Effects of Antioxidants on Human Macular Pigments

NCT ID: NCT00718653

Last Updated: 2009-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2007-12-31

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.

Conditions

Eye Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

1

lutein

Group Type: EXPERIMENTAL

Lutein

Intervention Type: DIETARY_SUPPLEMENT

Lutein (12 mg/d)

2

Lutein plus green tea extract

Group Type: EXPERIMENTAL

Lutein plus green tea extract

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Lutein

Lutein (12 mg/d)

Intervention Type: DIETARY_SUPPLEMENT

Lutein plus green tea extract

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: lead

Responsible Party

Tufts Univeristy

Principal Investigators

Kyung-Jin Yeum, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

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

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18806766 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=18806766

Related Info

Other Identifiers

R03EY015674

Identifier Type: NIH

Identifier Source: secondary_id

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R03EY015674

Identifier Type: NIH

Identifier Source: org_study_id

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