Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery
Condition: Caloric Restriction; Exercise
Intervention: Sesame Oil; testosterone enanthate
Intervention description: 200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35; 200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: Male
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this study is to determine whether maintaining a eugonadal state, during
      severe, sustained energy deficit, attenuates physiological decrements, particularly the loss
      of lean body mass.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physically active (at least 2 days per week aerobic and/or resistance exercise)

          -  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

               -  At the discretion of the study physician, wash-out period for medications,
                  supplements, and over-the-counter medications is ≥ 1 to 4 weeks

               -  Wash-out period for caffeine and alcohol is ≥ 7 days

          -  Willing to live on the Pennington Biomedical Research Center inpatient unit for 28
             consecutive days

          -  Willing to have a urine drug screening

          -  Meets age-specific U.S. 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, total
             testosterone (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

          -  Any use of antibiotics, except topical antibiotics, within 3 months of study
             participation

          -  Colonoscopy within 3 months of study participation

          -  Chronic use of laxatives, stool softeners, antacids, or anti-diarrheal medications (≥
             once a week)

          -  History of gastrointestinal disease (e.g., celiac, irritable bowel syndrome, colitis,
             Crohn's disease)

          -  Restrained eater (the Three-Factor Eating Questionnaire) as assessed by the study's
             psychological and behavioral assessment staff

          -  Adults unable to consent

          -  Women

          -  Prisoners

          -  Metal implants, claustrophobia, head size incompatible with MRI equipment, etc.

          -  Sedentary or engages in <2 days of physical activity per week (aerobic and/or
             resistance training)

          -  Exceeds age-specific U.S. 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

          -  Findings of lab results of prostate-specific antigen > 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