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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Caloric Restriction
Exercise
Interventions Drug: Sesame Oil
Drug: testosterone enanthate
Enrollment 53
Recruitment Details  
Pre-assignment Details Three participants discontinued the study during phase 1, prior to intervention assignment to a study arm: 1 was unable to tolerate study procedures and 2 had conflicting work/time commitments.
Arm/Group Title Energy Deficit Energy Deficit + Testosterone
Hide Arm/Group Description

Participants randomly assigned to the control condition were subjected to exercise-induced energy expenditure resulting in a 55% energy deficit and were administered sesame oil placebo injections during phase 2 of the trial.

Sesame Oil: 200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35

Participants randomly assigned to the intervention condition were subjected to exercise-induced energy expenditure resulting in a 55% energy deficit and were administered testosterone enanthate injections during phase 2 of the trial.

testosterone enanthate: 200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35

Period Title: Overall Study
Started 26 24
Completed 26 24
Not Completed 0 0
Arm/Group Title Energy Deficit Energy Deficit + Testosterone Total
Hide Arm/Group Description

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.

Sesame Oil: 200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35

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.

testosterone enanthate: 200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35

Total of all reporting groups
Overall Number of Baseline Participants 26 24 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 24 participants 50 participants
25  (1) 25  (1) 25  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
26
 100.0%
24
 100.0%
50
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Non-Hispanic Black
7
  26.9%
6
  25.0%
13
  26.0%
Non-Hispanic White
16
  61.5%
14
  58.3%
30
  60.0%
Hispanic
0
   0.0%
3
  12.5%
3
   6.0%
Other
3
  11.5%
1
   4.2%
4
   8.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 26 participants 24 participants 50 participants
178  (1) 178  (2) 178  (7)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 26 participants 24 participants 50 participants
76  (2) 81  (3) 78  (12)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kilograms per square meter
Number Analyzed 26 participants 24 participants 50 participants
24  (1) 25  (1) 25  (3)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Millimeters mercury
Number Analyzed 26 participants 24 participants 50 participants
117  (2) 119  (2) 118  (9)
Diastolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  Millimeters mercury
Number Analyzed 26 participants 24 participants 50 participants
74  (2) 72  (2) 73  (7)
Total Testosterone  
Mean (Standard Deviation)
Unit of measure:  Nanograms per deciliter
Number Analyzed 26 participants 24 participants 50 participants
430  (19) 495  (27) 461  (118)
Free Testosterone  
Mean (Standard Deviation)
Unit of measure:  Nanograms per deciliter
Number Analyzed 26 participants 24 participants 50 participants
9  (1) 10  (1) 9.3  (2.8)
Follicle Stimulating Hormone  
Mean (Standard Deviation)
Unit of measure:  Milli-international units per milliliter
Number Analyzed 26 participants 24 participants 50 participants
4  (0.4) 3  (0.4) 3.6  (2.1)
Estradiol  
Mean (Standard Deviation)
Unit of measure:  Picograms per milliliter
Number Analyzed 26 participants 24 participants 50 participants
42  (3) 43  (3) 42.5  (14.2)
Sex Hormone Binding Globulin  
Mean (Standard Deviation)
Unit of measure:  Nanomoles per liter
Number Analyzed 26 participants 24 participants 50 participants
32.0  (1.8) 37.4  (3.6) 34.5  (14.5)
Luteinizing Hormone  
Mean (Standard Deviation)
Unit of measure:  Milli-international units per milliliter
Number Analyzed 26 participants 24 participants 50 participants
4.4  (2.0) 3.7  (1.3) 4.1  (1.7)
Insulin-like Growth Factor-1  
Mean (Standard Deviation)
Unit of measure:  Nanograms per milliliter
Number Analyzed 26 participants 24 participants 50 participants
277  (88) 280  (72) 278  (80)
Glucose  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 26 participants 24 participants 50 participants
89  (1) 88  (1) 88.5  (5.8)
Insulin  
Mean (Standard Deviation)
Unit of measure:  Micro-international units per milliliter
Number Analyzed 26 participants 24 participants 50 participants
7.9  (7.3) 9.7  (15.3) 8.8  (11.8)
Cortisol  
Mean (Standard Deviation)
Unit of measure:  Micrograms per deciliter
Number Analyzed 26 participants 24 participants 50 participants
14.9  (5.1) 13.4  (3.9) 14.2  (4.6)
Total Cholesterol  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 26 participants 24 participants 50 participants
168  (7) 162  (6) 165  (30)
High-Density Lipoprotein Cholesterol  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 26 participants 24 participants 50 participants
53  (2) 57  (3) 54.7  (11.9)
Low-Density Lipoprotein Cholesterol  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 26 participants 24 participants 50 participants
100  (5) 91  (4) 95.4  (24.4)
Triglyceride  
Mean (Standard Deviation)
Unit of measure:  Milligrams per deciliter
Number Analyzed 26 participants 24 participants 50 participants
77  (9) 72  (7) 74.6  (40.2)
Hemoglobin  
Mean (Standard Deviation)
Unit of measure:  Grams per deciliter
Number Analyzed 26 participants 24 participants 50 participants
15  (0.2) 15  (0.2) 15  (1)
Hematocrit  
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 26 participants 24 participants 50 participants
44  (0.5) 45  (0.5) 44  (3)
Prostate-Specific Antigen  
Mean (Standard Deviation)
Unit of measure:  Nanograms per milliliter
Number Analyzed 26 participants 24 participants 50 participants
0.65  (0.1) 0.72  (0.1) 0.72  (0.5)
Alanine Aminotransferase  
Mean (Standard Deviation)
Unit of measure:  International units per liter
Number Analyzed 26 participants 24 participants 50 participants
20.9  (1.6) 23.6  (1.7) 22.2  (8.2)
Body Mass Composition  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 26 participants 24 participants 50 participants
Total 76.6  (2.0) 80.9  (2.8) 78.7  (12.1)
Fat-free 56.0  (1.1) 60.7  (2.1) 58.2  (8.2)
Fat 17.4  (1.3) 17.0  (1.4) 17.2  (6.7)
Peak Oxygen Uptake  
Mean (Standard Deviation)
Unit of measure:  Liters per minute
Number Analyzed 26 participants 24 participants 50 participants
3.4  (0.6) 3.6  (0.8) 3.5  (0.7)
Absolute Intake  
Mean (Standard Deviation)
Unit of measure:  Kilocalories per day
Number Analyzed 26 participants 24 participants 50 participants
Energy 2478  (950) 2432  (777) 2456  (863)
Carbohydrate 281  (114) 258  (99) 270  (107)
Protein 113  (40) 118  (39) 115  (39)
Fat 103  (49) 106  (38) 104  (43)
Relative Intake  
Mean (Standard Deviation)
Unit of measure:  Kilocalories/kilogram body mass/day
Number Analyzed 26 participants 24 participants 50 participants
Energy 33.1  (13.4) 31.7  (13.4) 32  (13)
Carbohydrate 3.8  (1.6) 3.4  (1.7) 3.6  (1.6)
Protein 1.5  (0.5) 1.5  (0.6) 1.5  (0.6)
Fat 1.4  (0.7) 1.4  (0.6) 1.4  (0.6)
1.Primary Outcome
Title Body Composition at the End of Each Study Phase
Hide Description 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.
Time Frame end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Energy Deficit Energy Deficit + Testosterone
Hide Arm/Group Description:

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.

Sesame Oil: 200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35

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.

testosterone enanthate: 200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35

Overall Number of Participants Analyzed 26 24
Least Squares Mean (95% Confidence Interval)
Unit of Measure: kilograms
Total Body Mass at end of Phase 1
78.3
(77.7 to 78.9)
78.0
(77.4 to 78.7)
Total Body Mass at end of Phase 2
73.3
(72.7 to 74.0)
75.8
(75.1 to 76.5)
Total Body Mass at end of Phase 3
76.5
(75.8 to 77.1)
79.3
(78.6 to 79.9)
Fat-free Mass at end of Phase 1
58.3
(57.7 to 58.9)
57.9
(57.3 to 58.5)
Fat-free Mass at end of Phase 2
58.0
(57.4 to 58.6)
60.4
(59.8 to 61.0)
Fat-free Mass at end of Phase 3
60.5
(60.0 to 61.1)
63.1
(62.5 to 63.7)
Fat Mass at end of Phase 1
16.8
(16.4 to 17.2)
16.8
(16.3 to 17.2)
Fat Mass at end of Phase 2
12.2
(11.8 to 12.6)
12.0
(11.6 to 12.4)
Fat Mass at end of Phase 3
12.8
(12.4 to 13.2)
12.8
(12.4 to 13.2)
Time Frame Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Energy Deficit Energy Deficit + Testosterone
Hide Arm/Group Description

Participants randomly assigned to the control condition were subject to exercise-induced energy expenditure resulting in a 55% energy deficit and were administered sesame oil placebo injections during phase 2 of the trial.

Sesame Oil: 200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35

Participants randomly assigned to the intervention condition were subject to exercise-induced energy expenditure resulting in a 55% energy deficit and were administered testosterone enanthate injections during phase 2 of the trial.

testosterone enanthate: 200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35

All-Cause Mortality
Energy Deficit Energy Deficit + Testosterone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/24 (0.00%) 
Hide Serious Adverse Events
Energy Deficit Energy Deficit + Testosterone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   4/24 (16.67%) 
Blood and lymphatic system disorders     
Abnormal Lab Results   0/26 (0.00%)  1/24 (4.17%) 
Hepatobiliary disorders     
Elevated Alanine Aminotransferase   0/26 (0.00%)  2/24 (8.33%) 
Infections and infestations     
Biopsy Infection, Cellulitis   0/26 (0.00%)  1/24 (4.17%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Energy Deficit Energy Deficit + Testosterone
Affected / at Risk (%) Affected / at Risk (%)
Total   26/26 (100.00%)   23/24 (95.83%) 
Gastrointestinal disorders     
Gastrointestinal   5/26 (19.23%)  6/24 (25.00%) 
General disorders     
Foot Pain   7/26 (26.92%)  6/24 (25.00%) 
Insomnia   6/26 (23.08%)  9/24 (37.50%) 
Headache   4/26 (15.38%)  7/24 (29.17%) 
Allergy/Eye Irritation/Ear Pain   8/26 (30.77%)  6/24 (25.00%) 
Other   6/26 (23.08%)  8/24 (33.33%) 
Musculoskeletal and connective tissue disorders     
Joint/Muscle Soreness   18/26 (69.23%)  13/24 (54.17%) 
Skin and subcutaneous tissue disorders     
Blister/Chafing   7/26 (26.92%)  8/24 (33.33%) 
Dermatological   6/26 (23.08%)  6/24 (25.00%) 
Surgical and medical procedures     
Biopsy Pain   20/26 (76.92%)  19/24 (79.17%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer C. Rood
Organization: Pennington Biomedical Research Center
Phone: 225-763-2524
EMail: jennifer.rood@pbrc.edu
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.
Layout table for additonal information
Responsible Party: Jennifer C. Rood, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02734238    
Other Study ID Numbers: PBRC 2015-063
First Submitted: March 31, 2016
First Posted: April 12, 2016
Results First Submitted: December 10, 2018
Results First Posted: January 2, 2019
Last Update Posted: January 16, 2019