The Effect of Eggs and Egg Products on Macular Pigment
NCT00527553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2018-04-26
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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