search
Back to results

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

Primary Purpose

Sleep, Inadequate

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protein Nutrition During Recovery
Sponsored by
United States Army Research Institute of Environmental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep, Inadequate

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • US Army Research Institute of Environmental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Protein Nutrition Even

Protein Nutrition Skewed

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Whole-body Protein Balance
15N labeled stable isotope
Integrated Muscle Protein Synthesis
deuterium oxide integrated stable isotope

Secondary Outcome Measures

Full Information

First Posted
October 4, 2023
Last Updated
October 4, 2023
Sponsor
United States Army Research Institute of Environmental Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT06073080
Brief Title
Recovery Protein Nutrition as a Countermeasure for Anabolic Resistance Following Sleep Loss
Acronym
PSL
Official Title
Recovery Protein Nutrition as a Countermeasure for Anabolic Resistance Following Sleep Loss
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Research Institute of Environmental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Inadequate

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Protein Nutrition Even
Arm Type
Experimental
Arm Description
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.
Arm Title
Protein Nutrition Skewed
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Protein Nutrition During Recovery
Intervention Description
Dietary Protein Nutrition Distribution
Primary Outcome Measure Information:
Title
Whole-body Protein Balance
Description
15N labeled stable isotope
Time Frame
24h
Title
Integrated Muscle Protein Synthesis
Description
deuterium oxide integrated stable isotope
Time Frame
72h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jess A Gwin, PhD
Phone
508-206-2300
Email
jessica.a.gwin.civ@health.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jess A Gwin, PhD
Organizational Affiliation
United States Army Research Institute of Environmental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
US Army Research Institute of Environmental Medicine
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jess Gwin, PhD
Phone
508-206-2300
Email
jessica.a.gwin.civ@health.mil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared.

Learn more about this trial

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

We'll reach out to this number within 24 hrs