Dietary Rice Bran Supplementation
Conditions
Keywords
rice bran, infants, stool metabolome, stool microbiome, dietary intervention
Brief summary
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
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.
Interventions
Participants will be observed and not provided any dietary supplementation.
DIETARY_SUPPLEMENTRice bran
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).
Sponsors
National Autonomous University of Nicaragua
Virginia Polytechnic Institute and State University
University of North Carolina, Chapel Hill
Colorado State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Months to 13 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who are compliant to consuming rice bran daily and in amounts provided | 6 months | Record daily rice bran consumption and track compliance to diet intervention by regular visits from local study personnel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with microbial modulations in stool as detected by microbiome sequencing. | 6 months | Measure the stool microbiome modulation with rice bran consumption for gut health and diarrhea prevention compared to no rice bran consumption. |
| Number of participants with metabolite modulations in stool as detected by Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS) | 6 months | Measure the stool metabolome modulation with rice bran consumption for gut health and diarrheal prevention compared to no rice bran consumption. |
Countries
Nicaragua, United States
Outcome results
None listed