Gastrointestinal Tract
Conditions
Keywords
Gut microbiota, Intestinal permeability, Gut barrier integrity
Brief 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.
Interventions
OTHERMRE
MRE consumption
Sponsors
United States Army Research Institute of Environmental Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 62 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in gut barrier integrity | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in C-reactive protein concentrations | Baseline to 10 days, 21 days and 31 days | Serum C-reactive protein |
| Change in TNF-alpha concentrations | Baseline to 10 days, 21 days and 31 days | Serum TNF-alpha |
| Change in interleukin-6 concentrations | Baseline to 10 days, 21 days and 31 days | Serum IL-6 |
| Change in lipopolysaccharide concentrations | Baseline to 10 days, 21 days and 31 days | Plasma LPS |
| Change in iron status | Baseline to 10 days, 21 days and 31 days | Blood ferritin, soluble transferrin receptor, hemoglobin, hematocrit |
| Change in gut microbiota composition | Baseline to 10 days, 21 days and 31 days | 16S rRNA gene sequencing |
| Change in B-vitamin status | Baseline to 10 days, 21 days and 31 days | Blood folate, vitamin B12, homocysteine |
| Change in nutritional status | Baseline to 10 days, 21 days and 31 days | Blood prealbumin |
| Change in calcium absorption | Baseline to 10 days, 21 days and 31 days | Urine calcium |
| Change in zinc status | Baseline to 10 days, 21 days and 31 days | Blood zinc, zinc receptor expression |
| Change in vitamin D status | Baseline to 10 days, 21 days and 31 days | Blood 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone |
Countries
United States
Outcome results
None listed