Pilot Feasibility of Rice Bran Supplementation in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Dietary Rice Bran Supplementation
• Intervention / Treatment: Dietary supplement: Vitamin A; Dietary supplement: Rice Bran + Vitamin A

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: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mali
  • Bamako, Mali
    • University of Science, Techniques and Technologies of Bamako
• United States
  • Colorado
    • Fort Collins, Colorado, United States, 80523
      • Colorado State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vitamin A; Randomized participants will receive a one-dose of vitamin A supplementation (100,000 IU) at the beginning of the trial.	Dietary supplement: Vitamin A; 100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation.
Experimental: Rice Bran + Vitamin A; Randomized participants will receive a one-dose of vitamin A supplementation (100,000 IU) at the beginning of the trial plus consume a measured dose of rice bran daily.	Dietary supplement: 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); Other Names: whole food dietary intervention

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.	Record daily rice bran consumption and track compliance to diet intervention by regular visits from local community health workers.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: University of the Sciences, Techniques and Technologies of Bamako

Publications and helpful links

General Publications

• 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).
• 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.
• Borresen EC, Stone C, Bore 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):571. doi: 10.3390/ijerph13060571.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: September 11, 2015
• First Submitted That Met QC Criteria: September 21, 2015
• First Posted (Estimate): September 23, 2015

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: infants; dietary intervention; rice bran; stool metabolome and microbiome
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Micronutrients; Antioxidants; Anticarcinogenic Agents; Vitamins; Vitamin A; Retinol palmitate
• Other Study ID Numbers: 15-5744H; OPP1043255 (Other Grant/Funding Number: Bill and Melinda Gates Foundation)