPPLEMENT

Placebo control

Placebo control supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

8 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes