Cognitive ChangeNCT05177679
Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption
A study testing Active supplement in people with Cognitive Change and Achievement, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Achievement, Macular Pigmentation
- What is being tested?
- Active supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2022to 12 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Urbana-Champaign
Urbana, Illinois, 61801
About this study
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.
Read the detailed 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).
- Conditions
- Cognitive Change, Achievement, Macular Pigmentation
- Being tested
- Active supplement, Placebo control
- Keywords
- Lutein, Zeaxanthin, Carotenoids, Child, Spatial memory, Hippocampus, Academic success, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active supplementDietary supplement
Carotenoid supplement comprised of 10mg lutein and 2mg zeaxanthin.
Placebo controlDietary supplement
Placebo control supplement
| Study group | Role | What they receive |
|---|---|---|
| Active Supplement | Experimental | The active supplementation group participants will be asked to consume a daily carotenoid supplement for 9 months. Receives: Dietary Supplement: Active supplement |
| Placebo Control | Placebo comparator | The placebo control group participants will be asked to consume a placebo supplement for 9 months. Receives: Dietary Supplement: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attentional Accuracy
Changes in accuracy (%) between groups using a computerized flanker task.
Measured: 9 months (Baseline vs Follow-up)
Attentional Reaction Time
Changes in reaction time (ms) between groups using a computerized flanker task.
Measured: 9 months (Baseline vs Follow-up)
Hippocampal-dependent Relational memory
Spatial memory task accuracy
Measured: 9 months (Baseline vs Follow-up)
Composite Academic Achievement
Kaufman Test of Academic and Educational Achievement II (KTEA III) composite or comprehensive academic achievement score. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome.
Measured: 9 months (Baseline vs Follow-up)
Secondary outcomes (7)
Macular Pigment Optical Density
Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer.
Measured: 9 months (Baseline vs Follow-up)
Attentional Resource Allocation
Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task.
Measured: 9 months (Baseline vs Follow-up)
Attentional Processing Speed
Changes in P3 event related potential latency (ms) between groups using a computerized flanker task.
Measured: 9 months (Baseline vs Follow-up)
Math
Assessed as Mass subtest standard scores on the KTEA III. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome.
Measured: 9 months (Baseline vs Follow-up)
Reading
Assessed as Reading subtest standard scores on the KTEA III. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome.
Measured: 9 months (Baseline vs Follow-up)
Written Language
Assessed as Written Language subtest standard scores on the KTEA III. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome.
Measured: 9 months (Baseline vs Follow-up)
Reading Fluency
Assessed as Reading Fluency subtest standard scores on the KTEA III. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome.
Measured: 9 months (Baseline vs Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start23 Jun 2022
- Primary completion12 Jul 2026
- Study completion12 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blind trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University, University of Georgia
- Responsible party
- Sponsor
- Investigators
- Naiman Khan, PhD, Principal investigator, University of Illinois Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177679
- Sponsor's protocol ID
- 21066
- Status last verified
- Sep 2025
- First submitted
- 2 Nov 2021
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cannavale CN, Keye SA, Rosok L, Martell S, Holthaus TA, Reeser G, Raine LB, Mullen SP, Cohen NJ, Hillman CH, Hammond BR, Renzi-Hammond L, Khan NA. Enhancing children's cognitive function and achievement through carotenoid consumption: The Integrated Childhood Ocular Nutrition Study (iCONS) protocol. Contemp Clin Trials. 2022 Nov;122:106964. doi: 10.1016/j.cct.2022.106964. Epub 2022 Oct 15.
PubMed 36252934
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption
- ClinicalTrials.gov ID
- NCT05177679
- Acronym / sponsor ID
- 21066
- Conditions
- Cognitive Change, Achievement, Macular Pigmentation
- Keywords
- Lutein, Zeaxanthin, Carotenoids, Child, Spatial memory, Hippocampus, Academic success, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Northeastern University, University of Georgia
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 12 Jul 2026 (actual)
- Study completion
- 12 Jul 2026 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, double-blind trial.
| Arm | Type | Receives |
|---|---|---|
| Active Supplement | Experimental | Dietary Supplement: Active supplementThe active supplementation group participants will be asked to consume a daily carotenoid supplement for 9 months. |
| Placebo Control | Placebo comparator | Dietary Supplement: Placebo controlThe placebo control group participants will be asked to consume a placebo supplement for 9 months. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active supplementCarotenoid supplement comprised of 10mg lutein and 2mg zeaxanthin. | Dietary supplement | Active Supplement |
| Placebo controlPlacebo control supplement | Dietary supplement | Placebo Control |
Primary outcome
Attentional Accuracy
Time frame: 9 months (Baseline vs Follow-up)
Changes in accuracy (%) between groups using a computerized flanker task.
Attentional Reaction Time
Time frame: 9 months (Baseline vs Follow-up)
Changes in reaction time (ms) between groups using a computerized flanker task.
Hippocampal-dependent Relational memory
Time frame: 9 months (Baseline vs Follow-up)
Spatial memory task accuracy
Composite Academic Achievement
Time frame: 9 months (Baseline vs Follow-up)
Kaufman Test of Academic and Educational Achievement II (KTEA III) composite or comprehensive academic achievement score. The scores are standard scores with a minimum score of 40 and a maximum score of 160 where a higher score indicates a better outcome.
7 secondary outcomes
Macular Pigment Optical Density
Time frame: 9 months (Baseline vs Follow-up)
Attentional Resource Allocation
Time frame: 9 months (Baseline vs Follow-up)
Attentional Processing Speed
Time frame: 9 months (Baseline vs Follow-up)
Math
Time frame: 9 months (Baseline vs Follow-up)
Reading
Time frame: 9 months (Baseline vs Follow-up)
Written Language
Time frame: 9 months (Baseline vs Follow-up)
Reading Fluency
Time frame: 9 months (Baseline vs Follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Derived from this study: PubMed 36252934Cannavale CN, Keye SA, Rosok L, Martell S, Holthaus TA, Reeser G, Raine LB, Mullen SP, Cohen NJ, Hillman CH, Hammond BR, Renzi-Hammond L, Khan NA. Enhancing children's cognitive function and achievement through carotenoid consumption: The Integrated Childhood Ocular Nutrition Study (iCONS) protocol. Contemp Clin Trials. 2022 Nov;122:106964. doi: 10.1016/j.cct.2022.106964. Epub 2022 Oct 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naiman Khan, PhD principal investigator
University of Illinois Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active supplement in people with Cognitive Change and Achievement, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attentional Accuracy (time frame: 9 months (Baseline vs Follow-up)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05177679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.