Oxytocin for Oxidative Stress and Inflammation

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

In addition to breathing high pressure gases at depth, prolonged cold water immersion and inadequate recovery from sustained physical exertion negatively impact individual and team performance.

It had two arms (groups): Oxytocin nasal spray (experimental) and Placebo nasal spray (placebo comparator).

4x per day (QID) intranasal treatment with placebo (identical to oxytocin nose spray minus the oxytocin).

The registry classes the interventions as drug.

More on the Plan

In addition to breathing high pressure and hyperoxic gases at depth, prolonged cold water immersion and inadequate recovery from sustained physical exertion negatively impact individual and team performance.

Oxytocin (OT) has a wide range of actions both locally in the brain and peripherally including skeletal muscle and a number of peripheral targets.

These effects can be mediated by classic ligand-receptor activation given the abundant expression of the oxytocin receptor in peripheral tissues, along with local expression of OT in peripheral tissues where it is likely to act in an autocrine manner.

The central hypothesis will be tested via two specific aims - using a rigorous, double-blind, placebo-controlled, randomized trial leveraging a wash-in design, enrolling N=40 18-39 y/o men.

Who Took Part

The registry lists 40 actual participants took part.

It was open to men only aged from 18 years up to 39 years.

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

Examples of who could join: Apparently healthy (assessed via health, activity, and medical history). BMI \< 30. No chronic conditions that would preclude participation. Recreationally skilled swimmer capable of a continuous 30 min kickboard swim.

The full record lists 4 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-02-01 with completion listed for 2023-09-15.

It ran at 3 sites in United States (3).

Its stated primary purpose is prevention.

What Was Measured

It also tracked 1 secondary outcome, for example Change in systemic inflammation via serum concentration of interleukin-6 (IL-6).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 40 people.

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

More context: the Oxytocin compound page, all human trials.