Trial Outcomes & Findings for Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery (NCT NCT02734238)

Last Updated: 2019-01-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

53 participants

Primary outcome timeframe

end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3

Results posted on

2019-01-16

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Energy Deficit 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	Energy Deficit + Testosterone 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
Overall Study STARTED	26	24
Overall Study COMPLETED	26	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Energy Deficit n=26 Participants 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	Energy Deficit + Testosterone n=24 Participants 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 n=50 Participants Total of all reporting groups
Absolute Intake Energy	2478 kilocalories per day STANDARD_DEVIATION 950 • n=99 Participants	2432 kilocalories per day STANDARD_DEVIATION 777 • n=107 Participants	2456 kilocalories per day STANDARD_DEVIATION 863 • n=206 Participants
Absolute Intake Carbohydrate	281 kilocalories per day STANDARD_DEVIATION 114 • n=99 Participants	258 kilocalories per day STANDARD_DEVIATION 99 • n=107 Participants	270 kilocalories per day STANDARD_DEVIATION 107 • n=206 Participants
Age, Continuous	25 years STANDARD_DEVIATION 1 • n=99 Participants	25 years STANDARD_DEVIATION 1 • n=107 Participants	25 years STANDARD_DEVIATION 5 • n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	26 Participants n=99 Participants	24 Participants n=107 Participants	50 Participants n=206 Participants
Race/Ethnicity, Customized Non-Hispanic Black	7 Participants n=99 Participants	6 Participants n=107 Participants	13 Participants n=206 Participants
Race/Ethnicity, Customized Non-Hispanic White	16 Participants n=99 Participants	14 Participants n=107 Participants	30 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized Other	3 Participants n=99 Participants	1 Participants n=107 Participants	4 Participants n=206 Participants
Height	178 centimeters STANDARD_DEVIATION 1 • n=99 Participants	178 centimeters STANDARD_DEVIATION 2 • n=107 Participants	178 centimeters STANDARD_DEVIATION 7 • n=206 Participants
Weight	76 kilograms STANDARD_DEVIATION 2 • n=99 Participants	81 kilograms STANDARD_DEVIATION 3 • n=107 Participants	78 kilograms STANDARD_DEVIATION 12 • n=206 Participants
Body Mass Index	24 kilograms per square meter STANDARD_DEVIATION 1 • n=99 Participants	25 kilograms per square meter STANDARD_DEVIATION 1 • n=107 Participants	25 kilograms per square meter STANDARD_DEVIATION 3 • n=206 Participants
Systolic Blood Pressure	117 millimeters mercury STANDARD_DEVIATION 2 • n=99 Participants	119 millimeters mercury STANDARD_DEVIATION 2 • n=107 Participants	118 millimeters mercury STANDARD_DEVIATION 9 • n=206 Participants
Diastolic Blood Pressure	74 millimeters mercury STANDARD_DEVIATION 2 • n=99 Participants	72 millimeters mercury STANDARD_DEVIATION 2 • n=107 Participants	73 millimeters mercury STANDARD_DEVIATION 7 • n=206 Participants
Total Testosterone	430 nanograms per deciliter STANDARD_DEVIATION 19 • n=99 Participants	495 nanograms per deciliter STANDARD_DEVIATION 27 • n=107 Participants	461 nanograms per deciliter STANDARD_DEVIATION 118 • n=206 Participants
Free Testosterone	9 nanograms per deciliter STANDARD_DEVIATION 1 • n=99 Participants	10 nanograms per deciliter STANDARD_DEVIATION 1 • n=107 Participants	9.3 nanograms per deciliter STANDARD_DEVIATION 2.8 • n=206 Participants
Follicle Stimulating Hormone	4 milli-international units per milliliter STANDARD_DEVIATION 0.4 • n=99 Participants	3 milli-international units per milliliter STANDARD_DEVIATION 0.4 • n=107 Participants	3.6 milli-international units per milliliter STANDARD_DEVIATION 2.1 • n=206 Participants
Estradiol	42 picograms per milliliter STANDARD_DEVIATION 3 • n=99 Participants	43 picograms per milliliter STANDARD_DEVIATION 3 • n=107 Participants	42.5 picograms per milliliter STANDARD_DEVIATION 14.2 • n=206 Participants
Sex Hormone Binding Globulin	32.0 nanomoles per liter STANDARD_DEVIATION 1.8 • n=99 Participants	37.4 nanomoles per liter STANDARD_DEVIATION 3.6 • n=107 Participants	34.5 nanomoles per liter STANDARD_DEVIATION 14.5 • n=206 Participants
Luteinizing Hormone	4.4 milli-international units per milliliter STANDARD_DEVIATION 2.0 • n=99 Participants	3.7 milli-international units per milliliter STANDARD_DEVIATION 1.3 • n=107 Participants	4.1 milli-international units per milliliter STANDARD_DEVIATION 1.7 • n=206 Participants
Insulin-like Growth Factor-1	277 nanograms per milliliter STANDARD_DEVIATION 88 • n=99 Participants	280 nanograms per milliliter STANDARD_DEVIATION 72 • n=107 Participants	278 nanograms per milliliter STANDARD_DEVIATION 80 • n=206 Participants
Glucose	89 milligrams per deciliter STANDARD_DEVIATION 1 • n=99 Participants	88 milligrams per deciliter STANDARD_DEVIATION 1 • n=107 Participants	88.5 milligrams per deciliter STANDARD_DEVIATION 5.8 • n=206 Participants
Insulin	7.9 micro-international units per milliliter STANDARD_DEVIATION 7.3 • n=99 Participants	9.7 micro-international units per milliliter STANDARD_DEVIATION 15.3 • n=107 Participants	8.8 micro-international units per milliliter STANDARD_DEVIATION 11.8 • n=206 Participants
Cortisol	14.9 micrograms per deciliter STANDARD_DEVIATION 5.1 • n=99 Participants	13.4 micrograms per deciliter STANDARD_DEVIATION 3.9 • n=107 Participants	14.2 micrograms per deciliter STANDARD_DEVIATION 4.6 • n=206 Participants
Total Cholesterol	168 milligrams per deciliter STANDARD_DEVIATION 7 • n=99 Participants	162 milligrams per deciliter STANDARD_DEVIATION 6 • n=107 Participants	165 milligrams per deciliter STANDARD_DEVIATION 30 • n=206 Participants
High-Density Lipoprotein Cholesterol	53 milligrams per deciliter STANDARD_DEVIATION 2 • n=99 Participants	57 milligrams per deciliter STANDARD_DEVIATION 3 • n=107 Participants	54.7 milligrams per deciliter STANDARD_DEVIATION 11.9 • n=206 Participants
Low-Density Lipoprotein Cholesterol	100 milligrams per deciliter STANDARD_DEVIATION 5 • n=99 Participants	91 milligrams per deciliter STANDARD_DEVIATION 4 • n=107 Participants	95.4 milligrams per deciliter STANDARD_DEVIATION 24.4 • n=206 Participants
Triglyceride	77 milligrams per deciliter STANDARD_DEVIATION 9 • n=99 Participants	72 milligrams per deciliter STANDARD_DEVIATION 7 • n=107 Participants	74.6 milligrams per deciliter STANDARD_DEVIATION 40.2 • n=206 Participants
Hemoglobin	15 grams per deciliter STANDARD_DEVIATION 0.2 • n=99 Participants	15 grams per deciliter STANDARD_DEVIATION 0.2 • n=107 Participants	15 grams per deciliter STANDARD_DEVIATION 1 • n=206 Participants
Hematocrit	44 percentage STANDARD_DEVIATION 0.5 • n=99 Participants	45 percentage STANDARD_DEVIATION 0.5 • n=107 Participants	44 percentage STANDARD_DEVIATION 3 • n=206 Participants
Prostate-Specific Antigen	0.65 nanograms per milliliter STANDARD_DEVIATION 0.1 • n=99 Participants	0.72 nanograms per milliliter STANDARD_DEVIATION 0.1 • n=107 Participants	0.72 nanograms per milliliter STANDARD_DEVIATION 0.5 • n=206 Participants
Alanine Aminotransferase	20.9 international units per liter STANDARD_DEVIATION 1.6 • n=99 Participants	23.6 international units per liter STANDARD_DEVIATION 1.7 • n=107 Participants	22.2 international units per liter STANDARD_DEVIATION 8.2 • n=206 Participants
Body Mass Composition Total	76.6 kilograms STANDARD_DEVIATION 2.0 • n=99 Participants	80.9 kilograms STANDARD_DEVIATION 2.8 • n=107 Participants	78.7 kilograms STANDARD_DEVIATION 12.1 • n=206 Participants
Body Mass Composition Fat-free	56.0 kilograms STANDARD_DEVIATION 1.1 • n=99 Participants	60.7 kilograms STANDARD_DEVIATION 2.1 • n=107 Participants	58.2 kilograms STANDARD_DEVIATION 8.2 • n=206 Participants
Body Mass Composition Fat	17.4 kilograms STANDARD_DEVIATION 1.3 • n=99 Participants	17.0 kilograms STANDARD_DEVIATION 1.4 • n=107 Participants	17.2 kilograms STANDARD_DEVIATION 6.7 • n=206 Participants
Peak Oxygen Uptake	3.4 liters per minute STANDARD_DEVIATION 0.6 • n=99 Participants	3.6 liters per minute STANDARD_DEVIATION 0.8 • n=107 Participants	3.5 liters per minute STANDARD_DEVIATION 0.7 • n=206 Participants
Absolute Intake Protein	113 kilocalories per day STANDARD_DEVIATION 40 • n=99 Participants	118 kilocalories per day STANDARD_DEVIATION 39 • n=107 Participants	115 kilocalories per day STANDARD_DEVIATION 39 • n=206 Participants
Absolute Intake Fat	103 kilocalories per day STANDARD_DEVIATION 49 • n=99 Participants	106 kilocalories per day STANDARD_DEVIATION 38 • n=107 Participants	104 kilocalories per day STANDARD_DEVIATION 43 • n=206 Participants
Relative Intake Energy	33.1 kilocalories/kilogram body mass/day STANDARD_DEVIATION 13.4 • n=99 Participants	31.7 kilocalories/kilogram body mass/day STANDARD_DEVIATION 13.4 • n=107 Participants	32 kilocalories/kilogram body mass/day STANDARD_DEVIATION 13 • n=206 Participants
Relative Intake Carbohydrate	3.8 kilocalories/kilogram body mass/day STANDARD_DEVIATION 1.6 • n=99 Participants	3.4 kilocalories/kilogram body mass/day STANDARD_DEVIATION 1.7 • n=107 Participants	3.6 kilocalories/kilogram body mass/day STANDARD_DEVIATION 1.6 • n=206 Participants
Relative Intake Protein	1.5 kilocalories/kilogram body mass/day STANDARD_DEVIATION 0.5 • n=99 Participants	1.5 kilocalories/kilogram body mass/day STANDARD_DEVIATION 0.6 • n=107 Participants	1.5 kilocalories/kilogram body mass/day STANDARD_DEVIATION 0.6 • n=206 Participants
Relative Intake Fat	1.4 kilocalories/kilogram body mass/day STANDARD_DEVIATION 0.7 • n=99 Participants	1.4 kilocalories/kilogram body mass/day STANDARD_DEVIATION 0.6 • n=107 Participants	1.4 kilocalories/kilogram body mass/day STANDARD_DEVIATION 0.6 • n=206 Participants

PRIMARY outcome

Timeframe: end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3

Outcome measures

Outcome measures
Measure	Energy Deficit n=26 Participants 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	Energy Deficit + Testosterone n=24 Participants 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
Body Composition at the End of Each Study Phase Fat Mass at end of Phase 3	12.8 kilograms Interval 12.4 to 13.2	12.8 kilograms Interval 12.4 to 13.2
Body Composition at the End of Each Study Phase Total Body Mass at end of Phase 1	78.3 kilograms Interval 77.7 to 78.9	78.0 kilograms Interval 77.4 to 78.7
Body Composition at the End of Each Study Phase Total Body Mass at end of Phase 2	73.3 kilograms Interval 72.7 to 74.0	75.8 kilograms Interval 75.1 to 76.5
Body Composition at the End of Each Study Phase Total Body Mass at end of Phase 3	76.5 kilograms Interval 75.8 to 77.1	79.3 kilograms Interval 78.6 to 79.9
Body Composition at the End of Each Study Phase Fat-free Mass at end of Phase 1	58.3 kilograms Interval 57.7 to 58.9	57.9 kilograms Interval 57.3 to 58.5
Body Composition at the End of Each Study Phase Fat-free Mass at end of Phase 2	58.0 kilograms Interval 57.4 to 58.6	60.4 kilograms Interval 59.8 to 61.0
Body Composition at the End of Each Study Phase Fat-free Mass at end of Phase 3	60.5 kilograms Interval 60.0 to 61.1	63.1 kilograms Interval 62.5 to 63.7
Body Composition at the End of Each Study Phase Fat Mass at end of Phase 1	16.8 kilograms Interval 16.4 to 17.2	16.8 kilograms Interval 16.3 to 17.2
Body Composition at the End of Each Study Phase Fat Mass at end of Phase 2	12.2 kilograms Interval 11.8 to 12.6	12.0 kilograms Interval 11.6 to 12.4

Adverse Events

Energy Deficit

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Energy Deficit + Testosterone

Serious events: 4 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Energy Deficit n=26 participants at risk 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	Energy Deficit + Testosterone n=24 participants at risk 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
Hepatobiliary disorders Elevated Alanine Aminotransferase	0.00% 0/26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.	8.3% 2/24 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
Blood and lymphatic system disorders Abnormal Lab Results	0.00% 0/26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.	4.2% 1/24 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
Infections and infestations Biopsy Infection, Cellulitis	0.00% 0/26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.	4.2% 1/24 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.

Other adverse events

Other adverse events
Measure	Energy Deficit n=26 participants at risk 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	Energy Deficit + Testosterone n=24 participants at risk 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
Surgical and medical procedures Biopsy Pain	76.9% 20/26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.	79.2% 19/24 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
Skin and subcutaneous tissue disorders Blister/Chafing	26.9% 7/26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.	33.3% 8/24 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
General disorders Foot Pain	26.9% 7/26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.	25.0% 6/24 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
Musculoskeletal and connective tissue disorders Joint/Muscle Soreness	69.2% 18/26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.	54.2% 13/24 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
Gastrointestinal disorders Gastrointestinal	19.2% 5/26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.	25.0% 6/24 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
Skin and subcutaneous tissue disorders Dermatological	23.1% 6/26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.	25.0% 6/24 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
General disorders Insomnia	23.1% 6/26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.	37.5% 9/24 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
General disorders Headache	15.4% 4/26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.	29.2% 7/24 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
General disorders Allergy/Eye Irritation/Ear Pain	30.8% 8/26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.	25.0% 6/24 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.
General disorders Other	23.1% 6/26 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.	33.3% 8/24 • Adverse event data was collected from the time of the screening visit until study completion, up to 4 months.

Additional Information

Jennifer C. Rood

Pennington Biomedical Research Center

Phone: 225-763-2524

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place