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| Name | Class |
|---|---|
| University of Arkansas | OTHER |
| Eastern Michigan University | OTHER |
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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.
Short-term negative energy balance downregulates muscle protein synthesis and upregulates whole-body proteolysis and amino acid (AA) oxidation, thereby increasing nitrogen excretion and exacerbating whole-body and skeletal muscle protein loss. Consumption of quality proteins high in essential amino acid (EAA) content may attenuate protein loss during energy deficit by restoring whole-body and skeletal muscle anabolic potential to that observed in a eucaloric state. During energy balance, muscle protein synthesis appears to be maximally stimulated after consuming 15 g of EAA at rest and after conventional resistance-type exercise. In response to a short-term energy deficit that downregulated basal muscle protein synthesis by as much as 27%, consuming 15 g (~7.5 g EAA) and 30 g (~15 g EAA) of whey protein after a bout of resistance exercise restored muscle protein synthesis rates to resting, fasted rates observed in the eucaloric state in a dose dependent manner. The effect of EAA intakes above 15 g on resting and post-exercise muscle protein synthesis and the whole-body protein anabolic response during acute energy deficit has not been determined. This study will assess resting and post-resistance exercise whole-body and skeletal muscle protein synthesis responses to across a spectrum of EAA intakes following a well-controlled, short-term (5-d) energy deficit (30% energy deficit). Using a randomized, double-blind, cross-over design, 20 resistance trained (≥ 2 d/wk for the past 6 mo) adults will undergo two, non-consecutive 5-d energy deficit periods, separated by a 14-d washout period. Resting and post-resistance exercise (single leg exercise model) whole-body protein turnover and skeletal muscle protein synthesis responses to two different doses of EAA (standard, 0.10 g/kg vs high, 0.30 g/kg) will be determined the morning after completing the 5-d energy deficit. This design will test the hypothesis that higher absolute doses of EAA are required to maintain resting and post-exercise anabolic responses during energy deficit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard EAA Dose | Experimental | EAA dose provided at 0.10 g/kg body mass |
|
| High EAA Dose | Experimental | EAA dose provided at 0.30 g/kg body mass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard EAA | Dietary Supplement | EAA provided relative to body mass at a standard dose (0.10 g/kg) during energy deprivation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial, Resting Muscle Protein Synthesis Rates | Assessed using stable isotope infusions of phenylalanine. | 3 hour measure of muscle protein synthesis |
| Postprandial, Post-exercise Muscle Protein Synthesis Rates | Assess using stable isotope infusions of phenylalanine. | 3 hour measure of muscle protein synthesis |
| 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 | Assessed using stable isotope infusions of tyrosine. Net Whole-body Protein Balance is defined as whole-body protein synthesis - whole-body protein breakdown) | 3 hour measure of whole-body protein balance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan M Pasiakos, PhD | Military Nutrition Division, USARIEM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Army Research Institute of Environmental Medicine | Natick | Massachusetts | 01760 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32768315 | Derived | Gwin JA, Church DD, Hatch-McChesney A, Howard EE, Carrigan CT, Murphy NE, Wilson MA, Margolis LM, Carbone JW, Wolfe RR, Ferrando AA, Pasiakos SM. Effects of high versus standard essential amino acid intakes on whole-body protein turnover and mixed muscle protein synthesis during energy deficit: A randomized, crossover study. Clin Nutr. 2021 Mar;40(3):767-777. doi: 10.1016/j.clnu.2020.07.019. Epub 2020 Jul 22. |
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This was a cross-over design study. 19 volunteers completed both the standard and high EAA testing phases.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low EAA First, Then High EAA | Participants received EAA provided relative to body mass at a standard dose (0.10 g/kg; LOW)) during energy deprivation first, then received EAA provided relative to body mass at a high dose (0.3 g/kg; HIGH) during energy deprivation. |
| FG001 | High EAA First, Then Low EAA | Participants received EAA provided relative to body mass at a high dose (0.30 g/kg; HIGH) during energy deprivation first, then received EAA provided relative to body mass at a low dose (0.1 g/kg; LOW) during energy deprivation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (5 d Energy Deficit) |
| |||||||||||||
| Washout (14 d) |
| |||||||||||||
| Second Intervention (5 d Energy Deficit) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants were randomized to receive all interventions. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postprandial, Resting Muscle Protein Synthesis Rates | Assessed using stable isotope infusions of phenylalanine. | Posted | Mean | Standard Deviation | percent per hour | 3 hour measure of muscle protein synthesis |
|
1 day
non-serious adverse event
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low EAA First, Then High EAA: Low EAA Treatment | EAA dose provided at 0.10 g/kg body mass during first intervention, then EAA dose provided at 0.30 g/kg body mass during second intervention. Low EAA Treatment Period |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild erythema | Skin and subcutaneous tissue disorders | Systematic Assessment | Non-serious adverse event, very mild erythema. No cellulitis or e/o abscess. No significant pain or tenderness. Diagnosis: contact dermitits. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jess Gwin | US Army Research Institute of Environmental Medicine | 508-206-2300 | jessica.a.gwin.ctr@mail.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2019 | Mar 9, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 25, 2018 | Mar 9, 2020 | ICF_001.pdf |
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Randomized, double-blind, cross-over controlled trial
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| High EAA | Dietary Supplement | EAA provided relative to body mass at a high dose (0.30 g/kg) during energy deprivation |
|
| NOT COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kilograms per meter squared |
|
| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Postprandial, Post-exercise Muscle Protein Synthesis Rates | Assess using stable isotope infusions of phenylalanine. | Posted | Mean | Standard Deviation | percent per hour | 3 hour measure of muscle protein synthesis |
|
|
|
| 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 | Assessed using stable isotope infusions of tyrosine. Net Whole-body Protein Balance is defined as whole-body protein synthesis - whole-body protein breakdown) | Posted | Mean | Standard Deviation | grams of protein per 180min | 3 hour measure of whole-body protein balance |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | High EAA First, Then Low EAA: Low EAA Treatment | EAA dose provided at 0.30 g/kg body mass during first intervention, then EAA dose provided at 0.10 g/kg body mass during second intervention. Low EAA Treatment Period | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Low EAA First, Then High EAA: High EAA Treatment | EAA dose provided at 0.10 g/kg body mass during first intervention, then EAA dose provided at 0.30 g/kg body mass during second intervention. High EAA Treatment Period | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | High EAA First, Then Low EAA: High EAA Treatment | EAA dose provided at 0.30 g/kg body mass during first intervention, then EAA dose provided at 0.10 g/kg body mass during second intervention. High EAA Treatment Period | 0 | 10 | 0 | 10 | 1 | 10 |
|
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