Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations

Sleep Clinical Trial

— OPS II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120363
• Other study ID #: PBRC 2019-017
• Secondary ID: W81XWH19C0162W81
• Status: Completed
• Phase: Phase 4
• Start date: September 23, 2019
• Est. completion date: July 8, 2021

Study information

• Verified date: September 2022
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 8, 2021
• Est. primary completion date: July 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Men aged 18-35 years

• Ability to understand verbal or written instructions/testing materials in English

• Physically active (as determined by accelerometry and review of a physical activity log)

• Not taking any prescription medications and/or willing to refrain from all medication use prior to and throughout the entire study period, unless provided/approved by the study physician

• Willing to refrain from alcohol, smoking, e-cigarettes or use of any nicotine product, caffeine, and dietary supplement use throughout the entire study period

• Willing to live on the Pennington Biomedical Research Center inpatient unit for 20 consecutive days

• Meets age-specific US Army body composition standards according to Army Regulation 600-9, which includes estimates of percent body fat based on height, weight, and circumference measures (neck and waist)

• Total testosterone concentration is within the normal physiological range (300-1,000 ng/dL)

Exclusion Criteria:

• Musculoskeletal injuries that compromise exercise capability

• Diagnosed cardiometabolic disorders (i.e., hypertension, hyperlipidemia, kidney disease, diabetes, etc.)

• Allergies or intolerance to foods, vegetarian practices, or history of complications with lidocaine

• Anabolic steroid, human growth hormone, or nutritional testosterone precursor-like supplement use within the past 6 months

• Will not refrain from smoking (any nicotine product), alcohol, caffeine, or any other dietary supplement during the study

• Adults unable to consent

• Women

• Prisoners

• Sedentary or engages in insufficient quantities of physical activity per week (aerobic and/or resistance training as determined by accelerometry and review of a physical activity log)

• Exceeds age-specific US Army body composition standards according to Army Regulation 600-9

• Previous history of kidney stones unless otherwise approved by the medical investigator

• Systolic blood pressure > 150 or diastolic blood pressure > 95 mmHg

• Previous history of breast or prostate cancer

• Previous history of Chronic Obstructive Pulmonary Disease or Obstructive Sleep Apnea

• Prostate-Specific Antigen (PSA) > 3ng/ml, Hematocrit > 50%, or positive urine drug screening

• Based on the investigative team's clinical judgment, a subject may not be appropriate for participation in the study

Related Conditions & MeSH terms

• Caloric Restriction
• Exercise
• Sleep

Intervention

Drug:
• Testosterone Undecanoate
single intramuscular injection of 750 mg testosterone undecanoate
• Sesame Oil
single intramuscular injection of 750 mg sesame oil solution

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (4)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	United States Army Research Institute of Environmental Medicine, United States Department of Defense, University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Load Carriage Time	A load carriage time trial (a militarily relevant aerobic performance assessment) was conducted near the end of each study phase to assess aerobic performance.	Day 5 (Phase 1), Day 26 (Phase 2), Day 47 (Phase 3)
Primary	Vertical Jump Height	Lower-body peak power was assessed near the end of each phase using a vertical jump test.	Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
Primary	Total Mass Lifted	A 3-repetition maximum deadlift assessed muscular strength, endurance, and explosive power near the end of each study phase.	Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
Primary	Wingate Peak Power	Anaerobic capacity was assessed using a Wingate anaerobic cycle test near the end of each study phase.	Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
Primary	Peak Aerobic Capacity	Peak aerobic capacity was measured via treadmill VO2peak near the end of each study phase.	Day 4 (Phase 1), Day 25 (Phase 2), Day 46 (Phase 3)
Secondary	Body Composition	A four-compartment (4C) model factoring in body mass, body volume, total body water, and bone mineral content was used to calculate fat-free body mass and fat mass at the end of each study phase.	Day 7 (Phase 1), Day 28 (Phase 2), Day 49 (Phase 3)