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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physiological Efficacy and Acceptability of Essential Amino Acid-enhanced and Energy Density-enhanced Combat Ration Products During Multi-stressor Operations

Conditions
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Military Operational Stress Reaction, Malnutrition (Calorie), Weight Loss, Muscle Wasting

Intervention / Treatment
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* Dietary Supplement: EAA
* Dietary Supplement: Energy Dense
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |