An interventional study of not enriched egg and lutein in Age-related Macular Degeneration, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-26.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Prevention
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.
This will be a randomized placebo-controlled trial. The total study time will be two years of which 3 months are actual trial and follow-up time. Every individual will have 3 measuring points at set intervals. At every measuring point (days 1, 45 and 90), these subjects will undergo 6 different non-invasive measuring techniques. These are the mean visual acuity test using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, contrast sensitivity using the Pelli-Robson chart, Scanning Laser Ophthalmoscope (SLO), Optical Coherence Tomography (OCT) and Heterochromatic Flicker Photometry (HFP) and the Reflectometer. A questionnaire will be taken at the beginning of the trail. The invasive part of the study involves blood sampling at all three times, measuring the serum concentration of lutein, zeaxanthin, omega-3 and lipoprotein using the HPLC analysis.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 100 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
daily consumption of a regular egg
Dietary Supplement: not enriched egg
daily consumption of a lutein-enriched egg, eggs laid by chickens on a lutein-enriched feed.
Dietary Supplement: lutein
daily consumtion of a zeaxanthin-enriched egg, eggs laid by chickens on a zeaxantin-enriched feed.
Dietary Supplement: zeaxanthin
daily egg product from enriched eggs
Dietary Supplement: egg product from enriched eggs
control subjects were not blinded as they did not receive any aditional supplementation. Only markers measured during the trial period as a control.
daily consumption of a regular egg, not enriched with either lutien nor zeaxanthin
daily lutein enriched egg
daily zeaxanthin enriched egg
daily egg product from lutein enriched eggs
Measurable macular pigment
Time frame: 3 months
Plasma Lutein and zeaxanthin concentrations, lipid profile
Time frame: 3 months
This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Maastricht University Medical Center