The Effect of Eggs and Egg Products on Macular Pigment

NCT ID: NCT00527553

Last Updated: 2018-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-02-29

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.

Conditions

Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

A

daily consumption of a regular egg

Group Type: EXPERIMENTAL

not enriched egg

Intervention Type: DIETARY_SUPPLEMENT

daily consumption of a regular egg, not enriched with either lutien nor zeaxanthin

B

daily consumption of a lutein-enriched egg, eggs laid by chickens on a lutein-enriched feed.

Group Type: EXPERIMENTAL

lutein

Intervention Type: DIETARY_SUPPLEMENT

daily lutein enriched egg

C

daily consumtion of a zeaxanthin-enriched egg, eggs laid by chickens on a zeaxantin-enriched feed.

Group Type: EXPERIMENTAL

zeaxanthin

Intervention Type: DIETARY_SUPPLEMENT

daily zeaxanthin enriched egg

D

daily egg product from enriched eggs

Group Type: EXPERIMENTAL

egg product from enriched eggs

Intervention Type: DIETARY_SUPPLEMENT

daily egg product from lutein enriched eggs

E

control subjects were not blinded as they did not receive any aditional supplementation. Only markers measured during the trial period as a control.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

not enriched egg

daily consumption of a regular egg, not enriched with either lutien nor zeaxanthin

Intervention Type: DIETARY_SUPPLEMENT

lutein

daily lutein enriched egg

Intervention Type: DIETARY_SUPPLEMENT

zeaxanthin

daily zeaxanthin enriched egg

Intervention Type: DIETARY_SUPPLEMENT

egg product from enriched eggs

daily egg product from lutein enriched eggs

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SenterNovem

UNKNOWN

Sponsor Role: collaborator

Newtricious BV

UNKNOWN

Sponsor Role: collaborator

Globus Ei BV

UNKNOWN

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

T. T.J. Berendschot, Dr.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

University Hostpital Maastricht

Maastricht, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 24675775 (View on PubMed)

Other Identifiers

061127

Identifier Type: -

Identifier Source: org_study_id