Caloric RestrictionPhase 4OPSNCT02734238
Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery
A Phase 4 study testing Sesame Oil and testosterone enanthate in people with Caloric Restriction and Exercise, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Caloric Restriction, Exercise
- What is being tested?
- Sesame Oil and testosterone enanthate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Dec 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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).
Who cannot join
- 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
Show all 22Show fewer
- 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)
- Exceeds age-specific U.S. Army body composition standards according to Army Regulation 600-9
- Previous history of kidney stones unless otherwise approved by the medical investigator
- Systolic blood pressure > 150 or diastolic blood pressure > 95 mmHg
- Previous history of breast or prostate cancer
- Previous history of Chronic Obstructive Pulmonary Disease or Obstructive Sleep Apnea
- Findings of lab results of prostate-specific antigen > 3ng/ml, Hematocrit > 50%, or positive urine drug screening
- Based on the investigative team's clinical judgment, a subject may not be appropriate for participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery: a Randomized, Placebo Controlled Trial
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.
Read the detailed description
This study will enroll up to 60 physically active men in a 3-phase randomized, placebo-controlled trial. After completing a 14-day (free-living, phase 1), energy-adequate, diet-acclimation phase (protein, 1.6 g∙kg-1∙d-1; fat 30% total energy intake, with remaining energy derived from carbohydrate), participants will be randomized to one of two experimental groups and undergo a 28-day (live-in, phase 2), 55% energy deficit phase: energy deficit alone (DEF) or energy deficit + exogenous testosterone (DEF+TEST). Recovery (free-living, phase 3) will be assessed after completing phase 2 to determine when body mass has been recovered within ± 2.5% of initial body mass (duration will vary, 42-day maximum for phase 3). This study will delineate the contribution of testosterone declines from the physical and mental demands encountered by Warfighters during military training and combat operations on complex markers of physiological and psychological status, addressing a direct, consistently observed, gap in knowledge.
- Conditions
- Caloric Restriction, Exercise
- Being tested
- Sesame Oil, testosterone enanthate
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sesame OilDrug
200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35
testosterone enanthateDrug
200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: testosterone enanthate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (138)Papers the sponsor has linked to this study.
- Other trials for Caloric RestrictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Army Research Institute of Environmental Medicine, MyoSyntax, Defence Research and Development Canada, United States Department of Defense
- Responsible party
- Principal investigator, Jennifer C. Rood, Pennington Biomedical Research Center
- Investigators
- Jennifer C Rood, Ph.D., Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734238
- Sponsor's protocol ID
- PBRC 2015-063
- Acronym
- OPS
- Status last verified
- Jan 2019
- First submitted
- 31 Mar 2016
- Last updated
- 16 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25550460Lieberman 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.
PubMed 25220844Friedl KE, Moore RJ, Hoyt RW, Marchitelli LJ, Martinez-Lopez LE, Askew EW. Endocrine markers of semistarvation in healthy lean men in a multistressor environment. J Appl Physiol (1985). 2000 May;88(5):1820-30. doi: 10.1152/jappl.2000.88.5.1820.
PubMed 10797147Opstad PK. The hypothalamo-pituitary regulation of androgen secretion in young men after prolonged physical stress combined with energy and sleep deprivation. Acta Endocrinol (Copenh). 1992 Sep;127(3):231-6. doi: 10.1530/acta.0.1270231.
PubMed 1414148Henning 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.
PubMed 24423293Nindl 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.
PubMed 9298770Nindl 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.
PubMed 17412783Carbone 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.
PubMed 22516719Knapik JJ, Ang P, Meiselman H, Johnson W, Kirk J, Bensel C, Hanlon W. Soldier performance and strenuous road marching: influence of load mass and load distribution. Mil Med. 1997 Jan;162(1):62-7.
PubMed 9002707Knapik JJ, Reynolds KL, Harman E. Soldier load carriage: historical, physiological, biomechanical, and medical aspects. Mil Med. 2004 Jan;169(1):45-56. doi: 10.7205/milmed.169.1.45.
PubMed 14964502Roy 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.
PubMed 21882780Roy 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.
PubMed 22730849Christensen 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.
PubMed 18816929Alemany 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.
PubMed 18450989Hoyt RW, Opstad PK, Haugen AH, DeLany JP, Cymerman A, Friedl KE. Negative energy balance in male and female rangers: effects of 7 d of sustained exercise and food deprivation. Am J Clin Nutr. 2006 May;83(5):1068-75. doi: 10.1093/ajcn/83.5.1068.
PubMed 16685048
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological and Psychological Effects of Testosterone During Severe Energy Deficit and Recovery: a Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02734238
- Acronym / sponsor ID
- OPS / PBRC 2015-063
- Conditions
- Caloric Restriction, Exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- United States Army Research Institute of Environmental Medicine, MyoSyntax, Defence Research and Development Canada, United States Department of Defense
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Posted 2 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will enroll up to 60 physically active men in a 3-phase randomized, placebo-controlled trial. After completing a 14-day (free-living, phase 1), energy-adequate, diet-acclimation phase (protein, 1.6 g∙kg-1∙d-1; fat 30% total energy intake, with remaining energy derived from carbohydrate), participants will be randomized to one of two experimental groups and undergo a 28-day (live-in, phase 2), 55% energy deficit phase: energy deficit alone (DEF) or energy deficit + exogenous testosterone (DEF+TEST). Recovery (free-living, phase 3) will be assessed after completing phase 2 to determine when body mass has been recovered within ± 2.5% of initial body mass (duration will vary, 42-day maximum for phase 3). This study will delineate the contribution of testosterone declines from the physical and mental demands encountered by Warfighters during military training and combat operations on complex markers of physiological and psychological status, addressing a direct, consistently observed, gap in knowledge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy Deficit | Placebo comparator | Drug: Sesame OilParticipants 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. |
| Energy Deficit + Testosterone | Experimental | Drug: testosterone enanthateParticipants 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
- Willing to live on the Pennington Biomedical Research Center inpatient unit for 28 consecutive days
- Willing to have a urine drug screening
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sesame Oil200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35 | Drug | Energy Deficit |
| testosterone enanthate200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35 | Drug | Energy Deficit + Testosterone |
Primary outcome
Body Composition at the End of Each Study Phase
Time frame: end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25550460Pasiakos 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: PubMed 25220844Lieberman 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.
- Background: PubMed 10797147Friedl KE, Moore RJ, Hoyt RW, Marchitelli LJ, Martinez-Lopez LE, Askew EW. Endocrine markers of semistarvation in healthy lean men in a multistressor environment. J Appl Physiol (1985). 2000 May;88(5):1820-30. doi: 10.1152/jappl.2000.88.5.1820.
- Background: PubMed 1414148Opstad PK. The hypothalamo-pituitary regulation of androgen secretion in young men after prolonged physical stress combined with energy and sleep deprivation. Acta Endocrinol (Copenh). 1992 Sep;127(3):231-6. doi: 10.1530/acta.0.1270231.
- Background: PubMed 24423293Henning 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: PubMed 9298770Nindl 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: PubMed 17412783Nindl 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: PubMed 22516719Carbone 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.
- Background: PubMed 9002707Knapik JJ, Ang P, Meiselman H, Johnson W, Kirk J, Bensel C, Hanlon W. Soldier performance and strenuous road marching: influence of load mass and load distribution. Mil Med. 1997 Jan;162(1):62-7.
- Background: PubMed 14964502Knapik JJ, Reynolds KL, Harman E. Soldier load carriage: historical, physiological, biomechanical, and medical aspects. Mil Med. 2004 Jan;169(1):45-56. doi: 10.7205/milmed.169.1.45.
- Background: PubMed 21882780Roy 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: PubMed 22730849Roy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer C Rood, Ph.D. principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sesame Oil and testosterone enanthate in people with Caloric Restriction and Exercise, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition at the End of Each Study Phase (time frame: end of each study phase: Day 11 for Phase 1, Day 39 for Phase 2, up to Day 85 for Phase 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02734238, which also lists 138 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.