protocolSection identificationModule nctId: NCT06261437, orgStudyIdInfo id: M-11053, secondaryIdInfos id: MO230060, type: OTHER_GRANT, domain: Military Operational Medicine Research Program (MOMRP), briefTitle: Effect of Ration Formulations on Warfighter Energy Balance and Physical Performance During a Field Training Exercise, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-22, primaryCompletionDateStruct date: 2024-03-04, completionDateStruct date: 2024-03-04, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: United States Army Research Institute of Environmental Medicine, class: FED, descriptionModule briefSummary: 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., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: CCAR, interventions name: FSR, outcomesModule primaryOutcomes measure: Energy intake, primaryOutcomes measure: Energy expenditure, primaryOutcomes measure: Energy balance, secondaryOutcomes measure: Physical performance (vertical jump), secondaryOutcomes measure: Physical performance (peak power), secondaryOutcomes measure: Physical performance (Anaerobic capacity), secondaryOutcomes measure: Physical performance (lower-body strength), secondaryOutcomes measure: Food acceptance scale, secondaryOutcomes measure: Gastrointestinal Quality of Life Index, secondaryOutcomes measure: Hunger and Satiety Visual Analog Scales, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: U.S. Army Research Institute of Environmental Medicine, city: Natick, state: Massachusetts, zip: 01760, country: United States, contacts name: USARIEM, role: CONTACT, phone: 508-206-2200, email: usarmy.natick.medcom-usariem.mbx.usariem-webmaster@health.mil, contacts name: Michael A Dawson, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.28343, lon: -71.3495, hasResults: False