Clinical trial NCT02423551: MRE Consumption and Gut Health
Official title: Effects of Meal, Ready-to-Eat (MRE) Consumption on Gut Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tract
Keywords: Gut microbiota
Intestinal permeability
Gut barrier integrity
Lead sponsor: United States Army Research Institute of Environmental Medicine
Sponsor class: FED
First posted: 2015-04-22
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in gut barrier integrity
timeFrame: Baseline to 10 days, 21 days and 31 days
Secondary outcomes:
measure: Change in gut microbiota composition
timeFrame: Baseline to 10 days, 21 days and 31 days
measure: Change in C-reactive protein concentrations
timeFrame: Baseline to 10 days, 21 days and 31 days
measure: Change in TNF-alpha concentrations
timeFrame: Baseline to 10 days, 21 days and 31 days
measure: Change in interleukin-6 concentrations
timeFrame: Baseline to 10 days, 21 days and 31 days
measure: Change in lipopolysaccharide concentrations
timeFrame: Baseline to 10 days, 21 days and 31 days
measure: Change in iron status
timeFrame: Baseline to 10 days, 21 days and 31 days
measure: Change in vitamin D status
timeFrame: Baseline to 10 days, 21 days and 31 days
measure: Change in B-vitamin status
timeFrame: Baseline to 10 days, 21 days and 31 days
measure: Change in nutritional status
timeFrame: Baseline to 10 days, 21 days and 31 days
measure: Change in calcium absorption
timeFrame: Baseline to 10 days, 21 days and 31 days
measure: Change in zinc status
timeFrame: Baseline to 10 days, 21 days and 31 days
Other outcomes:
Locations:
city: Natick
country: United States
facility: USARIEM
state: Massachusetts
Study officials:
References:
citation: 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.
citation: 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.