Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery (NCT02734238) | Clinical Trial Compass
CompletedPhase 4
Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery
United States53 participantsStarted 2016-04
Plain-language 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.
Who can participate
Age range18 Years – 39 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Body Composition at the End of Each Study Phase
Timeframe: end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3