The Effect of Eggs and Egg Products on Macular Pigment

NCT00527553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-04-26

No results posted yet for this study

Summary

Age-related macula degeneration (AMD, encompassing both dry and wet form), the late stage of Age-related maculopathy (ARM), is the leading cause of blindness in many developed countries in older persons (usually over 60 years of age). Visual compromise rises exponentially after the age of 70 with a 5-year incidence of around 1%. Studies have shown a possible protective effect of lutein on progression of AMD, where visual acuity improves after increased lutein intake. The incidence of bilateral AMD in persons with unilateral late ARM observed over a period of 10 years is over 50% with a 2.1-2.8% overall incidence in the study population.

Blue light hazard (excitation peak 440 nm) was shown to have a major impact on photoreceptor and RPE function inducing photochemical damage and cellular apoptosis, leading to retinal degeneration in an animal study. The current belief is that lutein accumulated in the macular region helps in the prevention of blindness by absorbing blue light and protecting the retina from oxidative stress. With the lipid matrix of the egg yolk being a proven vehicle for the efficient absorption of dietary lutein, it might be possible to increase plasma levels of lutein to therapeutic levels and control or prevent AMD. This, the investigators hope, will be accomplished by means of filtering out harmful blue light and the scavenging of free radicals by lutein and zeaxanthin.

Conditions

  • Age-related Macular Degeneration

Interventions

DIETARY_SUPPLEMENT

not enriched egg

daily consumption of a regular egg, not enriched with either lutien nor zeaxanthin

DIETARY_SUPPLEMENT

lutein

daily lutein enriched egg

DIETARY_SUPPLEMENT

zeaxanthin

daily zeaxanthin enriched egg

DIETARY_SUPPLEMENT

egg product from enriched eggs

daily egg product from lutein enriched eggs

Sponsors & Collaborators

  • SenterNovem

    collaborator UNKNOWN
  • Newtricious BV

    collaborator UNKNOWN
  • Globus Ei BV

    collaborator UNKNOWN
  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • T. T.J. Berendschot, Dr. · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • Netherlands

Study Locations

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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 NCT00527553 on ClinicalTrials.gov