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| ID | Type | Description | Link |
|---|---|---|---|
| OPP1043255 | Other Grant/Funding Number | Bill and Melinda Gates Foundation |
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| Name | Class |
|---|---|
| University of the Sciences, Techniques and Technologies of Bamako | OTHER |
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The purpose of this study is to assess feasibility of rice bran consumption in weaning children and to identify dietary rice bran mediated changes to the stool microbiome and stool metabolome.
Rice bran is a globally accessible, underutilized food ingredient with an array of beneficial nutrients (e.g. phytochemicals and prebiotics) that promote health and potentially prevent diseases. The investigators will determine if dietary rice bran intake can modulate the infant gut microbiome and metabolome to promote gut immunity for the benefit of preventing diarrheal diseases that increase risk for malnutrition and stunting.
The investigators hope to learn about the feasibility of dietary supplementation of heat-stabilized rice bran in weaning children living in regions with increased susceptibility to diarrhea and malnutrition, and whether or not rice bran consumption can modulate the stool microbiome and metabolome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin A | Placebo Comparator | Randomized participants will receive a one-dose of vitamin A supplementation (100,000 IU) at the beginning of the trial. |
|
| Rice Bran + Vitamin A | Experimental | Randomized participants will receive a one-dose of vitamin A supplementation (100,000 IU) at the beginning of the trial plus consume a measured dose of rice bran daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin A | Dietary Supplement | 100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who are compliant to consuming rice bran daily and in amounts provided. | Record daily rice bran consumption and track compliance to diet intervention by regular visits from local community health workers. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with microbial modulations in stool as detected by microbiome sequencing | Measure the stool microbiome modulation with rice bran consumption for gut health and diarrhea prevention compared to a Vitamin A supplementation alone. | 3 months |
| Number of participants with metabolite modulations in stool as detected by Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado State University | Fort Collins | Colorado | 80523 | United States | ||
| University of Science, Techniques and Technologies of Bamako |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Goodyear A, Kumar A, Ehrhart EJ, Swanson KS, Grusak MA, Leach JE, Dow SW, McClung A, Ryan EP. Dietary rice bran supplementation differentially prevents Salmonella colonization across varieties and by priming intestinal immunity. J Funct Foods (2015 - in press). | ||
| 25080551 | Background | Yang X, Wen K, Tin C, Li G, Wang H, Kocher J, Pelzer K, Ryan E, Yuan L. Dietary rice bran protects against rotavirus diarrhea and promotes Th1-type immune responses to human rotavirus vaccine in gnotobiotic pigs. Clin Vaccine Immunol. 2014 Oct;21(10):1396-403. doi: 10.1128/CVI.00210-14. Epub 2014 Jul 30. | |
| Background | Borresen EC, Ryan EP. Rice Bran: A food ingredient with Global Public Health Opportunities In: Watson RR, Preedy, V. R. and Zibadi, S.,editor. Wheat and Rice in Disease Prevention and Health: Benefits, risks, and mechanisms of whole grains in health promotion. 1st ed. Oxford, UK: Elsevier; 2014 p. 301-11. | ||
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| ID | Term |
|---|---|
| D014801 | Vitamin A |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Rice Bran + Vitamin A | Dietary Supplement | 100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation. Dietary rice bran consumed daily and amounts increase throughout the 3 month intervention (6 months of age: 1 g/day rice bran, 7 months: 2 g/day rice bran, 8 months: 3 g/day) |
|
|
Measure the stool metabolome modulation with rice bran consumption for gut health and diarrheal prevention compared to a Vitamin A supplementation alone. |
| 3 months |
| Bamako |
| Mali |
| 22583915 |
| Background |
| Kumar A, Henderson A, Forster GM, Goodyear AW, Weir TL, Leach JE, Dow SW, Ryan EP. Dietary rice bran promotes resistance to Salmonella enterica serovar Typhimurium colonization in mice. BMC Microbiol. 2012 Jul 4;12:71. doi: 10.1186/1471-2180-12-71. |
| 22248178 | Background | Henderson AJ, Kumar A, Barnett B, Dow SW, Ryan EP. Consumption of rice bran increases mucosal immunoglobulin A concentrations and numbers of intestinal Lactobacillus spp. J Med Food. 2012 May;15(5):469-75. doi: 10.1089/jmf.2011.0213. Epub 2012 Jan 16. |
| 27338428 | Result | Borresen EC, Stone C, Bore A, Cissoko A, Maiga A, Koita OA, Ryan EP. Assessing Community Readiness to Reduce Childhood Diarrheal Disease and Improve Food Security in Dioro, Mali. Int J Environ Res Public Health. 2016 Jun 8;13(6):571. doi: 10.3390/ijerph13060571. |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |