The Effect of Eggs and Egg Products on Macular Pigment
Primary Purpose
Age-related Macular Degeneration
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
not enriched egg
lutein
zeaxanthin
egg product from enriched eggs
Sponsored by
About this trial
This is an interventional prevention trial for Age-related Macular Degeneration focused on measuring Macular pigment, AMD, ARM
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
Sites / Locations
- University Hostpital Maastricht
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
No Intervention
Arm Label
A
B
C
D
E
Arm Description
daily consumption of a regular egg
daily consumption of a lutein-enriched egg, eggs laid by chickens on a lutein-enriched feed.
daily consumtion of a zeaxanthin-enriched egg, eggs laid by chickens on a zeaxantin-enriched feed.
daily egg product from enriched eggs
control subjects were not blinded as they did not receive any aditional supplementation. Only markers measured during the trial period as a control.
Outcomes
Primary Outcome Measures
Measurable macular pigment
Secondary Outcome Measures
Plasma Lutein and zeaxanthin concentrations, lipid profile
Full Information
NCT ID
NCT00527553
First Posted
September 3, 2007
Last Updated
April 25, 2018
Sponsor
Maastricht University Medical Center
Collaborators
SenterNovem, Newtricious BV, Globus Ei BV
1. Study Identification
Unique Protocol Identification Number
NCT00527553
Brief Title
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
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
SenterNovem, Newtricious BV, Globus Ei BV
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
Macular pigment, AMD, ARM
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
daily consumption of a regular egg
Arm Title
B
Arm Type
Experimental
Arm Description
daily consumption of a lutein-enriched egg, eggs laid by chickens on a lutein-enriched feed.
Arm Title
C
Arm Type
Experimental
Arm Description
daily consumtion of a zeaxanthin-enriched egg, eggs laid by chickens on a zeaxantin-enriched feed.
Arm Title
D
Arm Type
Experimental
Arm Description
daily egg product from enriched eggs
Arm Title
E
Arm Type
No Intervention
Arm Description
control subjects were not blinded as they did not receive any aditional supplementation. Only markers measured during the trial period as a control.
Intervention Type
Dietary Supplement
Intervention Name(s)
not enriched egg
Intervention Description
daily consumption of a regular egg, not enriched with either lutien nor zeaxanthin
Intervention Type
Dietary Supplement
Intervention Name(s)
lutein
Intervention Description
daily lutein enriched egg
Intervention Type
Dietary Supplement
Intervention Name(s)
zeaxanthin
Intervention Description
daily zeaxanthin enriched egg
Intervention Type
Dietary Supplement
Intervention Name(s)
egg product from enriched eggs
Intervention Description
daily egg product from lutein enriched eggs
Primary Outcome Measure Information:
Title
Measurable macular pigment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Plasma Lutein and zeaxanthin concentrations, lipid profile
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T. T.J. Berendschot, Dr.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hostpital Maastricht
City
Maastricht
ZIP/Postal Code
6202AZ
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
24675775
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.
Results Reference
derived
Learn more about this trial
The Effect of Eggs and Egg Products on Macular Pigment
We'll reach out to this number within 24 hrs