Trials / Completed
CompletedNCT00909090
Macular Pigment and Glare Disability
Effects of Lutein and Zeaxanthin Upon MPOD and Its Effects Upon Glare Disability, Photostress Recovery, and Contrast Enhancement in Healthy Subjects: A Randomized, Double-blind Placebo-controlled Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- University of Georgia · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is: I. To measure MP optical density (MPOD) in two groups (experimental and placebo) of 50 subjects each (N = 100), during an Lutein + Zeaxanthin supplementation period of 12 months. II. To test the hypothesis that increases in MP (via 12 mg daily Lutein + Zeaxanthin supplementation) will result in significantly improved visual performance under disability glare conditions. III. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in significantly reduced photostress recovery times. IV. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in improved contrast enhancement.
Detailed description
The following measurements will be taken, before and after supplementation with lutein and zeaxanthin: Macular pigment optical density (MPOD) Visual performance under glare conditions Photostress recovery times chromatic contrast sensitivity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 12 mg Lutein + Zeaxanthin | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year |
| DIETARY_SUPPLEMENT | Visually identical placebo | Visually identical placebo, taken once daily for one year |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2009-05-27
- Last updated
- 2020-07-13
- Results posted
- 2020-07-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00909090. Inclusion in this directory is not an endorsement.