NCT05210205

Physiological Response to Protein and Energy-enhanced Food Products During Winter Military Training

Completed NA Last updated 26 May 2022

What this trial tests

NA trial testing EAA in Military Operational Stress Reaction in 68 participants. Completed in 26 March 2022.

Timeline

13 March 2022

Primary endpoint
26 March 2022

26 March 2022

Quick facts

Lead sponsor	United States Army Research Institute of Environmental Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	68
Start date	13 March 2022
Primary completion	26 March 2022
Estimated completion	26 March 2022
Sites	1 location across Norway

Drugs / interventions tested

• EAA
• Energy Dense
• Control

Conditions studied

• Military Operational Stress Reaction — all drugs for Military Operational Stress Reaction →
• Malnutrition (Calorie) — all drugs for Malnutrition (Calorie) →
• Weight Loss — all drugs for Weight Loss →
• Muscle Wasting — all drugs for Muscle Wasting →

Sponsor

United States Army Research Institute of Environmental Medicine

Who can join

18 and older, any sex, with Military Operational Stress Reaction or Malnutrition (Calorie). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Soldiers commonly lose muscle mass during training and combat operations that produce large energy deficits (i.e., calories burned \> calories consumed). Developing new combat ration products that increase energy intake (i.e., energy dense foods) or the amount and quality of protein consumed (i.e., essential amino acid \[EAA\] content) may prevent muscle breakdown and stimulate muscle repair and muscle maintenance during unavoidable energy deficit. The primary objective of this study is to determine the effects of prototype recovery food products that are energy dense or that provide increased amounts of EAAs (anabolic component of dietary protein) on energy balance, whole-body net protein balance, and indices of physiological status during strenuous winter military training.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Changes in Circulating MicroRNA Profiles During Arctic Military Training Target Inflammatory Pathways Independent of Macronutrient Intake.
   Margolis LM, Teien HK, Hatch-McChesney A, Robillard JT, et al · · 2026 · PMID 42176985 · DOI 10.1016/j.tjnut.2026.101602
2. Whole-Body Protein Balance during Arctic Military Training Is Unaffected by Dietary Essential Amino Acid or Energy Density.
   Howard EE, Teien HK, Hatch-McChesney A, Robillard JT, et al · · 2026 · PMID 41932364 · DOI 10.1016/j.tjnut.2026.101514