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Completed

NCT Number: NCT02423551

MRE Consumption and Gut Health

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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Key information

Age range

18 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USARIEM

Natick, Massachusetts, 01760, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI </= 30

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

Treatment and study plan

MRE

Other

MRE consumption

Primary outcomes

  1. Change in gut barrier integrity

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

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

Secondary outcomes

  1. Change in gut microbiota composition

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

    16S rRNA gene sequencing

  2. Change in C-reactive protein concentrations

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

    Serum C-reactive protein

  3. Change in TNF-alpha concentrations

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

    Serum TNF-alpha

  4. Change in interleukin-6 concentrations

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

    Serum IL-6

  5. Change in lipopolysaccharide concentrations

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

    Plasma LPS

  6. Change in iron status

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

    Blood ferritin, soluble transferrin receptor, hemoglobin, hematocrit

  7. Change in vitamin D status

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

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

  8. Change in B-vitamin status

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

    Blood folate, vitamin B12, homocysteine

  9. Change in nutritional status

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

    Blood prealbumin

  10. Change in calcium absorption

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

    Urine calcium

  11. Change in zinc status

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

    Blood zinc, zinc receptor expression

Sponsors and collaborators

Lead sponsor

United States Army Research Institute of Environmental Medicine

Fed

Registry information

Official study title

Effects of Meal, Ready-to-Eat (MRE) Consumption on Gut Health

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 22, 2015
Registry last updated
Apr 16, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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