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Effects of Protein Quality on Post-exercise Skeletal Muscle and Whole-body Protein Kinetics During Energy Deficit

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ClinicalTrials.gov Identifier: NCT04004715
Recruitment Status : Completed
First Posted : July 2, 2019
Last Update Posted : March 12, 2020
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Stefan Pasiakos, United States Army Research Institute of Environmental Medicine

Tracking Information
First Submitted Date  ICMJE June 28, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date March 12, 2020
Actual Study Start Date  ICMJE April 25, 2019
Actual Primary Completion Date December 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
How fast participants build skeletal muscle after ingesting varying forms of essential amino acid-containing proteins after exercise [ Time Frame: ~4.5 hour measure of muscle protein synthesis ]
Assessed using stable isotope infusions of phenylalanine.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
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. [ Time Frame: ~4.5 hour measure of whole-body protein balance ]
Assessed using stable isotope infusions of tyrosine.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Protein Quality on Post-exercise Skeletal Muscle and Whole-body Protein Kinetics During Energy Deficit
Official Title  ICMJE Effects of Protein Quality on Post-exercise Skeletal Muscle and Whole-body Protein Kinetics During Negative Energy Balance
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.
Detailed Description Ten resistance-trained adults will complete this ~55-d randomized, cross-over study. Participants will participate in three, non-consecutive 5-d controlled energy deficit periods, each separated by a 14-d washout period (i.e., sufficient time to restore nitrogen and metabolic homeostasis after moderate weight loss). Post-exercise (whole-body exercise model) muscle protein synthesis (MPS) and whole-body protein turnover responses to varying EAA-containing protein formats will be determined the morning after completing the 5-d energy deficit.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Randomized, partially-blind, cross-over controlled trial
Masking: Double (Participant, Investigator)
Masking Description:
All participants and investigators will be blinded to the the beverage treatments. The meal treatment is not blinded.
Primary Purpose: Basic Science
Condition  ICMJE
  • Whole-body Protein Balance
  • Muscle Protein Synthesis
Intervention  ICMJE
  • Dietary Supplement: Essential Amino Acid Enriched Whey Protein
    protein powder formulation that includes whey and free-form essential amino acids
  • Dietary Supplement: Whey Protein
    commercially available whey protein isolate
  • Dietary Supplement: Military Ration Entree
    chili and beans entree; current meal component of the meals ready to eat rations
Study Arms  ICMJE
  • Experimental: Essential Amino Acid Enriched Whey Protein
    protein powder formulation that includes whey and free-form essential amino acids
    Intervention: Dietary Supplement: Essential Amino Acid Enriched Whey Protein
  • Active Comparator: Whey Protein
    commercially available whey protein isolate
    Intervention: Dietary Supplement: Whey Protein
  • Active Comparator: Military Ration Entree
    chili and beans entree; current meal component of the meals ready to eat rations
    Intervention: Dietary Supplement: Military Ration Entree
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 13, 2019
Actual Primary Completion Date December 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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) 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004715
Other Study ID Numbers  ICMJE 19-06HC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stefan Pasiakos, United States Army Research Institute of Environmental Medicine
Study Sponsor  ICMJE United States Army Research Institute of Environmental Medicine
Collaborators  ICMJE University of Arkansas
Investigators  ICMJE
Principal Investigator: Stefan Pasiakos, PhD United States Army Research Institute of Environmental Medicine
PRS Account United States Army Research Institute of Environmental Medicine
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP