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

NCT06073080 | Completed

• 1 other identifier: 23-27H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep, Inadequate

Outcome Measures

Primary Outcomes (2)

• Whole-body Protein Balance

  15N labeled stable isotope

  24 hours

• Integrated Muscle Protein Synthesis

  deuterium oxide integrated stable isotope

  72 hours

Study Arms (2)

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.

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.

Other: Protein Nutrition During Recovery

Interventions

Protein Nutrition During Recovery OTHER

Dietary Protein Nutrition Distribution

Protein Nutrition Even; Protein Nutrition Skewed

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Jess A Gwin, PhD

  United States Army Research Institute of Environmental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: March 21, 2024
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)