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Completed

NCT Number: NCT02615886

Pilot Feasibility of Rice Bran Supplementation 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.

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Key information

Age range

4 month–13 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Autonomous University of Nicaragua, León, León, Nicaragua

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Control

Other

Participants will be observed and not provided any dietary supplementation.

Rice Bran

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).

Other names: whole food dietary intervention

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • National Autonomous University of Nicaragua
  • University of North Carolina, Chapel Hill
  • Virginia Polytechnic Institute and State University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 26, 2015
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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