Pilot Feasibility of Rice Bran Supplementation in Nicaraguan Children

Dietary Rice Bran Supplementation Clinical Trial

Official title:

Pilot Feasibility of Dietary Heat-Stabilized Rice Bran Supplementation for Diarrheal Disease Prevention in Nicaraguan Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615886
• Other study ID #: 14-5233H
• Status: Completed
• Phase: N/A
• First received: November 24, 2015
• Last updated: July 18, 2017
• Start date: November 2014
• Est. completion date: October 2015

Study information

• Verified date: July 2017
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 13 Months

Eligibility

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

Related Conditions & MeSH terms

• Dietary Rice Bran Supplementation

Intervention

Other:
• Observational Control
Participants will be observed and not provided any dietary supplementation.

Dietary Supplement:
• Rice bran
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).

Locations

Country	Name	City	State
Nicaragua	National Autonomous University of Nicaragua, León	León
United States	Colorado State University	Fort Collins	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
Colorado State University	National Autonomous University of Nicaragua, University of North Carolina, Chapel Hill, Virginia Polytechnic Institute and State University

Countries where clinical trial is conducted

United States,  Nicaragua, 

References & Publications (5)

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.

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.

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 no rice bran consumption.	6 months
Secondary	Number of participants with metabolite modulations in stool as detected by Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS)	Measure the stool metabolome modulation with rice bran consumption for gut health and diarrheal prevention compared to no rice bran consumption.	6 months