Effects of Antioxidants on Human Macular Pigments

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.

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Key information

Conditions

Eye Health

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lutein

Dietary Supplement

Lutein (12 mg/d)

Lutein plus green tea extract

Dietary Supplement

lutein (12 mg/d) plus green tea extract (200 mg/d)

Primary outcomes

macular pigments, Plasma lutein concentrations

Time frame: Every month - baseline, 1, 2, 3, & 4 months

Sponsors and collaborators

Lead sponsor

National Eye Institute (NEI)

Nih

Registry information

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2007
First posted: Jul 21, 2008
Registry last updated: Mar 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed