Recovery Protein Nutrition as a Countermeasure for Anabolic Resistance Following Sleep Loss (PSL)

January 16, 2026 updated by: United States Army Research Institute of Environmental Medicine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Natick, Massachusetts, United States, 01760
        • US Army Research Institute of Environmental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Protein Nutrition Even
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.
Other: Protein Nutrition During Recovery
Dietary Protein Nutrition Distribution
Active Comparator: Protein Nutrition Skewed
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.
Other: Protein Nutrition During Recovery
Dietary Protein Nutrition Distribution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Whole-body Protein Balance
Time Frame: 24 hours
15N labeled stable isotope
24 hours
Integrated Muscle Protein Synthesis
Time Frame: 72 hours
deuterium oxide integrated stable isotope
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
United States Army Research Institute of Environmental Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jess A Gwin, PhD, United States Army Research Institute of Environmental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 4, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-27H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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