Pilot Feasibility of Rice Bran Supplementation in Children

Dietary Rice Bran Supplementation Clinical Trial

Official title:

Pilot Feasibility of Rice Bran Supplementation for Diarrheal Disease Prevention in Malian Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557373
• Other study ID #: 15-5744H
• Secondary ID: OPP1043255
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: July 18, 2017
• Start date: August 2015
• Est. completion date: May 2016

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 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.

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: 48
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 10 Months

Eligibility

Inclusion Criteria:

• Children between the ages of 4-6 months at beginning of recruitment

• Families willing to feed their infant a daily dose of study-provided heat-stabilized rice bran supplementation for 3 months

• Hemoglobin level >7 g/dl

• Absence of intestinal parasites or malaria infection

• Have not yet received Vitamin A supplementation

Exclusion Criteria:

• Have had a diarrheal episode between 5 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

• Hemoglobin level <7 g/dl

• Presence of intestinal parasites or malaria infection

Related Conditions & MeSH terms

• Dietary Rice Bran Supplementation

Intervention

Dietary Supplement:
• Vitamin A
100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation.
• Rice Bran + Vitamin A
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)

Locations

Country	Name	City	State
Mali	University of Science, Techniques and Technologies of Bamako	Bamako
United States	Colorado State University	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Colorado State University	University of the Sciences, Techniques and Technologies of Bamako

Countries where clinical trial is conducted

United States,  Mali, 

References & Publications (6)

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.

Borresen EC, Stone C, Boré 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). pii: E571. doi: 10.3390/i — View 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 - in press).

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 community health workers.	3 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 a Vitamin A supplementation alone.	3 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 a Vitamin A supplementation alone.	3 months