An interventional study of Vitamin A and Rice Bran + Vitamin A in Dietary Rice Bran Supplementation, sponsored by Colorado State University. Completed at 2 sites in 2 countries. Open to participants aged 4 Months to 10 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by Colorado State University · Not applicable, Interventional, and Other
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.
Colorado State University is the lead sponsor of 112 studies on the registry; 19 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Randomized participants will receive a one-dose of vitamin A supplementation (100,000 IU) at the beginning of the trial.
Dietary Supplement: Vitamin A
Randomized participants will receive a one-dose of vitamin A supplementation (100,000 IU) at the beginning of the trial plus consume a measured dose of rice bran daily.
Dietary Supplement: Rice Bran + Vitamin A
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)
Also known as: whole food dietary intervention
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
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
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Colorado State University