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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


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
See also
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