Healthy Subjects Clinical Trial
Oxidative stress has been implicated to play a pathogenic role in many disease processes,
especially in age-related disorders such as age-related macular degeneration. It has been
hypothesized that antioxidative agents such as vitamins and minerals, which are capable of
scavenging free radicals, may reduce oxidative stress and may, in turn, be beneficial for
patients with age-related disorders. Based on this hypothesis several different combinations
of vitamins have been introduced, all targeting at reducing oxidative stress. However, the
in-vivo effect of the antioxidative properties of a certain drug or vitamin combination is
hard to investigate. In the current study, we propose to investigate the effect of Retaron®,
a combination of carotoinoids, omega-3-fatty acids, a herbal extract of Aronia, vitamins and
trace elements, in a systemic in-vivo inflammation model.
In the present study, the infusion of LPS, which is a cell wall component of gram-negative
bacteria and a major mediator in the pathogenesis of septic shock, will be used as a
standardized experimental model of systemic inflammation in humans. Given that inflammation
is associated with enhanced oxidative stress and widespread endothelial dysfunction, the LPS
model is well suitable for determination of the antioxidative effects of Retaron®. As a main
outcome parameter the vascular reactivity of retinal vessels to systemic hyperoxia (induced
by breathing 100% oxygen) will be tested in presence or absence of the antioxidant
combination.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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