NCT02734238

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

Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery: a Randomized, Placebo Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: Male
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will enroll up to 60 physically active men in a 3-phase randomized, placebo-controlled trial. After completing a 14-day (free-living, phase 1), energy-adequate, diet-acclimation phase (protein, 1.6 g∙kg-1∙d-1; fat 30% total energy intake, with remaining energy derived from carbohydrate), participants will be randomized to one of two experimental groups and undergo a 28-day (live-in, phase 2), 55% energy deficit phase: energy deficit alone (DEF) or energy deficit + exogenous testosterone (DEF+TEST). Recovery (free-living, phase 3) will be assessed after completing phase 2 to determine when body mass has been recovered within ± 2.5% of initial body mass (duration will vary, 42-day maximum for phase 3). This study will delineate the contribution of testosterone declines from the physical and mental demands encountered by Warfighters during military training and combat operations on complex markers of physiological and psychological status, addressing a direct, consistently observed, gap in knowledge.

Conditions

• Caloric Restriction
• Exercise

Interventions

Type	Name	Description
DRUG	Sesame Oil	200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35
DRUG	testosterone enanthate	200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-04-12
• Last updated: 2019-01-16
• Results posted: 2019-01-02

Locations

1 site across 1 country: United States