The Effects of Repeated Operational Stress and Limited Recovery on Resilience Capacity

NCT06784544 | Not Yet Recruiting FDA Device

• 2 other identifiers: 24-33HCMO240019
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep, Inadequate; Energy Deficit; Iron Absorption; High Physical Activity

Outcome Measures

Primary Outcomes (3)

• Integrated muscle protein synthesis

  deuterium oxide stable isotope

  Days 1-13

• Whole-body protein balance

  15N alanine stable isotope

  24 hours

• Iron Absorption

  57-Fe dissolved in water

  24 hours

Study Arms (2)

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.

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.

Other: Operational Stressors

Interventions

Operational Stressors OTHER

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.

Active adults representative of normal weight phenotype; Active adults representative of overweight phenotype

Eligibility Criteria

• Age: 17 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead
• Pennington Biomedical Research Center: collaborator

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 Principal Investigator, PhD

  United States Army Research Institute of Environmental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jess A Gwin Principal Investigator, PhD

CONTACT

508-206-2300; jessica.a.gwin.civ@health.mil

Study Design

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

Model Details: 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).

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: May 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)