NCT05319717

Rice Bran-based Supplemental Foods for the Treatment of Childhood Malnutrition

Rice Bran in Ready-to-use Therapeutic Foods for Microbiota-targeted Treatment of Childhood Malnutrition

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Colorado State University · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of treating children with severe acute malnutrition (SAM) with a locally produced ready-to-use therapeutic food (RUTF) with or without rice bran.

Detailed description

Rice bran is a nutrient dense food ingredient with prebiotics and phytochemicals, as well as vitamins, fatty acids, and amino acids. The investigators will determine if the inclusion of rice bran to locally produced RUTFs will improve SAM treatment for children in Indonesia. This will be assessed by standard anthropometric measures and determining the modulation of the malnourished child's gut microbiome and metabolome. The study will also assess rates of relapse in the entire cohort. This study will yield new information of direct importance and impact to public health nutrition and advance our knowledge and treatment of SAM in Indonesia. Investigation of the gut-microbiota metabolism following consumption of rice bran provided in RUTFs compared to RUTF without rice bran included will provide key mechanistic insights for repairing nutrient absorptive functions in the gut, sustaining gut health in treated children and inform long-term treatment solutions for SAM.

Conditions

• Severe Acute Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ready-to-use therapeutic food with heat stabilized rice bran	Children assigned to the experimental group will be treated for severe acute malnutrition with a novel ready-to-use therapeutic food that contains 5% heat stabilized rice bran.
DIETARY_SUPPLEMENT	Ready-to-use therapeutic food (no rice bran)	Children assigned to the active comparator group will be treated for severe acute malnutrition with a novel ready-to-use therapeutic food (no rice bran).

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2022-04-08
• Last updated: 2024-06-07

Locations

1 site across 1 country: Indonesia