NCT02557373

Pilot Feasibility of Rice Bran Supplementation in Children

Pilot Feasibility of Rice Bran Supplementation for Diarrheal Disease Prevention in Malian Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Colorado State University · Academic / Other
• Sex: All
• Age: 4 Months – 10 Months
• Healthy volunteers: Accepted

Summary

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.

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
DIETARY_SUPPLEMENT	Vitamin A	100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation.
DIETARY_SUPPLEMENT	Rice Bran + Vitamin A	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)

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-09-23
• Last updated: 2017-07-21

Locations

2 sites across 2 countries: United States, Mali