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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00527553
Enrollment
100
Registered
2007-09-11
Start date
2007-10-31
Completion date
2008-02-29
Last updated
2018-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration

Keywords

Macular pigment, AMD, ARM

Brief 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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTnot enriched egg

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

DIETARY_SUPPLEMENTlutein

daily lutein enriched egg

DIETARY_SUPPLEMENTzeaxanthin

daily zeaxanthin enriched egg

DIETARY_SUPPLEMENTegg product from enriched eggs

daily egg product from lutein enriched eggs

Sponsors

SenterNovem
CollaboratorUNKNOWN
Newtricious BV
CollaboratorUNKNOWN
Globus Ei BV
CollaboratorUNKNOWN
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Measurable macular pigment3 months

Secondary

MeasureTime frame
Plasma Lutein and zeaxanthin concentrations, lipid profile3 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026