Clinical trial NCT04004715: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Whole-body Protein Balance
Muscle Protein Synthesis
Lead sponsor: United States Army Research Institute of Environmental Medicine
Sponsor class: FED
Collaborators: name: University of Arkansas
First posted: 2019-07-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, partially-blind, cross-over controlled trial
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: How fast participants build skeletal muscle after ingesting varying forms of essential amino acid-containing proteins after exercise
timeFrame: ~4.5 hour measure of muscle protein synthesis
Secondary outcomes:
measure: 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.
timeFrame: ~4.5 hour measure of whole-body protein balance
Other outcomes:
Locations:
city: Natick
country: United States
facility: US Army Research Institute of Environmental Medicine
state: Massachusetts
Study officials:
affiliation: United States Army Research Institute of Environmental Medicine
name: Stefan Pasiakos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.