Menu

 

The NASA Task Book
Advanced Search     

Project Title:  Testosterone Supplementation as a Countermeasure against Musculoskeletal Losses during Space Exploration Reduce
Fiscal Year: FY 2016 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 07/30/2010  
End Date: 07/31/2016  
Task Last Updated: 10/26/2016 
Download report in PDF pdf
Principal Investigator/Affiliation:   Urban, Randall  M.D. / University of Texas Medical Branch at Galveston 
Address:  301 University Blvd. 
Rt. 0569 - 4.124 JSA 
Galveston , TX 77555-0569 
Email: rurban@utmb.edu 
Phone: 409-772-1176  
Congressional District: 14 
Web:  
Organization Type: UNIVERSITY 
Organization Name: University of Texas Medical Branch at Galveston 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Durham, William  Ph.D. University of Texas Medical Branch 
Sheffield-Moore, Melinda  Ph.D. University of Texas Medical Branch 
Dillon, Edgar  Ph.D. University of Texas Medical Branch 
Project Information: Grant/Contract No. NNX10AP86G 
Responsible Center: NASA JSC 
Grant Monitor: Loerch, Linda  
Center Contact:  
linda.loerch-1@nasa.gov 
Solicitation / Funding Source: 2009 Crew Health NNJ09ZSA002N 
Grant/Contract No.: NNX10AP86G 
Project Type: GROUND 
Flight Program:  
TechPort: Yes 
No. of Post Docs:
No. of PhD Candidates:
No. of Master's Candidates:
No. of Bachelor's Candidates:
No. of PhD Degrees:
No. of Master's Degrees:
No. of Bachelor's Degrees:
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) Muscle:Risk of Impaired Performance Due to Reduced Muscle Mass, Strength and Endurance
Human Research Program Gaps: (1) M07:Develop the most efficient exercise program for maintenance of muscle fitness (IRP Rev F)
(2) M14:Indentify adjuncts to exercise countermeasures that can be used to better mitigate muscle loss (IRP Rev F)
Flight Assignment/Project Notes: NOTE: Risk/Gap changes per IRP Rev E (Ed., 3/25/14)

NOTE: Extended to 7/31/2016 per PI and NSSC information (Ed., Aug 2015)

NOTE: Extended to 7/29/2015, per NSSC information and L. Loerch/JSC (Ed., 8/26/13)

Task Description: The long-term goal of this proposal was to determine the therapeutic efficacy of testosterone at preserving lean muscle mass, muscle strength, and bone mineral density in healthy humans during spaceflight. We proposed to examine the interactive or additive effects of the combination of testosterone and exercise on lean body mass (LBM), muscle strength, and bone health. Our general hypothesis is that the maintenance of normal physiologic levels of testosterone during spaceflight will protect against the functional loss of muscle and bone, and will maximize the efficacy of existing resistance exercise protocols at preventing or reversing functional impairments that occur during bed rest.

To achieve these goals we tested the following specific hypotheses before, during, and after 70 days of bed rest:

1: Cycled testosterone replacement (weekly testosterone injections for 2 weeks, followed by 2 weeks off, etc.) in conjunction with exercise will have an additive effect in preventing loss of muscle mass and muscle strength in men representative of the astronaut population compared to exercise with placebo testosterone.

2: Cycled testosterone replacement (weekly testosterone injections for 2 weeks, followed by 2 weeks off, etc.) in conjunction with exercise will have an additive effect in preventing loss of bone mass and alterations in markers of bone metabolism in men representative of the astronaut population compared to exercise with placebo testosterone.

To address these hypotheses we investigated the following specific aims before, during, and after 70 days of bed rest:

Aim 1: To determine the effect of cycled testosterone replacement in conjunction with resistance exercise during bed rest on muscle mass, muscle strength, and fatigue in men aged 24-55 years.

Aim 2: To determine the effect of cycled testosterone replacement in conjunction with resistance exercise during bed rest on markers of bone metabolism and bone mass in men aged 24-55 years.

Research Impact/Earth Benefits: Results from this study will further elucidate the role of testosterone in the maintenance of skeletal muscle and bone during long term bed rest and spaceflight. The benefits to life on Earth are extensive.

This study demonstrates that testosterone treatment in conjunction with exercise countermeasures is corrective against head down bed rest (HDBR) induced changes in body composition of healthy men. Exercise countermeasures were protective against HDBR induced declines in LBM and strength. However, the addition of low dose intermittent testosterone treatment was necessary to promote increases in LBM and protect against increases in fat mass. Furthermore, changes in leg LBM correlated directly with changes in lower body strength. Understanding the unique synergy between exercise dosing and testosterone supplementation could have important implications for both clinical outcomes and spaceflight operations.

Task Progress & Bibliography Information FY2016 
Task Progress: This study has been completed and all main outcome measures have been analyzed. Manuscripts are in development and will be submitted for peer-review and publication.

The following main outcomes occurred with the addition of testosterone countermeasure to exercise:

- Did not negatively alter hormonal or lipid profiles.

- Increased lean body mass compared to Control and Exercise plus placebo.

- Prevented an increase in fat mass that occurred in Control and Exercise plus placebo.

- Prevented loss in calf strength compared to Control and Exercise plus placebo.

Additionally, Exercise with or without Testosterone:

- Blunted declines in strength compared to Control.

- Prevented late onset declines in pelvic bone density observed in Control but had no discernible effects on bone mass in other regions.

Bibliography Type: Description: (Last Updated: 01/11/2021) 

Show Cumulative Bibliography Listing
 
Articles in Peer-reviewed Journals Scott JM, Martin D, Ploutz-Snyder R, Downs M, Dillon EL, Sheffield-Moore M, Urban RJ, Ploutz-Snyder LL. "Efficacy of exercise and testosterone to mitigate atrophic cardiovascular remodeling." Med Sci Sports Exerc. 2018 Sep;50(9):1940-9. https://doi.org/10.1249/MSS.0000000000001619 ; PubMed PMID: 29570536; PubMed Central PMCID: PMC6095799 , Sep-2018
Articles in Peer-reviewed Journals Dillon EL, Sheffield-Moore M, Durham WJ, Ploutz-Snyder LL, Ryder JW, Danesi CP, Randolph KM, Gilkison CR, Urban RJ. "Efficacy of testosterone plus NASA exercise countermeasures during head-down bed rest." Med Sci Sports Exerc. 2018 Sep;50(9):1929-39. https://doi.org/10.1249/MSS.0000000000001616 ; PubMed PMID: 29924745; PubMed Central PMCID: PMC6095739 , Sep-2018
Articles in Peer-reviewed Journals Dillon EL, Soman KV, Wiktorowicz JE, Sur R, Jupiter D, Danesi CP, Randolph KM, Gilkison CR, Durham WJ, Urban RJ, Sheffield-Moore M. "Proteomic investigation of human skeletal muscle before and after 70 days of head down bed rest with or without exercise and testosterone countermeasures." PLoS One. 2019 Jun 13;14(6):e0217690. eCollection 2019. https://doi.org/10.1371/journal.pone.0217690 ; PubMed PMID: 31194764; PubMed Central PMCID: PMC6563988 , Jun-2019
Articles in Peer-reviewed Journals Downs ME, Scott JM, Ploutz-Snyder LL, Ploutz-Snyder R, Goetchius E, Buxton RE, Danesi CP, Randolph KM, Urban RJ, Sheffield-Moore M, Dillon EL. "Exercise and testosterone countermeasures to mitigate metabolic changes during bed rest." Life Sci Space Res. 2020 Aug;26:97-104. https://doi.org/10.1016/j.lssr.2020.03.008 ; PMID: 32718692; PMCID: PMC7387751 , Aug-2020
Project Title:  Testosterone Supplementation as a Countermeasure against Musculoskeletal Losses during Space Exploration Reduce
Fiscal Year: FY 2015 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 07/30/2010  
End Date: 07/31/2016  
Task Last Updated: 05/29/2015 
Download report in PDF pdf
Principal Investigator/Affiliation:   Urban, Randall  M.D. / University of Texas Medical Branch at Galveston 
Address:  301 University Blvd. 
Rt. 0569 - 4.124 JSA 
Galveston , TX 77555-0569 
Email: rurban@utmb.edu 
Phone: 409-772-1176  
Congressional District: 14 
Web:  
Organization Type: UNIVERSITY 
Organization Name: University of Texas Medical Branch at Galveston 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Durham, William  Ph.D. University of Texas Medical Branch 
Sheffield-Moore, Melinda  Ph.D. University of Texas Medical Branch 
Dillon, Edgar  Ph.D. University of Texas Medical Branch 
Project Information: Grant/Contract No. NNX10AP86G 
Responsible Center: NASA JSC 
Grant Monitor: Loerch, Linda  
Center Contact:  
linda.loerch-1@nasa.gov 
Solicitation / Funding Source: 2009 Crew Health NNJ09ZSA002N 
Grant/Contract No.: NNX10AP86G 
Project Type: GROUND 
Flight Program:  
TechPort: Yes 
No. of Post Docs:
No. of PhD Candidates:
No. of Master's Candidates:
No. of Bachelor's Candidates:
No. of PhD Degrees:
No. of Master's Degrees:
No. of Bachelor's Degrees:
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) Muscle:Risk of Impaired Performance Due to Reduced Muscle Mass, Strength and Endurance
Human Research Program Gaps: (1) M07:Develop the most efficient exercise program for maintenance of muscle fitness (IRP Rev F)
(2) M14:Indentify adjuncts to exercise countermeasures that can be used to better mitigate muscle loss (IRP Rev F)
Flight Assignment/Project Notes: NOTE: Risk/Gap changes per IRP Rev E (Ed., 3/25/14)

NOTE: Extended to 7/31/2016 per PI and NSSC information (Ed., Aug 2015)

NOTE: Extended to 7/29/2015, per NSSC information and L. Loerch/JSC (Ed., 8/26/13)

Task Description: The long-term goal of this proposal is to determine the therapeutic efficacy of testosterone at preserving lean muscle mass, muscle strength, and bone mineral density in healthy humans during spaceflight. We propose to examine the interactive or additive effects of the combination of testosterone and exercise on lean body mass (LBM), muscle strength, and bone health. Our general hypothesis is that the maintenance of normal physiologic levels of testosterone during spaceflight will protect against the functional loss of muscle and bone, and will maximize the efficacy of existing resistance exercise protocols at preventing or reversing functional impairments that occur during bed rest.

To achieve these goals we will test the following specific hypotheses before, during, and after 70 days of bed rest:

1: Cycled testosterone replacement (weekly testosterone injections for 2 weeks, followed by 2 weeks off, etc.) in conjunction with exercise will have an additive effect in preventing loss of muscle mass and muscle strength in men representative of the astronaut population compared to exercise with placebo testosterone.

2: Cycled testosterone replacement (weekly testosterone injections for 2 weeks, followed by 2 weeks off, etc.) in conjunction with exercise will have an additive effect in preventing loss of bone mass and alterations in markers of bone metabolism in men representative of the astronaut population compared to exercise with placebo testosterone.

To address these hypotheses we will investigate the following specific aims before, during, and after 70 days of bed rest:

Aim 1: To determine the effect of cycled testosterone replacement in conjunction with resistance exercise during bed rest on muscle mass, muscle strength, and fatigue in men aged 24-55 years.

Aim 2: To determine the effect of cycled testosterone replacement in conjunction with resistance exercise during bed rest on markers of bone metabolism and bone mass in men aged 24-55 years.

Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures. Results from this proposal will lay the ground work for the implementation of combinational countermeasures that will additively work to maintain preflight physiology of astronauts during long-term spaceflight missions.

Research Impact/Earth Benefits: Results from this study will further elucidate the role of testosterone in the maintenance of skeletal muscle and bone during long term bed rest as a model for spaceflight. The benefits to life on Earth are extensive.

It is hypothesized that maintaining appropriate balance between hormonal status, nutritional status, and physical activity during spaceflight is of critical importance in preventing musculoskeletal losses. It is our contention that the restoration of physiologic levels of testosterone is essential to prevent and/or restore spaceflight- and microgravity-induced losses in the musculoskeletal system. Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures.

Research Impact/Earth Benefits: Results from this study will further elucidate the role of testosterone in the maintenance of skeletal muscle and bone during long term bed rest as a model for spaceflight. The benefits to life on Earth are extensive.

It is hypothesized that maintaining appropriate balance between hormonal status, nutritional status, and physical activity during spaceflight is of critical importance in preventing musculoskeletal losses. It is our contention that the maintenance or restoration of physiologic levels of testosterone is essential to prevent and/or restore spaceflight- and microgravity-induced losses in the musculoskeletal system. Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures.

Task Progress & Bibliography Information FY2015 
Task Progress: During the past year we have completed analyses of secondary outcome measures and focused on the interpretation of the data and integration of our primary outcome results with those from our co-investigators. This work is ongoing and several manuscripts are under development for submission to peer-reviewed journals.

Bibliography Type: Description: (Last Updated: 01/11/2021) 

Show Cumulative Bibliography Listing
 
Abstracts for Journals and Proceedings Dillon EL, Danesi CP, Randolph KM, Gilkison CR, Quisenberry JM, Ploutz-Snyder L, Durham WJ, Sheffield-Moore M, Urban RJ. "Low Dose Testosterone Is a Safe and Effective Countermeasure against Muscle Loss from Simulated Flight/Bed Rest." Presented at the 2015 NASA Human Research Program Investigators’ Workshop, Galveston, TX, January 13-15, 2015.

2015 NASA Human Research Program Investigators’ Workshop, Galveston, TX, January 13-15, 2015. , Jan-2015

Project Title:  Testosterone Supplementation as a Countermeasure against Musculoskeletal Losses during Space Exploration Reduce
Fiscal Year: FY 2014 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 07/30/2010  
End Date: 07/29/2015  
Task Last Updated: 05/31/2014 
Download report in PDF pdf
Principal Investigator/Affiliation:   Urban, Randall  M.D. / University of Texas Medical Branch at Galveston 
Address:  301 University Blvd. 
Rt. 0569 - 4.124 JSA 
Galveston , TX 77555-0569 
Email: rurban@utmb.edu 
Phone: 409-772-1176  
Congressional District: 14 
Web:  
Organization Type: UNIVERSITY 
Organization Name: University of Texas Medical Branch at Galveston 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Durham, William  Ph.D. University of Texas Medical Branch 
Sheffield-Moore, Melinda  Ph.D. University of Texas Medical Branch 
Dillon, Edgar  Ph.D. University of Texas Medical Branch 
Project Information: Grant/Contract No. NNX10AP86G 
Responsible Center: NASA JSC 
Grant Monitor: Loerch, Linda  
Center Contact:  
linda.loerch-1@nasa.gov 
Solicitation / Funding Source: 2009 Crew Health NNJ09ZSA002N 
Grant/Contract No.: NNX10AP86G 
Project Type: GROUND 
Flight Program:  
TechPort: Yes 
No. of Post Docs:
No. of PhD Candidates:
No. of Master's Candidates:
No. of Bachelor's Candidates:
No. of PhD Degrees:
No. of Master's Degrees:
No. of Bachelor's Degrees:
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) Muscle:Risk of Impaired Performance Due to Reduced Muscle Mass, Strength and Endurance
Human Research Program Gaps: (1) M07:Develop the most efficient exercise program for maintenance of muscle fitness (IRP Rev F)
(2) M14:Indentify adjuncts to exercise countermeasures that can be used to better mitigate muscle loss (IRP Rev F)
Flight Assignment/Project Notes: NOTE: Risk/Gap changes per IRP Rev E (Ed., 3/25/14)

NOTE: Extended to 7/29/2015, per NSSC information and L. Loerch/JSC (Ed., 8/26/13)

Task Description: The long-term goal of this proposal is to determine the therapeutic efficacy of testosterone at preserving lean muscle mass, muscle strength, and bone mineral density in healthy humans during spaceflight. We propose to examine the interactive or additive effects of the combination of testosterone and exercise on lean body mass (LBM), muscle strength, and bone health. Our general hypothesis is that the maintenance of normal physiologic levels of testosterone during spaceflight will protect against the functional loss of muscle and bone, and will maximize the efficacy of existing resistance exercise protocols at preventing or reversing functional impairments that occur during bed rest.

To achieve these goals we will test the following specific hypotheses before, during, and after 70 days of bed rest:

1: Cycled testosterone replacement (weekly testosterone injections for 2 weeks, followed by 2 weeks off, etc.) in conjunction with exercise will have an additive effect in preventing loss of muscle mass and muscle strength in men representative of the astronaut population compared to exercise with placebo testosterone.

2: Cycled testosterone replacement (weekly testosterone injections for 2 weeks, followed by 2 weeks off, etc.) in conjunction with exercise will have an additive effect in preventing loss of bone mass and alterations in markers of bone metabolism in men representative of the astronaut population compared to exercise with placebo testosterone.

To address these hypotheses we will investigate the following specific aims before, during, and after 70 days of bed rest:

Aim 1: To determine the effect of cycled testosterone replacement in conjunction with resistance exercise during bed rest on muscle mass, muscle strength, and fatigue in men aged 24-55 years.

Aim 2: To determine the effect of cycled testosterone replacement in conjunction with resistance exercise during bed rest on markers of bone metabolism and bone mass in men aged 24-55 years.

Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures. Results from this proposal will lay the ground work for the implementation of combinational countermeasures that will additively work to maintain preflight physiology of astronauts during long-term spaceflight missions.

Research Impact/Earth Benefits: Results from this study will further elucidate the role of testosterone in the maintenance of skeletal muscle and bone during long term bed rest as a model for spaceflight. The benefits to life on Earth are extensive.

It is hypothesized that maintaining appropriate balance between hormonal status, nutritional status, and physical activity during spaceflight is of critical importance in preventing musculoskeletal losses. It is our contention that the restoration of physiologic levels of testosterone is essential to prevent and/or restore spaceflight- and microgravity-induced losses in the musculoskeletal system. Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures.

Research Impact/Earth Benefits: Results from this study will further elucidate the role of testosterone in the maintenance of skeletal muscle and bone during long term bed rest as a model for spaceflight. The benefits to life on Earth are extensive.

It is hypothesized that maintaining appropriate balance between hormonal status, nutritional status, and physical activity during spaceflight is of critical importance in preventing musculoskeletal losses. It is our contention that the maintenance or restoration of physiologic levels of testosterone is essential to prevent and/or restore spaceflight- and microgravity-induced losses in the musculoskeletal system. Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures.

Task Progress & Bibliography Information FY2014 
Task Progress: 1) A total of 24 subjects successfully completed the protocol (8 non-exercising control, 8 exercising placebo-treated, and 8 exercising testosterone-treated subjects).

2) Data were collected as planned.and final analyses are currently ongoing.

3) Preliminary results have been presented in abstracts at meetings listed in the Bibliography section.

4) All data collected during this protocol will be comprehensively interpreted and the efficacy of the tested countermeasures on muscle strength, fatigue, and other outcome measures will be assessed.

5) Final results will be submitted for peer-review and publication.

Bibliography Type: Description: (Last Updated: 01/11/2021) 

Show Cumulative Bibliography Listing
 
Abstracts for Journals and Proceedings Dillon EL, Danesi CP, Randolph KM, Quisenberry JM, Gilkison CR, Durham WJ, Sheffield-Moore M, Urban RJ. "Testosterone Supplementation as a Countermeasure Against Musculoskeletal Losses During Space Exploration: CFT70 Preliminary Results." 2014 NASA Human Research Program Investigators’ Workshop, Galveston, TX, February 12-13, 2014.

2014 NASA Human Research Program Investigators’ Workshop, Galveston, TX, February 12-13, 2014. http://www.hou.usra.edu/meetings/hrp2014/pdf/3157.pdf , Feb-2014

Project Title:  Testosterone Supplementation as a Countermeasure against Musculoskeletal Losses during Space Exploration Reduce
Fiscal Year: FY 2013 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 07/30/2010  
End Date: 07/29/2015  
Task Last Updated: 05/31/2013 
Download report in PDF pdf
Principal Investigator/Affiliation:   Urban, Randall  M.D. / University of Texas Medical Branch at Galveston 
Address:  301 University Blvd. 
Rt. 0569 - 4.124 JSA 
Galveston , TX 77555-0569 
Email: rurban@utmb.edu 
Phone: 409-772-1176  
Congressional District: 14 
Web:  
Organization Type: UNIVERSITY 
Organization Name: University of Texas Medical Branch at Galveston 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Durham, William  Ph.D. University of Texas Medical Branch 
Sheffield-Moore, Melinda  Ph.D. University of Texas Medical Branch 
Dillon, Edgar  Ph.D. University of Texas Medical Branch 
Project Information: Grant/Contract No. NNX10AP86G 
Responsible Center: NASA JSC 
Grant Monitor: Loerch, Linda  
Center Contact:  
linda.loerch-1@nasa.gov 
Solicitation / Funding Source: 2009 Crew Health NNJ09ZSA002N 
Grant/Contract No.: NNX10AP86G 
Project Type: GROUND 
Flight Program:  
TechPort: Yes 
No. of Post Docs:
No. of PhD Candidates:
No. of Master's Candidates:
No. of Bachelor's Candidates:
No. of PhD Degrees:
No. of Master's Degrees:
No. of Bachelor's Degrees:
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) Muscle:Risk of Impaired Performance Due to Reduced Muscle Mass, Strength and Endurance
Human Research Program Gaps: (1) M07:Develop the most efficient exercise program for maintenance of muscle fitness (IRP Rev F)
(2) M14:Indentify adjuncts to exercise countermeasures that can be used to better mitigate muscle loss (IRP Rev F)
Flight Assignment/Project Notes: NOTE: Risk/Gap changes per IRP Rev E (Ed., 3/25/14)

NOTE: Extended to 7/29/2015, per NSSC information and L. Loerch/JSC (Ed., 8/26/13)

Task Description: The long-term goal of this proposal is to determine the therapeutic efficacy of testosterone at preserving lean muscle mass, muscle strength, and bone mineral density in healthy humans during spaceflight. We propose to examine the interactive or additive effects of the combination of testosterone and exercise on lean body mass (LBM), muscle strength and bone health. Our general hypothesis is that the maintenance of normal physiologic levels of testosterone during spaceflight will protect against the functional loss of muscle and bone, and will maximize the efficacy of existing resistance exercise protocols at preventing or reversing functional impairments that occur during bed rest.

To achieve these goals we will test the following specific hypotheses before, during and after 70 days of bed rest:

1: Cycled testosterone replacement (weekly testosterone injections for 2 weeks, followed by 2 weeks off, etc.) in conjunction with exercise will have an additive effect in preventing loss of muscle mass and muscle strength in men representative of the astronaut population compared to exercise with placebo testosterone.

2: Cycled testosterone replacement (weekly testosterone injections for 2 weeks, followed by 2 weeks off, etc.) in conjunction with exercise will have an additive effect in preventing loss of bone mass and alterations in markers of bone metabolism in men representative of the astronaut population compared to exercise with placebo testosterone.

To address these hypotheses we will investigate the following specific aims before, during and after 70 days of bed rest:

Aim 1: To determine the effect of cycled testosterone replacement in conjunction with resistance exercise during bed rest on muscle mass, muscle strength, and fatigue in men aged 24-55 years.

Aim 2: To determine the effect of cycled testosterone replacement in conjunction with resistance exercise during bed rest on markers of bone metabolism and bone mass in men aged 24-55 years.

Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures. Results from this proposal will lay the ground work for the implementation of combinational countermeasures that will additively work to maintain preflight physiology of astronauts during long-term spaceflight missions.

Research Impact/Earth Benefits: Results from this study will further elucidate the role of testosterone in the maintenance of skeletal muscle and bone during long term bed rest as a model for space flight. The benefits to life on earth are extensive.

It is hypothesized that maintaining appropriate balance between hormonal status, nutritional status, and physical activity during spaceflight is of critical importance in preventing musculoskeletal losses. It is our contention that the restoration of physiologic levels of testosterone is essential to prevent and/or restore spaceflight- and microgravity-induced losses in the musculoskeletal system. Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures.

Research Impact/Earth Benefits: Results from this study will further elucidate the role of testosterone in the maintenance of skeletal muscle and bone during long term bed rest as a model for space flight. The benefits to life on Earth are extensive.

It is hypothesized that maintaining appropriate balance between hormonal status, nutritional status, and physical activity during spaceflight is of critical importance in preventing musculoskeletal losses. It is our contention that the maintenance or restoration of physiologic levels of testosterone is essential to prevent and/or restore spaceflight- and microgravity-induced losses in the musculoskeletal system. Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures.

Task Progress & Bibliography Information FY2013 
Task Progress: 1) To date, a total of 12 subjects (4 non-exercising control, 4 exercising placebo-treated, and 4 exercising testosterone-treated subjects) successfully completed the protocol and data were collected as planned.

2) Four subjects are currently enrolled and this project is actively recruiting subjects for enrollment.

3) Data collection and analyses are currently ongoing.

4) Preliminary data have been presented in abstracts at meetings listed below.

Bibliography Type: Description: (Last Updated: 01/11/2021) 

Show Cumulative Bibliography Listing
 
Abstracts for Journals and Proceedings Dillon EL (presenter), Danesi CP, Randolph KM, Lynch JP, Theodore S, Gilkison CR, Durham WJ, Sheffield-Moore M, Urban RJ. "Standard and Noninvasive Measurements of Glucose Tolerance during Long Term Bed Rest." 28th Annual Meeting of the American Society for Gravitational and Space Research, New Orleans, LA, November 27-December 2, 2012. Oral presentation.

28th Annual Meeting of the American Society for Gravitational and Space Research, New Orleans, LA, November 27-December 2, 2012. Program and abstracts, p. 72. , Nov-2012

Abstracts for Journals and Proceedings Dillon EL, Danesi CP, Randolph KM, Lynch JP, Theodore S, Gilkison CR, Durham WJ, Sheffield-Moore M, Urban RJ. "Standard and Noninvasive Measurements of Glucose Tolerance during Long Term Bed Rest." 2013 NASA Human Research Program Investigators’ Workshop, Galveston, TX, February 12-14, 2013.

2013 NASA Human Research Program Investigators’ Workshop, Galveston, TX, February 12-14, 2013. Abstract #1120. , Feb-2013

Project Title:  Testosterone Supplementation as a Countermeasure against Musculoskeletal Losses during Space Exploration Reduce
Fiscal Year: FY 2012 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 07/30/2010  
End Date: 07/29/2013  
Task Last Updated: 05/30/2012 
Download report in PDF pdf
Principal Investigator/Affiliation:   Urban, Randall  M.D. / University of Texas Medical Branch at Galveston 
Address:  301 University Blvd. 
Rt. 0569 - 4.124 JSA 
Galveston , TX 77555-0569 
Email: rurban@utmb.edu 
Phone: 409-772-1176  
Congressional District: 14 
Web:  
Organization Type: UNIVERSITY 
Organization Name: University of Texas Medical Branch at Galveston 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Durham, William  Ph.D. University of Texas Medical Branch 
Sheffield-Moore, Melinda  Ph.D. University of Texas Medical Branch 
Dillon, Edgar  Ph.D. University of Texas Medical Branch 
Key Personnel Changes / Previous PI: May 2012 report: Dr. Paddon-Jones is no longer listed as a CoI on this project.
Project Information: Grant/Contract No. NNX10AP86G 
Responsible Center: NASA JSC 
Grant Monitor: Loerch, Linda  
Center Contact:  
linda.loerch-1@nasa.gov 
Solicitation / Funding Source: 2009 Crew Health NNJ09ZSA002N 
Grant/Contract No.: NNX10AP86G 
Project Type: GROUND 
Flight Program:  
TechPort: Yes 
No. of Post Docs:
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) Muscle:Risk of Impaired Performance Due to Reduced Muscle Mass, Strength and Endurance
Human Research Program Gaps: (1) M07:Develop the most efficient exercise program for maintenance of muscle fitness (IRP Rev F)
(2) M14:Indentify adjuncts to exercise countermeasures that can be used to better mitigate muscle loss (IRP Rev F)
Task Description: The long-term goal of this proposal is to determine the therapeutic efficacy of testosterone at preserving lean muscle mass, muscle strength, and bone mineral density in healthy humans during spaceflight. We propose to examine the interactive or additive effects of the combination of testosterone and exercise on lean body mass (LBM), muscle strength and bone health. Our general hypothesis is that the maintenance of normal physiologic levels of testosterone during spaceflight will protect against the functional loss of muscle and bone, and will maximize the efficacy of existing resistance exercise protocols at preventing or reversing functional impairments that occur during bed rest.

To achieve these goals we will test the following specific hypotheses before, during and after 70 days of bed rest:

1: Cycled testosterone replacement (weekly testosterone injections for 2 weeks, followed by 2 weeks off, etc.) in conjunction with exercise will have an additive effect in preventing loss of muscle mass and muscle strength in men representative of the astronaut population compared to exercise with placebo testosterone.

2: Cycled testosterone replacement (weekly testosterone injections for 2 weeks, followed by 2 weeks off, etc.) in conjunction with exercise will have an additive effect in preventing loss of bone mass and alterations in markers of bone metabolism in men representative of the astronaut population compared to exercise with placebo testosterone.

To address these hypotheses we will investigate the following specific aims before, during and after 70 days of bed rest:

Aim 1: To determine the effect of cycled testosterone replacement in conjunction with resistance exercise during bed rest on muscle mass, muscle strength, and fatigue in men aged 24-55 years.

Aim 2: To determine the effect of cycled testosterone replacement in conjunction with resistance exercise during bed rest on markers of bone metabolism and bone mass in men aged 24-55 years.

Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures. Results from this proposal will lay the ground work for the implementation of combinational countermeasures that will additively work to maintain preflight physiology of astronauts during long-term spaceflight missions.

Research Impact/Earth Benefits: Results from this study will further elucidate the role of testosterone in the maintenance of skeletal muscle and bone during long term bed rest as a model for space flight. The benefits to life on earth are extensive.

It is hypothesized that maintaining appropriate balance between hormonal status, nutritional status, and physical activity during spaceflight is of critical importance in preventing musculoskeletal losses. It is our contention that the restoration of physiologic levels of testosterone is essential to prevent and/or restore spaceflight- and microgravity-induced losses in the musculoskeletal system. Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures.

Research Impact/Earth Benefits: Results from this study will further elucidate the role of testosterone in the maintenance of skeletal muscle and bone during long term bed rest as a model for space flight. The benefits to life on earth are extensive.

It is hypothesized that maintaining appropriate balance between hormonal status, nutritional status, and physical activity during spaceflight is of critical importance in preventing musculoskeletal losses. It is our contention that the maintenance or restoration of physiologic levels of testosterone is essential to prevent and/or restore spaceflight- and microgravity-induced losses in the musculoskeletal system. Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures.

Task Progress & Bibliography Information FY2012 
Task Progress: 1. One non-exercising subject successfully completed the study protocol.

2. Currently, three exercising subjects are enrolled in the bed rest phase of the experiment.

3. No data are currently available in order to maintain the double-blinded design of treatment in the experiment.

Bibliography Type: Description: (Last Updated: 01/11/2021) 

Show Cumulative Bibliography Listing
 
Abstracts for Journals and Proceedings Dillon EL, Durham WJ, Sheffield-Moore M, Urban RJ. "Testosterone Supplementation as a Countermeasure against Musculoskeletal Losses during Space Exploration." Presented at the 2012 NASA Human Research Program Investigators’ Workshop, Houston, TX, February 14-16, 2012.

2012 NASA Human Research Program Investigators’ Workshop, Houston, TX, February 14-16, 2012. Abstract # 4094. , Feb-2012

Project Title:  Testosterone Supplementation as a Countermeasure against Musculoskeletal Losses during Space Exploration Reduce
Fiscal Year: FY 2011 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 07/30/2010  
End Date: 07/29/2013  
Task Last Updated: 06/09/2011 
Download report in PDF pdf
Principal Investigator/Affiliation:   Urban, Randall  M.D. / University of Texas Medical Branch at Galveston 
Address:  301 University Blvd. 
Rt. 0569 - 4.124 JSA 
Galveston , TX 77555-0569 
Email: rurban@utmb.edu 
Phone: 409-772-1176  
Congressional District: 14 
Web:  
Organization Type: UNIVERSITY 
Organization Name: University of Texas Medical Branch at Galveston 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Durham, William J Ph.D. University of Texas Medical Branch 
Paddon-Jones, Douglas  Ph.D. University of Texas Medical Branch 
Sheffield-Moore, Melinda  Ph.D. University of Texas Medical Branch 
Dillon, Edgar Lichar Ph.D. University of Texas Medical Branch 
Project Information: Grant/Contract No. NNX10AP86G 
Responsible Center: NASA JSC 
Grant Monitor: Norsk, Peter  
Center Contact:  
Peter.norsk@nasa.gov 
Solicitation / Funding Source: 2009 Crew Health NNJ09ZSA002N 
Grant/Contract No.: NNX10AP86G 
Project Type: GROUND 
Flight Program:  
TechPort: Yes 
No. of Post Docs:
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) Muscle:Risk of Impaired Performance Due to Reduced Muscle Mass, Strength and Endurance
Human Research Program Gaps: (1) M07:Develop the most efficient exercise program for maintenance of muscle fitness (IRP Rev F)
(2) M14:Indentify adjuncts to exercise countermeasures that can be used to better mitigate muscle loss (IRP Rev F)
Task Description: The long-term goal of this proposal is to determine the therapeutic efficacy of testosterone at preserving lean muscle mass, muscle strength, and bone mineral density in healthy humans during spaceflight. We propose to examine the interactive or additive effects of the combination of testosterone and exercise on lean body mass (LBM), muscle strength and bone health. Our general hypothesis is that the maintenance of normal physiologic levels of testosterone during spaceflight will protect against the functional loss of muscle and bone, and will maximize the efficacy of existing resistance exercise protocols at preventing or reversing functional impairments that occur during bed rest.

To achieve these goals we will test the following specific hypotheses before, during and after 70 days of bed rest: 1: Cycled testosterone replacement (weekly testosterone injections for 2 weeks, followed by 2 weeks off, etc.) in conjunction with exercise will have an additive effect in preventing loss of muscle mass and muscle strength in men representative of the astronaut population compared to exercise with placebo testosterone. 2: Cycled testosterone replacement (weekly testosterone injections for 2 weeks, followed by 2 weeks off, etc.) in conjunction with exercise will have an additive effect in preventing loss of bone mass and alterations in markers of bone metabolism in men representative of the astronaut population compared to exercise with placebo testosterone.

To address these hypotheses we will investigate the following specific aims before, during and after 70 days of bed rest: Aim 1: To determine the effect of cycled testosterone replacement in conjunction with resistance exercise during bed rest on muscle mass, muscle strength, and fatigue in men aged 24-55 years. Aim 2: To determine the effect of cycled testosterone replacement in conjunction with resistance exercise during bed rest on markers of bone metabolism and bone mass in men aged 24-55 years

Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures. Results from this proposal will lay the ground work for the implementation of combinational countermeasures that will additively work to maintain preflight physiology of astronauts during long-term spaceflight missions.

Research Impact/Earth Benefits: Results from this study will further elucidate the role of testosterone in the maintenance of skeletal muscle and bone during long term bed rest as a model for space flight. The benefits to life on earth are extensive. It is hypothesized that maintaining appropriate balance between hormonal status, nutritional status, and physical activity during spaceflight is of critical importance in preventing musculoskeletal losses. It is our contention that the restoration of physiologic levels of testosterone is essential to prevent and/or restore spaceflight- and microgravity-induced losses in the musculoskeletal system. Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures.

Research Impact/Earth Benefits: Results from this study will further elucidate the role of testosterone in the maintenance of skeletal muscle and bone during long term bed rest as a model for space flight. The benefits to life on earth are extensive.

It is hypothesized that maintaining appropriate balance between hormonal status, nutritional status, and physical activity during spaceflight is of critical importance in preventing musculoskeletal losses. It is our contention that the restoration of physiologic levels of testosterone is essential to prevent and/or restore spaceflight- and microgravity-induced losses in the musculoskeletal system. Current evidence suggests that the combination of testosterone and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures.

Task Progress & Bibliography Information FY2011 
Task Progress: The protocol was approved by NASA CPHS (Committee for the Protection of Human Subjects) following the May 19, 2011 review and will be included in the 70 day bed rest campaign (Countermeasures and Functional Testing in Head-Down Tilt Bed Rest, CFT70). The first subject is currently scheduled for enrollment June 19, 2011.

Bibliography Type: Description: (Last Updated: 01/11/2021) 

Show Cumulative Bibliography Listing
 
 None in FY 2011
Project Title:  Testosterone Supplementation as a Countermeasure against Musculoskeletal Losses during Space Exploration Reduce
Fiscal Year: FY 2010 
Division: Human Research 
Research Discipline/Element:
HRP HHC:Human Health Countermeasures
Start Date: 07/30/2010  
End Date: 07/29/2013  
Task Last Updated: 08/20/2010 
Download report in PDF pdf
Principal Investigator/Affiliation:   Urban, Randall  M.D. / University of Texas Medical Branch at Galveston 
Address:  301 University Blvd. 
Rt. 0569 - 4.124 JSA 
Galveston , TX 77555-0569 
Email: rurban@utmb.edu 
Phone: 409-772-1176  
Congressional District: 14 
Web:  
Organization Type: UNIVERSITY 
Organization Name: University of Texas Medical Branch at Galveston 
Joint Agency:  
Comments:  
Co-Investigator(s)
Affiliation: 
Durham, Bill  University Of Texas, Galveston 
Grady, James  University Of Texas, Galveston 
Paddon-Jones, Douglas  University Of Texas, Galveston 
Sheffield-Moore, Melinda  University Of Texas, Galveston 
Project Information: Grant/Contract No. NNX10AP86G 
Responsible Center: NASA JSC 
Grant Monitor: Norsk, Peter  
Center Contact:  
Peter.norsk@nasa.gov 
Solicitation / Funding Source: 2009 Crew Health NNJ09ZSA002N 
Grant/Contract No.: NNX10AP86G 
Project Type: GROUND 
Flight Program:  
TechPort: Yes 
No. of Post Docs:  
No. of PhD Candidates:  
No. of Master's Candidates:  
No. of Bachelor's Candidates:  
No. of PhD Degrees:  
No. of Master's Degrees:  
No. of Bachelor's Degrees:  
Human Research Program Elements: (1) HHC:Human Health Countermeasures
Human Research Program Risks: (1) Muscle:Risk of Impaired Performance Due to Reduced Muscle Mass, Strength and Endurance
Human Research Program Gaps: (1) M07:Develop the most efficient exercise program for maintenance of muscle fitness (IRP Rev F)
(2) M14:Indentify adjuncts to exercise countermeasures that can be used to better mitigate muscle loss (IRP Rev F)
Task Description: The long-term goal of this proposal is to determine the therapeutic efficacy of testosterone and leucine at preserving lean muscle mass, muscle strength, and bone mineral density in healthy humans during spaceflight. We propose to examine the interactive or additive effects of the combination of testosterone or leucine and exercise on lean body mass (LBM), muscle strength and bone health. Our general hypothesis is that the maintenance of normal physiologic levels of testosterone in males or increasing leucine availability in females during spaceflight will protect against the functional loss of muscle and bone, and will maximize the efficacy of existing resistance exercise protocols at preventing or reversing functional impairments that occur during 3 months of bed rest in both men and women.

To achieve these goals we will test the following specific hypotheses before, during and after 90 days of bed rest:

1) Monthly cycled testosterone replacement (daily testosterone for 1st month, followed by one month off, etc.) in conjunction with exercise will have an additive effect in preventing loss of muscle mass, muscle strength, bone mass, and markers of bone metabolism in men representative of the astronaut population compared to exercise with placebo testosterone.

2) Daily leucine supplementation (3 x 4g taken with meals) in conjunction with exercise will have an additive effect in preventing loss of muscle mass and muscle strength in women representative of the astronaut population compared to exercise with placebo leucine.

To address these hypotheses we will investigate the following specific aims before, during and after 90 days of bed rest:

Specific Aim 1A: To determine the effect of monthly cycled testosterone replacement in conjunction with resistance exercise on muscle mass, muscle strength, bone mass and markers of bone metabolism in men aged 35-55.

Specific Aim 2B: To determine the effect of daily leucine supplementation in conjunction with resistance exercise on muscle mass and muscle strength, bone mass, and markers of bone metabolism in women aged 35-55.

Current evidence suggests that the combination of testosterone, amino acids, and exercise will optimize the effectiveness of the existing exercise and nutritional countermeasures. Results from this proposal will lay the ground work for the implementation of combinational countermeasures that will additively work to maintain preflight physiology of female and male astronauts during long-term spaceflight missions.

Research Impact/Earth Benefits: 0

Task Progress & Bibliography Information FY2010 
Task Progress: New project for FY2010.

Bibliography Type: Description: (Last Updated: 01/11/2021) 

Show Cumulative Bibliography Listing
 
 None in FY 2010