## Protocol Section
### Identification Module
**NCT ID:** NCT05177679

**Brief Title:** Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption

**Official Title:** Enhancing Children's Cognitive Function and Achievement Through Carotenoid Consumption

#### Organization Study ID Info
**ID:** 21066
#### Organization
**Class:** OTHER
**Full Name:** University of Illinois at Urbana-Champaign
### Status Module
#### Completion Date
**Date:** 2026-04-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-04-27

**Type:** ACTUAL

**Last Update Submit Date:** 2023-04-26

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-06-23

**Type:** ACTUAL

**Status Verified Date:** 2023-04

#### Study First Post Date
**Date:** 2022-01-04
**Type:** ACTUAL
**Study First Submit Date:** 2021-11-02
**Study First Submit QC Date:** 2021-12-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Northeastern University

**Class:** OTHER

**Name:** University of Georgia

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Illinois at Urbana-Champaign

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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 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).

### Conditions Module

**Conditions:**

- Cognitive Change

- Achievement

- Macular Pigmentation

**Keywords:**

- Lutein

- Zeaxanthin

- Carotenoids

- Child

- Spatial memory

- Hippocampus

- Academic success

- Cognition

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Randomized, placebo-controlled, double-blind trial.

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 288

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Dietary Supplement: Active supplement

**Label:** Active Supplement

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Dietary Supplement: Placebo control

**Label:** Placebo Control

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Active Supplement

**Description:** Carotenoid supplement comprised of 10mg lutein and 2mg zeaxanthin.

**Name:** Active supplement

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Placebo Control

**Description:** Placebo control supplement

**Name:** Placebo control

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** Changes in accuracy (%) between groups using a computerized flanker task.

**Measure:** Attentional Accuracy

**Time Frame:** 9 months (Baseline vs Follow-up)

**Description:** Changes in reaction time (ms) between groups using a computerized flanker task.

**Measure:** Attentional Reaction Time

**Time Frame:** 9 months (Baseline vs Follow-up)

**Description:** Spatial memory task accuracy

**Measure:** Hippocampal-dependent Relational memory

**Time Frame:** 9 months (Baseline vs Follow-up)

**Description:** 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.

**Measure:** Composite Academic Achievement

**Time Frame:** 9 months (Baseline vs Follow-up)

#### Secondary Outcomes

**Description:** Changes in Macular Pigment Optical Density (log units) between groups using a macular densitometer.

**Measure:** Macular Pigment Optical Density

**Time Frame:** 9 months (Baseline vs Follow-up)

**Description:** Changes in P3 event related potential amplitude (microvolts) between groups using a computerized flanker task.

**Measure:** Attentional Resource Allocation

**Time Frame:** 9 months (Baseline vs Follow-up)

**Description:** Changes in P3 event related potential latency (ms) between groups using a computerized flanker task.

**Measure:** Attentional Processing Speed

**Time Frame:** 9 months (Baseline vs Follow-up)

**Description:** 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.

**Measure:** Math

**Time Frame:** 9 months (Baseline vs Follow-up)

**Description:** 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.

**Measure:** Reading

**Time Frame:** 9 months (Baseline vs Follow-up)

**Description:** 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.

**Measure:** Written Language

**Time Frame:** 9 months (Baseline vs Follow-up)

**Description:** 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.

**Measure:** Reading Fluency

**Time Frame:** 9 months (Baseline vs Follow-up)

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 10 Years

**Minimum Age:** 8 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nakhan2@illinois.edu

**Name:** Naiman Khan, PhD

**Phone:** 217-300-2197

**Role:** CONTACT

**Contact 2:**

**Email:** reeser2@illinois.edu

**Name:** Ginger Reeser, MS

**Phone:** 217-244-8442

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Urbana

**Contacts:**

***Contact 1:***

- **Email:** nakhan2@illinois.edu

- **Name:** Naiman Khan, PhD

- **Phone:** 217-300-2197

- **Role:** CONTACT

***Contact 2:***

- **Email:** reeser2@illinois.edu

- **Name:** Ginger Reeser, MS

- **Phone:** 217-244-8442

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Illinois Urbana-Champaign

**State:** Illinois

**Status:** RECRUITING

**Zip:** 61801

#### Overall Officials

**Official 1:**

**Affiliation:** University of Illinois Urbana-Champaign

**Name:** Naiman Khan, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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.

**PMID:** 36252934

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M5592

- Name: Carotenoids

- Relevance: LOW

- As Found: Unknown

- ID: T407

- Name: Lutein

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
