What is the mechanism of action of this treatment?

Carotenoid supplementation, which includes antioxidants like lutein and zeaxanthin, works by neutralizing free radicals and reducing oxidative stress in the brain. This is crucial for cognitive impairment patients because oxidative stress is a key factor in the progression of neurodegenerative diseases. By protecting neurons from damage, carotenoids can potentially slow down cognitive decline and improve brain function. Other treatments with similar antioxidant properties, such as vitamins C and E, also aim to protect brain cells from oxidative damage, thereby supporting cognitive health and potentially enhancing cognitive performance.

What side effects are associated with this type of intervention?

Common treatments for cognitive impairment with antioxidant properties and potential neuroprotective effects include carotenoid supplementation, vitamin E, and N-acetylcysteine (NAC). Carotenoid supplementation is generally well-tolerated, but high doses can cause skin discoloration (carotenodermia). Vitamin E, while also generally safe, can increase the risk of hemorrhagic stroke and all-cause mortality at high doses (≥400 units daily). N-acetylcysteine may cause gastrointestinal disturbances such as nausea, vomiting, and diarrhea. It is important to use these treatments under medical supervision to manage potential side effects effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of cognitive impairment, particularly in Alzheimer's disease. These include cholinesterase inhibitors such as donepezil, rivastigmine, and galantamine, which work by increasing levels of acetylcholine in the brain. Another approved drug is memantine, an NMDA receptor antagonist that helps regulate glutamate activity to improve memory and learning. While these drugs do not have direct antioxidant properties, ongoing research is exploring the potential neuroprotective effects of various antioxidants, including carotenoids, which are being studied for their ability to enhance cognitive function and protect against neurodegeneration.

What other types of research exist?

Promising novel alternatives to carotenoid supplementation for cognitive impairment include omega-3 fatty acids, vitamin E, and vitamin C. These supplements have demonstrated antioxidant properties and potential neuroprotective effects. Additionally, emerging treatments like gene therapy and specific vitamin combinations (e.g., vitamin A and E) may offer new avenues for managing cognitive impairment.

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Carotenoid Supplement

Carotenoid Supplements for Children's Cognitive Function and Achievement

N/A

Recruiting

Led By Naiman Khan, PhD

Research Sponsored by University of Illinois at Urbana-Champaign

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

8-10 years of age

Be younger than 18 years old

Must not have

Above/below 8-10 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months (baseline vs follow-up)

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

The information provided does not specify side effects; however, as with any supplement, there may be potential risks which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 8 and 10 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months (baseline vs follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months (baseline vs follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months (baseline vs follow-up) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Attentional Accuracy

Attentional Reaction Time

Composite Academic Achievement

+1 more

Secondary study objectives

Attentional Processing Speed

Attentional Resource Allocation

Macular Pigment Optical Density

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active SupplementExperimental Treatment1 Intervention

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

Group II: Placebo ControlPlacebo Group1 Intervention

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Carotenoid supplementation, which includes antioxidants like lutein and zeaxanthin, works by neutralizing free radicals and reducing oxidative stress in the brain. This is crucial for cognitive impairment patients because oxidative stress is a key factor in the progression of neurodegenerative diseases. By protecting neurons from damage, carotenoids can potentially slow down cognitive decline and improve brain function. Other treatments with similar antioxidant properties, such as vitamins C and E, also aim to protect brain cells from oxidative damage, thereby supporting cognitive health and potentially enhancing cognitive performance.

Vitamins: a nutritional intervention to modulate the Alzheimer's disease progression.