Clinical trial NCT00527553: The Effect of Eggs and Egg Products on Macular Pigment
Official title: The Effect of Modified Eggs and Egg Products on the Measurable Macular Pigment in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration
Keywords: Macular pigment
AMD
ARM
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: SenterNovem
name: Newtricious BV
name: Globus Ei BV
First posted: 2007-09-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurable macular pigment
timeFrame: 3 months
Secondary outcomes:
measure: Plasma Lutein and zeaxanthin concentrations, lipid profile
timeFrame: 3 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hostpital Maastricht
Study officials:
affiliation: Maastricht University Medical Center
name: T. T.J. Berendschot, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kelly ER, Plat J, Haenen GR, Kijlstra A, Berendschot TT. The effect of modified eggs and an egg-yolk based beverage on serum lutein and zeaxanthin concentrations and macular pigment optical density: results from a randomized trial. PLoS One. 2014 Mar 27;9(3):e92659. doi: 10.1371/journal.pone.0092659. eCollection 2014.