Solutions to Enhance Health with Alternative Treatments (SEHAT) protocol: a double-blinded randomised controlled trial for gut microbiota-targeted treatment of severe acute malnutrition using rice bran in ready-to-use therapeutic foods in Indonesia.

INTRODUCTION: Current formulations of ready-to-use therapeutic foods (RUTFs) to treat severe acute malnutrition (SAM) in children focus on nutrient density and quantity. Less attention is given to foods targeting gut microbiota metabolism and mucosal barrier functions. Heat-stabilised rice bran contains essential nutrients, prebiotics, vitamins and unique phytochemicals that have demonstrated favourable bioactivity to modulate gut microbiota composition and mucosal immunity. This study seeks to examine the impact of RUTF with rice bran on the microbiota during SAM treatment, recovery and post-treatment growth outcomes in Jember, Indonesia. Findings are expected to provide insights into rice bran as a novel food ingredient to improve SAM treatment outcomes. METHODS AND ANALYSIS: A total of 200 children aged 6-59 months with uncomplicated SAM (weight-for-height z-scores (WHZ) <-3, or mid-upper arm circumference (MUAC) <115 mm or having bilateral pitting oedema +/++) or approaching SAM (WHZ<-2.5) will be enrolled in a double-blinded, randomised controlled trial. Children in the active control arm will receive a locally produced RUTF; those in the intervention arm will receive the local RUTF with 5% rice bran. Children will receive daily RUTF treatment for 8 weeks and be monitored for 8 weeks of follow-up. Primary outcomes include the effectiveness of RUTF as measured by changes in weight, WHO growth z-scores, MUAC and morbidity. Secondary outcomes include modulation of the gut microbiome and dried blood spot metabolome, the percentage of children recovered at weeks 8 and 12, and malnutrition relapse at week 16. An intention-to-treat analysis will be conducted for each outcome. ETHICS AND DISSEMINATION: The findings of this trial will be submitted to peer-reviewed journals and will be presented at relevant conferences. Ethics approval obtained from the Medical and Health Research Ethical Committee at the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Madain Yogyakarta Ref. No.: KE/FK/0546/EC/2022 and KE/FK/0703/EC/2023 and from Colorado State University IRB#1823, OHRP FWA00000647. TRIAL REGISTRATION NUMBER: NCT05319717.

The Effect of Coconut Water on Adipocyte Differentiation and Lipid Accumulation in 3T3-L1 Cells.

Coconut water is reported to have lipid-lowering effects in animal studies. However, there is lack of published reports regarding its effect on adipocytes. This study observed the effect of coconut water on adipocyte differentiation and lipid accumulation in 3T3-L1 cells. The sample used in this study was mature coconut water from tall variety. Based on a preliminary study, the sample was heat-treated and added with certain amino acids as precursors for Maillard reaction to improve its original flavor. As a comparison, aromatic coconut water was used since it is highly preferred as a fresh beverage. Six samples were supplemented to 3T3-L1 cells, which were then analyzed for cell proliferation, lipid accumulation, triglyceride content, and gene expression. Arginine and vitamin C contents of the samples were also determined. The data were analyzed with ANOVA and followed by Tukey's test. Results showed that aromatic coconut water could slightly suppress lipid accumulation, while mature coconut water had a significantly lower percentage of accumulation compared to the control sample (p<0.05). Canned and fresh samples had no significant difference in terms of lipid-lowering activity (p>0.05). Similarly, the addition of lysine and proline in canned samples did not significantly affect the cells' differentiation. There was no significant effect on expressions of C/EBP-α and PPARγ, indicating the possibility of other pathways involved in hypolipidemic effect of coconut water. This study showed that coconut water might have potential to inhibit adipogenesis in 3T3-L1 cells due to its bioactive compounds.