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

February 7, 2024 updated by: United States Army Research Institute of Environmental Medicine

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Army modernization priorities have identified the need to build the "capability to sustain multiple Brigade Combat Teams for up to seven days without periodic resupply to support semi-independent operations". To address this challenge and meet modernization requirements, ration developers from the Combat Feeding Division (CFD), Soldier Sustainment Directorate, Combat Capabilities Development Command - Soldier Center (DEVCOM-SC) developed the next generation ration, the Close Combat Assault Ration (CCAR). The CCAR is produced using novel food processing techniques that reduce weight and volume by removing air and water and increase the energy density by increasing the relative fat content. The result is a lightweight, low volume, energy-dense, shelf-stable, daily combat assault ration that provides Warfighters with meals that can be consumed while on the move, requiring no heating and little to no field preparation.

The ration will provide approximately 2800 kcals/day (47% carbohydrate, 12% protein, 41% fat) and includes a greater distribution of energy from fat to enable a smaller logistic footprint than the First Strike Ration (FSR, 2800 kcals/d; 58% carbohydrate, 12% protein, 30% fat).

This proposed project will evaluate the CCAR relative to the current recommended materiel solution (i.e., the FSR) in a field setting that approximates the operational conditions under which the ration will be consumed. Specifically, the proposed effort will compare energy intake, energy balance, physical performance, appetite, ration acceptability, and gastrointestinal responses in military personnel randomized to consume the CCAR or FSR in a multi-day training environment.

Participants will be randomized to consume the CCAR or FSR during a 7-day field training exercise. Physical performance will be assessed PRE and POST by the Running-Based Anaerobic Sprint Test, lower-body strength pull, and vertical jump. A subset of participants will consume doubly-labeled water and provide urine samples throughout the study period to measure energy expenditure. Appetite, ration acceptability, and gastrointestinal symptoms will be assessed by daily surveys. Energy intake will be measured by review of uneaten ration products and daily logs.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Close Combat Assault Ration
The CCAR will be consumed as the sole nutrition source during a 7-day physically demanding military training exercise
Other: CCAR
The CCAR will be consumed as the sole source of nutrition during a 7-day military training exercise.
Active Comparator: First Strike Ration
The FSR will be consumed as the sole nutrition source during a 7-day physically demanding military training exercise
Other: FSR
The FSR will be consumed as the sole source of nutrition during a 7-day military training exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Energy intake
Time Frame: From study day 1 through 7
Energy intake will be measured with daily food records and a review of food waste.
From study day 1 through 7
Energy expenditure
Time Frame: From baseline to study day 7
Energy expenditure will be measured using the doubly-labeled water method.
From baseline to study day 7
Energy balance
Time Frame: From baseline to study day 7.
Energy balance will measure the difference between energy intake and expenditure.
From baseline to study day 7.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical performance (vertical jump)
Time Frame: At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)
The maximum height of the vertical jump will be measured in cm.
At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)
Physical performance (peak power)
Time Frame: At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)

Peak power will be calculated from the vertical jump measure using the following equation:

Peak Power (Watts) = [60.7 x jump height (cm)] + [45.3 x body mass (kg)] - 2055
At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)
Physical performance (Anaerobic capacity)
Time Frame: At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)
Anaerobic capacity will be measured by the time to complete the Running-Based Anaerobic Sprint Test.
At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)
Physical performance (lower-body strength)
Time Frame: At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)
Lower-body isometric strength will be measured using a Takei Back and Leg Dynamometer. The maximum strength (kg) during three trials will be used for analysis.
At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)
Food acceptance scale
Time Frame: From study day 1 through 7
Food acceptance will be measured using a version of the Food Action Rating Scale. The Food Action Rating Scale is a Likert scale that measures food acceptance on a scale of 1-9. The scale ranges from dislike extremely (1) to like extremely (9).
From study day 1 through 7
Gastrointestinal Quality of Life Index
Time Frame: From baseline to study day 8
Gastrointestinal quality of life will be measured using a modified version of the Gastrointestinal Quality of Life Index (GIQLI). Ratings of abdominal bloating, pain, nausea, and gastrointestinal discomfort will be assessed using a 100mm visual analog scale with values corresponding a range of symptoms (0; no symptoms to 100; extremely severe). The sum of the scores will represent GIQLI.
From baseline to study day 8
Hunger and Satiety Visual Analog Scales
Time Frame: From baseline to study day 8
Ratings of subjective appetite sensations will be measured using 100 mm visual analog scales (VAS). Subjective ratings of hunger, fullness, desire to eat, and capacity to eat will be annotated on a 100mm line ranging from none (e.g., 0; Not at all hungry) to extremely (e.g., 100; extremely full).
From baseline to study day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Army Research Institute of Environmental Medicine

Investigators

  • Principal Investigator: Michael A Dawson, PhD, United States Army Research Institute of Environmental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 22, 2024

Primary Completion (Estimated)

March 4, 2024

Study Completion (Estimated)

March 4, 2024

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Estimated)

February 15, 2024

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • M-11053
  • MO230060 (Other Grant/Funding Number: Military Operational Medicine Research Program (MOMRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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