Vitamin A
Dietary Supplement100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation.
NCT Number: NCT02557373
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.
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Notify Me4 month–10 month
All sexes
Interventional
Not applicable
University of Science, Techniques and Technologies of Bamako, Bamako, Mali
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
100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation.
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)
Other names: whole food dietary intervention
Time frame: 3 months
Record daily rice bran consumption and track compliance to diet intervention by regular visits from local community health workers.
Time frame: 3 months
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
Measure the stool metabolome modulation with rice bran consumption for gut health and diarrheal prevention compared to a Vitamin A supplementation alone.
Colorado State University
Other
Pilot Feasibility of Rice Bran Supplementation for Diarrheal Disease Prevention in Malian Children
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