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

January 3, 2019 updated by: Jennifer C. Rood, Pennington Biomedical Research Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

United States Department of Defense
Defence Research and Development Canada
United States Army Research Institute of Environmental Medicine
MyoSyntax

Investigators

  • Principal Investigator: Jennifer C Rood, Ph.D., Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 2015-063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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