Sleep, InadequatePSLNCT06073080
Recovery Protein Nutrition as a Countermeasure for Anabolic Resistance Following Sleep Loss
A study testing Protein Nutrition During Recovery in people with Sleep, Inadequate, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial summary
The current study will determine protein nutritional status (MPS and WBPB) in response to military-relevant sleep loss, and whether an even protein nutrition distribution during recovery optimally supports MPS and WBPB. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Inadequate
- What is being tested?
- Protein Nutrition During Recovery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2024to 4 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18 - 39 years
- Body mass index < 30.0 kg/m2
- Self-report weight stable for the past 2 months (± ~3 kg)
- Healthy without evidence of chronic illness, musculoskeletal injury, or diagnosed sleep disorder (i.e., insomnia) as determined by the USARIEM Office of Medical Support and Oversight (OMSO) or home duty station medical support
- Self-report participates in aerobic and/or resistance exercise, on average, ≥2 days per week for previous 6 months
- Willing to refrain from alcohol, smoking/using any nicotine product (includes e-cigarettes, vaping, chewing tobacco), caffeine, and dietary supplements during the intervention periods of the study
- Supervisor approval for federal civilian employees and non-HRV active duty military personnel
- Biological females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or able to provide self-report documentation of sustained (i.e., ~ >3 months) oral/hormonal contraceptive use which contains low-dose estrogen/progesterone to maintain continuous hormonal levels (i.e., IUD or no oral placebos)
Who cannot join
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., abnormal blood clotting, kidney disease, diabetes, cardiovascular disease, anemia etc.) as determined by OMSO or home duty station medical support
- History of complications with lidocaine (or similar local anesthetic)
- Present condition of substance abuse (e.g., alcoholism, anabolic steroid use etc.) as self-report or determined by OMSO or home duty station medical support
- Cumulative blood donation of greater than 550mL within 8-wk of beginning scheduled study blood collection
- Cumulative blood donation of greater than 550mL within 8-wk after completing scheduled study blood collection
- Pregnant, trying to become pregnant, and/or breastfeeding (results of urine pregnancy test prior to body composition scans and self-report for breastfeeding)
- Unwilling or unable to consume study diets or foods provided due to personal preference, dietary restrictions, and/or food allergies
- Unwilling or unable to adhere to study physical restrictions or sleep prescriptions
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
About this study
The current study will determine protein nutritional status (MPS and WBPB) in response to military-relevant sleep loss, and whether an even protein nutrition distribution during recovery optimally supports MPS and WBPB. Adults (n=20) will complete a 7d sleep satiated phase (~7-9h target/d), a 4d military-relevant sleep restriction phase (~4h /d), and a 3d recovery phase (~7-9h target/d) in a randomized, parallel design. During recovery, volunteers will consume 1.6 g protein/kg/d as an even (~0.4/0.4/0.4/0.4 g/kg) or skewed (~0.11/0.27/1.15/0.07 g/kg) distribution. Sleep will be monitored throughout the study using wrist actigraphy and diaries. During each phase, integrated daily MPS will be estimated using ingested deuterium oxide, salivary and blood sampling, and muscle biopsies, while WBPB will be estimated using ingested 15-N alanine and urine collections. At the end of each phase, metabolic testing will be used to assess the effects of sleep loss on substrate utilization and include consuming a carbohydrate beverage, serial blood draws, indirect calorimetry, and steady-state aerobic exercise. The knowledge products derived from the proposed effort will be informative to next generation ration development and support military-specific recovery nutrition guidance following operations involving sleep loss.
Read the detailed description
The nutritional fitness of Service Members directly influences recovery from operational stress. Inadequate recovery nutrition following military missions, including sleep loss, exacerbates skeletal muscle loss and contributes to degraded physical performance. Muscle loss and performance declines following stress are in part due to inadequate nutritional fitness, impaired muscle recovery, and negative whole-body protein balance (WBPB). Sleep loss dysregulates anabolic hormones, induces catabolism, and reduces muscle protein synthesis (MPS). However, WBPB has not been assessed following military-relevant sleep loss (i.e., 4h/d) alone. This presents an important knowledge gap given the influence of WBPB on health and readiness. Consuming increased dietary protein following sleep loss could enhance muscle recovery by stimulating MPS and supporting WBPB, but whether protein recovery nutrition counteracts the stress of sleep loss is unknown. Beyond the quantity of protein consumed, optimizing the timing/distribution of daily protein consumption is required to augment anabolism. Consuming a skewed protein distribution results in meals (i.e., breakfast and lunch) that deliver a suboptimal protein quantity for maximally stimulating MPS. Alternatively, targeting an even protein distribution may optimize anabolism and recovery following stress by providing per meal protein quantities that maximally stimulate MPS and support WBPB. The efficacy of manipulating protein distribution for counteracting the stress of sleep loss is unknown. The proposed effort will determine protein nutritional status (MPS and WBPB) in response to military-relevant sleep loss, and whether an even protein nutrition distribution during recovery optimally supports MPS and WBPB. Adults (n=20) will complete a 7d sleep satiated phase (~7-9h target/d), a 4d military-relevant sleep restriction phase (~4h /d), and a 3d recovery phase (~7-9h target/d) in a randomized, parallel design. During recovery, volunteers will consume 1.6 g protein/kg/d as an even (~0.4/0.4/0.4/0.4 g/kg) or skewed (~0.11/0.27/1.15/0.07 g/kg) distribution. Sleep will be monitored throughout the study using wrist actigraphy and diaries. During each phase, integrated daily MPS will be estimated using ingested deuterium oxide, salivary and blood sampling, and muscle biopsies, while WBPB will be estimated using ingested 15-N alanine and urine collections. At the end of each phase, metabolic testing will be used to assess the effects of sleep loss on substrate utilization and include consuming a carbohydrate beverage, serial blood draws, indirect calorimetry, and steady-state aerobic exercise. The knowledge products derived from the proposed effort will be informative to next generation ration development and support military-specific recovery nutrition guidance following operations involving sleep loss.
- Conditions
- Sleep, Inadequate
- Being tested
- Protein Nutrition During Recovery
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein Nutrition During RecoveryOther
Dietary Protein Nutrition Distribution
| Study group | Role | What they receive |
|---|---|---|
| Protein Nutrition Even | Experimental | Volunteers will consume 1.6 g protein/kg/d as an even (~0.4/0.4/0.4/0.4 g/kg) distribution across breakfast, lunch, dinner, and a snack. Receives: Other: Protein Nutrition During Recovery |
| Protein Nutrition Skewed | Active comparator | Volunteers will consume 1.6 g protein/kg/d as a skewed (~0.11/0.27/1.15/0.07 g/kg) distribution across breakfast, lunch, dinner, and a snack. Receives: Other: Protein Nutrition During Recovery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body Protein Balance
15N labeled stable isotope
Measured: 24 hours
Integrated Muscle Protein Synthesis
deuterium oxide integrated stable isotope
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start21 Mar 2024
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel arm study. All volunteers will complete a sleep satiated phase and sleep restriction phase before randomized allocation to either an even protein nutrition intervention or a skewed protein nutrition intervention during a recovery phase.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jess A Gwin, PhD, Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073080
- Sponsor's protocol ID
- 23-27H
- Acronym
- PSL
- Status last verified
- Jan 2026
- First submitted
- 4 Oct 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Protein Nutrition as a Countermeasure for Anabolic Resistance Following Sleep Loss
- ClinicalTrials.gov ID
- NCT06073080
- Acronym / sponsor ID
- PSL / 23-27H
- Conditions
- Sleep, Inadequate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 10 Oct 2023 (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.
The current study will determine protein nutritional status (MPS and WBPB) in response to military-relevant sleep loss, and whether an even protein nutrition distribution during recovery optimally supports MPS and WBPB. Adults (n=20) will complete a 7d sleep satiated phase (~7-9h target/d), a 4d military-relevant sleep restriction phase (~4h /d), and a 3d recovery phase (~7-9h target/d) in a randomized, parallel design. During recovery, volunteers will consume 1.6 g protein/kg/d as an even (~0.4/0.4/0.4/0.4 g/kg) or skewed (~0.11/0.27/1.15/0.07 g/kg) distribution. Sleep will be monitored throughout the study using wrist actigraphy and diaries. During each phase, integrated daily MPS will be estimated using ingested deuterium oxide, salivary and blood sampling, and muscle biopsies, while WBPB will be estimated using ingested 15-N alanine and urine collections. At the end of each phase, metabolic testing will be used to assess the effects of sleep loss on substrate utilization and include consuming a carbohydrate beverage, serial blood draws, indirect calorimetry, and steady-state aerobic exercise. The knowledge products derived from the proposed effort will be informative to next generation ration development and support military-specific recovery nutrition guidance following operations involving sleep loss.
Detailed description
The nutritional fitness of Service Members directly influences recovery from operational stress. Inadequate recovery nutrition following military missions, including sleep loss, exacerbates skeletal muscle loss and contributes to degraded physical performance. Muscle loss and performance declines following stress are in part due to inadequate nutritional fitness, impaired muscle recovery, and negative whole-body protein balance (WBPB). Sleep loss dysregulates anabolic hormones, induces catabolism, and reduces muscle protein synthesis (MPS). However, WBPB has not been assessed following military-relevant sleep loss (i.e., 4h/d) alone. This presents an important knowledge gap given the influence of WBPB on health and readiness. Consuming increased dietary protein following sleep loss could enhance muscle recovery by stimulating MPS and supporting WBPB, but whether protein recovery nutrition counteracts the stress of sleep loss is unknown. Beyond the quantity of protein consumed, optimizing the timing/distribution of daily protein consumption is required to augment anabolism. Consuming a skewed protein distribution results in meals (i.e., breakfast and lunch) that deliver a suboptimal protein quantity for maximally stimulating MPS. Alternatively, targeting an even protein distribution may optimize anabolism and recovery following stress by providing per meal protein quantities that maximally stimulate MPS and support WBPB. The efficacy of manipulating protein distribution for counteracting the stress of sleep loss is unknown. The proposed effort will determine protein nutritional status (MPS and WBPB) in response to military-relevant sleep loss, and whether an even protein nutrition distribution during recovery optimally supports MPS and WBPB. Adults (n=20) will complete a 7d sleep satiated phase (~7-9h target/d), a 4d military-relevant sleep restriction phase (~4h /d), and a 3d recovery phase (~7-9h target/d) in a randomized, parallel design. During recovery, volunteers will consume 1.6 g protein/kg/d as an even (~0.4/0.4/0.4/0.4 g/kg) or skewed (~0.11/0.27/1.15/0.07 g/kg) distribution. Sleep will be monitored throughout the study using wrist actigraphy and diaries. During each phase, integrated daily MPS will be estimated using ingested deuterium oxide, salivary and blood sampling, and muscle biopsies, while WBPB will be estimated using ingested 15-N alanine and urine collections. At the end of each phase, metabolic testing will be used to assess the effects of sleep loss on substrate utilization and include consuming a carbohydrate beverage, serial blood draws, indirect calorimetry, and steady-state aerobic exercise. The knowledge products derived from the proposed effort will be informative to next generation ration development and support military-specific recovery nutrition guidance following operations involving sleep loss.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, parallel arm study. All volunteers will complete a sleep satiated phase and sleep restriction phase before randomized allocation to either an even protein nutrition intervention or a skewed protein nutrition intervention during a recovery phase.
| Arm | Type | Receives |
|---|---|---|
| Protein Nutrition Even | Experimental | Other: Protein Nutrition During RecoveryVolunteers will consume 1.6 g protein/kg/d as an even (~0.4/0.4/0.4/0.4 g/kg) distribution across breakfast, lunch, dinner, and a snack. |
| Protein Nutrition Skewed | Active comparator | Other: Protein Nutrition During RecoveryVolunteers will consume 1.6 g protein/kg/d as a skewed (~0.11/0.27/1.15/0.07 g/kg) distribution across breakfast, lunch, dinner, and a snack. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adults aged 18 - 39 years
- Body mass index < 30.0 kg/m2
- Self-report weight stable for the past 2 months (± ~3 kg)
- Healthy without evidence of chronic illness, musculoskeletal injury, or diagnosed sleep disorder (i.e., insomnia) as determined by the USARIEM Office of Medical Support and Oversight (OMSO) or home duty station medical support
- Self-report participates in aerobic and/or resistance exercise, on average, ≥2 days per week for previous 6 months
Key exclusion criteria (8 listed)
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., abnormal blood clotting, kidney disease, diabetes, cardiovascular disease, anemia etc.) as determined by OMSO or home duty station medical support
- History of complications with lidocaine (or similar local anesthetic)
- Present condition of substance abuse (e.g., alcoholism, anabolic steroid use etc.) as self-report or determined by OMSO or home duty station medical support
- Cumulative blood donation of greater than 550mL within 8-wk of beginning scheduled study blood collection
- Cumulative blood donation of greater than 550mL within 8-wk after completing scheduled study blood collection
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 |
|---|---|---|
| Protein Nutrition During RecoveryDietary Protein Nutrition Distribution | Other | Protein Nutrition Even, Protein Nutrition Skewed |
Primary outcome
Whole-body Protein Balance
Time frame: 24 hours
15N labeled stable isotope
Integrated Muscle Protein Synthesis
Time frame: 72 hours
deuterium oxide integrated stable isotope
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- 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. This study is not recruiting at the moment.
Jess A Gwin, 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 Protein Nutrition During Recovery in people with Sleep, Inadequate, 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 8 inclusion and 8 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 21 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Whole-body Protein Balance (time frame: 24 hours). The study lists 2 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 21 Jan 2026.