The effect of supplement containing lutein on macular pigment optical density and visual performance
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000031870
- Lead Sponsor
- Deaprtment of Ophthalmology, Seirei Hamamatsu General Hospital
- Brief Summary
Total volume of macular pigment optical density (MPOD) within 9 degrees eccentricity significantly increased by week 8 and continued to increase until week 16 (p < 0.0001, two-way factorial ANOVA). Skin carotenoid levels increased significantly by week 4 and continued to increase until week 16 (p < 0.0001, two-way factorial ANOVA). All subjects completed the study without any serious adverse events.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
1) Subjects with serious eye diseases 2) Visual acuity of less than 0.8 3) Myopia of -6.0 D and more 4) Subjects who have a gastrointestinal disorders such as malabsorption syndrome and history of gastrectomy causing absorption deficiency 5) Subjects who have under treatment of diabetes mellitus 6) Presence of cataract of a severity sufficient to affect the measurement of macular pigment 7) Pupil size less than 6.5 mm 8) Use of lutein and zeaxanthin supplements 9) Subjects who have an allergic to lutein, zeaxanthin or test food 10) Subjects who are in pregnancy, or lactation, or who planning to become pregnant or lactating during 11) Any candidates considered to be unsuitable for enrollment in the opinion of physician-in-charge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Macular pigment optical density (at 4,8,12,16 weeks after administration)
- Secondary Outcome Measures
Name Time Method visual acuity contrast sensitivity glare sensitivity skin carotenoid levels skin AGEs levels