Pilot Feasibility of Rice Bran Supplementation in Children

NCT02557373 | Completed

• 2 other identifiers: 15-5744HOPP1043255
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Dietary Rice Bran Supplementation

Keywords

rice bran; infants; stool metabolome and microbiome; dietary intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

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

  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)

  3 months

Study Arms (2)

Vitamin A

PLACEBO COMPARATOR

Randomized participants will receive a one-dose of vitamin A supplementation (100,000 IU) at the beginning of the trial.

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.

Dietary Supplement: Rice Bran + Vitamin A

Interventions

Vitamin A DIETARY_SUPPLEMENT

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

Vitamin A

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)

Also known as: whole food dietary intervention

Rice Bran + Vitamin A

Eligibility Criteria

• Age: 4 Months - 10 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead
• University of the Sciences, Techniques and Technologies of Bamako: collaborator

Study Sites (2)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

University of Science, Techniques and Technologies of Bamako

Bamako, Mali

Location

Related Publications (6)

• 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).

  BACKGROUND

• 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.

  PMID: 25080551 BACKGROUND

• Borresen 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

• 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.

  PMID: 22583915 BACKGROUND

• Henderson 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.

  PMID: 22248178 BACKGROUND

• Borresen 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.

  PMID: 27338428 RESULT

MeSH Terms

Interventions

Vitamin A

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 23, 2015
• Study Start: August 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1); MA (1)