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
1 other identifier
interventional
47
2 countries
2
Brief Summary
The purpose is to assess feasibility of rice bran consumption in weaning children and collect pilot data on gut microbiome and metabolome modulation with rice bran intake for diarrheal prevention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 24, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedJuly 19, 2017
July 1, 2017
11 months
November 24, 2015
July 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 study personnel.
6 months
Secondary Outcomes (2)
Number of participants with microbial modulations in stool as detected by microbiome sequencing.
6 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)
6 months
Study Arms (2)
Observational Control
EXPERIMENTALRandomized participants will be observed for diarrhea incidences throughout the 6 month trial with no intervention.
Rice Bran
EXPERIMENTALRandomized participants will consume a measured dose of rice bran daily throughout the 6 month trial.
Interventions
Participants will be observed and not provided any dietary supplementation.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Colorado State Universitylead
- National Autonomous University of Nicaraguacollaborator
- Virginia Polytechnic Institute and State Universitycollaborator
- University of North Carolina, Chapel Hillcollaborator
Study Sites (2)
Colorado State University
Fort Collins, Colorado, 80521, United States
National Autonomous University of Nicaragua, León
León, Nicaragua
Related Publications (6)
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.
BACKGROUNDYang 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.
PMID: 25080551BACKGROUNDBorresen 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.
BACKGROUNDKumar 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.
PMID: 22583915BACKGROUNDHenderson 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.
PMID: 22248178BACKGROUNDZambrana 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.
PMID: 34514286DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 24, 2015
First Posted
November 26, 2015
Study Start
November 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
July 19, 2017
Record last verified: 2017-07