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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05314647
Other study ID # NorthcentralU
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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