Gastrointestinal TractNCT02423551
MRE Consumption and Gut Health
A study testing MRE in people with Gastrointestinal Tract, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 62 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tract
- What is being tested?
- MRE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI </= 30
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Gastrointestinal Tract
- Being tested
- MRE
- Keywords
- Gut microbiota, Intestinal permeability, Gut barrier integrity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MREOther
MRE consumption
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual diet |
| MRE | Experimental | MRE consumption Receives: Other: MRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut barrier integrity
Urine excretion of saccharide probes; circulating zonulin, intestinal fatty acid binding protein, claudin-3, lipopolysaccharide and GLP2 concentrations
Measured: Baseline to 10 days, 21 days and 31 days
Secondary outcomes (11)
Change in gut microbiota composition
16S rRNA gene sequencing
Measured: Baseline to 10 days, 21 days and 31 days
Change in C-reactive protein concentrations
Serum C-reactive protein
Measured: Baseline to 10 days, 21 days and 31 days
Change in TNF-alpha concentrations
Serum TNF-alpha
Measured: Baseline to 10 days, 21 days and 31 days
Change in interleukin-6 concentrations
Serum IL-6
Measured: Baseline to 10 days, 21 days and 31 days
Change in lipopolysaccharide concentrations
Plasma LPS
Measured: Baseline to 10 days, 21 days and 31 days
Change in iron status
Blood ferritin, soluble transferrin receptor, hemoglobin, hematocrit
Measured: Baseline to 10 days, 21 days and 31 days
Change in vitamin D status
Blood 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone
Measured: Baseline to 10 days, 21 days and 31 days
Change in B-vitamin status
Blood folate, vitamin B12, homocysteine
Measured: Baseline to 10 days, 21 days and 31 days
Change in nutritional status
Blood prealbumin
Measured: Baseline to 10 days, 21 days and 31 days
Change in calcium absorption
Urine calcium
Measured: Baseline to 10 days, 21 days and 31 days
Change in zinc status
Blood zinc, zinc receptor expression
Measured: Baseline to 10 days, 21 days and 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal TractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, James Philip Karl, United States Army Research Institute of Environmental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02423551
- Sponsor's protocol ID
- 15-12HC
- Status last verified
- Apr 2019
- First submitted
- 14 Apr 2015
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36774101Pantoja-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.
PubMed 36707764McClung 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.
PubMed 32828737
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Meal, Ready-to-Eat (MRE) Consumption on Gut Health
- ClinicalTrials.gov ID
- NCT02423551
- Acronym / sponsor ID
- 15-12HC
- Conditions
- Gastrointestinal Tract
- Keywords
- Gut microbiota, Intestinal permeability, Gut barrier integrity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- Apr 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual diet |
| MRE | Experimental | Other: MREMRE consumption |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI </= 30
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MREMRE consumption | Other | MRE |
Primary outcome
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
11 secondary outcomes
Change in gut microbiota composition
Time frame: 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
Change in TNF-alpha concentrations
Time frame: 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
Change in lipopolysaccharide concentrations
Time frame: Baseline to 10 days, 21 days and 31 days
Change in iron status
Time frame: 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
Change in B-vitamin status
Time frame: Baseline to 10 days, 21 days and 31 days
Change in nutritional status
Time frame: Baseline to 10 days, 21 days and 31 days
Change in calcium absorption
Time frame: Baseline to 10 days, 21 days and 31 days
Change in zinc status
Time frame: Baseline to 10 days, 21 days and 31 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 36774101Karl 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.
- Derived from this study: PubMed 36707764Pantoja-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.
- Derived from this study: PubMed 32828737McClung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRE in people with Gastrointestinal Tract, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut barrier integrity (time frame: Baseline to 10 days, 21 days and 31 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02423551, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.