MRE Consumption and Gut Health

April 14, 2019 updated by: James Philip Karl, United States Army Research Institute of Environmental Medicine

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Natick, Massachusetts, United States, 01760
        • USARIEM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual diet
Experimental: MRE
MRE consumption
Other: MRE
MRE consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to 10 days, 21 days and 31 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United States Army Research Institute of Environmental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

April 17, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 14, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15-12HC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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