NCT03372928

Essential Amino Acids and Protein Kinetics During Caloric Deprivation

Completed NA Results posted Last updated 20 November 2020

What this trial tests

NA trial testing Standard EAA in Muscle Protein Synthesis in 20 participants. Completed in 20 March 2019.

Timeline

1 September 2018

Primary endpoint
20 March 2019

20 March 2019

Quick facts

Lead sponsor	United States Army Research Institute of Environmental Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	20
Start date	1 September 2018
Primary completion	20 March 2019
Estimated completion	20 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Standard EAA
• High EAA

Conditions studied

• Muscle Protein Synthesis — all drugs for Muscle Protein Synthesis →
• Whole-body Protein Balance — all drugs for Whole-body Protein Balance →

Sponsor

United States Army Research Institute of Environmental Medicine

Who can join

Adults 18 to 35, any sex, with Muscle Protein Synthesis or Whole-body Protein Balance. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Postprandial, Resting Muscle Protein Synthesis Rates Primary · 3 hour measure of muscle protein synthesis

Assessed using stable isotope infusions of phenylalanine.

Group	Value	95% CI
Standard EAA Dose	0.055	± 0.01
High EAA Dose	0.061	± 0.02

Postprandial, Post-exercise Muscle Protein Synthesis Rates Primary · 3 hour measure of muscle protein synthesis

Assess using stable isotope infusions of phenylalanine.

Group	Value	95% CI
Standard EAA	0.055	± 0.01
High EAA	0.065	± 0.02

How Well Participants Suppress the Degradation of Body Proteins While Stimulating the Growth of New Proteins After Ingesting Varying Doses of EAA at Rest and After Exercise. Net Whole-body Protein Balance Primary · 3 hour measure of whole-body protein balance

Assessed using stable isotope infusions of tyrosine. Net Whole-body Protein Balance is defined as whole-body protein synthesis - whole-body protein breakdown)

Group	Value	95% CI
Standard EAA	2.7	± 1.7
High EAA	21.3	± 3.4

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 day. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Low EAA First, Then High EAA: Low EAA Treatment

Serious: 0/10 (0%)

Deaths: 0/10

High EAA First, Then Low EAA: Low EAA Treatment

Serious: 0/10 (0%)

Deaths: 0/10

Low EAA First, Then High EAA: High EAA Treatment

Serious: 0/10 (0%)

Deaths: 0/10

High EAA First, Then Low EAA: High EAA Treatment

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (1 terms — click to expand)

Reaction	System	Low EAA First, Then High E…	High EAA First, Then Low E…	Low EAA First, Then High E…	High EAA First, Then Low E…
mild erythema	Skin and subcutaneous tissue disorders	—	—	—	—

Data from ClinicalTrials.gov NCT03372928 adverse events section.

Sponsor's own description

The amount of essential amino acids (EAA) 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 the resting and post-exercise muscle and whole-body protein kinetic responses to ingesting varying amounts of EAA 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of high versus standard essential amino acid intakes on whole-body protein turnover and mixed muscle protein synthesis during energy deficit: A randomized, crossover study.
   Gwin JA, Church DD, Hatch-McChesney A, Howard EE, et al · · 2021 · cited 25× · PMID 32768315 · DOI 10.1016/j.clnu.2020.07.019