Effect of Retaron® on Oxygen Induced Retinal Vasoconstriction in LPS Induced Inflammatory Model in Humans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Retinal Vascular Reactivity
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men aged between 18 and 35 years, nonsmokers
- •Body mass index between 15th and 85th percentile (Must et al. 1991)
- •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, ametropy < 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 well
- •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 structure
- •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
Arms & Interventions
Retaron
Intervention: Escherichia coli Endotoxin (Drug)
Retaron
Intervention: Retaron® (Dietary Supplement)
Placebo
Intervention: Escherichia coli Endotoxin (Drug)
Placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Change in Retinal Vascular Reactivity
Time Frame: Study day 1 and 2
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).
Secondary Outcomes
- Change in impaired endothelial function(Study day 1 and 2)
- Change in antioxidative capacity(Study day 1 and 2)
- Change in Ocular blood flow(Study day 1 and 2)
Investigators
Gerhard Garhofer
assoc. Prof. Dr.med.univ.
Medical University of Vienna