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Effect of Lutein-enriched-egg Beverage on Age-Related Macular Degeneration (AMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00902408
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : November 6, 2013
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
After a pilot trial where we showed an substantial increase in plasma lutein levels and a increase in macular pigment optical density after only 3 months of daily consumption of a lutein-enriched egg-beverage, we now propose to study the effect these changes have on subjects with early ( undiagnosed) stages of macular degeneration. Age-related macula degeneration, is the leading cause of blindness in many developed countries[1-6] in older persons (usually over 55 years of age). Visual compromise rises exponentially after age of 70[7] with a 5-year incidence of around 1%. The incidence of bilateral AMD in persons with unilateral late ARM observed over a period of 10 years of over 50% with a 2.1-2.8% overall incidence in study population[8]. To date there is no curative way of fighting AMD. With the results of this trial we hope to show that with daily consumption of these enriched beverage, we can slow the progression of AMD. (Protocol page 8-10)

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Dietary Supplement: Lutein enriched eggs Not Applicable

Detailed Description:

Rationale: In our pilot study (MEC 07-1-127) we saw an increase in both plasma as macular levels of lutein and zeaxanthin. Current believe is that this increase might help against the further deterioration of the retina seen in age-related macular degeneration (AMD) by scavenging for free radicals and filtering out harmful blue light rays[1, 2]. For the purpose of establishing whether these believes hold some truth, we want now to investigate the effect of lutein and zeaxanthin increase in subject with early signs of AMD on visual acuity, visual field and contrast sensibility. To relate these results to our previous study we will also measure the changes in plasma and macular concentrations of these xanthophylls. Once more we will be using the egg-beverage from the pilot study. These have been proven safe and showed no changes in lipid levels after 3 months of consumption.

Objective: To assess whether there is the same increase in macular pigment optical density as in healthy subject and to see if there is any change in visual function after a year of intervention.

Study design: This will be a randomized, double blind, placebo controlled, interventional trial. Subjects will be randomized, stratified for gender and age, into two groups (N=50 each) receiving either the intervention product (base on 1.5 yolk of a lutein enriched egg containing 0.921 ± 0.106mg of lutein and 0.137 ± 0.014mg of zeaxanthin per yolk) or a placebo. Subject will be followed for 1 year and will be seen three times for measurements.

Study population: 100 subjects, ages 50 and older with drusen and/or Retinal pigment epithelium (RPE) alterations on retinal image.

Main study parameters/endpoints: Changes in amount of early macular degeneration signs on fundus photographs. Macular pigment optical density. Plasma lutein and zeaxanthin levels.

Nature and extend of the burden and risks associated with participation, benefit and group relatedness: Subjects will be seen three times with a total of 22 ( + 1 hour screening) hours. Methods used in this trial are commonly used techniques which have been proven safe in either previous trials or clinical practice. Subjects' sight will be limited for the investigated eye for a few hours after every visit because of the use of Tropicamide, this is standard practice at our ophthalmology department with only sporadic, and treatable side effects (acute angle-closure glaucoma in 0.03%). Subjects in the intervention group are expected to show a slower progression of the disease than those in the placebo group. We will be using the same egg-beverage as in the pilot study which showed no changes in lipid levels.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Lutein-enriched-egg Beverage on Progression of Age-related Macular Degeneration, a Randomized Trial
Study Start Date : July 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

Arm Intervention/treatment
Experimental: Lutein
Lutein enriched eggs
Dietary Supplement: Lutein enriched eggs
1 year of daily enriched lutein eggs or placebo

Placebo Comparator: Placebo
Non enriched
Dietary Supplement: Lutein enriched eggs
1 year of daily enriched lutein eggs or placebo

Primary Outcome Measures :
  1. Changes in amount of early macular degeneration signs on fundus photographs. Macular pigment optical density. Plasma lutein and zeaxanthin levels. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Assessing morphological changes of the retina, visual acuity, contrast sensitivity, field of vision, and rod function. [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Early signs of AMD on fundus photographs (drusen and or retinal pigment epithelium alterations in at least one eye)
  • 50 years and older
  • Vision > 0.5
  • Non-smoker
  • No ocular media opacity
  • Uses no nutritional supplements containing Lutein or Zeaxanthin
  • BMI < 30
  • No known cardiovascular disease

Exclusion Criteria:

  • Diabetes
  • Known lipid metabolism disease
  • Blood lipid level modifiers (e.g. Statin)
  • Known allergy to eggs or egg products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00902408

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University Eye Clinic Maastrich
Maastricht, Limburg, Netherlands, 6202AZ
Sponsors and Collaborators
Maastricht University Medical Center
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Principal Investigator: Elton Kellly, MD Maastricht University Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center Identifier: NCT00902408    
Other Study ID Numbers: MEC 07-1-127
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases