Observational Control
OtherParticipants will be observed and not provided any dietary supplementation.
NCT Number: NCT02615886
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.
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Notify Me4 month–13 month
All sexes
Interventional
Not applicable
National Autonomous University of Nicaragua, León, León, Nicaragua
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will be observed and not provided any dietary supplementation.
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).
Other names: whole food dietary intervention
Time frame: 6 months
Record daily rice bran consumption and track compliance to diet intervention by regular visits from local study personnel.
Time frame: 6 months
Measure the stool microbiome modulation with rice bran consumption for gut health and diarrhea prevention compared to no rice bran consumption.
Time frame: 6 months
Measure the stool metabolome modulation with rice bran consumption for gut health and diarrheal prevention compared to no rice bran consumption.
Colorado State University
Other
Pilot Feasibility of Dietary Heat-Stabilized Rice Bran Supplementation for Diarrheal Disease Prevention in Nicaraguan Children
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