Actively Recruiting
Adaptions and Resiliency to Multi-Stressor OpeRations
Led by Bradley Nindl · Updated on 2025-08-24
120
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
B
Bradley Nindl
Lead Sponsor
U
U.S. Army Medical Research and Development Command
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adaptions and Resiliency to Multi-Stressor OpeRations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-40 years
- Body mass index (BMI) between 18 and 30 kg/m2
- Stable weight within ±10 pounds in the past 2 months
- Engages in moderate physical activity for at least 150 minutes per week
- Currently free from upper or lower body injury or impairment
- Able to commit to the study duration
- Agrees to follow all study requirements
- Not taking prescription medications or willing to stop them before and during the study unless approved by the study physician
- For men, total testosterone levels within the normal range (300-1000 ng/dL)
- For women, regular menstrual cycles every 26 to 35 days and no use of hormonal contraceptives in the past 3 months
You will not qualify if you...
- Current smoker
- Clinical diagnosis of an eating disorder
- Using medications that interfere with reproductive or metabolic hormone measurements or study outcomes
- Women with irregular or absent menstruation (oligo/amenorrhea)
- Any metabolic or endocrine disease
- Medical conditions preventing exercise
- Currently pregnant or becomes pregnant during the study
- History of heart disease or high blood pressure
- Physician requires medically supervised physical activity only
- History of drug addiction or regular recreational drug use
- Current or past treatment for mental health conditions
- Irregular lab results such as PSA over 3 ng/mL
- Diagnosed disorders affecting bone metabolism (e.g., hyperthyroidism, osteomalacia, diabetes, renal insufficiency)
- Use of medications affecting bone metabolism including estrogens, androgens, bisphosphonates, calcitonin, glucocorticoids, and others as specified
- History of blood clotting disorders or thrombosis
- History of stroke or heart attack
- Low vitamin D levels (less than 20 ng/mL)
- Thyroid dysfunction
- High serum creatinine levels (over 2 mg/dL)
- Personal or first-degree relative history of breast cancer
- Elevated liver enzymes or bilirubin above normal limits
- Low hemoglobin or abnormal hematocrit levels
- Bone fracture within the last 6 months
- Abnormal testosterone levels outside 270-1070 ng/dL
- High blood pressure above systolic 160 or diastolic 95
- Active substance abuse
- High fasting triglycerides (over 150)
- History of hereditary angioedema
- History of chest pain at rest or during normal activity
- Musculoskeletal injury removing subject from activity for over a month within past 2 years
- Recreational drug use more than twice per month in past 6 months
- Vision worse than 20/20
- Participation in another clinical trial with investigational drugs in past 6 months
- Eating disorder diagnosis
- Food allergies, intolerances, restrictions, or special diet needs
- History of endometriosis
- Current reproductive health issues or abnormal vaginal bleeding
- Currently breastfeeding or within 2 months of stopping breastfeeding
- Dietary restrictions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Neuromuscular Research Laboratory
Pittsburgh, Pennsylvania, United States, 15203
Actively Recruiting
Research Team
B
Bradley C Nindl, PhD
CONTACT
K
Kristin J Koltun, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
6
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