Autonomic Nervous Activity During the Systemic Inflammatory Response in Trained and Untrained Healthy Volunteers

What Was Tested

In this early phase 1 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

Critical illness, severe infection, extensive trauma or tissue damage cause an inflammatory (irritative) reaction in the body.

This reaction contributes to the development of considerable organ damage and possibly organ failure.

It had four arms (groups): Untrained, healthy volunteers A (experimental), Well-trained healthy volunteers A (experimental), Untrained, healthy volunteers B (experimental) and Well-trained healthy volunteers B (experimental).

(Endotoxin) before (Endotoxin + Nicotine).

(Endotoxin) before (Endotoxin + Nicotine).

(Endotoxin + Nicotine) before (Endotoxin).

The registry classes the interventions as other.

More on the Plan

Aim The investigators wish to study the inflammatory response in very well-trained and relatively untrained healthy volunteers using the human endotoxemia model.

Also, the investigators wish to study the effect on nicotine on the inflammatory response..

Systemic inflammation and the endotoxin model Inflammation is the organisms response to invasion of microorganisms, trauma, endogenic or exogenic tissue damage.

Systemic inflammation, activated cascades and microcirculatory disruptions are considered important pathogenic elements ind the development of organ dysfunction, which is a frequent and serious complication to critical illness regardless of the underlying cause.

Who Took Part

23 actual participants took part.

It was open to men only aged from 18 years up to 35 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 18-35 years. BMI \< 30 kg/m2.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: daily medicine intake (excl. antihistamines during pollen season); smoking or use of nicotine substitutes; previous allergic reaction to nicotine pads.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

Each person switched between Therapeutic nicotine (patch, non-peptide) and the comparison at some point, usually with a gap in between.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-06 with completion listed for 2013-01.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Cytokines (time frame: up to 8 hours).

It also tracked 1 secondary outcome, for example Heart Rate Variability (HRV).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Therapeutic nicotine (patch, non-peptide) in 23 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.