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Phase 4 N=50 Randomized Quadruple-blind Prevention

Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery

Caloric Restriction · Exercise

Enrolled (actual)
50
Serious AEs
8.0%
Results posted
Jan 2019
Primary outcome: Primary: Body Composition at the End of Each Study Phase — 78.3; 78.0; 73.3; 75.8 kilograms

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Sesame Oil (Drug); testosterone enanthate (Drug)
Age
Adult · 18+ yrs
Sex
Male
Sponsor
Pennington Biomedical Research Center
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Body Composition at the End of Each Study Phase
78.3; 78.0; 73.3; 75.8; 76.5; 79.3

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02734238). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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