Lutein Supplementation in Healthy Children

Not Applicable

Active, not recruiting

• Conditions: Cognitive Change; Eye Fatigue; Diet, Healthy
• Interventions: Dietary Supplement: placebo; Dietary Supplement: lutein

• Registration Number: NCT05314647
• Lead Sponsor: Northcentral University

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.

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 Timeline

• Study First Submitted: 2022-03-05
• Study First Submitted QC: 2022-04-03
• Study First Posted: 2022-04-06
• Study Start: 2023-07-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-30
• Primary Completion: 2024-03
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	0 mg lutein gummy taken daily for 180 days
Lutein	lutein	5 mg lutein gummy taken daily for 180 days

Primary Outcome Measures

Name	Time	Method
Macular Pigment Optical Density - heterochromatic flicker photometry	6 months	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.
Macular Pigment Optical Density - haidinger's brushes	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Digital Eye strain change from baseline	6 months	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)
Sleep score change from baseline	6 months	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.
Verbal Fluency	6 months	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

Trial Locations

Locations (1)

Kemin Industries; 🇺🇸 Des Moines, Iowa, United States