Effects of Antioxidants on Human Macular Pigments

Eye Health Clinical Trial

Official title:

Effects of Antioxidants on Human Macular Pigments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718653
• Other study ID #: R03EY015674
• Secondary ID: R03EY015674
• Status: Completed
• Phase: N/A
• First received: July 17, 2008
• Last updated: February 27, 2009
• Start date: September 2004
• Est. completion date: December 2007

Study information

• Verified date: February 2009
• Source: National Eye Institute (NEI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Eye Health

Intervention

Dietary Supplement:
• Lutein
Lutein (12 mg/d)
• Lutein plus green tea extract
lutein (12 mg/d) plus green tea extract (200 mg/d)

Locations

Country	Name	City	State
United States	Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	macular pigments, Plasma lutein concentrations		Every month - baseline, 1, 2, 3, & 4 months	No

External Links

•   Link