Eye Health, Vision
Conditions
Brief summary
The primary study outcomes are to investigate the effects of 4-month daily carotenoid complex supplementation on carotenoid status in the macula and skin and visual fatigue among adults 20-45 years of age. Secondary outcomes will examine the supplementation effects on cognitive function.
Detailed description
Lutein and zeaxanthin are carotenoids or plant-based pigments that accumulate in various human tissues including the eye, skin, adipose/fat, and the brain where they play important roles as antioxidants and light filters. Previous correlational work has shown that lutein and zeaxanthin intake is associated with multiple markers of health including visual and cognitive outcomes. However, experimental or intervention research examining the effects of lutein and zeaxanthin supplementation on the accumulation of these carotenoids in the eye and skin and implications for visual and cognitive function is still emerging. Additionally, virtually all the previous research has relied on single nutrient supplementation (e.g., only lutein or zeaxanthin) resulting in limited knowledge of the benefits of providing these carotenoids with other possibly healthful nutrients (e.g., astaxanthin, vitamin E). Accordingly, this project will test the effects of lutein and zeaxanthin supplementation provided in a complex with other antioxidants and nutrients on outcomes of nutritional status in the eye and skin as well as visual and cognitive health. The study aims will be addressed using a double-blind randomized controlled trial design. Adults 20-45 years of age will be asked to participate in a daily 4-month double-blind randomized controlled clinical trial. Treatment group (N=20) participants will be asked to consume 2 daily softgels with a daily total containing 20mg free lutein (10mg/softgel), 4 mg free zeaxanthin (2mg/softgel), 40mg maqui berry extract (20mg/softgel), 6 mg astaxanthin (3 mg/softgel), 80mg bilberry extract (40mg/softgel), flaxseed oil (150mg/softgel), and vitamin E (5IU/softgel). Participants will be asked to consume the supplements with a meal of their choosing. Control group participants will be asked to consume similar-looking placebo softgels over the same period.
Interventions
DIETARY_SUPPLEMENTCarotenoid Group
Treatment will contain 20mg free lutein (10mg/softgel), 4 mg free zeaxanthin (2mg/softgel), 40mg maqui berry extract (20mg/softgel), 6 mg astaxanthin (3 mg/softgel), 80mg bilberry extract (40mg/softgel), flaxseed oil (150mg/softgel), and vitamin E (5IU/softgel)
DIETARY_SUPPLEMENTControl (placebo) group
Flaxseed Oil (330mg)
Sponsors
Daiken Biomedical Co., Ltd.
University of Illinois at Urbana-Champaign
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. not pregnant 2. not breastfeeding 3. absence of hypertension 4. absence of diabetes 5. absence of cerebrovascular disease 6. absence of cardiovascular disease 7. absence of liver disease 8. absence of kidney disease 9. absence of gastrointestinal disease 10. absence of age-related macular degeneration 11. no allergy to carotenoids 12. 20/20 or corrected vision 13. MPOD less than or equal to 0.60 14. Age between 20-45 years
Exclusion criteria
1. pregnant 2. breastfeeding 3. presence of hypertension 4. presence of diabetes 5. presence of cerebrovascular disease 6. presence of cardiovascular disease 7. presence of liver disease 8. presence of kidney disease 9. presence of gastrointestinal disease 10. presence of age-related macular degeneration 11. allergy to carotenoids 12. not 20/20 or uncorrected vision 13. MPOD greater than 0.60 14. Younger than 20 years or older than 45 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Macular Pigment Optical Density | From enrollment to end of treatment at 4 months | Macular carotenoids assessed using heterochromatic flicker photometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin carotenoids | From enrollment to end of treatment at 4 months | Carotenoids in skin assessed using skin reflection spectroscopy |
| Visual Fatigue | From enrollment to end of treatment at 4 months | Visual fatigue as assessed by the Computer Vision Syndrome Questionnaire |
Countries
United States
Outcome results
None listed