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Completed

NCT Number: NCT02557373

Pilot Feasibility of Rice Bran Supplementation in 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.

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Key information

Age range

4 month–10 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Science, Techniques and Technologies of Bamako, Bamako, Mali

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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 4-6 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

Treatment and study plan

Vitamin A

Dietary Supplement

100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation.

Rice Bran + Vitamin A

Dietary Supplement

100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation. Dietary rice bran consumed daily and amounts increase throughout the 3 month intervention (6 months of age: 1 g/day rice bran, 7 months: 2 g/day rice bran, 8 months: 3 g/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: 3 months

    Record daily rice bran consumption and track compliance to diet intervention by regular visits from local community health workers.

Secondary outcomes

  1. Number of participants with microbial modulations in stool as detected by microbiome sequencing

    Time frame: 3 months

    Measure the stool microbiome modulation with rice bran consumption for gut health and diarrhea prevention compared to a Vitamin A supplementation alone.

  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: 3 months

    Measure the stool metabolome modulation with rice bran consumption for gut health and diarrheal prevention compared to a Vitamin A supplementation alone.

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • University of the Sciences, Techniques and Technologies of Bamako

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2015
Registry last updated
Jul 21, 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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