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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).

Publication ,  Journal Article
Pasiakos, SM; Berryman, CE; Karl, JP; Lieberman, HR; Orr, JS; Margolis, LM; Caldwell, JA; Young, AJ; Montano, MA; Evans, WJ; Vartanian, O ...
Published in: Contemp Clin Trials
July 2017

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: 1.6g∙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: 200mg 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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Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

July 2017

Volume

58

Start / End Page

47 / 57

Location

United States

Related Subject Headings

  • Young Adult
  • Testosterone
  • Sleep
  • Research Design
  • Public Health
  • Personality Assessment
  • Muscle, Skeletal
  • Military Personnel
  • Mental Fatigue
  • Male
 

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Pasiakos, S. M., Berryman, C. E., Karl, J. P., Lieberman, H. R., Orr, J. S., Margolis, L. M., … Rood, J. C. (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). Contemp Clin Trials, 58, 47–57. https://doi.org/10.1016/j.cct.2017.05.001
Pasiakos, Stefan M., Claire E. Berryman, J Philip Karl, Harris R. Lieberman, Jeb S. Orr, Lee M. Margolis, John A. Caldwell, et al. “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 58 (July 2017): 47–57. https://doi.org/10.1016/j.cct.2017.05.001.
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.
Journal cover image

Published In

Contemp Clin Trials

DOI

EISSN

1559-2030

Publication Date

July 2017

Volume

58

Start / End Page

47 / 57

Location

United States

Related Subject Headings

  • Young Adult
  • Testosterone
  • Sleep
  • Research Design
  • Public Health
  • Personality Assessment
  • Muscle, Skeletal
  • Military Personnel
  • Mental Fatigue
  • Male