drugset / Trial / NCT02734238
Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery
Phase 4
Completed
53 enrolled
Pennington Biomedical Research Center
Defence Research and Development Canada · collabMyoSyntax · collabUnited States Army Research Institute of Environmental Medicine · collabUnited States Department of Defense · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2016-04
- Primary completion
- 2017-12
- Completion
- 2017-12
Publications
- Background Pasiakos SM, Margolis LM, Orr JS. Optimized dietary strategies to protect skeletal muscle mass during periods of unavoidable energy deficit. FASEB J. 2015 Apr;29(4):1136-42. doi: 10.1096/fj.14-266890. Epub 2014 Dec 30.
- Background Lieberman HR, Thompson LA, Caruso CM, Niro PJ, Mahoney CR, McClung JP, Caron GR. The catecholamine neurotransmitter precursor tyrosine increases anger during exposure to severe psychological stress. Psychopharmacology (Berl). 2015 Mar;232(5):943-51. doi: 10.1007/s00213-014-3727-7. Epub 2014 Sep 16.
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- Background Henning PC, Scofield DE, Spiering BA, Staab JS, Matheny RW Jr, Smith MA, Bhasin S, Nindl BC. Recovery of endocrine and inflammatory mediators following an extended energy deficit. J Clin Endocrinol Metab. 2014 Mar;99(3):956-64. doi: 10.1210/jc.2013-3046. Epub 2013 Dec 11.
- Background Nindl BC, Friedl KE, Frykman PN, Marchitelli LJ, Shippee RL, Patton JF. Physical performance and metabolic recovery among lean, healthy men following a prolonged energy deficit. Int J Sports Med. 1997 Jul;18(5):317-24. doi: 10.1055/s-2007-972640.
- Background Nindl BC, Alemany JA, Kellogg MD, Rood J, Allison SA, Young AJ, Montain SJ. Utility of circulating IGF-I as a biomarker for assessing body composition changes in men during periods of high physical activity superimposed upon energy and sleep restriction. J Appl Physiol (1985). 2007 Jul;103(1):340-6. doi: 10.1152/japplphysiol.01321.2006. Epub 2007 Apr 5.
- Background Carbone JW, McClung JP, Pasiakos SM. Skeletal muscle responses to negative energy balance: effects of dietary protein. Adv Nutr. 2012 Mar 1;3(2):119-26. doi: 10.3945/an.111.001792.
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- Background Roy TC. Diagnoses and mechanisms of musculoskeletal injuries in an infantry brigade combat team deployed to Afghanistan evaluated by the brigade physical therapist. Mil Med. 2011 Aug;176(8):903-8. doi: 10.7205/milmed-d-11-00006.
- Background Roy TC, Ritland BM, Knapik JJ, Sharp MA. Lifting tasks are associated with injuries during the early portion of a deployment to Afghanistan. Mil Med. 2012 Jun;177(6):716-22. doi: 10.7205/milmed-d-11-00402.
- Background Christensen PA, Jacobsen O, Thorlund JB, Madsen T, Moller C, Jensen C, Suetta C, Aagaard P. Changes in maximum muscle strength and rapid muscle force characteristics after long-term special support and reconnaissance missions: a preliminary report. Mil Med. 2008 Sep;173(9):889-94. doi: 10.7205/milmed.173.9.889.
- Background Alemany JA, Nindl BC, Kellogg MD, Tharion WJ, Young AJ, Montain SJ. Effects of dietary protein content on IGF-I, testosterone, and body composition during 8 days of severe energy deficit and arduous physical activity. J Appl Physiol (1985). 2008 Jul;105(1):58-64. doi: 10.1152/japplphysiol.00005.2008. Epub 2008 May 1.
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- Background Margolis LM, Rood J, Champagne C, Young AJ, Castellani JW. Energy balance and body composition during US Army special forces training. Appl Physiol Nutr Metab. 2013 Apr;38(4):396-400. doi: 10.1139/apnm-2012-0323. Epub 2013 Apr 3.
- Background Nindl BC, Barnes BR, Alemany JA, Frykman PN, Shippee RL, Friedl KE. Physiological consequences of U.S. Army Ranger training. Med Sci Sports Exerc. 2007 Aug;39(8):1380-7. doi: 10.1249/MSS.0b013e318067e2f7.
- Background Nindl BC, Rarick KR, Castellani JW, Tuckow AP, Patton JF, Young AJ, Montain SJ. Altered secretion of growth hormone and luteinizing hormone after 84 h of sustained physical exertion superimposed on caloric and sleep restriction. J Appl Physiol (1985). 2006 Jan;100(1):120-8. doi: 10.1152/japplphysiol.01415.2004. Epub 2005 Sep 1.
- Background Nindl BC, Leone CD, Tharion WJ, Johnson RF, Castellani JW, Patton JF, Montain SJ. Physical performance responses during 72 h of military operational stress. Med Sci Sports Exerc. 2002 Nov;34(11):1814-22. doi: 10.1097/00005768-200211000-00019.
- Background Welsh TT, Alemany JA, Montain SJ, Frykman PN, Tuckow AP, Young AJ, Nindl BC. Effects of intensified military field training on jumping performance. Int J Sports Med. 2008 Jan;29(1):45-52. doi: 10.1055/s-2007-964970. Epub 2007 Sep 18.
- Background Thorlund JB, Jakobsen O, Madsen T, Christensen PA, Nedergaard A, Andersen JL, Suetta C, Aagaard P. Changes in muscle strength and morphology after muscle unloading in Special Forces missions. Scand J Med Sci Sports. 2011 Dec;21(6):e56-63. doi: 10.1111/j.1600-0838.2010.01149.x. Epub 2010 Jun 18.
- Background Areta JL, Burke LM, Camera DM, West DW, Crawshay S, Moore DR, Stellingwerff T, Phillips SM, Hawley JA, Coffey VG. Reduced resting skeletal muscle protein synthesis is rescued by resistance exercise and protein ingestion following short-term energy deficit. Am J Physiol Endocrinol Metab. 2014 Apr 15;306(8):E989-97. doi: 10.1152/ajpendo.00590.2013. Epub 2014 Mar 4.
- Background Wycherley TP, Moran LJ, Clifton PM, Noakes M, Brinkworth GD. Effects of energy-restricted high-protein, low-fat compared with standard-protein, low-fat diets: a meta-analysis of randomized controlled trials. Am J Clin Nutr. 2012 Dec;96(6):1281-98. doi: 10.3945/ajcn.112.044321. Epub 2012 Oct 24.
- Background Pasiakos SM, Cao JJ, Margolis LM, Sauter ER, Whigham LD, McClung JP, Rood JC, Carbone JW, Combs GF Jr, Young AJ. Effects of high-protein diets on fat-free mass and muscle protein synthesis following weight loss: a randomized controlled trial. FASEB J. 2013 Sep;27(9):3837-47. doi: 10.1096/fj.13-230227. Epub 2013 Jun 5.
- Background Pasiakos SM, Margolis LM, McClung JP, Cao JJ, Whigham LD, Combs GF, Young AJ. Whole-body protein turnover response to short-term high-protein diets during weight loss: a randomized controlled trial. Int J Obes (Lond). 2014 Jul;38(7):1015-8. doi: 10.1038/ijo.2013.197. Epub 2013 Oct 29.
- Background Pasiakos SM, Austin KG, Lieberman HR, Askew EW. Efficacy and safety of protein supplements for U.S. Armed Forces personnel: consensus statement. J Nutr. 2013 Nov;143(11):1811S-1814S. doi: 10.3945/jn.113.176859. Epub 2013 Sep 11.
- Background Margolis LM, Murphy NE, Martini S, Spitz MG, Thrane I, McGraw SM, Blatny JM, Castellani JW, Rood JC, Young AJ, Montain SJ, Gundersen Y, Pasiakos SM. Effects of winter military training on energy balance, whole-body protein balance, muscle damage, soreness, and physical performance. Appl Physiol Nutr Metab. 2014 Dec;39(12):1395-401. doi: 10.1139/apnm-2014-0212.
- Background Bhasin S, Woodhouse L, Casaburi R, Singh AB, Bhasin D, Berman N, Chen X, Yarasheski KE, Magliano L, Dzekov C, Dzekov J, Bross R, Phillips J, Sinha-Hikim I, Shen R, Storer TW. Testosterone dose-response relationships in healthy young men. Am J Physiol Endocrinol Metab. 2001 Dec;281(6):E1172-81. doi: 10.1152/ajpendo.2001.281.6.E1172.
- Background Finkelstein JS, Yu EW, Burnett-Bowie SA. Gonadal steroids and body composition, strength, and sexual function in men. N Engl J Med. 2013 Dec 19;369(25):2457. doi: 10.1056/NEJMc1313169. No abstract available.
- Background Kvorning T, Andersen M, Brixen K, Madsen K. Suppression of endogenous testosterone production attenuates the response to strength training: a randomized, placebo-controlled, and blinded intervention study. Am J Physiol Endocrinol Metab. 2006 Dec;291(6):E1325-32. doi: 10.1152/ajpendo.00143.2006. Epub 2006 Jul 25.
- Background Mauras N, Hayes V, Welch S, Rini A, Helgeson K, Dokler M, Veldhuis JD, Urban RJ. Testosterone deficiency in young men: marked alterations in whole body protein kinetics, strength, and adiposity. J Clin Endocrinol Metab. 1998 Jun;83(6):1886-92. doi: 10.1210/jcem.83.6.4892.
- Background Henning PC, Margolis LM, McClung JP, Young AJ, Pasiakos SM. High protein diets do not attenuate decrements in testosterone and IGF-I during energy deficit. Metabolism. 2014 May;63(5):628-32. doi: 10.1016/j.metabol.2014.02.007. Epub 2014 Feb 17.
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- Background Stanton SJ, Liening SH, Schultheiss OC. Testosterone is positively associated with risk taking in the Iowa Gambling Task. Horm Behav. 2011 Feb;59(2):252-6. doi: 10.1016/j.yhbeh.2010.12.003. Epub 2010 Dec 15.
- Background Apicella CL, Dreber A, Mollerstrom J. Salivary testosterone change following monetary wins and losses predicts future financial risk-taking. Psychoneuroendocrinology. 2014 Jan;39:58-64. doi: 10.1016/j.psyneuen.2013.09.025. Epub 2013 Oct 6.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Testosterone Enanthate | Small molecule | 200 mg | Intramuscular |
Indications
No indication recorded.