Carotenoid Supplements for Children's Cognitive Function and Achievement

Overseen by Naiman Khan, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Illinois at Urbana-Champaign

Must not be taking: Lutein supplements

Disqualifiers: Learning disability, Vision issues, others

Trial Summary

What is the purpose of this trial?

This trial tests if carotenoid supplements can improve cognitive function and academic achievement in pre-adolescent children by protecting brain cells and supporting memory and learning. Carotenoids have been studied for their potential benefits on cognitive function due to their antioxidant properties.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken lutein supplements in the past 6 months, except for multivitamins with less than 1 mg of lutein per day.

What evidence supports the effectiveness of the treatment for improving children's cognitive function and achievement?

Research suggests that lutein and zeaxanthin, which are part of the treatment, are linked to better cognitive function in children, as they accumulate in the brain and may enhance memory and attention. Studies have shown that higher levels of these carotenoids in the body are associated with improved cognitive abilities, such as executive processes and intellectual ability, in children. ^{1 2 3 4 5}

Is it safe for children to take carotenoid supplements like lutein and zeaxanthin?

Research on lutein and zeaxanthin supplements, which are found in colorful fruits and vegetables, suggests they are generally safe for humans, including children. These supplements have been studied in various age groups without significant safety concerns. ^{1 2 3 6 7}

How is the carotenoid supplement treatment different from other treatments for improving children's cognitive function?

The carotenoid supplement, containing lutein and zeaxanthin, is unique because it targets cognitive function by accumulating in neural tissue, potentially enhancing memory and academic abilities in children. Unlike other treatments, it specifically focuses on increasing macular carotenoids, which are linked to cognitive improvements, and is being tested in a structured 9-month trial to assess its impact on children's cognitive development. ^{1 2 3 4 7}

Research Team

Naiman Khan, PhD

Principal Investigator

University of Illinois Urbana-Champaign

Eligibility Criteria

This trial is for children aged 8-10 with normal or corrected vision and no recent lutein supplementation. They must not have a learning disability, be in early puberty (Tanner scale ≤2), and have both child assent and parent/guardian consent.

Inclusion Criteria

I haven't taken lutein supplements in the last 6 months, except for low-dose in multivitamins.

Child assent and parent/guardian consent

Absence of learning disability (parent-reported)

Exclusion Criteria

I am either younger than 8 or older than 10 years old.

Non-assent of child or non-consent of guardian

Not 20/20 or uncorrected vision

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a carotenoid supplement or placebo daily for 9 months

9 months

Follow-up

Participants are monitored for changes in cognitive function and academic achievement

4 weeks

Treatment Details

Interventions

• Active supplement (Carotenoid Supplement)
• Placebo control (Behavioural Intervention)

Trial Overview The study tests if taking carotenoid supplements can improve cognitive function and academic achievement in children over a school year, compared to a waitlist group receiving a placebo.

Participant Groups

Group I: Active Supplement Experimental Treatment 1 Intervention

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

Group II: Placebo Control Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials

203

Recruited

40,600+

Chris Harlan

University of Illinois at Urbana-Champaign

Chief Executive Officer since 2019

MBA from the University of Illinois at Urbana-Champaign

Eric Minor

University of Illinois at Urbana-Champaign

Chief Marketing Officer since 2019

Bachelor’s degree in Electrical Engineering from the University of Illinois and MBA from the University of Chicago

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

Jared Auclair

Northeastern University

Chief Executive Officer

PhD in Biomedical Science from the University of Massachusetts Medical School

Anantdeep Kaur

Northeastern University

Chief Medical Officer since 2023

Master’s and Doctorate in Biotechnology from the University of Technology Sydney

University of Georgia

Collaborator

Trials

109

Recruited

43,500+

Dr. Biao He

University of Georgia

Chief Executive Officer

PhD in Veterinary Medicine

Dr. Hank Radziewicz

University of Georgia

Chief Medical Officer

MD from Duke University, MSCR from Emory University

Findings from Research

The Integrated Childhood Ocular Nutrition Study will investigate the effects of lutein and zeaxanthin supplementation on cognitive abilities and macular carotenoids in 288 preadolescent children over a 9-month period.

The study aims to determine if L + Z supplementation can enhance memory, attentional control, and academic performance, with the hypothesis that improvements will be linked to increased macular pigment density.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing children's cognitive function and achievement through carotenoid consumption: The Integrated Childhood Ocular Nutrition Study (iCONS) protocol. Cannavale, CN., Keye, SA., Rosok, L., et al.[2023]

In a study of 160 children aged 5.6 to 5.9 years, higher plasma lutein levels were significantly correlated with lutein intake measured over three 24-hour recalls, suggesting that more accurate dietary assessments can better reflect lutein status.

Despite the correlation between lutein intake and plasma levels, no direct associations were found between lutein intake or plasma lutein concentrations and cognitive performance, indicating that the role of lutein in cognitive development in young children remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma lutein concentrations are related to dietary intake, but unrelated to dietary saturated fat or cognition in young children. Mulder, KA., Innis, SM., Rasmussen, BF., et al.[2021]

In a study of 1378 children, higher intake of lutein and zeaxanthin (L/Z) in early childhood was associated with better receptive vocabulary scores, indicating potential cognitive benefits.

Children with the highest L/Z intake showed improved executive function in mid-childhood, suggesting that these carotenoids may play a role in cognitive development, although the overall evidence remains inconclusive and warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Childhood Lutein and Zeaxanthin Intake Is Positively Associated with Early Childhood Receptive Vocabulary and Mid-Childhood Executive Function But No Other Cognitive or Behavioral Outcomes in Project Viva. Mahmassani, HA., Switkowski, KM., Johnson, EJ., et al.[2023]

In a study of 51 children aged 7-13, higher levels of macular pigment optical density (MPOD), which reflects dietary intake of lutein and zeaxanthin, were significantly associated with better Executive Processes and Brief Intellectual Ability.

These findings suggest that the intake of macular carotenoids may support cognitive development in children, similar to what has been observed in adults, highlighting the potential importance of these nutrients during critical growth periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Macular Carotenoids are Associated with Cognitive Function in Preadolescent Children. Saint, SE., Renzi-Hammond, LM., Khan, NA., et al.[2018]

In a study of 40 prepubescent children aged 7 to 10, higher levels of macular pigment optical density (MPOD) were found to significantly predict better relational memory performance, even when accounting for factors like aerobic fitness and central adiposity.

Aerobic fitness was negatively associated with memory errors, while higher central adiposity was linked to more memory errors, suggesting that both physical fitness and body composition can influence cognitive functions in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macular Carotenoids, Aerobic Fitness, and Central Adiposity Are Associated Differentially with Hippocampal-Dependent Relational Memory in Preadolescent Children. Hassevoort, KM., Khazoum, SE., Walker, JA., et al.[2018]

Lutein is the most abundant carotenoid in the infant brain, making up 59% of total carotenoids, and its levels are significantly lower in preterm infants compared to term infants, indicating a potential nutritional gap.

The study suggests that the type of feeding (breast milk vs. formula) influences brain lutein concentrations, with term infants showing higher levels of lutein when they have measurable brain cryptoxanthin, which is low in formula.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lutein and preterm infants with decreased concentrations of brain carotenoids. Vishwanathan, R., Kuchan, MJ., Sen, S., et al.[2014]

References

1. United States pubmed.ncbi.nlm.nih.gov

Enhancing children's cognitive function and achievement through carotenoid consumption: The Integrated Childhood Ocular Nutrition Study (iCONS) protocol. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Plasma lutein concentrations are related to dietary intake, but unrelated to dietary saturated fat or cognition in young children. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Early Childhood Lutein and Zeaxanthin Intake Is Positively Associated with Early Childhood Receptive Vocabulary and Mid-Childhood Executive Function But No Other Cognitive or Behavioral Outcomes in Project Viva. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Macular Carotenoids are Associated with Cognitive Function in Preadolescent Children. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Macular Carotenoids, Aerobic Fitness, and Central Adiposity Are Associated Differentially with Hippocampal-Dependent Relational Memory in Preadolescent Children. [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a Lutein and Zeaxanthin Intervention on Cognitive Function: A Randomized, Double-Masked, Placebo-Controlled Trial of Younger Healthy Adults. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Lutein and preterm infants with decreased concentrations of brain carotenoids. [2014]