Effects of Antioxidants on Human Macular Pigments

Study Overview
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Brief Summary
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Age-related macular degeneration (AMD) is the leading cause of blindness in the United States. Low dietary intake or low blood levels of lutein and zeaxanthin, which are the only pigments found in the macular region of the human retina, has been associated with an increased risk for AMD. We have reported that the dietary supplementation of lutein and zeaxanthin can increase the macular pigments (MP) of the eye. MP effectively absorbs blue light as well as quenches reactive oxygen species (ROS). Green tea polyphenols are also effective scavenger of ROS in vitro. Our goal is to elucidate how to effectively increase MP by physiologic levels of antioxidant supplementation. We hypothesize that lutein and tea polyphenols protect the macula of the eye by increasing MP carotenoids effectively through an antioxidant mechanism.

Official Title
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Effects of Antioxidants on Human Macular Pigments

Conditions
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Eye Health

Intervention / Treatment
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* Dietary Supplement: Lutein
* Dietary Supplement: Lutein plus green tea extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption and no drug intake which would interfere with fat absorption, metabolism or blood clotting non-smokers Exclusion Criteria: A history of kidney stones, active small bowel disease or resection, atrophic gastritis, hyperlipidemia, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders Exogenous hormone users weighing greater than 20% above or below the NHANES median standard subjects with serum lutein/zeaxanthin concentrations that are more than 150 % of median of normal population (as previously reported in NHANES III at same age group) early age related macular degeneration, cataract, or glaucoma except for those with age appropriate progression of the eye status.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>lutein | Dietary Supplement: Lutein<br>* Lutein (12 mg/d)<br>|
| Experimental: 2<br>Lutein plus green tea extract | Dietary Supplement: Lutein plus green tea extract<br>* lutein (12 mg/d) plus green tea extract (200 mg/d)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macular pigments, Plasma lutein concentrations |  | Every month - baseline, 1, 2, 3, & 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular pigment, lutein, green tea extract, antioxidant