Effects of Antioxidants on Human Macular Pigments

Not Applicable

Completed

• Conditions: Eye Health
• Interventions: Dietary Supplement: Lutein; Dietary Supplement: Lutein plus green tea extract

• Registration Number: NCT00718653
• Lead Sponsor: National Eye Institute (NEI)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-17
• Study First Posted: 2008-07-21
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-27
• Last Update Posted: 2009-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lutein	lutein
2	Lutein plus green tea extract	Lutein plus green tea extract

Primary Outcome Measures

Name	Time	Method
macular pigments, Plasma lutein concentrations	Every month - baseline, 1, 2, 3, & 4 months

Trial Locations

Locations (1)

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