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Sponsors and Collaborators: |
Maastricht University Medical Center SenterNovem Newtricious BV Globus Ei BV |
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Information provided by: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT00527553 |
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.
Condition | Intervention |
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Age-Related Macular Degeneration |
Dietary Supplement: not enriched egg Dietary Supplement: lutein Dietary Supplement: zeaxanthin Dietary Supplement: egg product from enriched eggs Dietary Supplement: normal diet |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Bio-availability Study |
Official Title: | The Effect of Modified Eggs and Egg Products on the Measurable Macular Pigment in Healthy Subjects |
Enrollment: | 100 |
Study Start Date: | October 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Placebo Comparator
daily not enriched egg
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Dietary Supplement: not enriched egg
daily egg, not enriched
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B: Experimental
daily lutein-enriched egg
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Dietary Supplement: lutein
daily enriched egg
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C: Experimental
daily zeaxanthin-enriched egg
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Dietary Supplement: zeaxanthin
daily zeaxanthin enriched egg
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D: Experimental
daily egg product from enriched eggs
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Dietary Supplement: egg product from enriched eggs
daily egg product from enriched eggs
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E: No Intervention
control, normal diet, no additional eggs
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Dietary Supplement: normal diet
control, normal diet, no additional eggs
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
University Hostpital Maastricht | |
Maastricht, Netherlands, 6202AZ |
Principal Investigator: | T. T.J. Berendschot, Dr. | Maastricht University Medical Center |
Responsible Party: | University Eye Clinic Maastricht ( Dr. T. Berendschot ) |
Study ID Numbers: | 061127 |
Study First Received: | September 3, 2007 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00527553 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Macular pigment AMD ARM |
Eye Diseases Retinal Degeneration Macular Degeneration Healthy Retinal Diseases |
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |