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

NCT02734238 | Completed Phase 4 Results DMC

• 1 other identifier: PBRC 2015-063
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Caloric Restriction; Exercise

Outcome Measures

Primary Outcomes (1)

• Body Composition at the End of Each Study Phase

  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

Study Arms (2)

Energy Deficit

PLACEBO COMPARATOR

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

Energy Deficit + Testosterone

EXPERIMENTAL

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

Interventions

Sesame Oil DRUG

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

Energy Deficit

testosterone enanthate DRUG

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

Energy Deficit + Testosterone

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• United States Army Research Institute of Environmental Medicine: collaborator
• MyoSyntax: collaborator
• Defence Research and Development Canada: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

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• Vartanian O, Lam TK, Mandel DR, Ann Saint S, Navarrete G, Carmichael OT, Murray K, Pillai SR, Shankapal P, Caldwell J, Berryman CE, Karl JP, Harris M, Rood JC, Pasiakos SM, Rice E, Duncan M, Lieberman HR. Effect of exogenous testosterone in the context of energy deficit on risky choice: Behavioural and neural evidence from males. Biol Psychol. 2023 Jan;176:108468. doi: 10.1016/j.biopsycho.2022.108468. Epub 2022 Dec 5.

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• Howard EE, Shankaran M, Evans WJ, Berryman CE, Margolis LM, Lieberman HR, Karl JP, Young AJ, Montano MA, Matthews MD, Bizieff A, Nyangao E, Mohammed H, Harris MN, Hellerstein MK, Rood JC, Pasiakos SM. Effects of Testosterone on Mixed-Muscle Protein Synthesis and Proteome Dynamics During Energy Deficit. J Clin Endocrinol Metab. 2022 Jul 14;107(8):e3254-e3263. doi: 10.1210/clinem/dgac295.

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• Karl JP, Berryman CE, Harris MN, Lieberman HR, Gadde KM, Rood JC, Pasiakos SM. Effects of Testosterone Supplementation on Ghrelin and Appetite During and After Severe Energy Deficit in Healthy Men. J Endocr Soc. 2020 Mar 3;4(4):bvaa024. doi: 10.1210/jendso/bvaa024. eCollection 2020 Apr 1.

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• Hennigar SR, Berryman CE, Harris MN, Karl JP, Lieberman HR, McClung JP, Rood JC, Pasiakos SM. Testosterone Administration During Energy Deficit Suppresses Hepcidin and Increases Iron Availability for Erythropoiesis. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz316. doi: 10.1210/clinem/dgz316.

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• Pasiakos SM, Berryman CE, Karl JP, Lieberman HR, Orr JS, Margolis LM, Caldwell JA, Young AJ, Montano MA, Evans WJ, Vartanian O, Carmichael OT, Gadde KM, Harris M, Rood JC. Physiological and psychological effects of testosterone during severe energy deficit and recovery: A study protocol for a randomized, placebo-controlled trial for Optimizing Performance for Soldiers (OPS). Contemp Clin Trials. 2017 Jul;58:47-57. doi: 10.1016/j.cct.2017.05.001. Epub 2017 May 4.

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MeSH Terms

Conditions

Motor Activity

Interventions

Sesame Oil; testosterone enanthate

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Jennifer C. Rood
• Organization: Pennington Biomedical Research Center

jennifer.rood@pbrc.edu

225-763-2524

Study Officials

• Jennifer C Rood, Ph.D.

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 12, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 16, 2019
• Results First Posted: January 2, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)