ClinicalTrials.Veeva

Menu

Effects of Antioxidants on Human Macular Pigments

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status

Completed

Conditions

Eye Health

Treatments

Dietary Supplement: Lutein
Dietary Supplement: Lutein plus green tea extract

Study type

Interventional

Funder types

NIH

Identifiers

NCT00718653
R03EY015674 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

1
Experimental group
Description:
lutein
Treatment:
Dietary Supplement: Lutein
2
Experimental group
Description:
Lutein plus green tea extract
Treatment:
Dietary Supplement: Lutein plus green tea extract

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems