Physiological Response to Protein and Energy-enhanced Food Products During Winter Military Training
Physiological Efficacy and Acceptability of Essential Amino Acid-enhanced and Energy Density-enhanced Combat Ration Products During Multi-stressor Operations
1 other identifier
interventional
68
1 country
1
Brief Summary
Soldiers commonly lose muscle mass during training and combat operations that produce large energy deficits (i.e., calories burned \> calories consumed). Developing new combat ration products that increase energy intake (i.e., energy dense foods) or the amount and quality of protein consumed (i.e., essential amino acid \[EAA\] content) may prevent muscle breakdown and stimulate muscle repair and muscle maintenance during unavoidable energy deficit. The primary objective of this study is to determine the effects of prototype recovery food products that are energy dense or that provide increased amounts of EAAs (anabolic component of dietary protein) on energy balance, whole-body net protein balance, and indices of physiological status during strenuous winter military training.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2021
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedStudy Start
First participant enrolled
March 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2022
CompletedMay 26, 2022
May 1, 2022
13 days
December 9, 2021
May 24, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Protein balance
Use stable isotope methodologies to measure whole-body protein balance
10 hours
Energy Expenditure
Use stable isotope methodologies to measure energy expenditure during the training exercise.
8 days
Energy intake
Use food logs and collect food wrappers to measure energy intake during the training exercise.
8 days
Secondary Outcomes (4)
Intestinal Permeability
24 hours
Gut microbiome composition
Study days -1 and 9
Vertical jump
Study day 0 and 9
Pull Strength Test
Study day 0 and 9
Study Arms (3)
EAA-enhanced food products
EXPERIMENTALConsume approximately 1500 calories of EAA-enhanced food products plus ad libitum consumption of 3 combat rations each day during training.
Energy dense food products
EXPERIMENTALConsume approximately 1500 calories of energy dense food products plus ad libitum consumption of 3 combat rations each day during training.
Control food products
ACTIVE COMPARATORConsume approximately 1500 calories of low energy dense food products plus ad libitum consumption of 3 combat rations each day during training.
Interventions
Energy dense snack bars (same calories in a smaller volume of food)
Low energy dense snack bars (same calories in a greater volume of food)
Eligibility Criteria
You may qualify if:
- Male and female Norwegian Soldiers aged 18 years or older participating in the winter training exercise at the Garrison in Sør-Varanger.
You may not qualify if:
- Any injury or health condition limiting full participation in the training program.
- Allergies or intolerance to foods used in the study (including but not limited to lactose intolerance/milk allergy) or vegetarian practices.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Garrison in Sør-Varanger
Kirkenes, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emily E Howard, PhD
United States Army Research Institute of Environmental Medicine
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
December 9, 2021
First Posted
January 27, 2022
Study Start
March 13, 2022
Primary Completion
March 26, 2022
Study Completion
March 26, 2022
Last Updated
May 26, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share