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

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

Tracking Information

• First Submitted Date: June 28, 2019
• First Posted Date: July 2, 2019
• Last Update Posted Date: March 12, 2020
• Actual Study Start Date: April 25, 2019
• Actual Primary Completion Date: December 13, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Protein Quality on Post-exercise Skeletal Muscle and Whole-body Protein Kinetics During Energy Deficit
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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

• Whole-body Protein Balance
• Muscle Protein Synthesis

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 28, 2019): 10
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 13, 2019
• Actual Primary Completion Date: December 13, 2019 (Final data collection date for primary outcome measure)

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) 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

• Sexes Eligible for Study: All

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04004715
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Stefan Pasiakos, United States Army Research Institute of Environmental Medicine
• Study Sponsor: United States Army Research Institute of Environmental Medicine
• Collaborators: University of Arkansas

Investigators

• 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