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Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.

Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Retina; Regional Blood Flow; Endotoxin, Escherichia Coli

Intervention: vitamin and mineral supplement (Drug); Escherichia coli Endotoxin (LPS) (Drug); 100% O2 (Drug); nitroglycerin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Michael Wolzt, MD, Principal Investigator, Affiliation: Department of Clinical Pharmacology, Medical University of Vienna


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.

Clinical Details

Official title: Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Retinal blood flow

Secondary outcome:

Choroidal blood flow

Flow mediated dilation (FMD) of brachial artery assessed with ultrasound

Blood pressure, heart rate

Body temperature

Concentration of cytokines in plasma


Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Male.


Inclusion Criteria:

- Men aged between 18 and 35 years, nonsmokers

- Body mass index between 15th and 85th percentile

- Normal findings in the medical history and physical examination unless the

investigator considers an abnormality to be clinically irrelevant

- Normal laboratory values unless the investigator considers an abnormality to be

clinically irrelevant

- Normal ophthalmic findings, ametropia < 3 Dpt

Exclusion Criteria:

- Regular use of medication, abuse of alcoholic beverages, participation in a clinical

trial in the 3 weeks preceding the study

- Treatment in the previous 3 weeks with any drug, vitamins and minerals supplements as


- Symptoms of a clinically relevant illness in the 3 weeks before the first study day

- History of hypersensitivity to the trial drug or to drugs with a similar chemical


- History or presence of gastrointestinal, liver or kidney disease, or other conditions

known to interfere with, distribution, metabolism or excretion of study drugs

- Blood donation during the previous 3 weeks

Locations and Contacts

Department of Clinical Pharmacology, Medical University of Vienna, Vienna 1090, Austria
Additional Information

Starting date: September 2006
Last updated: July 1, 2008

Page last updated: August 23, 2015

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