Pilot Feasibility of Rice Bran Supplementation in Children

Colorado State University (CSU)

Status: Completed

Conditions: Dietary Rice Bran Supplementation

Treatments: Dietary Supplement: Rice Bran + Vitamin A; Dietary Supplement: Vitamin A

Study type: Interventional

Funder types: Other

Identifiers

NCT02557373

OPP1043255 (Other Grant/Funding Number)

15-5744H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 4 to 10 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups, including a placebo group

Vitamin A

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Vitamin A

Rice Bran + Vitamin A

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Rice Bran + Vitamin A