NCT00527553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2007

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

April 26, 2018

Status Verified

November 1, 2008

Enrollment Period

4 months

First QC Date

September 3, 2007

Last Update Submit

April 25, 2018

Conditions

Age-related Macular Degeneration

Keywords

Macular pigmentAMDARM

Outcome Measures

Primary Outcomes (1)

  • Measurable macular pigment

    3 months

Secondary Outcomes (1)

  • Plasma Lutein and zeaxanthin concentrations, lipid profile

    3 months

Study Arms (5)

A

EXPERIMENTAL

daily consumption of a regular egg

Dietary Supplement: not enriched egg

B

EXPERIMENTAL

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

Dietary Supplement: lutein

C

EXPERIMENTAL

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

Dietary Supplement: zeaxanthin

D

EXPERIMENTAL

daily egg product from enriched eggs

Dietary Supplement: egg product from enriched eggs

E

NO INTERVENTION

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

Interventions

not enriched eggDIETARY_SUPPLEMENT

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

A
luteinDIETARY_SUPPLEMENT

daily lutein enriched egg

B
zeaxanthinDIETARY_SUPPLEMENT

daily zeaxanthin enriched egg

C
egg product from enriched eggsDIETARY_SUPPLEMENT

daily egg product from lutein enriched eggs

D

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No history of ARM or AMD
  • 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

You may not qualify if:

  • Diabetes
  • Other known eye disease
  • Known lipid metabolism disease
  • Blood lipid level modifiers (e.g., Statin)
  • Known allergy to eggs or egg products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hostpital Maastricht

Maastricht, 6202AZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 24675775DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

LuteinZeaxanthins

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

XanthophyllsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • T. T.J. Berendschot, Dr.

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2007

First Posted

September 11, 2007

Study Start

October 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

April 26, 2018

Record last verified: 2008-11

Locations

NL(1)