Effects of Antioxidants on Human Macular Pigments
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Eye Health |
Dietary Supplement: Lutein Dietary Supplement: Lutein plus green tea extract |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
| Official Title: | Effects of Antioxidants on Human Macular Pigments |
- macular pigments, Plasma lutein concentrations [ Time Frame: Every month - baseline, 1, 2, 3, & 4 months ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | September 2004 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
lutein
|
Dietary Supplement: Lutein
Lutein (12 mg/d)
|
|
Experimental: 2
Lutein plus green tea extract
|
Dietary Supplement: Lutein plus green tea extract
lutein (12 mg/d) plus green tea extract (200 mg/d)
|
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Massachusetts | |
| Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University | |
| Boston, Massachusetts, United States, 02111 | |
| Principal Investigator: | Kyung-Jin Yeum, Ph.D. | Tufts Medical Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Kyung-Jin Yeum, Tufts Univeristy |
| ClinicalTrials.gov Identifier: | NCT00718653 History of Changes |
| Other Study ID Numbers: | R03EY015674, R03EY015674 |
| Study First Received: | July 17, 2008 |
| Last Updated: | February 27, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Eye Institute (NEI):
|
Macular pigment, lutein, green tea extract, antioxidant |
Additional relevant MeSH terms:
|
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013