NCT02423551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

April 14, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.8 years

First QC Date

April 14, 2015

Last Update Submit

April 14, 2019

Conditions

Gastrointestinal Tract

Keywords

Gut microbiotaIntestinal permeabilityGut barrier integrity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change in gut microbiota composition

    Baseline to 10 days, 21 days and 31 days

  • Change in C-reactive protein concentrations

    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 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

  • +6 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Usual diet

MRE

EXPERIMENTAL

MRE consumption

Other: MRE

Interventions

MREOTHER

MRE consumption

MRE

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \</= 30

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

Location

Related Publications (3)

  • Karl JP, Armstrong NJ, Player RA, Rood JC, Soares JW, McClung HL. The Fecal Metabolome Links Diet Composition, Foacidic positive ion conditions, chromatographicallyod Processing, and the Gut Microbiota to Gastrointestinal Health in a Randomized Trial of Adults Consuming a Processed Diet. J Nutr. 2022 Nov;152(11):2343-2357. doi: 10.1093/jn/nxac161. Epub 2022 Jul 26.

    PMID: 36774101DERIVED

  • Pantoja-Feliciano IG, Karl JP, Perisin M, Doherty LA, McClung HL, Armstrong NJ, Renberg R, Racicot K, Branck T, Arcidiacono S, Soares JW. In vitro gut microbiome response to carbohydrate supplementation is acutely affected by a sudden change in diet. BMC Microbiol. 2023 Jan 28;23(1):32. doi: 10.1186/s12866-023-02776-2.

    PMID: 36707764DERIVED

  • 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.

    PMID: 32828737DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Dietitian

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 22, 2015

Study Start

April 1, 2015

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

US(1)