- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02615886
Pilot Feasibility of Rice Bran Supplementation in Nicaraguan Children
Pilot Feasibility of Dietary Heat-Stabilized Rice Bran Supplementation for Diarrheal Disease Prevention in Nicaraguan Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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León, Nicaragua
- National Autonomous University of Nicaragua, León
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Colorado
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Fort Collins, Colorado, United States, 80521
- Colorado State University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children between the ages of 4 months and 6 months at beginning of recruitment
- Have received the 3 doses of the rotavirus vaccination (RV5)
- Families willing to feed their infant a daily dose of study-provided heat-stabilized rice bran for 6 months
Exclusion Criteria:
- Have had a diarrheal episode between 4 and 6 months of age
- Have had a prior hospitalization
- Have had an antibiotic or prophylactic treatment within 1 month prior to participation
- Have an ongoing illness, a known immunocompromising condition, or use of medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Observational Control
Randomized participants will be observed for diarrhea incidences throughout the 6 month trial with no intervention.
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Participants will be observed and not provided any dietary supplementation.
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Experimental: Rice Bran
Randomized participants will consume a measured dose of rice bran daily throughout the 6 month trial.
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Dietary rice bran consumed daily and amounts increase throughout the 6 month intervention (6 months of age: 1 g/day rice bran, 7 months: 2 g/day rice bran, 8 months: 2 g/day, 9 months: 3g/day, 10 months: 4g/day, 11 months: 5g/day).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who are compliant to consuming rice bran daily and in amounts provided
Time Frame: 6 months
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Record daily rice bran consumption and track compliance to diet intervention by regular visits from local study personnel.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with microbial modulations in stool as detected by microbiome sequencing.
Time Frame: 6 months
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Measure the stool microbiome modulation with rice bran consumption for gut health and diarrhea prevention compared to no rice bran consumption.
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6 months
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Number of participants with metabolite modulations in stool as detected by Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS)
Time Frame: 6 months
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Measure the stool metabolome modulation with rice bran consumption for gut health and diarrheal prevention compared to no rice bran consumption.
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6 months
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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 Oct;18A: 653-64.
- Zambrana LE, Weber AM, Borresen EC, Zarei I, Perez J, Perez C, Rodriguez I, Becker-Dreps S, Yuan L, Vilchez S, Ryan EP. Daily Rice Bran Consumption for 6 Months Influences Serum Glucagon-Like Peptide 2 and Metabolite Profiles without Differences in Trace Elements and Heavy Metals in Weaning Nicaraguan Infants at 12 Months of Age. Curr Dev Nutr. 2021 Jul 21;5(9):nzab101. doi: 10.1093/cdn/nzab101. eCollection 2021 Sep.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 14-5233H
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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