The Effect of Eggs and Egg Products on Macular Pigment

April 25, 2018 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6202AZ
        • University Hostpital Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
daily consumption of a regular egg
Dietary supplement: not enriched egg
daily consumption of a regular egg, not enriched with either lutien nor zeaxanthin
Experimental: B
daily consumption of a lutein-enriched egg, eggs laid by chickens on a lutein-enriched feed.
Dietary supplement: lutein
daily lutein enriched egg
Experimental: C
daily consumtion of a zeaxanthin-enriched egg, eggs laid by chickens on a zeaxantin-enriched feed.
Dietary supplement: zeaxanthin
daily zeaxanthin enriched egg
Experimental: D
daily egg product from enriched eggs
Dietary supplement: egg product from enriched eggs
daily egg product from lutein enriched eggs
No Intervention: E
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?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurable macular pigment
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma Lutein and zeaxanthin concentrations, lipid profile
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

SenterNovem
Newtricious BV
Globus Ei BV

Investigators

  • Principal Investigator: T. T.J. Berendschot, Dr., Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

September 3, 2007

First Submitted That Met QC Criteria

September 10, 2007

First Posted (Estimate)

September 11, 2007

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 061127

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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