Dietary Rice Bran SupplementationNCT02557373
Pilot Feasibility of Rice Bran Supplementation in Children
A study testing Vitamin A and Rice Bran + Vitamin A in people with Dietary Rice Bran Supplementation, run by Colorado State University at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 10 monthsHealthy volunteers can take part
- Conditions the study is for
- Dietary Rice Bran Supplementation
- What is being tested?
- Vitamin A and Rice Bran + Vitamin A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Colorado State University
Fort Collins, Colorado, 80523
About this study
Official title: Pilot Feasibility of Rice Bran Supplementation for Diarrheal Disease Prevention in Malian 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.
Read the 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.
- Conditions
- Dietary Rice Bran Supplementation
- Being tested
- Vitamin A, Rice Bran + Vitamin A
- Keywords
- rice bran, infants, stool metabolome and microbiome, dietary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin ADietary supplement
100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation.
Rice Bran + Vitamin ADietary supplement
Also called whole food dietary intervention
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)
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A | Placebo comparator | Randomized participants will receive a one-dose of vitamin A supplementation (100,000 IU) at the beginning of the trial. Receives: Dietary Supplement: Vitamin A |
| Rice Bran + Vitamin A | Experimental | Randomized participants will receive a one-dose of vitamin A supplementation (100,000 IU) at the beginning of the trial plus consume a measured dose of rice bran daily. Receives: Dietary Supplement: Rice Bran + Vitamin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who are compliant to consuming rice bran daily and in amounts provided.
Record daily rice bran consumption and track compliance to diet intervention by regular visits from local community health workers.
Measured: 3 months
Secondary outcomes (2)
Number of participants with microbial modulations in stool as detected by microbiome sequencing
Measure the stool microbiome modulation with rice bran consumption for gut health and diarrhea prevention compared to a Vitamin A supplementation alone.
Measured: 3 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)
Measure the stool metabolome modulation with rice bran consumption for gut health and diarrheal prevention compared to a Vitamin A supplementation alone.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dietary Rice Bran SupplementationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Sciences, Techniques and Technologies of Bamako
- Responsible party
- Principal investigator, Elizabeth P Ryan, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557373
- Sponsor's protocol ID
- 15-5744H
- Other IDs
- OPP1043255
- Status last verified
- Jul 2017
- First submitted
- 11 Sep 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Goodyear A, Kumar A, Ehrhart EJ, Swanson KS, Grusak MA, Leach JE, Dow SW, McClung A, Ryan EP. Dietary rice bran supplementation differentially prevents Salmonella colonization across varieties and by priming intestinal immunity. J Funct Foods (2015 - in press).
Yang X, Wen K, Tin C, Li G, Wang H, Kocher J, Pelzer K, Ryan E, Yuan L. Dietary rice bran protects against rotavirus diarrhea and promotes Th1-type immune responses to human rotavirus vaccine in gnotobiotic pigs. Clin Vaccine Immunol. 2014 Oct;21(10):1396-403. doi: 10.1128/CVI.00210-14. Epub 2014 Jul 30.
PubMed 25080551Borresen EC, Ryan EP. Rice Bran: A food ingredient with Global Public Health Opportunities In: Watson RR, Preedy, V. R. and Zibadi, S.,editor. Wheat and Rice in Disease Prevention and Health: Benefits, risks, and mechanisms of whole grains in health promotion. 1st ed. Oxford, UK: Elsevier; 2014 p. 301-11.
Kumar A, Henderson A, Forster GM, Goodyear AW, Weir TL, Leach JE, Dow SW, Ryan EP. Dietary rice bran promotes resistance to Salmonella enterica serovar Typhimurium colonization in mice. BMC Microbiol. 2012 Jul 4;12:71. doi: 10.1186/1471-2180-12-71.
PubMed 22583915Henderson AJ, Kumar A, Barnett B, Dow SW, Ryan EP. Consumption of rice bran increases mucosal immunoglobulin A concentrations and numbers of intestinal Lactobacillus spp. J Med Food. 2012 May;15(5):469-75. doi: 10.1089/jmf.2011.0213. Epub 2012 Jan 16.
PubMed 22248178Borresen EC, Stone C, Bore A, Cissoko A, Maiga A, Koita OA, Ryan EP. Assessing Community Readiness to Reduce Childhood Diarrheal Disease and Improve Food Security in Dioro, Mali. Int J Environ Res Public Health. 2016 Jun 8;13(6):571. doi: 10.3390/ijerph13060571.
PubMed 27338428
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility of Rice Bran Supplementation for Diarrheal Disease Prevention in Malian Children
- ClinicalTrials.gov ID
- NCT02557373
- Acronym / sponsor ID
- 15-5744H
- Conditions
- Dietary Rice Bran Supplementation
- Keywords
- rice bran, infants, stool metabolome and microbiome, dietary intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- University of the Sciences, Techniques and Technologies of Bamako
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin A | Placebo comparator | Dietary Supplement: Vitamin ARandomized participants will receive a one-dose of vitamin A supplementation (100,000 IU) at the beginning of the trial. |
| Rice Bran + Vitamin A | Experimental | Dietary Supplement: Rice Bran + Vitamin ARandomized participants will receive a one-dose of vitamin A supplementation (100,000 IU) at the beginning of the trial plus consume a measured dose of rice bran daily. |
Who may qualify
- Ages
- 4 to 10 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin A100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation. | Dietary supplement | Vitamin A |
| Rice Bran + Vitamin AAlso: whole food dietary intervention100,000 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) | Dietary supplement | Rice Bran + Vitamin A |
Primary outcome
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.
2 secondary outcomes
Number of participants with microbial modulations in stool as detected by microbiome sequencing
Time frame: 3 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: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- BackgroundGoodyear A, Kumar A, Ehrhart EJ, Swanson KS, Grusak MA, Leach JE, Dow SW, McClung A, Ryan EP. Dietary rice bran supplementation differentially prevents Salmonella colonization across varieties and by priming intestinal immunity. J Funct Foods (2015 - in press).
- Background: PubMed 25080551Yang X, Wen K, Tin C, Li G, Wang H, Kocher J, Pelzer K, Ryan E, Yuan L. Dietary rice bran protects against rotavirus diarrhea and promotes Th1-type immune responses to human rotavirus vaccine in gnotobiotic pigs. Clin Vaccine Immunol. 2014 Oct;21(10):1396-403. doi: 10.1128/CVI.00210-14. Epub 2014 Jul 30.
- BackgroundBorresen EC, Ryan EP. Rice Bran: A food ingredient with Global Public Health Opportunities In: Watson RR, Preedy, V. R. and Zibadi, S.,editor. Wheat and Rice in Disease Prevention and Health: Benefits, risks, and mechanisms of whole grains in health promotion. 1st ed. Oxford, UK: Elsevier; 2014 p. 301-11.
- Background: PubMed 22583915Kumar A, Henderson A, Forster GM, Goodyear AW, Weir TL, Leach JE, Dow SW, Ryan EP. Dietary rice bran promotes resistance to Salmonella enterica serovar Typhimurium colonization in mice. BMC Microbiol. 2012 Jul 4;12:71. doi: 10.1186/1471-2180-12-71.
- Background: PubMed 22248178Henderson AJ, Kumar A, Barnett B, Dow SW, Ryan EP. Consumption of rice bran increases mucosal immunoglobulin A concentrations and numbers of intestinal Lactobacillus spp. J Med Food. 2012 May;15(5):469-75. doi: 10.1089/jmf.2011.0213. Epub 2012 Jan 16.
- Results publication: PubMed 27338428Borresen EC, Stone C, Bore A, Cissoko A, Maiga A, Koita OA, Ryan EP. Assessing Community Readiness to Reduce Childhood Diarrheal Disease and Improve Food Security in Dioro, Mali. Int J Environ Res Public Health. 2016 Jun 8;13(6):571. doi: 10.3390/ijerph13060571.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A and Rice Bran + Vitamin A in people with Dietary Rice Bran Supplementation, run by Colorado State University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who are compliant to consuming rice bran daily and in amounts provided. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02557373, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.