Healthy subjects
Conditions
Interventions
ngestion of supplementary drug containing lutein (16 weeks).
Sponsors
Deaprtment of Ophthalmology, Seirei Hamamatsu General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Healthy subjects aged 30 to 60 years-old 2. Macular pigment optical density of 0.64 or less in the measurement with Macular Metrics (Macular Metrics Inc.) at 0.5 eccentricity
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Macular pigment optical density (at 4,8,12,16 weeks after administration) | — |
Secondary
| Measure | Time frame |
|---|---|
| visual acuity contrast sensitivity glare sensitivity skin carotenoid levels skin AGEs levels | — |
Countries
Japan
Contacts
Public ContactMItuo Kimata
Seirei Hamamatsu General Hospital Clinical research management center
Outcome results
None listed