Effects of Meal, Ready-to-Eat (MRE) Consumption on Gut Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Change in gut barrier integrity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 62 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
MRE
MRE consumption
Intervention: MRE (Other)
Control
Usual diet
Outcomes
Primary Outcomes
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
- Change in vitamin D status(Baseline to 10 days, 21 days and 31 days)
- Change in nutritional status(Baseline to 10 days, 21 days and 31 days)
- Change in interleukin-6 concentrations(Baseline to 10 days, 21 days and 31 days)
- Change in lipopolysaccharide concentrations(Baseline to 10 days, 21 days and 31 days)
- Change in iron status(Baseline to 10 days, 21 days and 31 days)
- Change in B-vitamin status(Baseline to 10 days, 21 days and 31 days)
- Change in zinc status(Baseline to 10 days, 21 days and 31 days)
- Change in gut microbiota composition(Baseline to 10 days, 21 days and 31 days)
- Change in TNF-alpha concentrations(Baseline to 10 days, 21 days and 31 days)
- Change in calcium absorption(Baseline to 10 days, 21 days and 31 days)
- Change in C-reactive protein concentrations(Baseline to 10 days, 21 days and 31 days)
Investigators
James Philip Karl
Research Dietitian
United States Army Research Institute of Environmental Medicine