Healthy VolunteersNCT06261437
Effect of Ration Formulations on Warfighter Energy Balance and Physical Performance During a Field Training Exercise
A study testing CCAR and FSR in people with Healthy Volunteers, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CCAR and FSR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2024to 4 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S. Army Research Institute of Environmental Medicine
Natick, Massachusetts, 01760
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- CCAR, FSR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCAROther
The CCAR will be consumed as the sole source of nutrition during a 7-day military training exercise.
FSROther
The FSR will be consumed as the sole source of nutrition during a 7-day military training exercise.
| Study group | Role | What they receive |
|---|---|---|
| Close Combat Assault Ration | Experimental | The CCAR will be consumed as the sole nutrition source during a 7-day physically demanding military training exercise Receives: 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 Receives: Other: FSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
Energy intake will be measured with daily food records and a review of food waste.
Measured: From study day 1 through 7
Energy expenditure
Energy expenditure will be measured using the doubly-labeled water method.
Measured: From baseline to study day 7
Energy balance
Energy balance will measure the difference between energy intake and expenditure.
Measured: From baseline to study day 7.
Secondary outcomes (7)
Physical performance (vertical jump)
The maximum height of the vertical jump will be measured in cm.
Measured: At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)
Physical performance (peak power)
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
Measured: At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)
Physical performance (Anaerobic capacity)
Anaerobic capacity will be measured by the time to complete the Running-Based Anaerobic Sprint Test.
Measured: At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)
Physical performance (lower-body strength)
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.
Measured: At baseline (PRE) and POST the 7-day FTX (i.e., study day 8)
Food acceptance scale
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).
Measured: From study day 1 through 7
Gastrointestinal Quality of Life Index
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.
Measured: From baseline to study day 8
Hunger and Satiety Visual Analog Scales
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).
Measured: From baseline to study day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start22 Feb 2024
- Primary completion4 Mar 2024
- Study completion4 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michael A Dawson, PhD, Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261437
- Sponsor's protocol ID
- M-11053
- Other IDs
- MO230060
- Status last verified
- Mar 2025
- First submitted
- 29 Jan 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23713532Hoyt 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.
PubMed 8160893Karl 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.
PubMed 33441218Dawson MA, Hatch-McChesney A, Ndou TV, McNiff J, Broaddus JHP, Howard EE, Karl JP, Margolis LM, Smith TJ, McClung JP, Jayne JM. Higher Fat Ration Formulations Minimize Energy Deficit During a Short Field Training Exercise. Mil Med. 2026 Apr 1:usag134. doi: 10.1093/milmed/usag134. Online ahead of print.
PubMed 41921503
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ration Formulations on Warfighter Energy Balance and Physical Performance During a Field Training Exercise
- ClinicalTrials.gov ID
- NCT06261437
- Acronym / sponsor ID
- M-11053
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 4 Mar 2024 (actual)
- Study completion
- 4 Mar 2024 (actual)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Close Combat Assault Ration | Experimental | Other: CCARThe CCAR will be consumed as the sole nutrition source during a 7-day physically demanding military training exercise |
| First Strike Ration | Active comparator | Other: FSRThe FSR will be consumed as the sole nutrition source during a 7-day physically demanding military training exercise |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCARThe CCAR will be consumed as the sole source of nutrition during a 7-day military training exercise. | Other | Close Combat Assault Ration |
| FSRThe FSR will be consumed as the sole source of nutrition during a 7-day military training exercise. | Other | First Strike Ration |
Primary outcome
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.
Energy expenditure
Time frame: From baseline to study day 7
Energy expenditure will be measured using the doubly-labeled water method.
Energy balance
Time frame: From baseline to study day 7.
Energy balance will measure the difference between energy intake and expenditure.
7 secondary outcomes
Physical performance (vertical jump)
Time frame: 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)
Physical performance (Anaerobic capacity)
Time frame: 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)
Food acceptance scale
Time frame: From study day 1 through 7
Gastrointestinal Quality of Life Index
Time frame: From baseline to study day 8
Hunger and Satiety Visual Analog Scales
Time frame: From baseline to study day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Background: PubMed 23713532Margolis 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.
- Background: PubMed 8160893Hoyt 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.
- Background: PubMed 33441218Karl 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.
- Derived from this study: PubMed 41921503Dawson MA, Hatch-McChesney A, Ndou TV, McNiff J, Broaddus JHP, Howard EE, Karl JP, Margolis LM, Smith TJ, McClung JP, Jayne JM. Higher Fat Ration Formulations Minimize Energy Deficit During a Short Field Training Exercise. Mil Med. 2026 Apr 1:usag134. doi: 10.1093/milmed/usag134. Online ahead of print.
- Individual participant dataSharing planned: No
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Dawson, PhD principal investigator
United States Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCAR and FSR in people with Healthy Volunteers, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy intake (time frame: From study day 1 through 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06261437, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.