Lutein Supplementation in Healthy Children

Cognitive Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05314647
• Other study ID #: NorthcentralU
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: Northcentral University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 59
• Est. completion date: May 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthenopia
• Cognitive Change
• Diet, Healthy
• Eye Fatigue
• Fatigue

Intervention

Dietary Supplement:
• lutein
daily dose of 5 mg lutein
• placebo
daily dose of 0 mg lutein

Locations

Country	Name	City	State
United States	Kemin Industries	Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Northcentral University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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