Eye Fatigue, Diet, Healthy, Cognitive Change
Conditions
Keywords
lutein, carotenoids, blue light, screen time, digital stress
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.
Interventions
DIETARY_SUPPLEMENTlutein
daily dose of 5 mg lutein
DIETARY_SUPPLEMENTplacebo
daily dose of 0 mg lutein
Sponsors
Northcentral University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Each participant will be assigned to a group based on a permuted block randomization stratified by participant self-reported sex. Participants may identify male, female or other. If other is selected, assignment as male or female for randomization purposes will be determined by a coin flip. Randomized block lists with a size of 4 will be prepared using a computer generated random number sequence, http://www.jerrydallal.com/random/assigndoc.htm#num (J. Kim & Shin, 2014). Based on group placement, participants will be provided with Bottle A or Bottle B of gummies to last for the next 90 days.
Intervention model description
randomized, double-blind, placebo controlled
Eligibility
Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
United States
Outcome results
None listed