Effects of Antioxidants on Human Macular Pigments - Full Text View

Sponsored by:	National Eye Institute (NEI)
Information provided by:	National Eye Institute (NEI)
ClinicalTrials.gov Identifier:	NCT00718653

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

MedlinePlus related topics: Antioxidants Dietary Supplements

Drug Information available for: Lutein

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	Effects of Antioxidants on Human Macular Pigments

Further study details as provided by National Eye Institute (NEI):

Primary Outcome Measures:

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
1: Experimental lutein	Dietary Supplement: Lutein Lutein (12 mg/d)
2: Experimental 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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718653

Locations

United States, Massachusetts
Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111

Sponsors and Collaborators

National Eye Institute (NEI)

Investigators

Principal Investigator:

Kyung-Jin Yeum, Ph.D.

Tufts Medical Center

More Information

Responsible Party:	Tufts Univeristy ( Kyung-Jin Yeum )
Study ID Numbers:	R03EY015674, R03EY015674
Study First Received:	July 17, 2008
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00718653
Health Authority:	United States: Federal Government

Keywords provided by National Eye Institute (NEI):

Macular pigment, lutein, green tea extract, antioxidant

ClinicalTrials.gov processed this record on January 13, 2009