Macular Pigment and Glare Disability
This trial is active, not recruiting.
|Condition||glare disability in healthy subjects|
|Treatments||lutein and zeaxanthin supplements, placebo|
|Phase||phase 2/phase 3|
|Sponsor||University of Georgia|
|Start date||May 2009|
|End date||December 2011|
|Trial size||100 participants|
|Trial identifier||NCT00909090, UGA-2009-10141-1|
The purpose of this study is:
I. To measure MP optical density (MPOD) spatial profiles in two groups (experimental and placebo) of 50 subjects each (N = 100), during an L + Z supplementation period of 12 months.
II. To test the hypothesis that increases in MP (via 12 mg daily L + Z 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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Disability glare and contrast enhancement thresholds, photostress recovery times
time frame: every three months
Male or female participants from 20 years up to 40 years old.
Inclusion Criteria: - Gender: male or female - Age: 20 - 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 Criteria: - BMI <20 or >30 - Age <20 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 HFP 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
|Official title||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|
|Principal investigator||Billy R Hammond, Ph.D.|
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