Effects of Protein Quality on Post-exercise Skeletal Muscle and Whole-body Protein Kinetics During Energy Deficit
1 other identifier
interventional
10
1 country
1
Brief Summary
The optimal EAA-containing protein format 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 post, whole-body exercise muscle and whole-body protein kinetic responses to ingesting varying EAA-containing protein formats 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2019
CompletedFirst Submitted
Initial submission to the registry
June 28, 2019
CompletedFirst Posted
Study publicly available on registry
July 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2019
CompletedMarch 12, 2020
March 1, 2020
8 months
June 28, 2019
March 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
How fast participants build skeletal muscle after ingesting varying forms of essential amino acid-containing proteins after exercise
Assessed using stable isotope infusions of phenylalanine.
~4.5 hour measure of muscle protein synthesis
Secondary Outcomes (1)
How well participants suppress the degradation of body proteins while stimulating the growth of new proteins after ingesting varying forms of essential amino acid-containing proteins after exercise.
~4.5 hour measure of whole-body protein balance
Study Arms (3)
Essential Amino Acid Enriched Whey Protein
EXPERIMENTALprotein powder formulation that includes whey and free-form essential amino acids
Whey Protein
ACTIVE COMPARATORcommercially available whey protein isolate
Military Ration Entree
ACTIVE COMPARATORchili and beans entree; current meal component of the meals ready to eat rations
Interventions
protein powder formulation that includes whey and free-form essential amino acids
chili and beans entree; current meal component of the meals ready to eat rations
Eligibility Criteria
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) or home duty station medical support
- 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 or home duty station 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
- 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)
- Unwillingness or inability to consume study diets or foods provided
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
US Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760, United States
Related Publications (1)
Gwin JA, Church DD, Hatch-McChesney A, Allen JT, Wilson MA, Varanoske AN, Carrigan CT, Murphy NE, Margolis LM, Carbone JW, Wolfe RR, Ferrando AA, Pasiakos SM. Essential amino acid-enriched whey enhances post-exercise whole-body protein balance during energy deficit more than iso-nitrogenous whey or a mixed-macronutrient meal: a randomized, crossover study. J Int Soc Sports Nutr. 2021 Jan 7;18(1):4. doi: 10.1186/s12970-020-00401-5.
PMID: 33413462DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Pasiakos, PhD
United States Army Research Institute of Environmental Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- All participants and investigators will be blinded to the the beverage treatments. The meal treatment is not blinded.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nutritional Physiologist
Study Record Dates
First Submitted
June 28, 2019
First Posted
July 2, 2019
Study Start
April 25, 2019
Primary Completion
December 13, 2019
Study Completion
December 13, 2019
Last Updated
March 12, 2020
Record last verified: 2020-03