An interventional study of Escherichia coli Endotoxin and Retaron® in Imparied Retinal Vascular Reactivity and Healthy Subjects, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-20.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Basic science
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.
Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
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Exclusion Criteria:
Drug: Escherichia coli Endotoxin · Dietary Supplement: Retaron®
Drug: Escherichia coli Endotoxin · Other: Placebo
dose: 2 ng/kg bodyweight (corresponding to 20 IU/kg), i.v. bolus on both study days.
Also known as: LPS, US Standard Reference Endotoxin
Dosage 1 capsule Retaron® per day.: Lutein 10mg, Zeaxanthin 2mg, Fishoil 500mg (with 250 mg DHA, 30 mg EPA), Vitamin C 100mg, Zinc 10mg, Selen 25µg, Vitamin E 25mg, Taurin 50mg, Aroniaextract 50mg, administered for 14 days
Placebo capsules identical in appearance to Retaron capsules
Change in Retinal Vascular Reactivity
To investigate the effect of oral antioxidative supplementation (Retaron®) on impaired retinal vascular reactivity after LPS administration. Measurements will be performed using the Dynamic Vessel Analyzer (Imedos, Jena, Germany).
Time frame: Study day 1 and 2
Change in Ocular blood flow
To investigate the effect of oral antioxidative supplementation on ocular blood flow during inflammation. Measurements will be performed using Laser Doppler Velocimetry (LDV) and the Blue Field entoptic technique.
Time frame: Study day 1 and 2
Change in impaired endothelial function
To investigate the effect of oral vitamins and minerals supplementation on impaired endothelial function caused by E. coli endotoxin as assessed by Laser Doppler Velocimetry, the Blue Field entoptic technique and the Dynamic Vessel Analyzer.
Time frame: Study day 1 and 2
Change in antioxidative capacity
To investigate the antioxidative capacity in the blood by determination of malondialdehyd (MDA) levels
Time frame: Study day 1 and 2
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna