Pilot Feasibility of Rice Bran Supplementation in Children

Colorado State University48 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Dietary Rice Bran Supplementation

Interventions

Vitamin ADIETARY_SUPPLEMENT

100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation.

Rice Bran + Vitamin ADIETARY_SUPPLEMENT

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)

Eligibility

Sex: ALLMin age: 4 MonthsMax age: 10 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Colorado State University

Fort Collins, Colorado, United States

University of Science, Techniques and Technologies of Bamako

Bamako, Mali

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 3 months

Data from ClinicalTrials.gov

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