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Effects of Antioxidants on Human Macular Pigments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00718653
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : March 3, 2009
Information provided by:
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.

Condition or disease Intervention/treatment
Eye Health Dietary Supplement: Lutein Dietary Supplement: Lutein plus green tea extract

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Antioxidants on Human Macular Pigments
Study Start Date : September 2004
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
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)

Primary Outcome Measures :
  1. macular pigments, Plasma lutein concentrations [ Time Frame: Every month - baseline, 1, 2, 3, & 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718653

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)
Principal Investigator: Kyung-Jin Yeum, Ph.D. Tufts Medical Center

Additional Information:
Responsible Party: Kyung-Jin Yeum, Tufts Univeristy
ClinicalTrials.gov Identifier: NCT00718653     History of Changes
Other Study ID Numbers: R03EY015674 ( U.S. NIH Grant/Contract )
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: March 3, 2009
Last Verified: February 2009

Keywords provided by National Eye Institute (NEI):
Macular pigment, lutein, green tea extract, antioxidant

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs