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Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery (OPS)

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ClinicalTrials.gov Identifier: NCT02734238
Recruitment Status : Completed
First Posted : April 12, 2016
Results First Posted : January 2, 2019
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
United States Army Research Institute of Environmental Medicine
MyoSyntax
Defence Research and Development Canada
United States Department of Defense
Information provided by (Responsible Party):
Jennifer C. Rood, Pennington Biomedical Research Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Caloric Restriction Exercise Drug: Sesame Oil Drug: testosterone enanthate Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery: a Randomized, Placebo Controlled Trial
Actual Study Start Date : April 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Energy Deficit
Participants randomly assigned to the control condition will be subject to exercise-induced energy expenditure resulting in a 55% energy deficit and will be administered sesame oil placebo injections during phase 2 of the trial.
 Drug: Sesame Oil
200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35
Experimental: Energy Deficit + Testosterone
Participants randomly assigned to the intervention condition will be subject to exercise-induced energy expenditure resulting in a 55% energy deficit and will be administered testosterone enanthate injections during phase 2 of the trial.
 Drug: testosterone enanthate
200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35


Outcome Measures
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Primary Outcome Measures :
  1. Body Composition at the End of Each Study Phase [ Time Frame: end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3 ]
    Height was measured using a stadiometer. Weight was measured using a calibrated digital scale. Body composition was determined using dual-energy X-ray absorptiometry. These data were used to calculate fat-free body mass, fat mass, and total body tissue mass.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02734238


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
United States Army Research Institute of Environmental Medicine
MyoSyntax
Defence Research and Development Canada
United States Department of Defense
Investigators
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Principal Investigator: Jennifer C Rood, Ph.D. Pennington Biomedical Research Center
  Study Documents (Full-Text)

Documents provided by Jennifer C. Rood, Pennington Biomedical Research Center:
Study Protocol and Statistical Analysis Plan  [PDF] October 3, 2017

More Information
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Publications:
Butcher J, Graham J, Tellegen A, Dahlstrom W, Kaemmer B. Minnesota Multiphasic Personality Inventory-2 (MMPI-2): Manual for administration, scoring, and interpretation 2nd ed. Minneapolis, MN: University of Minnesota Press; 2001.
Weiner IB, Greene RL. Handbook of Personality Assessment. Hoboken, NJ: Wiley; 2006.
Spiro A, Butcher JN, Levenson RM, Aldwin CM, Bossé R. Change and stability in personality: A 5-year study of the MMPI-2 in older men. In: Butcher JN, ed. Fundamentals of MMPI-2: Research and application Minneapolis, MN: University of Minnesota Press; 2000:443-462.
McNair DM, Lorr M, Droppleman LF. Profile of Mood States Manual. San Diego, CA: Educational and Industrial Testing Service; 1971.
Lieberman HR, Bathalon GP, Falco CM, et al. The Fog of War: Documenting Cognitive Decrements Associated with the Stress of Combat. 2002.
Dinges DF, Powell JW. Microcomputer analyses of performance on a portable, simple, visual RT task during sustained operations. Vol 171985:652-655.
Baddeley AD. A 3 min reasoning test based on grammatical transformation. Psychon Sci. 1968;10(10):341-342.
Vartanian O, Mandel DR, Duncan M. Money or life: Behavioral and neural context effects on choice under uncertainty. Journal of Neuroscience, Psychology, and Economics. 2011;4(1):25-36.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jennifer C. Rood, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02734238    
Other Study ID Numbers: PBRC 2015-063
First Posted: April 12, 2016    Key Record Dates
Results First Posted: January 2, 2019
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents