Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations — OPS II  

Sleep Clinical Trial

Official title: A Randomized, Double-blind, Placebo Controlled Trial of Testosterone Undecanoate for Optimizing Physical and Cognitive Performance During Military Operations (OPS II)

Status Completed

Clinical Trial Summary

The objective of this study is to determine the effects of a single dose of testosterone undecanoate during and in recovery from simulated operational stress.

Clinical Trial Description

This is a double-blind, randomized, placebo controlled trial in 32 physically active men exposed to 20 complete days (days 8-27) of simulated operational stress followed by 20 complete days of recovery (days 29-48). After completing baseline testing (Phase 1), participants will be randomized to receive either a single intramuscular injection of testosterone undecanoate or an isovolumetric placebo (Day 8). The 20-day simulated operational stress (Phase 2) will be highly controlled (live-in study) and consist of 4 successive cycles of undulating stress, starting with 2 consecutive days of low stress followed by 3 consecutive days of high stress. Low- and high-stress days will result from low and high militarily-relevant exercise-induced energy expenditures, adequate and restricted sleep (8 hours vs. 4 hours daily), and diet restriction to produce energy deficits. After completing Phase 2, participants will be released to resume their habitual physical activity routines and will be provided a controlled diet to consume (Phase 3), to assess recovery from sustained, severe operational stress. ;

Related Conditions & MeSH terms

• Caloric Restriction
• Exercise
• Sleep

• NCT number: NCT04120363
• Study type: Interventional
• Source: Pennington Biomedical Research Center
• Status: Completed
• Phase: Phase 4
• Start date: September 23, 2019
• Completion date: July 8, 2021