Pilot Feasibility of Rice Bran Supplementation in Children



Status:Active, not recruiting
Healthy:No
Age Range:Any
Updated:7/27/2016
Start Date:August 2015
End Date:January 2017

Use our guide to learn which trials are right for you!

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

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.

Inclusion Criteria:

- Children between the ages of 4-6 months at beginning of recruitment

- Families willing to feed their infant a daily dose of study-provided heat-stabilized
rice bran supplementation for 3 months

- Hemoglobin level >7 g/dl

- Absence of intestinal parasites or malaria infection

- Have not yet received Vitamin A supplementation

Exclusion Criteria:

- Have had a diarrheal episode between 5 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

- Hemoglobin level <7 g/dl

- Presence of intestinal parasites or malaria infection
We found this trial at
2
sites
Fort Collins, Colorado 80523
Principal Investigator: Elizabeth P Ryan, PhD
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
Bamako,
Principal Investigator: Ousmane Koita, PharmD, PhD
Phone: +223 63638888
?
mi
from
Bamako,
Click here to add this to my saved trials