Oxytocin for Oxidative Stress and Inflammation

Completed · Phase 2 · Has a placebo group

Conditions studied: Oxidative Stress, Inflammation

In brief

Naval Special Warfare (NSW) operators are exposed to a variety of extreme environmental conditions and intense physical demands. 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. Biotechnologies that could mitigate the effects of cold as well as support physical recovery represent a significant unmet need for the NSW operational community. Oxytocin (OT) has a wide range of actions both locally in the brain and peripherally in the body including skeletal muscle. These peripheral 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. Exogenous OT via intranasal administration is FDA Investigational New Drug (IND)-approved and has been demonstrated as an easy and safe method to increase circulating OT concentrations that may augment actions on peripheral tissues. Due to the pleiotropic effects of OT on whole body metabolism, thermogenesis, stress responses, pain, mood, inflammation, appetite, glycemic control, skeletal homeostasis, and skeletal muscle repair and regeneration, there is increasing interest in the administration of exogenous OT for benefits to human health, performance and resilience. However, the biological mechanisms by which OT exerts tissue-specific effects (e.g., skeletal muscle) remain poorly understood, particularly in humans. This project is designed to significantly advance this understanding while testing the central hypothesis that intranasally administered OT attenuates systemic and skeletal muscle oxidative stress and inflammation induced by the combined stressor of resistance swim exercise and hyperoxia.

Key facts

Study ID

NCT04732247

Run by

Florida Institute for Human and Machine Cognition

People needed

40

Starts

2022-02-01

Expected to finish

2023-09-15

Last updated by the study team

2024-02-22

Who can join

Age: 18 and older, up to 39. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Regular smoking. The smoking exclusion includes all forms (cigarettes, vaping, etc) due to well-established effects on lung function and systemic oxidative stress and inflammation

Where it is running

• Translational Genomics Research Institute — Phoenix, Arizona, United States
• University of Florida — Gainesville, Florida, United States
• Florida Institute for Human and Machine Cognition — Pensacola, Florida, United States

Full record on ClinicalTrials.gov

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