Effects of Antioxidants on Human Macular Pigments
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 17, 2008
CompletedFirst Posted
Study publicly available on registry
July 21, 2008
CompletedMarch 3, 2009
February 1, 2009
3.2 years
July 17, 2008
February 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
macular pigments, Plasma lutein concentrations
Every month - baseline, 1, 2, 3, & 4 months
Study Arms (2)
1
EXPERIMENTALlutein
2
EXPERIMENTALLutein plus green tea extract
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111, United States
Related Publications (1)
Li L, Duker JS, Yoshida Y, Niki E, Rasmussen H, Russell RM, Yeum KJ. Oxidative stress and antioxidant status in older adults with early cataract. Eye (Lond). 2009 Jun;23(6):1464-8. doi: 10.1038/eye.2008.281. Epub 2008 Sep 19.
PMID: 18806766RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung-Jin Yeum, Ph.D.
Tufts Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
July 17, 2008
First Posted
July 21, 2008
Study Start
September 1, 2004
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
March 3, 2009
Record last verified: 2009-02