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NCT04732247 · ClinicalTrials.gov registry record · Phase 2
Oxytocin for Oxidative Stress and Inflammation
A Phase 2 study of Inflammation and Oxidative Stress, sponsored by Florida Institute for Human and Machine Cognition.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 3
- Study locations
NCT04732247 is a Phase 2 study of Inflammation and Oxidative Stress that has completed, run by Florida Institute for Human and Machine Cognition. The registered enrollment target is 40 participants, below the 288-participant average among 132 other Inflammation trials with a reported enrollment target (86% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT04732247, a Phase 2 study of Inflammation and Oxidative Stress, has completed, sponsored by Florida Institute for Human and Machine Cognition.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Oxytocin nasal spray
- DRUG Placebo nasal spray
Study Locations (3)
Florida
- University of Florida - Gainesville
- Florida Institute for Human and Machine Cognition - Pensacola
Arizona
- Translational Genomics Research Institute - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2023-09-15 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04732247
The ClinicalTrials.gov registry entry for NCT04732247 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 288-participant average among 132 other Inflammation trials with a reported enrollment target (86% lower). The listed sponsor is Florida Institute for Human and Machine Cognition, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Inflammation appearing as the primary indexed condition, and to 2 interventions - of which Oxytocin nasal spray is the first listed.
NCT04732247 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04732247 about?
NCT04732247 is a clinical study titled "Oxytocin for Oxidative Stress and Inflammation". 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...
What is the current status of trial NCT04732247?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-02-01. Estimated completion is 2023-09-15.
What conditions does trial NCT04732247 study?
This clinical trial studies the following conditions: Inflammation, Oxidative Stress.
What interventions are being tested in trial NCT04732247?
The interventions under investigation include: Oxytocin nasal spray (DRUG), Placebo nasal spray (DRUG).
Who is sponsoring clinical trial NCT04732247?
This trial is sponsored by Florida Institute for Human and Machine Cognition, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04732247 being conducted?
This trial has 3 study locations across Arizona, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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