Clinical trial NCT02615886: Pilot Feasibility of Rice Bran Supplementation in Nicaraguan Children
Official title: Pilot Feasibility of Dietary Heat-Stabilized Rice Bran Supplementation for Diarrheal Disease Prevention in Nicaraguan Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Rice Bran Supplementation
Keywords: rice bran
infants
stool metabolome
stool microbiome
dietary intervention
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: National Autonomous University of Nicaragua
name: Virginia Polytechnic Institute and State University
name: University of North Carolina, Chapel Hill
First posted: 2015-11-26
Enrollment: 47
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants who are compliant to consuming rice bran daily and in amounts provided
timeFrame: 6 months
Secondary outcomes:
measure: Number of participants with microbial modulations in stool as detected by microbiome sequencing.
timeFrame: 6 months
measure: Number of participants with metabolite modulations in stool as detected by Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
city: León
country: Nicaragua
facility: National Autonomous University of Nicaragua, León
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.