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Effect of Lutein-enriched-egg Beverage on Age-Related Macular Degeneration (AMD)

NCT00902408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-11-06

No results posted yet for this study

Summary

After a pilot trial where we showed an substantial increase in plasma lutein levels and a increase in macular pigment optical density after only 3 months of daily consumption of a lutein-enriched egg-beverage, we now propose to study the effect these changes have on subjects with early ( undiagnosed) stages of macular degeneration. Age-related macula degeneration, is the leading cause of blindness in many developed countries\[1-6\] in older persons (usually over 55 years of age). Visual compromise rises exponentially after age of 70\[7\] with a 5-year incidence of around 1%. The incidence of bilateral AMD in persons with unilateral late ARM observed over a period of 10 years of over 50% with a 2.1-2.8% overall incidence in study population\[8\]. To date there is no curative way of fighting AMD. With the results of this trial we hope to show that with daily consumption of these enriched beverage, we can slow the progression of AMD. (Protocol page 8-10)

Conditions

  • Age Related Macular Degeneration

Interventions

DIETARY_SUPPLEMENT

Lutein enriched eggs

1 year of daily enriched lutein eggs or placebo

Sponsors & Collaborators

  • Newtricious

    collaborator UNKNOWN

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Elton Kellly, MD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00902408 on ClinicalTrials.gov