The Effect of Eggs and Egg Products on Macular Pigment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Age-related Macular Degeneration

Intervention / Treatment
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* Dietary Supplement: not enriched egg
* Dietary Supplement: lutein
* Dietary Supplement: zeaxanthin
* Dietary Supplement: egg product from enriched eggs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>daily consumption of a regular egg | Dietary Supplement: not enriched egg<br>* daily consumption of a regular egg, not enriched with either lutien nor zeaxanthin<br>|
| Experimental: B<br>daily consumption of a lutein-enriched egg, eggs laid by chickens on a lutein-enriched feed. | Dietary Supplement: lutein<br>* daily lutein enriched egg<br>|
| Experimental: C<br>daily consumtion of a zeaxanthin-enriched egg, eggs laid by chickens on a zeaxantin-enriched feed. | Dietary Supplement: zeaxanthin<br>* daily zeaxanthin enriched egg<br>|
| Experimental: D<br>daily egg product from enriched eggs | Dietary Supplement: egg product from enriched eggs<br>* daily egg product from lutein enriched eggs<br>|
| No Intervention: E<br>control subjects were not blinded as they did not receive any aditional supplementation. Only markers measured during the trial period as a control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurable macular pigment |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Lutein and zeaxanthin concentrations, lipid profile |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular pigment, AMD, ARM