Adaptions and Resiliency to Multi-Stressor OpeRations

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-40
SponsorBradley Nindl

About this trial

Non-combat-related muscle, tendon and bone injuries are the most common injuries suffered by military personnel, particularly in new recruits. These injuries impact military readiness and are responsible for roughly 60% of limited duty days, 65% of soldiers who are unable to deploy, and nearly $500 million in medical cost to the government annually in the Army alone. Drug interventions must be studied and developed to prevent these negative outcomes and prepare military personnel for the demands of military service. At the current time, military leadership has identified critical gaps in understanding how to minimize these injuries and train soldiers with drug intervention serving among those gaps.

The goal of this study is to determine how a hormonal intervention can change muscle, tendon, and bone function as well as physical and psychological performance in response to mental and physical stress. To do so, we will examine sex hormone (testosterone, estrogen) levels, muscle, tendon, and bone images, blood samples, and physical and mental performance. We will look at things like changes in hormone levels, chemicals released from active skeletal muscles, and your body composition. The results from this study will be used to improve physical readiness training in the military with the goal of reducing injuries.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-40 years

body mass index (BMI) 18-30 kg/m2

weight stable (±10 lbs) in past 2 months

takes part in moderate physical activity for at least 150 minutes/week

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Goserelin 3.6 MG

    Drug

    Goserelin acetate (Zoladex) is a gonadotropin-releasing hormone agonist (GnRH). GnRH agonists induce a transient increase in sex hormone concentrations, but subsequently inhibit gonadotropin secretion and the production of testosterone in men and estrogen in women. An equilibration period will occur to allow steroid concentrations to reduce.

  • Multi-Stressor Training

    Other intervention

    A 4-week physical training program that mimics military training.

  • Testosterone gel (AndroGel 5g)

    Drug

    Male subjects will be randomly assigned to receive a topical testosterone gel (5g dose).

  • Testosterone gel (AndroGel 1.25g)

    Drug

    Male subjects will be randomly assigned to receive a topical testosterone gel (1.25g dose).

Treatment groups

120 Participants
are divided into 5 treatment groups
Group A: CONTROL (men + women)No intervention 0 interventions
Group B: STRESS (men + women): Multi-Stressor TrainingActive comparator 1 intervention
Group C: SUPPRESS (men): Multi-Stressor Training + Zoladex + AndroGel 1.25gExperimental treatment 3 interventions
Group D: Hormonal Contraceptive Use (women): Multi-stressor training + Hormonal Contraceptive UseActive comparator 1 intervention
Group E: REPLACE (men): Multi-Stressor Training + Zoladex + AndroGel 5gExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Biomechanical: Tendon Cross-Sectional Area, change from baseline and throughout training, mean

Time frame
Through study completion, an average of 8 weeks
2

Biomechanical: Tendon Shear Wave Elastography, change from baseline and throughout training, mean

Time frame
Through study completion, an average of 8 weeks
3

Biomechanical: Tendon Thickness, change from baseline and throughout training, mean

Time frame
Through study completion, an average of 8 weeks
4

Biomechanical: Quadriceps Muscle Cross-sectional Area, change from baseline and throughout training, mean

Time frame
Through study completion, an average of 8 weeks

Secondary outcomes

1

Bone microarchitecture: High Resolution- peripheral Computed Tomography, change from baseline, mean

Time frame
Through study completion, an average of 8 weeks
2

Biochemical: Cell culture, extracellular vesicles, micro- RNAs, change from baseline and throughout study, mean

Time frame
Through study completion, an average of 8 weeks
3

Biochemical: Measures of inflammation (IL6, IL-1B, TNFa, CRP), change from baseline and throughout study, mean

Time frame
Through study completion, an average of 8 weeks
4

Biochemical: Measures of anabolism (Growth Hormone, Insulin-like growth factor-1), change from baseline and throughout study, mean

Time frame
Through study completion, an average of 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bradley Nindl

Lead sponsor

University of Pittsburgh

Sponsor institution

U.S. Army Medical Research and Development Command

Collaborator