Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06261437
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-15
First Post:
2024-01-29
Brief Title:
Effect of Ration Formulations on Warfighter Energy Balance and Physical Performance During a Field Training Exercise
Sponsor:
United States Army Research Institute of Environmental Medicine
Organization:
United States Army Research Institute of Environmental Medicine
Study Overview
Official Title:
Effect of Ration Formulations on Warfighter Energy Balance and Physical Performance During a Field Training Exercise
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 kcalsday 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 kcalsd 58 carbohydrate 12 protein 30 fat
This proposed project will evaluate the CCAR relative to the current recommended materiel solution ie 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
The ration will provide approximately 2800 kcalsday 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 kcalsd 58 carbohydrate 12 protein 30 fat
This proposed project will evaluate the CCAR relative to the current recommended materiel solution ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MO230060 | OTHER_GRANT | Military Operational Medicine Research Program MOMRP | None |