MRE Consumption and Gut Health

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastrointestinal Tract

Intervention / Treatment
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* Other: MRE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 62 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual diet | |
| Experimental: MRE<br>MRE consumption | Other: MRE<br>* MRE consumption<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gut barrier integrity | Urine excretion of saccharide probes; circulating zonulin, intestinal fatty acid binding protein, claudin-3, lipopolysaccharide and GLP2 concentrations | Baseline to 10 days, 21 days and 31 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gut microbiota composition | 16S rRNA gene sequencing | Baseline to 10 days, 21 days and 31 days | 
| Change in C-reactive protein concentrations | Serum C-reactive protein | Baseline to 10 days, 21 days and 31 days | 
| Change in TNF-alpha concentrations | Serum TNF-alpha | Baseline to 10 days, 21 days and 31 days | 
| Change in interleukin-6 concentrations | Serum IL-6 | Baseline to 10 days, 21 days and 31 days | 
| Change in lipopolysaccharide concentrations | Plasma LPS | Baseline to 10 days, 21 days and 31 days | 
| Change in iron status | Blood ferritin, soluble transferrin receptor, hemoglobin, hematocrit | Baseline to 10 days, 21 days and 31 days | 
| Change in vitamin D status | Blood 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone | Baseline to 10 days, 21 days and 31 days | 
| Change in B-vitamin status | Blood folate, vitamin B12, homocysteine | Baseline to 10 days, 21 days and 31 days | 
| Change in nutritional status | Blood prealbumin | Baseline to 10 days, 21 days and 31 days | 
| Change in calcium absorption | Urine calcium | Baseline to 10 days, 21 days and 31 days | 
| Change in zinc status | Blood zinc, zinc receptor expression | Baseline to 10 days, 21 days and 31 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut microbiota, Intestinal permeability, Gut barrier integrity