The Effect of Eggs and Egg Products on Macular Pigment

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00527553
• Collaborator: SenterNovem (Other), Newtricious BV (Other), Globus Ei BV (Other)
• Enrollment: 100
• Location: 1
• Arms: 5
• Duration (Months): 4
• Patients Per Site Per Month: 24.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-related Macular Degeneration	Dietary Supplement: not enriched egg; Dietary Supplement: lutein; Dietary Supplement: zeaxanthin; Dietary Supplement: egg product from enriched eggs	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Prevention
• Official Title: The Effect of Modified Eggs and Egg Products on the Measurable Macular Pigment in Healthy Subjects
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Measurable macular pigment [3 months]

Secondary Outcome Measures

1. Plasma Lutein and zeaxanthin concentrations, lipid profile [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hostpital Maastricht	Maastricht		Netherlands	6202AZ

Sponsors and Collaborators

• Maastricht University Medical Center
• SenterNovem
• Newtricious BV
• Globus Ei BV

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University Medical Center
• ClinicalTrials.gov Identifier: NCT00527553
• Other Study ID Numbers: 061127
• First Posted: Sep 11, 2007
• Last Update Posted: Apr 26, 2018
• Last Verified: Nov 1, 2008

• Keywords provided by Maastricht University Medical Center: Macular pigment; AMD; ARM
• Additional relevant MeSH terms: Macular Degeneration

Study Results

No Results Posted as of Apr 26, 2018