Pilot Feasibility of Rice Bran Supplementation in Nicaraguan Children

Not Applicable

Completed

• Conditions: Dietary Rice Bran Supplementation
• Interventions: Other: Observational Control; Dietary Supplement: Rice bran

• Registration Number: NCT02615886
• Lead Sponsor: Colorado State University

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.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-26
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Observational Control	Observational Control	Randomized participants will be observed for diarrhea incidences throughout the 6 month trial with no intervention.
Rice Bran	Rice bran	Randomized participants will consume a measured dose of rice bran daily throughout the 6 month trial.

Primary Outcome Measures

Name	Time	Method
Number of participants who are compliant to consuming rice bran daily and in amounts provided	6 months	Record daily rice bran consumption and track compliance to diet intervention by regular visits from local study personnel.

Secondary Outcome Measures

Name	Time	Method
Number of participants with microbial modulations in stool as detected by microbiome sequencing.	6 months	Measure the stool microbiome modulation with rice bran consumption for gut health and diarrhea prevention compared to no rice bran consumption.
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	Measure the stool metabolome modulation with rice bran consumption for gut health and diarrheal prevention compared to no rice bran consumption.

Trial Locations

Locations (2)

National Autonomous University of Nicaragua, León; 🇳🇮 León, Nicaragua

Colorado State University; 🇺🇸 Fort Collins, Colorado, United States