Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-02-21 @ 4:17 PM
Study NCT ID:
NCT02423551
Status:
COMPLETED
Last Update Posted:
2019-04-16
First Post:
2015-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRE Consumption and Gut Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-14', 'studyFirstSubmitDate': '2015-04-14', 'studyFirstSubmitQcDate': '2015-04-17', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in gut barrier integrity', 'timeFrame': 'Baseline to 10 days, 21 days and 31 days', 'description': 'Urine excretion of saccharide probes; circulating zonulin, intestinal fatty acid binding protein, claudin-3, lipopolysaccharide and GLP2 concentrations'}], 'secondaryOutcomes': [{'measure': 'Change in gut microbiota composition', 'timeFrame': 'Baseline to 10 days, 21 days and 31 days', 'description': '16S rRNA gene sequencing'}, {'measure': 'Change in C-reactive protein concentrations', 'timeFrame': 'Baseline to 10 days, 21 days and 31 days', 'description': 'Serum C-reactive protein'}, {'measure': 'Change in TNF-alpha concentrations', 'timeFrame': 'Baseline to 10 days, 21 days and 31 days', 'description': 'Serum TNF-alpha'}, {'measure': 'Change in interleukin-6 concentrations', 'timeFrame': 'Baseline to 10 days, 21 days and 31 days', 'description': 'Serum IL-6'}, {'measure': 'Change in lipopolysaccharide concentrations', 'timeFrame': 'Baseline to 10 days, 21 days and 31 days', 'description': 'Plasma LPS'}, {'measure': 'Change in iron status', 'timeFrame': 'Baseline to 10 days, 21 days and 31 days', 'description': 'Blood ferritin, soluble transferrin receptor, hemoglobin, hematocrit'}, {'measure': 'Change in vitamin D status', 'timeFrame': 'Baseline to 10 days, 21 days and 31 days', 'description': 'Blood 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D, parathyroid hormone'}, {'measure': 'Change in B-vitamin status', 'timeFrame': 'Baseline to 10 days, 21 days and 31 days', 'description': 'Blood folate, vitamin B12, homocysteine'}, {'measure': 'Change in nutritional status', 'timeFrame': 'Baseline to 10 days, 21 days and 31 days', 'description': 'Blood prealbumin'}, {'measure': 'Change in calcium absorption', 'timeFrame': 'Baseline to 10 days, 21 days and 31 days', 'description': 'Urine calcium'}, {'measure': 'Change in zinc status', 'timeFrame': 'Baseline to 10 days, 21 days and 31 days', 'description': 'Blood zinc, zinc receptor expression'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gut microbiota', 'Intestinal permeability', 'Gut barrier integrity'], 'conditions': ['Gastrointestinal Tract']}, 'referencesModule': {'references': [{'pmid': '36774101', 'type': 'DERIVED', 'citation': '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': '36707764', 'type': 'DERIVED', 'citation': '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': '32828737', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '62 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\</= 30\n\nExclusion Criteria:\n\n* Use of antiobiotcs within 3 months of study participation\n* Use of pro- or prebiotic supplements within 2 weeks of study participation\n* Vegetarian diets\n* Use of laxatives, stool softeners, or anti-diarrheal medications at least once a week.\n* Fewer than 4 bowel movements, on average, per week\n* History of gastrointestinal disease\n* Colonoscopy within 3 months of study participation\n* Food allergies or aversions or other issues with foods that would preclude MRE consumption, including gluten, milk, nuts, or eggs.\n* 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.\n* Actively trying to lose weight\n* Pregnant or lactating\n* Recent blood donation'}, 'identificationModule': {'nctId': 'NCT02423551', 'briefTitle': 'MRE Consumption and Gut Health', 'organization': {'class': 'FED', 'fullName': 'United States Army Research Institute of Environmental Medicine'}, 'officialTitle': 'Effects of Meal, Ready-to-Eat (MRE) Consumption on Gut Health', 'orgStudyIdInfo': {'id': '15-12HC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual diet'}, {'type': 'EXPERIMENTAL', 'label': 'MRE', 'description': 'MRE consumption', 'interventionNames': ['Other: MRE']}], 'interventions': [{'name': 'MRE', 'type': 'OTHER', 'description': 'MRE consumption', 'armGroupLabels': ['MRE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01760', 'city': 'Natick', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'USARIEM', 'geoPoint': {'lat': 42.28343, 'lon': -71.3495}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Army Research Institute of Environmental Medicine', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Dietitian', 'investigatorFullName': 'James Philip Karl', 'investigatorAffiliation': 'United States Army Research Institute of Environmental Medicine'}}}}