Phase 4
N=50
Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery
Caloric Restriction · Exercise
Bottom Line
View on ClinicalTrials.gov: NCT02734238 ↗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
| Outcome | Result | p-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
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.