Lutein Supplementation in Healthy Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The problem to be addressed by this study is that children are not getting enough lutein in their diets which can lead to life-long problems with cognition as well as vision. The recommended daily intake of dark green leafy vegetables rich in the nutrient lutein (required for eye and brain function) is not being met by most children. In the United States alone, 99% of children between the ages of 2 to 18 years are not eating the recommended daily amount of dark, green leafy vegetables. While vegetable intake is close to the recommended doses in the 2-4-year-old age group, intake falls rapidly as children reach the age of 5 and remains well below the recommended levels throughout the adolescent years, especially for the dark green leafy vegetable category. Overall vegetable intake does not appear to be better from a global perspective where a recent national survey conducted in England found that only eight percent of children between the ages of 11 and 18 consumed the 5-a-day recommended daily intake of fruits and vegetables. In fact, a study of 28 low- and middle-income countries found that over eighty percent of individuals 15 years and older failed to meet the daily recommended intake levels. In addition to and possibly related to the low vegetable intake is the role of health literacy on dietary choices in the youth population. Unfortunately, little is known about health literacy in children and young adults, its potential role on healthy eating choices or the impact of parental health literacy on children's' eating behaviors. Vegetables provide important nutrients for human health. One important and lesser known nutrient that comes from fruits and vegetables is the carotenoid lutein. Research has shown that a daily adult intake of at least 10 mg of lutein from the diet each day can be beneficial for both eye and brain function in adults. Unfortunately, due to the lack of clinical trials in school-aged children, there is currently no standard by which to recommend daily target doses for individuals under the age of 18 years. However, surveys indicate that in the United States, the average daily intake of lutein is around only 1 mg per day. The situation is similar from a global perspective, with average intakes in the European Union and Asia-Pacific ranging from 0.5 mg to 4 mg. Studies show strong correlations between low intake of lutein and the major cause of blindness in adults, age-related macular degeneration as well as with cognitive decline and Alzheimer's Disease later in life. 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lutein 5 mg lutein gummy taken daily for 180 days |
Dietary Supplement: lutein
daily dose of 5 mg lutein
Other Names:
|
| Placebo Comparator: Placebo 0 mg lutein gummy taken daily for 180 days |
Dietary Supplement: placebo
daily dose of 0 mg lutein
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kemin Industries | Des Moines | Iowa | United States | 50307 |
Sponsors and Collaborators
- Northcentral University
Investigators
- Study Chair: Patrick McNamara, PhD, Northcentral University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NorthcentralU