Pilot Feasibility of Rice Bran Supplementation in Nicaraguan Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dietary Rice Bran Supplementation

Intervention / Treatment
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* Other: Observational Control
* Dietary Supplement: Rice bran


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 13 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observational Control<br>Randomized participants will be observed for diarrhea incidences throughout the 6 month trial with no intervention. | Other: Observational Control<br>* Participants will be observed and not provided any dietary supplementation.<br>|
| Experimental: Rice Bran<br>Randomized participants will consume a measured dose of rice bran daily throughout the 6 month trial. | Dietary Supplement: Rice bran<br>* 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).<br>* Other names: whole food dietary intervention;|

What is the study measuring?
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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 study personnel. | 6 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 no rice bran consumption. | 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) | Measure the stool metabolome modulation with rice bran consumption for gut health and diarrheal prevention compared to no rice bran consumption. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rice bran, infants, stool metabolome, stool microbiome, dietary intervention