MRE Consumption and Gut Health

Not Applicable

Completed

• Conditions: Gastrointestinal Tract
• Interventions: Other: MRE

• Registration Number: NCT02423551
• Lead Sponsor: United States Army Research Institute of Environmental Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-17
• Study First Posted: 2015-04-22
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-14
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRE	MRE	MRE consumption

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in vitamin D status	Baseline to 10 days, 21 days and 31 days	Blood 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone
Change in nutritional status	Baseline to 10 days, 21 days and 31 days	Blood prealbumin
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 B-vitamin status	Baseline to 10 days, 21 days and 31 days	Blood folate, vitamin B12, homocysteine
Change in zinc status	Baseline to 10 days, 21 days and 31 days	Blood zinc, zinc receptor expression
Change in gut microbiota composition	Baseline to 10 days, 21 days and 31 days	16S rRNA gene sequencing
Change in TNF-alpha concentrations	Baseline to 10 days, 21 days and 31 days	Serum TNF-alpha
Change in calcium absorption	Baseline to 10 days, 21 days and 31 days	Urine calcium
Change in C-reactive protein concentrations	Baseline to 10 days, 21 days and 31 days	Serum C-reactive protein

Trial Locations

Locations (1)

USARIEM; 🇺🇸 Natick, Massachusetts, United States