- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00902408
Effect of Lutein-enriched-egg Beverage on Age-Related Macular Degeneration (AMD)
The Effect of Lutein-enriched-egg Beverage on Progression of Age-related Macular Degeneration, a Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rationale: In our pilot study (MEC 07-1-127) we saw an increase in both plasma as macular levels of lutein and zeaxanthin. Current believe is that this increase might help against the further deterioration of the retina seen in age-related macular degeneration (AMD) by scavenging for free radicals and filtering out harmful blue light rays[1, 2]. For the purpose of establishing whether these believes hold some truth, we want now to investigate the effect of lutein and zeaxanthin increase in subject with early signs of AMD on visual acuity, visual field and contrast sensibility. To relate these results to our previous study we will also measure the changes in plasma and macular concentrations of these xanthophylls. Once more we will be using the egg-beverage from the pilot study. These have been proven safe and showed no changes in lipid levels after 3 months of consumption.
Objective: To assess whether there is the same increase in macular pigment optical density as in healthy subject and to see if there is any change in visual function after a year of intervention.
Study design: This will be a randomized, double blind, placebo controlled, interventional trial. Subjects will be randomized, stratified for gender and age, into two groups (N=50 each) receiving either the intervention product (base on 1.5 yolk of a lutein enriched egg containing 0.921 ± 0.106mg of lutein and 0.137 ± 0.014mg of zeaxanthin per yolk) or a placebo. Subject will be followed for 1 year and will be seen three times for measurements.
Study population: 100 subjects, ages 50 and older with drusen and/or Retinal pigment epithelium (RPE) alterations on retinal image.
Main study parameters/endpoints: Changes in amount of early macular degeneration signs on fundus photographs. Macular pigment optical density. Plasma lutein and zeaxanthin levels.
Nature and extend of the burden and risks associated with participation, benefit and group relatedness: Subjects will be seen three times with a total of 22 ( + 1 hour screening) hours. Methods used in this trial are commonly used techniques which have been proven safe in either previous trials or clinical practice. Subjects' sight will be limited for the investigated eye for a few hours after every visit because of the use of Tropicamide, this is standard practice at our ophthalmology department with only sporadic, and treatable side effects (acute angle-closure glaucoma in 0.03%). Subjects in the intervention group are expected to show a slower progression of the disease than those in the placebo group. We will be using the same egg-beverage as in the pilot study which showed no changes in lipid levels.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6202AZ
- University Eye Clinic Maastrich
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Early signs of AMD on fundus photographs (drusen and or retinal pigment epithelium alterations in at least one eye)
- 50 years and older
- Vision > 0.5
- Non-smoker
- No ocular media opacity
- Uses no nutritional supplements containing Lutein or Zeaxanthin
- BMI < 30
- No known cardiovascular disease
Exclusion Criteria:
- Diabetes
- Known lipid metabolism disease
- Blood lipid level modifiers (e.g. Statin)
- Known allergy to eggs or egg products
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lutein
Lutein enriched eggs
|
1 year of daily enriched lutein eggs or placebo
|
Placebo Comparator: Placebo
Non enriched
|
1 year of daily enriched lutein eggs or placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in amount of early macular degeneration signs on fundus photographs. Macular pigment optical density. Plasma lutein and zeaxanthin levels.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessing morphological changes of the retina, visual acuity, contrast sensitivity, field of vision, and rod function.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elton Kellly, MD, Maastricht University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC 07-1-127
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Age Related Macular Degeneration
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationChina
-
Hoffmann-La RocheWithdrawnNeovascular Age-Related Macular DegenerationDenmark, Argentina, Hong Kong, Thailand, Portugal, Greece, Spain
-
Novartis PharmaceuticalsCompletedNeovascular Age-Related Macular DegenerationSpain, Italy, Germany, Canada, Ireland
-
Novartis PharmaceuticalsTerminatedNeovascular Age-Related Macular Degeneration
-
Regeneron PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States
-
Innostellar Biotherapeutics Co.,LtdRecruitingNeovascular Age-Related Macular DegenerationChina
-
Hoffmann-La RocheRecruitingNeovascular Age-Related Macular DegenerationBelgium, United States, United Kingdom, Italy, Argentina, Spain, Israel, Australia, Austria, Brazil, Germany, Switzerland, Taiwan, France
-
Hoffmann-La RocheCompletedNeovascular Age-Related Macular DegenerationUnited States
-
First Affiliated Hospital of Chongqing Medical...Enrolling by invitationExudative Age-Related Macular DegenerationChina
-
Novartis PharmaceuticalsCompletedNeovascular Age Related Macular DegenerationUnited States
Clinical Trials on Lutein enriched eggs
-
University of ManitobaEgg Farmers of CanadaRecruiting
-
Maastricht University Medical CenterSenterNovem; Newtricious BV; Globus Ei BVCompleted
-
Wageningen UniversityCompleted
-
Alice StantonUniversity College Dublin; Devenish Nutrition, Belfast, United Kingdom.; Beaumont...Completed
-
Rabin Medical CenterUnknownHealthy VolunteersIsrael
-
Josip Juraj Strossmayer University of OsijekUnknownVitamin E | Selenium | Lutein | n-3 Polyunsaturated Fatty AcidsCroatia
-
Newtricious R&D BVSprim Advanced Life SciencesCompletedAge-related Macular Degeneration (AMD)United States, Germany, Netherlands, United Kingdom
-
King Abdulaziz UniversityUniversity College Dublin; Royal College of Surgeons, IrelandRecruitingHealthy Adults | Healthy NutritionSaudi Arabia
-
Ahmad Hussieny SalamaCompleted
-
Peking UniversityUnknownAge-related Macular DegenerationChina