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)

Stefan M. Pasiakos, Claire E. Berryman, J. Philip Karl, Harris R. Lieberman, Jeb S. Orr, Lee M. Margolis, John A. Caldwell, Andrew J. Young, Monty A. Montano, William J. Evans, Oshin Vartanian, Owen T. Carmichael, Kishore M. Gadde, Melissa Harris, Jennifer C. Rood

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background The physiological consequences of severe energy deficit include hypogonadism and the loss of fat-free mass. Prolonged energy deficit also impacts physical performance, mood, attentiveness, and decision-making capabilities. This study will determine whether maintaining a eugonadal state during severe, sustained energy deficit attenuates physiological decrements and maintains mental performance. This study will also assess the effects of normalizing testosterone levels during severe energy deficit and recovery on gut health and appetite regulation. Methods Fifty physically active men will participate in a 3-phase, randomized, placebo-controlled study. After completing a 14-d, energy-adequate, diet acclimation phase (protein: 1.6 g ∙ kg− 1 ∙ d− 1; fat: 30% total energy intake), participants will be randomized to undergo a 28-d, 55% energy deficit phase with (DEF + TEST: 200 mg testosterone enanthate per week) or without (DEF) exogenous testosterone. Diet and physical activity will be rigorously controlled. Recovery from the energy deficit (ad libitum diet, no testosterone) will be assessed until body mass has been recovered within ± 2.5% of initial body mass. Body composition, stable isotope methodologies, proteomics, muscle biopsies, whole-room calorimetry, molecular biology, activity/sleep monitoring, personality and cognitive function assessments, functional MRI, and comprehensive biochemistries will be used to assess physiological and psychological responses to energy restriction and recovery feeding while volunteers are in an expected hypogonadal versus eugonadal state. Discussion The Optimizing Performance for Soldiers (OPS) study aims to determine whether preventing hypogonadism will mitigate declines in physical and mental function that typically occur during prolonged energy deficit, and the efficacy of testosterone replacement on recovery from severe underfeeding. Trial Registration: NCT02734238.

Original languageEnglish (US)
Pages (from-to)47-57
Number of pages11
JournalContemporary Clinical Trials
Volume58
DOIs
StatePublished - Jul 1 2017
Externally publishedYes

Fingerprint

Military Personnel
Testosterone
Randomized Controlled Trials
Placebos
Psychology
Hypogonadism
Diet
Fats
Appetite Regulation
Calorimetry
Polysomnography
Acclimatization
Body Composition
Energy Intake
Isotopes
Biochemistry
Proteomics
Cognition
Personality
Molecular Biology

Keywords

  • Calorie restriction
  • Eugonadal
  • Functional MRI
  • Hypogonadal
  • Microbiome
  • Mood
  • Muscle mass
  • Negative energy balance
  • Protein synthesis
  • Vigilance

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology (medical)

Cite this

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). / Pasiakos, Stefan M.; Berryman, Claire E.; Karl, J. Philip; Lieberman, Harris R.; Orr, Jeb S.; Margolis, Lee M.; Caldwell, John A.; Young, Andrew J.; Montano, Monty A.; Evans, William J.; Vartanian, Oshin; Carmichael, Owen T.; Gadde, Kishore M.; Harris, Melissa; Rood, Jennifer C.

In: Contemporary Clinical Trials, Vol. 58, 01.07.2017, p. 47-57.

Research output: Contribution to journalArticle

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 2017, '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)', Contemporary Clinical Trials, vol. 58, pp. 47-57. https://doi.org/10.1016/j.cct.2017.05.001
Pasiakos, Stefan M. ; Berryman, Claire E. ; Karl, J. Philip ; Lieberman, Harris R. ; Orr, Jeb S. ; Margolis, Lee M. ; Caldwell, John A. ; Young, Andrew J. ; Montano, Monty A. ; Evans, William J. ; Vartanian, Oshin ; Carmichael, Owen T. ; Gadde, Kishore M. ; Harris, Melissa ; Rood, Jennifer C. / 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). In: Contemporary Clinical Trials. 2017 ; Vol. 58. pp. 47-57.
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abstract = "Background The physiological consequences of severe energy deficit include hypogonadism and the loss of fat-free mass. Prolonged energy deficit also impacts physical performance, mood, attentiveness, and decision-making capabilities. This study will determine whether maintaining a eugonadal state during severe, sustained energy deficit attenuates physiological decrements and maintains mental performance. This study will also assess the effects of normalizing testosterone levels during severe energy deficit and recovery on gut health and appetite regulation. Methods Fifty physically active men will participate in a 3-phase, randomized, placebo-controlled study. After completing a 14-d, energy-adequate, diet acclimation phase (protein: 1.6 g ∙ kg− 1 ∙ d− 1; fat: 30{\%} total energy intake), participants will be randomized to undergo a 28-d, 55{\%} energy deficit phase with (DEF + TEST: 200 mg testosterone enanthate per week) or without (DEF) exogenous testosterone. Diet and physical activity will be rigorously controlled. Recovery from the energy deficit (ad libitum diet, no testosterone) will be assessed until body mass has been recovered within ± 2.5{\%} of initial body mass. Body composition, stable isotope methodologies, proteomics, muscle biopsies, whole-room calorimetry, molecular biology, activity/sleep monitoring, personality and cognitive function assessments, functional MRI, and comprehensive biochemistries will be used to assess physiological and psychological responses to energy restriction and recovery feeding while volunteers are in an expected hypogonadal versus eugonadal state. Discussion The Optimizing Performance for Soldiers (OPS) study aims to determine whether preventing hypogonadism will mitigate declines in physical and mental function that typically occur during prolonged energy deficit, and the efficacy of testosterone replacement on recovery from severe underfeeding. Trial Registration: NCT02734238.",
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AU - Berryman, Claire E.

AU - Karl, J. Philip

AU - Lieberman, Harris R.

AU - Orr, Jeb S.

AU - Margolis, Lee M.

AU - Caldwell, John A.

AU - Young, Andrew J.

AU - Montano, Monty A.

AU - Evans, William J.

AU - Vartanian, Oshin

AU - Carmichael, Owen T.

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