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Completed

NCT Number: NCT04004715

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

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.

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Key information

Conditions

Whole-body Protein Balance Muscle Protein Synthesis

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

US Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Essential Amino Acid Enriched Whey Protein

Dietary Supplement

protein powder formulation that includes whey and free-form essential amino acids

Whey Protein

Dietary Supplement

commercially available whey protein isolate

Military Ration Entree

Dietary Supplement

chili and beans entree; current meal component of the meals ready to eat rations

Primary outcomes

  1. 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.

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.

    Time frame: ~4.5 hour measure of whole-body protein balance

    Assessed using stable isotope infusions of tyrosine.

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Collaborators

  • University of Arkansas

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2019
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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