An interventional study of lutein and placebo in Eye Fatigue, Diet, Healthy and Cognitive Change, sponsored by Northcentral University. Active, not recruiting at 1 site in United States. Open to participants aged 8 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-30.
Sponsored by Northcentral University · Not applicable, Interventional, and Treatment
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.
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.
67 studies on the registry are indexed under Asthenopia; 10 are open to participants now.
This study's enrollment of 59 is close to the median of 56 across 56 interventional studies indexed under Asthenopia.
Browse Asthenopia studies →This is the only study on the registry with Northcentral University as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
5 mg lutein gummy taken daily for 180 days
Dietary Supplement: lutein
0 mg lutein gummy taken daily for 180 days
Dietary Supplement: placebo
daily dose of 5 mg lutein
Also known as: FloraGLO Lutein
daily dose of 0 mg lutein
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.
Time frame: 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.
Time frame: 6 months
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)
Time frame: 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.
Time frame: 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
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Mar 2024, 8 months after the start.
Of 31 non-industry interventional studies with no phase under Asthenopia, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 9. This study's planned 8 months is above that.
Counting every sponsor, half of 38 studies reached it within 3 months; a quarter within 2 and three quarters within 9.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lutein