Effect of Ration Formulations on Warfighter Energy Balance and Physical Performance During a Field Training Exercise

NCT06261437 | Completed

• 2 other identifiers: M-11053MO230060
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized clinical trial is to determine the effects of consuming the Close Combat Assault Ration (CCAR) compared to the First Strike Ration (FSR) during a 7-day strenuous military training on energy intake and energy balance in healthy, Active Duty Warfighters. The main questions it aims to answer are:

• Will consuming the CCAR result in lower energy intake or energy balance compared to consumption of the FSR?
• Will consuming the CCAR result in lower lower body strength or anaerobic power compared to consuming the FSR?
• Will those consuming the CCAR report lower ration acceptability or greater gastrointestinal side effects compared to those consuming the FSR? Participants will be asked to consume either the CCAR or FSR as the sole nutrition source during a 7-day field training exercise (FTX). The vertical jump test, running-based anaerobic sprint test, and lower-body strength pull will be conducted pre and post the 7-day FTX to assess physical performance. Energy expenditure and intake will be measured by the doubly-labelled water method and dietary logs, respectively. Surveys will be completed to assess ration acceptability and gastrointestinal symptoms. Researchers will compare the CCAR and FSR groups to see if their consumption impacted energy intake, energy balance, physical performance, ration acceptance, or gastrointestinal side effects.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Energy intake

  Energy intake will be measured with daily food records and a review of food waste.

  From study day 1 through 7

• Energy expenditure

  Energy expenditure will be measured using the doubly-labeled water method.

  From baseline to study day 7

• Energy balance

  Energy balance will measure the difference between energy intake and expenditure.

  From baseline to study day 7.

Secondary Outcomes (7)

• Physical performance (vertical jump)

  At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)

• Physical performance (peak power)

  At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)

• Physical performance (Anaerobic capacity)

  At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)

• Physical performance (lower-body strength)

  At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)

• Food acceptance scale

  From study day 1 through 7

Study Arms (2)

Close Combat Assault Ration

EXPERIMENTAL

The CCAR will be consumed as the sole nutrition source during a 7-day physically demanding military training exercise

Other: CCAR

First Strike Ration

ACTIVE COMPARATOR

The FSR will be consumed as the sole nutrition source during a 7-day physically demanding military training exercise

Other: FSR

Interventions

CCAR OTHER

The CCAR will be consumed as the sole source of nutrition during a 7-day military training exercise.

Close Combat Assault Ration

FSR OTHER

The FSR will be consumed as the sole source of nutrition during a 7-day military training exercise.

First Strike Ration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Active-duty male or female military personnel who are actively participating in the 7-day strenuous military training exercise.
• Willing to consume only foods/beverages provided by study staff during the training exercise, except for coffee and water.

You may not qualify if:

• Any injury or health condition limiting full participation in the 7-day Field Training Exercise.
• Any food allergy, lactose intolerance, or vegetarian practices.
• Not willing to participate in all study procedures.

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

U.S. Army Research Institute of Environmental Medicine

Natick, Massachusetts, 01760, United States

Location

Related Publications (3)

• Margolis LM, Rood J, Champagne C, Young AJ, Castellani JW. Energy balance and body composition during US Army special forces training. Appl Physiol Nutr Metab. 2013 Apr;38(4):396-400. doi: 10.1139/apnm-2012-0323. Epub 2013 Apr 3.

  PMID: 23713532 BACKGROUND

• Hoyt RW, Jones TE, Baker-Fulco CJ, Schoeller DA, Schoene RB, Schwartz RS, Askew EW, Cymerman A. Doubly labeled water measurement of human energy expenditure during exercise at high altitude. Am J Physiol. 1994 Mar;266(3 Pt 2):R966-71. doi: 10.1152/ajpregu.1994.266.3.R966.

  PMID: 8160893 BACKGROUND

• Karl JP, Hatch-McChesney A, Allen JT, Fagnant HS, Radcliffe PN, Finlayson G, Gwin JA, Margolis LM, Hennigar SR, McClung JP, Pasiakos SM. Effects of energy balance on appetite and physiological mediators of appetite during strenuous physical activity: secondary analysis of a randomised crossover trial. Br J Nutr. 2021 Nov 28;126(10):1571-1584. doi: 10.1017/S0007114521000131. Epub 2021 Jan 14.

  PMID: 33441218 BACKGROUND

Study Officials

• Michael A Dawson, PhD

  United States Army Research Institute of Environmental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 15, 2024
• Study Start: February 22, 2024
• Primary Completion: March 4, 2024
• Study Completion: March 4, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)