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Completed

NCT Number: NCT05210205

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EAA

Dietary Supplement

EAA-enhanced protein snack bars

Energy Dense

Dietary Supplement

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

Control

Dietary Supplement

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

Primary outcomes

  1. Protein balance

    Time frame: 10 hours

    Use stable isotope methodologies to measure whole-body protein balance

  2. Energy Expenditure

    Time frame: 8 days

    Use stable isotope methodologies to measure energy expenditure during the training exercise.

  3. Energy intake

    Time frame: 8 days

    Use food logs and collect food wrappers to measure energy intake during the training exercise.

Secondary outcomes

  1. Intestinal Permeability

    Time frame: 24 hours

    Use dual sugar test (i.e., sucralose and erythritol) to measure intestinal permeability

  2. Gut microbiome composition

    Time frame: Study days -1 and 9

    Measure changes in fecal bacterial community, diversity, and relative abundance

  3. Vertical jump

    Time frame: Study day 0 and 9

    Measure changes in physical performance as determined by a vertical jump test

  4. Pull Strength Test

    Time frame: Study day 0 and 9

    Measure changes in physical performance as determined by a pull strength test

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Collaborators

  • Norwegian Defense Research Establishment
  • University of Arkansas

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2022
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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