Effect of Antioxidants on Oxygen Induced Vasoconstriction in Lipopolysaccharide (LPS) Induced Inflammatory Model in Humans

Summary

Oxidative stress has been implicated in playing a pathogenic role in many disease processes, especially in age-related disorders. 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 determination of the antioxidative properties of a certain drug or vitamin combination are hard to determine. In the current study, the researchers propose to investigate the effect of VITAMAC®, a combination of vitamins and minerals, 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 VITAMAC®. 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.

Conditions

• Healthy

Interventions

DRUG

Vitamin and mineral supplement

1 capsule/day in the morning for 14 days, containing: Lutein 12mg, Vitamin C 300mg, Zinc 10mg, Ginko Biloba 10mg, Flavonoids 25mg, Fish oil 300mg

DRUG

Vitamin and mineral supplement

1 capsule/day in the evening for 14 days, containing: Zeaxanthin 5mg, Vitamin E 60mg, Copper 1mg, Selene 20µg, Ginko Biloba 10mg, Flavonoids 25mg, Alpha Lipon acid: 150mg

DRUG

Placebo

2 capsules/day for 14 days

DRUG

100% Oxygen

breathing of 100% O2 for 30 minutes on both study days

DRUG

Escherichia coli Endotoxin

Escherichia coli Endotoxin (LPS, US Standard Reference Endotoxin, dose: 2 ng/kg bodyweight (corresponding to 20 IU/kg), i.v. bolus on both study days.

Sponsors & Collaborators

• Medical University of Vienna

  lead OTHER

Principal Investigators

• Gerhard Garhofer, MD · Department of Clinical Pharmacology, Medical University of Vienna

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2013-07-31

Completion

2013-07-31

Countries

• Austria

Study Locations