Military Operational Stress ReactionNCT05210205
Physiological Response to Protein and Energy-enhanced Food Products During Winter Military Training
A study testing EAA and Energy Dense in people with Military Operational Stress Reaction and Malnutrition (Calorie), run by United States Army Research Institute of Environmental Medicine at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Military Operational Stress Reaction, Malnutrition (Calorie), Weight Loss
- What is being tested?
- EAA and Energy Dense
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteNorway
- Study dates
- 13 Mar 2022to 26 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female Norwegian Soldiers aged 18 years or older participating in the winter training exercise at the Garrison in Sør-Varanger.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- EAA, Energy Dense, Control
- Medical subject headings
- Malnutrition, Weight Loss, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EAADietary supplement
EAA-enhanced protein snack bars
Energy DenseDietary supplement
Energy dense snack bars (same calories in a smaller volume of food)
ControlDietary supplement
Low energy dense snack bars (same calories in a greater volume of food)
| Study group | Role | What they receive |
|---|---|---|
| EAA-enhanced food products | Experimental | Consume approximately 1500 calories of EAA-enhanced food products plus ad libitum consumption of 3 combat rations each day during training. Receives: Dietary Supplement: EAA |
| Energy dense food products | Experimental | Consume approximately 1500 calories of energy dense food products plus ad libitum consumption of 3 combat rations each day during training. Receives: Dietary Supplement: Energy Dense |
| Control food products | Active comparator | Consume approximately 1500 calories of low energy dense food products plus ad libitum consumption of 3 combat rations each day during training. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein balance
Use stable isotope methodologies to measure whole-body protein balance
Measured: 10 hours
Energy Expenditure
Use stable isotope methodologies to measure energy expenditure during the training exercise.
Measured: 8 days
Energy intake
Use food logs and collect food wrappers to measure energy intake during the training exercise.
Measured: 8 days
Secondary outcomes (4)
Intestinal Permeability
Use dual sugar test (i.e., sucralose and erythritol) to measure intestinal permeability
Measured: 24 hours
Gut microbiome composition
Measure changes in fecal bacterial community, diversity, and relative abundance
Measured: Study days -1 and 9
Vertical jump
Measure changes in physical performance as determined by a vertical jump test
Measured: Study day 0 and 9
Pull Strength Test
Measure changes in physical performance as determined by a pull strength test
Measured: Study day 0 and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start13 Mar 2022
- Primary completion26 Mar 2022
- Study completion26 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Military Operational Stress ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Collaborators
- Norwegian Defense Research Establishment, University of Arkansas
- Responsible party
- Sponsor
- Investigators
- Emily E Howard, PhD, Principal investigator, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210205
- Sponsor's protocol ID
- 21-19HC
- Status last verified
- May 2022
- First submitted
- 9 Dec 2021
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Margolis LM, Teien HK, Hatch-McChesney A, Robillard JT, Murphy NE, Carrigan CT, Tanso R, Varanoske AN, Martini S, Stenberg PH, Karl JP, Gwin JA, Ferrando AA, Pasiakos SM, Howard EE. Changes in Circulating MicroRNA Profiles During Arctic Military Training Target Inflammatory Pathways Independent of Macronutrient Intake. J Nutr. 2026 Jul;156(7):101602. doi: 10.1016/j.tjnut.2026.101602. Epub 2026 May 22.
PubMed 42176985Howard EE, Teien HK, Hatch-McChesney A, Robillard JT, Murphy NE, Carrigan CT, Tanso R, Varanoske AN, Martini S, Stenberg PH, Karl JP, Gwin JA, Margolis LM, Ferrando AA, Pasiakos SM. Whole-Body Protein Balance during Arctic Military Training Is Unaffected by Dietary Essential Amino Acid or Energy Density. J Nutr. 2026 Jun;156(6):101514. doi: 10.1016/j.tjnut.2026.101514. Epub 2026 Apr 1.
PubMed 41932364
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Efficacy and Acceptability of Essential Amino Acid-enhanced and Energy Density-enhanced Combat Ration Products During Multi-stressor Operations
- ClinicalTrials.gov ID
- NCT05210205
- Acronym / sponsor ID
- 21-19HC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Collaborators
- Norwegian Defense Research Establishment, University of Arkansas
- Study start
- 13 Mar 2022 (actual)
- Primary completion
- 26 Mar 2022 (actual)
- Study completion
- 26 Mar 2022 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EAA-enhanced food products | Experimental | Dietary Supplement: EAAConsume approximately 1500 calories of EAA-enhanced food products plus ad libitum consumption of 3 combat rations each day during training. |
| Energy dense food products | Experimental | Dietary Supplement: Energy DenseConsume approximately 1500 calories of energy dense food products plus ad libitum consumption of 3 combat rations each day during training. |
| Control food products | Active comparator | Dietary Supplement: ControlConsume approximately 1500 calories of low energy dense food products plus ad libitum consumption of 3 combat rations each day during training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female Norwegian Soldiers aged 18 years or older participating in the winter training exercise at the Garrison in Sør-Varanger.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EAAEAA-enhanced protein snack bars | Dietary supplement | EAA-enhanced food products |
| Energy DenseEnergy dense snack bars (same calories in a smaller volume of food) | Dietary supplement | Energy dense food products |
| ControlLow energy dense snack bars (same calories in a greater volume of food) | Dietary supplement | Control food products |
Primary outcome
Protein balance
Time frame: 10 hours
Use stable isotope methodologies to measure whole-body protein balance
Energy Expenditure
Time frame: 8 days
Use stable isotope methodologies to measure energy expenditure during the training exercise.
Energy intake
Time frame: 8 days
Use food logs and collect food wrappers to measure energy intake during the training exercise.
4 secondary outcomes
Intestinal Permeability
Time frame: 24 hours
Gut microbiome composition
Time frame: Study days -1 and 9
Vertical jump
Time frame: Study day 0 and 9
Pull Strength Test
Time frame: Study day 0 and 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Derived from this study: PubMed 42176985Margolis LM, Teien HK, Hatch-McChesney A, Robillard JT, Murphy NE, Carrigan CT, Tanso R, Varanoske AN, Martini S, Stenberg PH, Karl JP, Gwin JA, Ferrando AA, Pasiakos SM, Howard EE. Changes in Circulating MicroRNA Profiles During Arctic Military Training Target Inflammatory Pathways Independent of Macronutrient Intake. J Nutr. 2026 Jul;156(7):101602. doi: 10.1016/j.tjnut.2026.101602. Epub 2026 May 22.
- Derived from this study: PubMed 41932364Howard EE, Teien HK, Hatch-McChesney A, Robillard JT, Murphy NE, Carrigan CT, Tanso R, Varanoske AN, Martini S, Stenberg PH, Karl JP, Gwin JA, Margolis LM, Ferrando AA, Pasiakos SM. Whole-Body Protein Balance during Arctic Military Training Is Unaffected by Dietary Essential Amino Acid or Energy Density. J Nutr. 2026 Jun;156(6):101514. doi: 10.1016/j.tjnut.2026.101514. Epub 2026 Apr 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily E Howard, PhD principal investigator
United States Army Research Institute of Environmental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EAA and Energy Dense in people with Military Operational Stress Reaction and Malnutrition (Calorie), run by United States Army Research Institute of Environmental Medicine at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein balance (time frame: 10 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05210205, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.