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

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.

Study Overview

• Status: Completed
• Conditions: Weight Loss; Military Operational Stress Reaction; Malnutrition (Calorie); Muscle Wasting
• Intervention / Treatment: Dietary supplement: EAA; Dietary supplement: Energy Dense; Dietary supplement: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Kirkenes, Norway
    • Garrison in Sør-Varanger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EAA-enhanced food products; Consume approximately 1500 calories of EAA-enhanced food products plus ad libitum consumption of 3 combat rations each day during training.	Dietary supplement: EAA; EAA-enhanced protein snack bars
Experimental: Energy dense food products; Consume approximately 1500 calories of energy dense food products plus ad libitum consumption of 3 combat rations each day during training.	Dietary supplement: Energy Dense; Energy dense snack bars (same calories in a smaller volume of food)
Active Comparator: Control food products; Consume approximately 1500 calories of low energy dense food products plus ad libitum consumption of 3 combat rations each day during training.	Dietary supplement: Control; Low energy dense snack bars (same calories in a greater volume of food)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intestinal Permeability	Use dual sugar test (i.e., sucralose and erythritol) to measure intestinal permeability	24 hours
Gut microbiome composition	Measure changes in fecal bacterial community, diversity, and relative abundance	Study days -1 and 9
Vertical jump	Measure changes in physical performance as determined by a vertical jump test	Study day 0 and 9
Pull Strength Test	Measure changes in physical performance as determined by a pull strength test	Study day 0 and 9

Collaborators and Investigators

• Sponsor: United States Army Research Institute of Environmental Medicine
• Collaborators: University of Arkansas; Norwegian Defense Research Establishment
• Investigators: Principal Investigator: Emily E Howard, PhD, United States Army Research Institute of Environmental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2022
• Primary Completion (Actual): March 26, 2022
• Study Completion (Actual): March 26, 2022

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Nutrition Disorders; Body Weight; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Body Weight Changes; Atrophy; Weight Loss; Muscular Atrophy; Malnutrition; Fractures, Stress
• Other Study ID Numbers: 21-19HC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No