Pilot Feasibility of Rice Bran Supplementation in Nicaraguan Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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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

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Dietary Rice Bran Supplementation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Observational Control

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

Group Type EXPERIMENTAL

Observational Control

Intervention Type OTHER

Participants will be observed and not provided any dietary supplementation.

Rice Bran

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

Group Type EXPERIMENTAL

Rice bran

Intervention Type DIETARY_SUPPLEMENT

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).

Interventions

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Observational Control

Participants will be observed and not provided any dietary supplementation.

Intervention Type OTHER

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).

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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whole food dietary intervention

Eligibility Criteria

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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

Minimum Eligible Age

4 Months

Maximum Eligible Age

13 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes