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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05210205
Enrollment
68
Registered
2022-01-27
Start date
2022-03-13
Completion date
2022-03-26
Last updated
2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIETARY_SUPPLEMENTControl

Low energy dense snack bars (same calories in a greater volume of food)

DIETARY_SUPPLEMENTEAA

EAA-enhanced protein snack bars

DIETARY_SUPPLEMENTEnergy Dense

Energy dense snack bars (same calories in a smaller volume of food)

Sponsors

Norwegian Defense Research Establishment
CollaboratorUNKNOWN
University of Arkansas
CollaboratorOTHER
United States Army Research Institute of Environmental Medicine
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Protein balance10 hoursUse stable isotope methodologies to measure whole-body protein balance
Energy Expenditure8 daysUse stable isotope methodologies to measure energy expenditure during the training exercise.
Energy intake8 daysUse food logs and collect food wrappers to measure energy intake during the training exercise.

Secondary

MeasureTime frameDescription
Intestinal Permeability24 hoursUse dual sugar test (i.e., sucralose and erythritol) to measure intestinal permeability
Pull Strength TestStudy day 0 and 9Measure changes in physical performance as determined by a pull strength test
Gut microbiome compositionStudy days -1 and 9Measure changes in fecal bacterial community, diversity, and relative abundance
Vertical jumpStudy day 0 and 9Measure changes in physical performance as determined by a vertical jump test

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026