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Completed
NCT06784544
The Effects of Repeated Operational Stress and Limited Recovery on Resilience Capacity
Conditions: Sleep, Inadequate, Energy Deficit, Iron Absorption, High Physical Activity
Sex: All
Ages: 17 Years – 39 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 27
Sponsor: United States Army Research Institute of Environmental Medicine
Location: US Army Research Institute of Environmental Medicine Natick Massachusetts
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.
Eligibility Criteria
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT06784544). StuddyBuddy aggregates publicly available trial information.