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CompletedNCT02423551Updated Apr 16, 2019

MRE Consumption and Gut Health

An interventional study of MRE in Gastrointestinal Tract, sponsored by United States Army Research Institute of Environmental Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 62 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-16.

Sponsored by United States Army Research Institute of Environmental Medicine · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years to 62 Years
Sex
All
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Study summary

The objective of this study is to determine the impact of consuming MREs as the sole source of subsistence for 21 days on gut bacteria community composition and gut health. Up to 80 free-living adults will be randomized to consume their usual diet or only MREs for 21 consecutive days. MREs will be provided by the Military Nutrition Division, US Army Research Institute of Environmental Medicine (USARIEM). Fecal, urine and blood samples will be collected periodically before, during and after the intervention to measure gut barrier integrity, gut bacteria community composition, and markers of gut health, inflammation, and nutritional status.

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Conditions studied

  • Gastrointestinal Tract

Keywords

  • Gut microbiota
  • Intestinal permeability
  • Gut barrier integrity
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In context

Lead sponsor

United States Army Research Institute of Environmental Medicine is the lead sponsor of 67 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 62 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • BMI \</= 30

Exclusion criteria

Exclusion Criteria:

  • Use of antiobiotcs within 3 months of study participation
  • Use of pro- or prebiotic supplements within 2 weeks of study participation
  • Vegetarian diets
  • Use of laxatives, stool softeners, or anti-diarrheal medications at least once a week.
  • Fewer than 4 bowel movements, on average, per week
  • History of gastrointestinal disease
  • Colonoscopy within 3 months of study participation
  • Food allergies or aversions or other issues with foods that would preclude MRE consumption, including gluten, milk, nuts, or eggs.
  • Use non-steroidal anti-inflammatory medications (NSAIDs) or antihistamine prescribed by a physician or clinician, or unwillingness to discontinue the use of these substances during the study.
  • Actively trying to lose weight
  • Pregnant or lactating
  • Recent blood donation
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
71 participants (actual)

Study arms

  • No intervention
    Control

    Usual diet

  • Experimental
    MRE

    MRE consumption

    Other: MRE

Interventions

  • OtherMRE

    MRE consumption

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What researchers measure

Primary outcomes

  1. Change in gut barrier integrity

    Urine excretion of saccharide probes; circulating zonulin, intestinal fatty acid binding protein, claudin-3, lipopolysaccharide and GLP2 concentrations

    Time frame: Baseline to 10 days, 21 days and 31 days

Secondary outcomes

  1. Change in gut microbiota composition

    16S rRNA gene sequencing

    Time frame: Baseline to 10 days, 21 days and 31 days

  2. Change in C-reactive protein concentrations

    Serum C-reactive protein

    Time frame: Baseline to 10 days, 21 days and 31 days

  3. Change in TNF-alpha concentrations

    Serum TNF-alpha

    Time frame: Baseline to 10 days, 21 days and 31 days

  4. Change in interleukin-6 concentrations

    Serum IL-6

    Time frame: Baseline to 10 days, 21 days and 31 days

  5. Change in lipopolysaccharide concentrations

    Plasma LPS

    Time frame: Baseline to 10 days, 21 days and 31 days

  6. Change in iron status

    Blood ferritin, soluble transferrin receptor, hemoglobin, hematocrit

    Time frame: Baseline to 10 days, 21 days and 31 days

  7. Change in vitamin D status

    Blood 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone

    Time frame: Baseline to 10 days, 21 days and 31 days

  8. Change in B-vitamin status

    Blood folate, vitamin B12, homocysteine

    Time frame: Baseline to 10 days, 21 days and 31 days

  9. Change in nutritional status

    Blood prealbumin

    Time frame: Baseline to 10 days, 21 days and 31 days

  10. Change in calcium absorption

    Urine calcium

    Time frame: Baseline to 10 days, 21 days and 31 days

  11. Change in zinc status

    Blood zinc, zinc receptor expression

    Time frame: Baseline to 10 days, 21 days and 31 days

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Study locations

1 site
  • USARIEM
    Natick, Massachusetts 01760, United States
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References and documents

Publications

  • Karl JP, Armstrong NJ, Player RA, Rood JC, Soares JW, McClung HL. The fecal metabolome links diet composition, food processing and the gut microbiota to gastrointestinal health in a randomized trial of adults consuming a processed diet. J Nutr. 2022 Jul 26:nxac161. doi: 10.1093/jn/nxac161. Online ahead of print. PubMed 35883231 ↗
  • McClung HL, Armstrong NJ, Hennigar SR, Staab JS, Montain SJ, Karl JP. Randomized Trial Comparing Consumption of Military Rations to Usual Intake for 21 Consecutive Days: Nutrient Adequacy and Indicators of Health Status. J Acad Nutr Diet. 2020 Nov;120(11):1791-1804. doi: 10.1016/j.jand.2020.06.018. Epub 2020 Aug 19. PubMed 32828737 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02423551
Lead sponsor
United States Army Research Institute of Environmental Medicine
Responsible party
James Philip Karl (Research Dietitian, United States Army Research Institute of Environmental Medicine) — Principal investigator
First posted
Apr 22, 2015
Start date
Apr 2015
Primary completion
Feb 2017
Completion
Feb 2017
Last update
Apr 16, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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