Trial | NCT00527553  Report issue

Title

The Effect of Eggs and Egg Products on Macular Pigment
The Effect of Modified Eggs and Egg Products on the Measurable Macular Pigment in Healthy Subjects

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    egg ...

  • Study Participants

    100
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.
Study Started
Oct 31
2007
Primary Completion
Feb 29
2008
Study Completion
Feb 29
2008
Last Update
Apr 26
2018

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

A Experimental

daily consumption of a regular egg

B Experimental

daily consumption of a lutein-enriched egg, eggs laid by chickens on a lutein-enriched feed.

C Experimental

daily consumtion of a zeaxanthin-enriched egg, eggs laid by chickens on a zeaxantin-enriched feed.

D Experimental

daily egg product from enriched eggs

E No Intervention

control subjects were not blinded as they did not receive any aditional supplementation. Only markers measured during the trial period as a control.

Criteria 

Inclusion Criteria:

No history of ARM or AMD
18 years and older
Non-smoker
No ocular media opacity
Uses no nutritional supplements containing Lutein, Zeaxanthin or Omega-3
BMI < 30
No known cardiovascular disease

Exclusion Criteria:

Diabetes
Other known eye disease
Known lipid metabolism disease
Blood lipid level modifiers (e.g., Statin)
Known allergy to eggs or egg products
No Results Posted