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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pennington Biomedical Research Center
• Collaborators: Defence Research and Development Canada; MyoSyntax; United States Army Research Institute of Environmental Medicine; United States Department of Defense
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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