Lutein Supplementation in Healthy Children

NCT05314647 | Unknown DMC

• 1 other identifier: NorthcentralU
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single site, randomized, double-blind placebo controlled parallel arm study assessing the effects of 6 months lutein supplementation on cognitive and visual outcomes in healthy children exposed to excessive digital screen time.

Conditions

Eye Fatigue; Diet, Healthy; Cognitive Change

Keywords

lutein; carotenoids; blue light; screen time; digital stress

Outcome Measures

Primary Outcomes (2)

• Macular Pigment Optical Density - heterochromatic flicker photometry

  Level of macular carotenoids deposited in the eye measured using the psychophysical technique of heterochromatic flicker photometry (QuantifEye MPS-II Device). Minimum score of 0, no maximum. Average values range from 0.0 to 1.0. Higher numbers represent greater macular pigment.

  6 months

• Macular Pigment Optical Density - haidinger's brushes

  Level of macular carotenoids deposited in the eye measured using haidinger's brushes (Azul Optics MP-Eye Device). Minimum score of 0, maximum score of 10. Higher values represent greater macular pigment.

  6 months

Secondary Outcomes (3)

• Digital Eye strain change from baseline

  6 months

• Sleep score change from baseline

  6 months

• Verbal Fluency

  6 months

Study Arms (2)

Lutein

EXPERIMENTAL

5 mg lutein gummy taken daily for 180 days

Dietary Supplement: lutein

Placebo

PLACEBO COMPARATOR

0 mg lutein gummy taken daily for 180 days

Dietary Supplement: placebo

Interventions

lutein DIETARY_SUPPLEMENT

daily dose of 5 mg lutein

Also known as: FloraGLO Lutein

Lutein

placebo DIETARY_SUPPLEMENT

daily dose of 0 mg lutein

Placebo

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age of 8 to 16 years
• guardian-reported general good health
• guardian-reported 4 hours or more of digital screen time daily

You may not qualify if:

• Currently using a supplement containing lutein or zeaxanthin

Sponsors & Collaborators

• Northcentral University: lead

Study Sites (1)

Kemin Industries

Des Moines, Iowa, 50307, United States

Location

MeSH Terms

Conditions

Asthenopia

Interventions

Lutein

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Patrick McNamara, PhD

  Northcentral University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each participant will be assigned to a group based on a permuted block randomization stratified by participant self-reported sex. Participants may identify male, female or other. If other is selected, assignment as male or female for randomization purposes will be determined by a coin flip. Randomized block lists with a size of 4 will be prepared using a computer generated random number sequence, http://www.jerrydallal.com/random/assigndoc.htm#num (J. Kim \& Shin, 2014). Based on group placement, participants will be provided with Bottle A or Bottle B of gummies to last for the next 90 days.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized, double-blind, placebo controlled

Study Record Dates

• First Submitted: March 5, 2022
• First Posted: April 6, 2022
• Study Start: July 15, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)