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NCT Number: NCT00527553

The Effect of Eggs and Egg Products on Macular Pigment

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hostpital Maastricht

Maastricht, 6202AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

not enriched egg

Dietary Supplement

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

Lutein

Dietary Supplement

daily lutein enriched egg

zeaxanthin

Dietary Supplement

daily zeaxanthin enriched egg

egg product from enriched eggs

Dietary Supplement

daily egg product from lutein enriched eggs

Primary outcomes

  1. Measurable macular pigment

    Time frame: 3 months

Secondary outcomes

  1. Plasma Lutein and zeaxanthin concentrations, lipid profile

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Globus Ei BV
  • Newtricious BV
  • SenterNovem

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 11, 2007
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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