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.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measuring macular pigment optical density, the amount of measurable macular
pigment in the macula region. Changes in amount of early macular degeneration
signs on fundus photographs (drusen or retinal pigment epithelium changes).
Contrast sensitivity.
Secondary outcome
Assessing morphological changes of the retina, visual acuity, plasma lutein and
zeaxanthin levels, field of vision, and rod function. Vascular function by
means of Intima media thickness, flow mediated vasodilatation, arterial
distensibility, and lipid metabolism will also be measured in the course of
this trial.
Background summary
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. 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.
Study 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.
Intervention
Daily beverage intake containing either 1.5 yolk from eggs enriched with lutein
or a placebo, for 1 year
Study burden and risks
Increased Cholesterol levels, induced by daily egg consumption has to date not
shown to contribute significantly to the development of heart disease[29]. To
date there are no known risk or potential risk from the consumption of lutein
or zeaxanthin [28, 30]. There is however evidence that lutein and zeaxanthin
may protect against age-related macula degeneration [1, 31-35].
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.
Postbus 5800
6202 AZ MAASTRICHT
Nederland
Postbus 5800
6202 AZ MAASTRICHT
Nederland
Listed location countries
Age
Inclusion criteria
- Early signs of AMD on fundus photo (drusen, REP changes)
- 50 years and older
- visus > 0.5
- non-smoker (for at least 2 years)
- clear optical media
- no use of supplementation containing lutein or zeaxanthin
- BMI < 30
- No heart disease
Exclusion criteria
- Diabetes
- Lipid metabolism disease
- Use of statins
- Egg allergie
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00902408 |
| CCMO | NL26882.068.09 |