This trial is active, not recruiting.

Condition dietary rice bran supplementation
Treatments observational control, rice bran
Sponsor Colorado State University
Collaborator National Autonomous University of Nicaragua
Start date November 2014
End date October 2015
Trial size 49 participants
Trial identifier NCT02615886, 14-5233H


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Randomized participants will be observed for diarrhea incidences throughout the 6 month trial with no intervention.
observational control
Participants will be observed and not provided any dietary supplementation.
Randomized participants will consume a measured dose of rice bran daily throughout the 6 month trial.
rice bran whole food dietary intervention
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).

Primary Outcomes

Number of participants who are compliant to consuming rice bran daily and in amounts provided
time frame: 6 months

Secondary Outcomes

Number of participants with microbial modulations in stool as detected by microbiome sequencing.
time frame: 6 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)
time frame: 6 months

Eligibility Criteria

Male or female participants from 4 months up to 13 months old.

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

Additional Information

Official title Pilot Feasibility of Dietary Heat-Stabilized Rice Bran Supplementation for Diarrheal Disease Prevention in Nicaraguan Children
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Colorado State University.