288 Participants Needed

Carotenoid Supplements for Children's Cognitive Function and Achievement

NK
GR
Overseen ByGinger Reeser, MS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Illinois at Urbana-Champaign

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a carotenoid supplement can boost cognitive function and school performance in children over a school year. Researchers will compare two groups: one taking a lutein and zeaxanthin supplement and another taking a placebo, a harmless pill with no active ingredients. Children aged 8-10, with normal vision, who haven't recently taken lutein supplements, and do not have a parent-reported learning disability, might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity for children to potentially enhance their cognitive abilities and academic performance.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lutein and zeaxanthin, the main ingredients in the supplement under study, can improve brain function in adults. Some studies suggest these nutrients might also play a role in brain development in children, but further research is needed to confirm this.

Currently, a complete review of their safety specifically for children is lacking. However, lutein and zeaxanthin are generally safe for adults, with no major side effects reported in studies. Since this trial is the first to test these supplements in children, monitoring their effects closely is crucial. The trial's "Not Applicable" phase label indicates it is an early study, so detailed safety information for children is still being gathered.12345

Why are researchers excited about this trial?

Unlike standard cognitive enhancers for children, which often involve medications or behavioral therapies, the carotenoid supplement is unique because it harnesses the power of naturally occurring substances found in fruits and vegetables. Carotenoids, known for their antioxidant properties, may have a novel mechanism of action by potentially improving brain health and cognitive function. Researchers are excited about this treatment because it could offer a safe, dietary-based approach to supporting children's cognitive development, with the added benefit of being easy to incorporate into daily life.

What evidence suggests that carotenoid supplements could be effective for improving children's cognitive function and achievement?

This trial will compare the effects of carotenoid supplements with a placebo on children's cognitive function and achievement. Research has shown that carotenoid supplements, such as lutein and zeaxanthin, can enhance thinking skills and school performance. One study found that these supplements improved vision and thinking abilities in adults. Another study discovered that lutein, zeaxanthin, and omega-3 fatty acids, like DHA, increased brain processing speed. These findings suggest that children might also benefit, potentially improving their school performance. The evidence supports the idea that carotenoid supplements could enhance thinking skills and academic success.12467

Who Is on the Research Team?

NK

Naiman Khan, PhD

Principal Investigator

University of Illinois Urbana-Champaign

Are You a Good Fit for This Trial?

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)
See 3 more

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
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Active supplement
  • Placebo control
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active SupplementExperimental Treatment1 Intervention
Group II: Placebo ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials
203
Recruited
40,600+

Northeastern University

Collaborator

Trials
103
Recruited
72,600+

University of Georgia

Collaborator

Trials
109
Recruited
43,500+

Published Research Related to This Trial

A year-long study with 51 young, healthy adults showed that daily supplementation with lutein and zeaxanthin significantly increased macular pigment optical density (MPOD), indicating improved levels of these nutrients in the central nervous system.
The supplementation also led to notable improvements in cognitive functions such as spatial memory, reasoning ability, and complex attention, suggesting that L + Z can enhance cognitive performance in younger adults.
Effects of a Lutein and Zeaxanthin Intervention on Cognitive Function: A Randomized, Double-Masked, Placebo-Controlled Trial of Younger Healthy Adults.Renzi-Hammond, LM., Bovier, ER., Fletcher, LM., 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.
Lutein and preterm infants with decreased concentrations of brain carotenoids.Vishwanathan, R., Kuchan, MJ., Sen, S., et al.[2014]
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.
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]

Citations

Enhancing children's cognitive function and achievement ...The hypothesis is that individuals who receive lutein and zeaxanthin supplementation will exhibit greater gains in composite academic achievement, math, reading ...
Lutein and Zeaxanthin Supplementation Improves Dynamic ...Supplementation with dietary neuro-pigments lutein (L) and zeaxanthin (Z) has been shown to improve many aspects of visual and cognitive function in adults.
Enhancing Children's Cognitive Function and Achievement ...The aim of this study is to test the casual relationship between carotenoid supplementation, cognitive function, and achievement over a school-year. The central ...
Lutein across the Lifespan: From Childhood Cognitive ...In this study, supplementation with lutein, zeaxanthin, and omega-3 fatty acids, including DHA, for 4 mo increased MP and improved neural processing speed.
Enhancing children's cognitive function and achievement ...It is hypothesized that L + Z supplementation will improve cognition and academic achievement. Further, benefits for cognition and achievement are anticipated ...
Lutein and ZeaxanthinNeuroscientists evaluate the potential benefit (or harm) for brain health, as well as for age-related health concerns that can affect brain health (e.g.,.
Lutein and zeaxanthin: The possible...Studies suggest that lutein and zeaxanthin may be important for cognitive development in children, but a comprehensive evidence synthesis is lacking.
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