Status:
COMPLETED
Macular Pigment and Glare Disability
Lead Sponsor:
University of Georgia
Collaborating Sponsors:
DSM Nutritional Products, Inc.
Conditions:
Vision, Entoptic
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief 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 1...
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 rec...
Eligibility Criteria
Inclusion
- Gender: male or female
- Age: 18 - 40 years
- BMI: 20-30
- No anticipated changes in dieting habits (as relevant to xanthophyll intake).
- No anticipated surgical procedures.
- Assessed as healthy, based on a pre-study examination including medical history, physical examination, and clinical laboratory. The examination will be performed by an MD or a Nurse Practitioner.
- Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.
- Corrected visual acuity (ETDRS): better than 20/60
Exclusion
- BMI \<20 or \>30
- Age \<18 or \>40 years
- Smokers
- Current or history of relevant diseases (such as AMD)
- Corrected visual acuity worse than 20/60
- Inability to reliably perform MPOD measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study.
- Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls.
- Current use of xanthophyll containing supplements
- Use of xanthophyll containing supplements in the past 6 months
- Participation in any other study during last 1 month.
- Blood donation during the last 3 months.
- Known hypersensitivity or allergy to xanthophylls.
- Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes.
- Suspected lack of compliance with any requirements of the study.
- Childbearing potential and unwillingness to refrain from acceptable anticonceptive measures (not including abstinence).
- Current pregnancy or breast feeding
- Any relevant abnormalities in the routine laboratory tests
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00909090
Start Date
May 1 2009
End Date
December 1 2012
Last Update
July 13 2020
Active Locations (1)
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1
Vision Sciences Laboratory, UGA
Athens, Georgia, United States, 30602