search
Back to results

Physiological Response to Protein and Energy-enhanced Food Products During Winter Military Training

Primary Purpose

Military Operational Stress Reaction, Malnutrition (Calorie), Weight Loss

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
EAA
Energy Dense
Control
Sponsored by
United States Army Research Institute of Environmental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Military Operational Stress Reaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male and female Norwegian Soldiers aged 18 years or older participating in the winter training exercise at the Garrison in Sør-Varanger.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Garrison in Sør-Varanger

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

EAA-enhanced food products

Energy dense food products

Control food products

Arm Description

Consume approximately 1500 calories of EAA-enhanced food products plus ad libitum consumption of 3 combat rations each day during training.

Consume approximately 1500 calories of energy dense food products plus ad libitum consumption of 3 combat rations each day during training.

Consume approximately 1500 calories of low energy dense food products plus ad libitum consumption of 3 combat rations each day during training.

Outcomes

Primary Outcome Measures

Protein balance
Use stable isotope methodologies to measure whole-body protein balance
Energy Expenditure
Use stable isotope methodologies to measure energy expenditure during the training exercise.
Energy intake
Use food logs and collect food wrappers to measure energy intake during the training exercise.

Secondary Outcome Measures

Intestinal Permeability
Use dual sugar test (i.e., sucralose and erythritol) to measure intestinal permeability
Gut microbiome composition
Measure changes in fecal bacterial community, diversity, and relative abundance
Vertical jump
Measure changes in physical performance as determined by a vertical jump test
Pull Strength Test
Measure changes in physical performance as determined by a pull strength test

Full Information

First Posted
December 9, 2021
Last Updated
May 24, 2022
Sponsor
United States Army Research Institute of Environmental Medicine
Collaborators
Norwegian Defense Research Establishment, University of Arkansas
search

1. Study Identification

Unique Protocol Identification Number
NCT05210205
Brief Title
Physiological Response to Protein and Energy-enhanced Food Products During Winter Military Training
Official Title
Physiological Efficacy and Acceptability of Essential Amino Acid-enhanced and Energy Density-enhanced Combat Ration Products During Multi-stressor Operations
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 13, 2022 (Actual)
Primary Completion Date
March 26, 2022 (Actual)
Study Completion Date
March 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Research Institute of Environmental Medicine
Collaborators
Norwegian Defense Research Establishment, University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Up to 96 Norwegian Soldiers participating in a winter training exercise at the Garrison in Sør-Varanger (GSV) will be enrolled in an approximately 11-day, randomized controlled study. Participants will be randomly assigned at the beginning of the training exercise to groups provided 3 Norwegian Army arctic combat rations and approximately 1500 supplemental calories from food products with increased energy density (EN-DENSE), increased essential amino acids (EAA), or low energy density (CONTROL) each day. Participants will be instructed to consume all of the supplemental food products provided to them and consume the arctic combat rations ad libitum. The effect of consuming EN-DENSE, EAA, or CONTROL food products during strenuous military training on physiological status and recovery will be assessed using dietary analysis, stable isotope methodologies, physical performance measures, gut health analyses, blood sampling, and questionnaires. This design will test the hypothesis that 1) EN-DENSE ration products will attenuate the energy deficit during the training, thereby limiting whole-body protein losses and decrements in physiological status; and 2) the protein-sparing benefit of EAA will limit whole-body protein loss regardless of the energy deficit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Military Operational Stress Reaction, Malnutrition (Calorie), Weight Loss, Muscle Wasting

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EAA-enhanced food products
Arm Type
Experimental
Arm Description
Consume approximately 1500 calories of EAA-enhanced food products plus ad libitum consumption of 3 combat rations each day during training.
Arm Title
Energy dense food products
Arm Type
Experimental
Arm Description
Consume approximately 1500 calories of energy dense food products plus ad libitum consumption of 3 combat rations each day during training.
Arm Title
Control food products
Arm Type
Active Comparator
Arm Description
Consume approximately 1500 calories of low energy dense food products plus ad libitum consumption of 3 combat rations each day during training.
Intervention Type
Dietary Supplement
Intervention Name(s)
EAA
Intervention Description
EAA-enhanced protein snack bars
Intervention Type
Dietary Supplement
Intervention Name(s)
Energy Dense
Intervention Description
Energy dense snack bars (same calories in a smaller volume of food)
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Low energy dense snack bars (same calories in a greater volume of food)
Primary Outcome Measure Information:
Title
Protein balance
Description
Use stable isotope methodologies to measure whole-body protein balance
Time Frame
10 hours
Title
Energy Expenditure
Description
Use stable isotope methodologies to measure energy expenditure during the training exercise.
Time Frame
8 days
Title
Energy intake
Description
Use food logs and collect food wrappers to measure energy intake during the training exercise.
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Intestinal Permeability
Description
Use dual sugar test (i.e., sucralose and erythritol) to measure intestinal permeability
Time Frame
24 hours
Title
Gut microbiome composition
Description
Measure changes in fecal bacterial community, diversity, and relative abundance
Time Frame
Study days -1 and 9
Title
Vertical jump
Description
Measure changes in physical performance as determined by a vertical jump test
Time Frame
Study day 0 and 9
Title
Pull Strength Test
Description
Measure changes in physical performance as determined by a pull strength test
Time Frame
Study day 0 and 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male and female Norwegian Soldiers aged 18 years or older participating in the winter training exercise at the Garrison in Sør-Varanger. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily E Howard, PhD
Organizational Affiliation
United States Army Research Institute of Environmental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Garrison in Sør-Varanger
City
Kirkenes
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Physiological Response to Protein and Energy-enhanced Food Products During Winter Military Training

We'll reach out to this number within 24 hrs