Pilot Feasibility of Rice Bran Supplementation in Nicaraguan Children

July 18, 2017 updated by: Elizabeth P Ryan, Colorado State University

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • León, Nicaragua
        • National Autonomous University of Nicaragua, León
    • Colorado
      • Fort Collins, Colorado, United States, 80521
        • Colorado State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Observational Control
Randomized participants will be observed for diarrhea incidences throughout the 6 month trial with no intervention.
Participants will be observed and not provided any dietary supplementation.
Experimental: Rice Bran
Randomized participants will consume a measured dose of rice bran daily throughout the 6 month trial.
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).
Other Names:
  • whole food dietary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who are compliant to consuming rice bran daily and in amounts provided
Time Frame: 6 months
Record daily rice bran consumption and track compliance to diet intervention by regular visits from local study personnel.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with microbial modulations in stool as detected by microbiome sequencing.
Time Frame: 6 months
Measure the stool microbiome modulation with rice bran consumption for gut health and diarrhea prevention compared to no rice bran consumption.
6 months
Number of participants with metabolite modulations in stool as detected by Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS)
Time Frame: 6 months
Measure the stool metabolome modulation with rice bran consumption for gut health and diarrheal prevention compared to no rice bran consumption.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

November 24, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 26, 2015

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 14-5233H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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