Lutein Supplementation in Healthy Children

Effects of Lutein Supplementation on Cognition and Vision in Healthy Children With Screen Time Exposure: A Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cognitive Change; Diet, Healthy; Eye Fatigue
• Intervention / Treatment: Dietary supplement: lutein; Dietary supplement: placebo

Detailed Description

Studies in humans and primates have also shown that appropriate daily intake of lutein provides protection to the eyes from blue light from screen time devices such as computers, televisions and phones. It has been well-documented that children are spending far over the recommended two hours screen time per day and excessive exposure to the high energy blue light associated with digital devices has been shown to cause both short-term and long-term visual damage as well as disruption to the sleep cycle. With a globally aging population, if this deficit is not addressed adequately early on in life then there will be substantial public health consequences. A recent study predicted that if individuals were to consume the recommended levels of lutein and zeaxanthin daily, there would be a seven percent reduced risk for age related eye disease and a potential savings of over five billion US dollars annually.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brenda Fonseca, MA; Phone Number: 515-421-0680; Email: brenda@brendafonseca.com

Study Locations

• United States
  • Iowa
    • Des Moines, Iowa, United States, 50307
      • Kemin Industries

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Currently using a supplement containing lutein or zeaxanthin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lutein; 5 mg lutein gummy taken daily for 180 days	Dietary supplement: lutein; daily dose of 5 mg lutein; Other Names: FloraGLO Lutein
Placebo Comparator: Placebo; 0 mg lutein gummy taken daily for 180 days	Dietary supplement: placebo; daily dose of 0 mg lutein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digital Eye strain change from baseline	Visual Fatigue Scale total score. Minimum score of 6, Maximum score of 24. Higher scores indicate higher levels of digital eye strain. Benedetto, S., Drai-Zerbib, V., Pedrotti, M., Tissier, G., & Baccino, T. (2013). E-readers and visual fatigue. PLoS One, 8(12)	6 months
Sleep score change from baseline	Total score on the Cleveland Adolescent Sleepiness Questionnaire. Minimum score of 16, Maximum score of 80. Higher scores indicate greater sleepiness. Spilsbury, J. C., et al. (2007). "The Cleveland adolescent sleepiness questionnaire: a new measure to assess excessive daytime sleepiness in adolescents." J Clin Sleep Med 3(6): 603-612.	6 months
Verbal Fluency	Letter and semantic fluency using letter and animal naming. Total number of words names in a 60 second time frame. Higher score indicates greater verbal fluency	6 months

Collaborators and Investigators

• Sponsor: Northcentral University
• Investigators: Study Chair: Patrick McNamara, PhD, Northcentral University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 5, 2022
• First Submitted That Met QC Criteria: April 3, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: lutein; screen time; blue light; carotenoids; digital stress
• Additional Relevant MeSH Terms: Eye Diseases; Fatigue; Asthenopia
• Other Study ID Numbers: NorthcentralU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No