N/A
Completed N=20
Essential Amino Acids and Protein Kinetics During Caloric Deprivation
Muscle Protein Synthesis · Whole-body Protein Balance
Source: ClinicalTrials.gov NCT03372928 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Postprandial, Resting Muscle Protein Synthesis Rates — 0.055; 0.061 percent per hour
Summary
The amount of essential amino acids (EAA) necessary to maximally stimulate muscle protein synthesis and optimize whole-body net protein balance during caloric deprivation has not been determined. This study will address that gap in knowledge by examining the resting and post-exercise muscle and whole-body protein kinetic responses to ingesting varying amounts of EAA after a 5 day period of negative energy balance. This study will provide the initial evidence to support the development of a recovery-based food product for military combat rations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postprandial, Resting Muscle Protein Synthesis Rates |
0.055; 0.061 | — |
| PRIMARY Postprandial, Post-exercise Muscle Protein Synthesis Rates |
0.055; 0.065 | — |
| PRIMARY How Well Participants Suppress the Degradation of Body Proteins While Stimulating the Growth of New Proteins After Ingesting Varying Doses of EAA at Rest and After Exercise. Net Whole-body Protein Balance |
2.7; 21.3 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women aged 18 - 35 years
- Body mass index < 30.0 kg/m2
- Healthy without evidence of chronic illness or musculoskeletal injury as determined by the USARIEM Office of Medical Support and Oversight (OMSO)
- Resistance exercise trained defined by self-report as performing ≥ 2 sessions/wk for previous 6 mo
- Refrain from taking any nonsteroidal anti-inflammatory drugs (e.g., aspirin, Advil®, Aleve®, Naprosyn®), or any other aspirin-containing product for 10 days before starting and at least 5 days after completing the study
- Willing to refrain from alcohol, smoking any nicotine product (includes e-cigarettes); vaping, chewing tobacco, caffeine, and dietary supplement use throughout the entire study period
- Supervisor approval for federal civilian employees and non-HRV active duty military personnel working within the US Army Natick Soldier Systems Center
Exclusion Criteria
- Musculoskeletal injuries that compromise exercise capability as determined by the USARIEM Office of Medical Support and Oversight (OMSO)
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.)
- Abnormal PT/PTT test or problems with blood clotting
- History of complications with lidocaine
- Present condition of alcoholism, anabolic steroids, or other substance abuse issues
- Blood donation within 8-wk of beginning the study
- Pregnancy (self-report or results of urine pregnancy test before body composition testing)
- Unwillingness or inability to consume study diets or foods provided
Data sourced from ClinicalTrials.gov (NCT03372928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.