Pilot Feasibility of Rice Bran Supplementation in Nicaraguan Children

Colorado State University (CSU)

Status: Completed

Conditions: Dietary Rice Bran Supplementation

Treatments: Other: Observational Control; Dietary Supplement: Rice bran

Study type: Interventional

Funder types: Other

Identifiers

NCT02615886

14-5233H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 4 to 13 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 2 patient groups

Observational Control

Experimental group

Description:

Randomized participants will be observed for diarrhea incidences throughout the 6 month trial with no intervention.

Treatment:

Other: Observational Control

Rice Bran

Experimental group

Description:

Randomized participants will consume a measured dose of rice bran daily throughout the 6 month trial.

Treatment:

Dietary Supplement: Rice bran