MRE Consumption and Gut Health

Gastrointestinal Tract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423551
• Other study ID #: 15-12HC
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: February 2017

Study information

• Verified date: April 2019
• Source: United States Army Research Institute of Environmental Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Tract

Intervention

Other:
• MRE
MRE consumption

Locations

Country	Name	City	State
United States	USARIEM	Natick	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Research Institute of Environmental Medicine

Country where clinical trial is conducted

United States, 

Outcome

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