NCT02615886

Pilot Feasibility of Rice Bran Supplementation in Nicaraguan Children

Pilot Feasibility of Dietary Heat-Stabilized Rice Bran Supplementation for Diarrheal Disease Prevention in Nicaraguan Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Colorado State University · Academic / Other
• Sex: All
• Age: 4 Months – 13 Months
• Healthy volunteers: Accepted

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.

Conditions

• Dietary Rice Bran Supplementation

Interventions

Type	Name	Description
OTHER	Observational Control	Participants will be observed and not provided any dietary supplementation.
DIETARY_SUPPLEMENT	Rice 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).

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-11-26
• Last updated: 2017-07-19

Locations

2 sites across 2 countries: United States, Nicaragua