Sleep, InadequateREP DEFNCT06784544
The Effects of Repeated Operational Stress and Limited Recovery on Resilience Capacity
A study testing Operational Stressors in people with Sleep, Inadequate and Energy Deficit, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial summary
This longitudinal study will examine the effects of repeated bouts of operational stress and limited recovery on integrated MPS, whole-body protein balance, iron absorption, and aerobic performance. Read more about this study
- Who is it for?
- Ages 17 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Inadequate, Energy Deficit, Iron Absorption
- What is being tested?
- Operational Stressors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2025to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 17 to 39 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Men and women aged 18 - 39 years (17 - 39 years if military personnel)
- Weight stable in the past 2 months (± approximately 5 kg)
- Healthy without evidence of chronic illness or musculoskeletal injury as determined by the USARIEM Office of Medical Support and Oversight (OMSO) or home duty station medical support (HMS)
- Functional exercise (i.e., step ups, box jumps, body mass movements) and/or aerobic exercise trained defined by self-report as performing ≥ 2 sessions/wk for previous 6 months
- Willing to refrain from alcohol, smoking any nicotine product (includes e-cigarettes); vaping, chewing tobacco, caffeine not provided in the study, and dietary supplement use throughout the dietary interventions
- Biological females must be on sustained (i.e., approximately >3 months) oral/hormonal contraceptive use which acts to maintain continuous hormonal levels (i.e., contains low-dose estrogen/progesterone with no oral placebos, hormonal IUD)
- Supervisor approval for federal civilian employees and non-HRV active duty military personnel)
Who cannot join
- Musculoskeletal injuries that compromise exercise capability as determined by OMSO or HMS
- Metabolic or cardiovascular abnormalities, sleep disorders (i.e., sleep apnea) gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.) as determined by OMSO or HMS
- Abnormal or problems with blood clotting as determined by OMSO or HMS
- History of complications with lidocaine or similar local anesthetic analogue
- Present condition of alcoholism, anabolic steroids, or other substance abuse issues
- Blood donation within 8-wk of beginning or completing study blood draws
Show all 11Show fewer
- Current diagnosis of Anemia (hemoglobin < 13 g/dL for males, hemoglobin < 12 g/dL for females) and Sickle Cell Anemia/Trait as determined by OMSO or HMS
- Pregnant, trying to become pregnant, and/or breastfeeding (results of urine pregnancy test or self-report for breastfeeding will be obtained before body composition testing)
- Claustrophobia or discomfort related to having enclosed equipment around the head
- Unwillingness or inability to consume study diets or foods provided due to personal preference or food allergies/sensitivities
- Unwillingness or inability to adhere to study exercise restrictions and prescriptions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
Jess A Gwin, PhD, 508-206-2300, jessica.a.gwin.civ@health.mil
About this study
This longitudinal study will examine the effects of repeated bouts of operational stress and limited recovery on integrated MPS, whole-body protein balance, iron absorption, and aerobic performance. Following baseline characterization measures, active adults (n=24) representative of normal weight phenotype (NW; n=12) and overweight phenotype (OW; n=12) will complete a 48h balance phase preceding two rounds of repeated 72h energy deficit exposure each immediately followed by a 48h recovery phase. NW cutoff will be defined ≤ 22% body fat for males and ≤ 32% body fat for females. OW cutoff will be defined as >22% body fat for males and >32% body fat for females. These body composition cutoffs are informed by the maximum allowable percent body fat standards outlined in current Army Regulation 600-9. Additional details for determining % body fat are outlined in the experimental procedures section of the protocol.
Read the detailed description
Operational stress inherent of military training and operations is largely unavoidable and jeopardizes Warfighter readiness and performance. Operational stressors, including high physical activity, severe energy deficiency, and restricted sleep, challenge Warfighter resilience. The characterization of physiological factors contributing to maintained or declining resilience during repeated stress exposures with limited recovery is therefore required to enable development of new, targeted interventions that maintain or enhance resilience. Previous efforts have characterized the regulation of physiological status, including muscle recovery and endocrine function, during operational stress. However, no studies have directly assessed the effects of limited recovery (i.e., 48h) on physiological and performance decrements associated with repeated operational stress or resilience capacity. It is possible that repeated missions and limited recovery will drive progressive declines of physiological status and performance. The effects of operational stress on nutrition status also negatively impact readiness and performance. Absorption of key dietary nutrients, such as iron, is required to sustain nutritional status; and iron status, specifically, has been associated with performance declines. Laboratory and field-based studies from our group have shown declines in iron status and absorption following a single simulated sustained operation. However, no studies have directly assessed the effects of limited recovery (i.e., 48h) on physiological and performance decrements associated with repeated operational stress or resilience capacity. It is possible that repeated missions and limited recovery will drive progressive declines of physiological status and performance. Beyond characterizing the effects of repeated cycles of operational stress, there is potential value in determining whether body composition phenotypes (i.e., "energy deficiency-sensitive" and "energy deficiency-resistant") may modulate resilience during energy deficiency. Should phenotype-based differences be determined and suggest more beneficial/resilient vs. less beneficial/less resilient body composition phenotypes, guidance to maintain or interventions to achieve optimal body composition are potential individualized strategies to enhance resilience.
This longitudinal study will examine the effects of repeated operational stress and limited recovery on integrated muscle protein synthesis, whole-body protein balance, iron absorption, and aerobic performance. Adults (n=24) representative of normal weight and overweight phenotype (n=12/phenotype) will complete a 48h balance phase preceding two repeated rounds of 72h energy deficit (increased physical activity and reduced dietary intake) with sleep restriction followed by a 48h recovery phase.
- Being tested
- Operational Stressors
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Operational StressorsOther
Intervention consists of a 48 hour energy balance phase preceding two rounds of repeated 72 hour energy deficit exposure each immediately followed by a 48h recovery phase. Balance and recovery phases will meet 100% of baseline energy requirements. Energy deficit phases will include an approximate 60% energy deficit of total daily energy requirements achieved through both a reduction in dietary intake and increased energy expenditure through physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Active adults representative of overweight phenotype | Experimental | Active adults representative of overweight phenotype will complete a 48h balance phase followed by two rounds of repeated 72h energy deficit exposure, each immediately followed by a 48h recovery phase. Receives: Other: Operational Stressors |
| Active adults representative of normal weight phenotype | Active comparator | Active adults representative of normal weight phenotype will complete a 48h balance phase followed by two rounds of repeated 72h energy deficit exposure, each immediately followed by a 48h recovery phase. Receives: Other: Operational Stressors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated muscle protein synthesis
deuterium oxide stable isotope
Measured: Days 1-13
Whole-body protein balance
15N alanine stable isotope
Measured: 24 hours
Iron Absorption
57-Fe dissolved in water
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study startMay 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep, InadequateStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel arm study. All volunteers will complete a 48h energy balance phase preceding two repeated rounds of 72h energy deficit (increased physical activity and reduced dietary intake) with sleep restriction (4h sleep opportunity / night) followed by a 48h recovery phase (energy balance, no physical activity, 7-9h sleep opportunity / night).
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- Pennington Biomedical Research Center
- Responsible party
- Sponsor
- Investigators
- Jess A Gwin Principal Investigator, PhD, Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784544
- Sponsor's protocol ID
- 24-33HC
- Other IDs
- MO240019
- Acronym
- REP DEF
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Repeated Operational Stress and Limited Recovery on Resilience Capacity
- ClinicalTrials.gov ID
- NCT06784544
- Acronym / sponsor ID
- REP DEF / 24-33HC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- Pennington Biomedical Research Center
- Study start
- May 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This longitudinal study will examine the effects of repeated bouts of operational stress and limited recovery on integrated MPS, whole-body protein balance, iron absorption, and aerobic performance. Following baseline characterization measures, active adults (n=24) representative of normal weight phenotype (NW; n=12) and overweight phenotype (OW; n=12) will complete a 48h balance phase preceding two rounds of repeated 72h energy deficit exposure each immediately followed by a 48h recovery phase. NW cutoff will be defined ≤ 22% body fat for males and ≤ 32% body fat for females. OW cutoff will be defined as >22% body fat for males and >32% body fat for females. These body composition cutoffs are informed by the maximum allowable percent body fat standards outlined in current Army Regulation 600-9. Additional details for determining % body fat are outlined in the experimental procedures section of the protocol.
Detailed description
Operational stress inherent of military training and operations is largely unavoidable and jeopardizes Warfighter readiness and performance. Operational stressors, including high physical activity, severe energy deficiency, and restricted sleep, challenge Warfighter resilience. The characterization of physiological factors contributing to maintained or declining resilience during repeated stress exposures with limited recovery is therefore required to enable development of new, targeted interventions that maintain or enhance resilience. Previous efforts have characterized the regulation of physiological status, including muscle recovery and endocrine function, during operational stress. However, no studies have directly assessed the effects of limited recovery (i.e., 48h) on physiological and performance decrements associated with repeated operational stress or resilience capacity. It is possible that repeated missions and limited recovery will drive progressive declines of physiological status and performance. The effects of operational stress on nutrition status also negatively impact readiness and performance. Absorption of key dietary nutrients, such as iron, is required to sustain nutritional status; and iron status, specifically, has been associated with performance declines. Laboratory and field-based studies from our group have shown declines in iron status and absorption following a single simulated sustained operation. However, no studies have directly assessed the effects of limited recovery (i.e., 48h) on physiological and performance decrements associated with repeated operational stress or resilience capacity. It is possible that repeated missions and limited recovery will drive progressive declines of physiological status and performance. Beyond characterizing the effects of repeated cycles of operational stress, there is potential value in determining whether body composition phenotypes (i.e., "energy deficiency-sensitive" and "energy deficiency-resistant") may modulate resilience during energy deficiency. Should phenotype-based differences be determined and suggest more beneficial/resilient vs. less beneficial/less resilient body composition phenotypes, guidance to maintain or interventions to achieve optimal body composition are potential individualized strategies to enhance resilience.
This longitudinal study will examine the effects of repeated operational stress and limited recovery on integrated muscle protein synthesis, whole-body protein balance, iron absorption, and aerobic performance. Adults (n=24) representative of normal weight and overweight phenotype (n=12/phenotype) will complete a 48h balance phase preceding two repeated rounds of 72h energy deficit (increased physical activity and reduced dietary intake) with sleep restriction followed by a 48h recovery phase.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel arm study. All volunteers will complete a 48h energy balance phase preceding two repeated rounds of 72h energy deficit (increased physical activity and reduced dietary intake) with sleep restriction (4h sleep opportunity / night) followed by a 48h recovery phase (energy balance, no physical activity, 7-9h sleep opportunity / night).
| Arm | Type | Receives |
|---|---|---|
| Active adults representative of overweight phenotype | Experimental | Other: Operational StressorsActive adults representative of overweight phenotype will complete a 48h balance phase followed by two rounds of repeated 72h energy deficit exposure, each immediately followed by a 48h recovery phase. |
| Active adults representative of normal weight phenotype | Active comparator | Other: Operational StressorsActive adults representative of normal weight phenotype will complete a 48h balance phase followed by two rounds of repeated 72h energy deficit exposure, each immediately followed by a 48h recovery phase. |
Who may qualify
- Ages
- 17 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Men and women aged 18 - 39 years (17 - 39 years if military personnel)
- Weight stable in the past 2 months (± approximately 5 kg)
- Healthy without evidence of chronic illness or musculoskeletal injury as determined by the USARIEM Office of Medical Support and Oversight (OMSO) or home duty station medical support (HMS)
- Functional exercise (i.e., step ups, box jumps, body mass movements) and/or aerobic exercise trained defined by self-report as performing ≥ 2 sessions/wk for previous 6 months
- Willing to refrain from alcohol, smoking any nicotine product (includes e-cigarettes); vaping, chewing tobacco, caffeine not provided in the study, and dietary supplement use throughout the dietary interventions
Key exclusion criteria (11 listed)
- Musculoskeletal injuries that compromise exercise capability as determined by OMSO or HMS
- Metabolic or cardiovascular abnormalities, sleep disorders (i.e., sleep apnea) gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.) as determined by OMSO or HMS
- Abnormal or problems with blood clotting as determined by OMSO or HMS
- History of complications with lidocaine or similar local anesthetic analogue
- Present condition of alcoholism, anabolic steroids, or other substance abuse issues
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 |
|---|---|---|
| Operational StressorsIntervention consists of a 48 hour energy balance phase preceding two rounds of repeated 72 hour energy deficit exposure each immediately followed by a 48h recovery phase. Balance and recovery phases will meet 100% of baseline energy requirements. Energy deficit phases will include an approximate 60% energy deficit of total daily energy requirements achieved through both a reduction in dietary intake and increased energy expenditure through physical activity. | Other | Active adults representative of normal weight phenotype, Active adults representative of overweight phenotype |
Primary outcome
Integrated muscle protein synthesis
Time frame: Days 1-13
deuterium oxide stable isotope
Whole-body protein balance
Time frame: 24 hours
15N alanine stable isotope
Iron Absorption
Time frame: 24 hours
57-Fe dissolved in water
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
Jess A Gwin Principal Investigator, PhD principal investigator
United States Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Operational Stressors in people with Sleep, Inadequate and Energy Deficit, run by United States Army Research Institute of Environmental Medicine 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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 20 Jan 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jess A Gwin Principal Investigator, PhD (508-206-2300, jessica.a.gwin.civ@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrated muscle protein synthesis (time frame: Days 1-13). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2025.