Age Related Macular DegenerationNCT00902408
Effect of Lutein-enriched-egg Beverage on Age-Related Macular Degeneration (AMD)
A study testing Lutein enriched eggs in people with Age Related Macular Degeneration, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
After a pilot trial where we showed an substantial increase in plasma lutein levels and a increase in macular pigment optical density after only 3 months of daily consumption of a lutein-enriched egg-beverage, we now propose to study the effect these changes have on subjects with early ( undiagnosed) stages of macular… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- Lutein enriched eggs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diabetes
- Known lipid metabolism disease
- Blood lipid level modifiers (e.g. Statin)
- Known allergy to eggs or egg products
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Eye Clinic Maastrich
Maastricht, Limburg, 6202AZ
About this study
Official title: The Effect of Lutein-enriched-egg Beverage on Progression of Age-related Macular Degeneration, a Randomized Trial
After a pilot trial where we showed an substantial increase in plasma lutein levels and a increase in macular pigment optical density after only 3 months of daily consumption of a lutein-enriched egg-beverage, we now propose to study the effect these changes have on subjects with early ( undiagnosed) stages of macular degeneration. Age-related macula degeneration, is the leading cause of blindness in many developed countries[1-6] in older persons (usually over 55 years of age). Visual compromise rises exponentially after age of 70[7] with a 5-year incidence of around 1%. The incidence of bilateral AMD in persons with unilateral late ARM observed over a period of 10 years of over 50% with a 2.1-2.8% overall incidence in study population[8]. To date there is no curative way of fighting AMD. With the results of this trial we hope to show that with daily consumption of these enriched beverage, we can slow the progression of AMD. (Protocol page 8-10)
Read the 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.
- Conditions
- Age Related Macular Degeneration
- Being tested
- Lutein enriched eggs
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutein enriched eggsDietary supplement
1 year of daily enriched lutein eggs or placebo
| Study group | Role | What they receive |
|---|---|---|
| Lutein | Experimental | Lutein enriched eggs Receives: Dietary Supplement: Lutein enriched eggs |
| Placebo | Placebo comparator | Non enriched Receives: Dietary Supplement: Lutein enriched eggs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in amount of early macular degeneration signs on fundus photographs. Macular pigment optical density. Plasma lutein and zeaxanthin levels.
Measured: 1 year
Secondary outcomes (1)
Assessing morphological changes of the retina, visual acuity, contrast sensitivity, field of vision, and rod function.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Newtricious
- Responsible party
- Sponsor
- Investigators
- Elton Kellly, MD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902408
- Sponsor's protocol ID
- MEC 07-1-127
- Status last verified
- Nov 2013
- First submitted
- 14 May 2009
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Made SM, Kelly ER, Berendschot TT, Kijlstra A, Lutjohann D, Plat J. Consuming a buttermilk drink containing lutein-enriched egg yolk daily for 1 year increased plasma lutein but did not affect serum lipid or lipoprotein concentrations in adults with early signs of age-related macular degeneration. J Nutr. 2014 Sep;144(9):1370-7. doi: 10.3945/jn.114.195503. Epub 2014 Jul 2.
PubMed 24991045
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lutein-enriched-egg Beverage on Progression of Age-related Macular Degeneration, a Randomized Trial
- ClinicalTrials.gov ID
- NCT00902408
- Acronym / sponsor ID
- MEC 07-1-127
- Conditions
- Age Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Newtricious
- Study start
- Jul 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After a pilot trial where we showed an substantial increase in plasma lutein levels and a increase in macular pigment optical density after only 3 months of daily consumption of a lutein-enriched egg-beverage, we now propose to study the effect these changes have on subjects with early ( undiagnosed) stages of macular degeneration. Age-related macula degeneration, is the leading cause of blindness in many developed countries[1-6] in older persons (usually over 55 years of age). Visual compromise rises exponentially after age of 70[7] with a 5-year incidence of around 1%. The incidence of bilateral AMD in persons with unilateral late ARM observed over a period of 10 years of over 50% with a 2.1-2.8% overall incidence in study population[8]. To date there is no curative way of fighting AMD. With the results of this trial we hope to show that with daily consumption of these enriched beverage, we can slow the progression of AMD. (Protocol page 8-10)
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lutein | Experimental | Dietary Supplement: Lutein enriched eggsLutein enriched eggs |
| Placebo | Placebo comparator | Dietary Supplement: Lutein enriched eggsNon enriched |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- Diabetes
- Known lipid metabolism disease
- Blood lipid level modifiers (e.g. Statin)
- Known allergy to eggs or egg products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutein enriched eggs1 year of daily enriched lutein eggs or placebo | Dietary supplement | Lutein, Placebo |
Primary outcome
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 secondary outcome
Assessing morphological changes of the retina, visual acuity, contrast sensitivity, field of vision, and rod function.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
- Derived from this study: PubMed 24991045van der Made SM, Kelly ER, Berendschot TT, Kijlstra A, Lutjohann D, Plat J. Consuming a buttermilk drink containing lutein-enriched egg yolk daily for 1 year increased plasma lutein but did not affect serum lipid or lipoprotein concentrations in adults with early signs of age-related macular degeneration. J Nutr. 2014 Sep;144(9):1370-7. doi: 10.3945/jn.114.195503. Epub 2014 Jul 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elton Kellly, MD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutein enriched eggs in people with Age Related Macular Degeneration, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in amount of early macular degeneration signs on fundus photographs. Macular pigment optical density. Plasma lutein and zeaxanthin levels. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00902408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013.