The Effect of Eggs and Egg Products on Macular Pigment

This study has been completed.
Sponsor:
Collaborators:
SenterNovem
Newtricious BV
Globus Ei BV
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00527553
First received: September 3, 2007
Last updated: December 30, 2008
Last verified: November 2008
  Purpose

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
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: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Modified Eggs and Egg Products on the Measurable Macular Pigment in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Measurable macular pigment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma Lutein and zeaxanthin concentrations, lipid profile [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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
Placebo Comparator: A
daily not enriched egg
Dietary Supplement: not enriched egg
daily egg, not enriched
Other Name: n.a.
Experimental: B
daily lutein-enriched egg
Dietary Supplement: lutein
daily enriched egg
Other Name: n.a.
Experimental: C
daily zeaxanthin-enriched egg
Dietary Supplement: zeaxanthin
daily zeaxanthin enriched egg
Other Name: n.a.
Experimental: D
daily egg product from enriched eggs
Dietary Supplement: egg product from enriched eggs
daily egg product from enriched eggs
Other Name: n.a.
No Intervention: E
control, normal diet, no additional eggs
Dietary Supplement: normal diet
control, normal diet, no additional eggs
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527553

Locations
Netherlands
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
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. T. Berendschot, University Eye Clinic Maastricht
ClinicalTrials.gov Identifier: NCT00527553     History of Changes
Other Study ID Numbers: 061127
Study First Received: September 3, 2007
Last Updated: December 30, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Macular pigment
AMD
ARM

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 18, 2014