Effect of Lutein-enriched-egg Beverage on Age-Related Macular Degeneration (AMD)
Condition: Age Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

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)
    

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.
    

Intervention name(s): Lutein enriched eggs
Intervention type(s): Dietary Supplement
Intervention description(s): 1 year of daily enriched lutein eggs or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention