Regional Blood Flow Clinical Trial
Official title:
Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.
Oxidative stress, which refers to cellular damage caused by reactive oxygen intermediates,
has been implicated in many disease processes, especially age-related disorders. Many trials
investigating use of antioxidants in protecting different tissues against oxidative stress
have been conducted, but the results are ambiguous.
Inflammation is generally associated with enhanced oxidative stress and widespread
endothelial dysfunction. 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 inflammatory response
in humans. The assessment of outcome parameters will include measurements of ocular blood
flow, forearm blood flow and plasma concentration of cytokines. Measurements of ocular
hemodynamics provide an unique chance to investigate local blood flow in humans
non-invasively. Moreover, the retina is especially susceptible to oxidative stress because
of its high consumption of oxygen, its high polyunsaturated fatty acid content, and its
exposure to visible light. Evidence from literature clearly supports a role for oxidative
stress in pathophysiology of several ocular diseases including diabetic retinopathy and
age-related macular degeneration. To investigate the retinal vascular reactivity we will use
systemic hyperoxia as a stimulus. The measurement of forearm blood flow will be use to
assess endothelial function. The main study objective is to investigate the effect of oral
vitamins and minerals supplementation on impaired retinal vascular reactivity after LPS
administration.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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