Essential Amino Acids and Protein Kinetics During Caloric Deprivation

NCT03372928 | Completed Results

• 1 other identifier: 17-32HC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Protein Synthesis; Whole-body Protein Balance

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Standard EAA Dose

EXPERIMENTAL

EAA dose provided at 0.10 g/kg body mass

Dietary Supplement: Standard EAA

High EAA Dose

EXPERIMENTAL

EAA dose provided at 0.30 g/kg body mass

Dietary Supplement: High EAA

Interventions

Standard EAA DIETARY_SUPPLEMENT

EAA provided relative to body mass at a standard dose (0.10 g/kg) during energy deprivation

Standard EAA Dose

High EAA DIETARY_SUPPLEMENT

EAA provided relative to body mass at a high dose (0.30 g/kg) during energy deprivation

High EAA Dose

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead
• University of Arkansas: collaborator
• Eastern Michigan University: collaborator

Study Sites (1)

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Location

Related Publications (1)

• 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.

  PMID: 32768315 DERIVED

Results Point of Contact

• Title: Jess Gwin
• Organization: US Army Research Institute of Environmental Medicine

jessica.a.gwin.ctr@mail.mil

508-206-2300

Study Officials

• Stefan M Pasiakos, PhD

  Military Nutrition Division, USARIEM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, cross-over controlled trial

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: December 14, 2017
• Study Start: September 1, 2018
• Primary Completion: March 20, 2019
• Study Completion: March 20, 2019
• Last Updated: November 20, 2020
• Results First Posted: November 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)