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Background Ready-to-use therapeutic food (RUTF) is used to treat children suffering from severe acute malnutrition (SAM). Standard RUTF uses milk as the primary protein source, which makes the product expensive, and given the high worldwide SAM burden, having a less expensive effective alternative is a public health priority. Objective The objective of this study was to evaluate whether newly developed amino acid-enriched milk-free RUTF (FSMS-RUTF) or amino acid-enriched low-milk RUTF (MSMS-RUTF) treatment could replenish plasma amino acids to levels comparable to those following standard peanut-milk RUTF (PM-RUTF) treatment and to improve understanding of the effects of treatment on anthropometric measurements. A secondary analysis was performed to test the noninferiority hypothesis of plasma essential amino acid (EAA) levels. Methods Plasma EAA levels were measured in a nonblinded, 3-arm, parallel-group simple randomized controlled trial conducted in Malawi to examine the efficacy of FSMS-RUTF, MSMSRUTF and PM-RUTF in the treatment of SAM in 2 groups of children aged 6-23 and 24-59 months (mo). Sample size calculations were performed based on the previous our study. A noninferiority margin was set at -25% of the PM-RUTF arm at discharge. Results The relative values of the differences (95% CI) in plasma EAA levels between PM-RUTF treatment and FSMS-RUTF and MSMS-RUTF treatments at discharge were -7.9% (-18.6, 2.8) and 9.8% (0.2, 19.5), respectively, in children aged 6-23 mo, while in those aged 24-59 mo, the difference values were 17.8% (1.6, 34.1) and 13.6% (-2.8, 29.9), respectively. Conclusion At discharge, the plasma EAA concentrations in 6-59-mo-old SAM children treated with FSMS-RUTF and MSMS-RUTF were not less than those of children treated with PM-RUTF. These findings indicate that treatment with either of the 3 RUTFs was associated with adequate protein synthesis and that all the formulations provided sufficient functional metabolites of plasma amino acids, SCOPUS: ar.j, info:eu-repo/semantics/published

Background: Development of more cost-effective ready-to-use therapeutic food (RUTF) is a global public health priority. To date, previous lower-cost recipes have been less effective than the standard peanut and milk (PM)–based RUTF, particularly in children aged,24 mo. Objective: We aimed to compare the efficacy of the PM-RUTF to a milk-free soya, maize, and sorghum (FSMS)–RUTF enriched with crystalline amino acids without cow milk powder and a milk, soya, maize, and sorghum (MSMS)–RUTF containing 9.3% skim cow milk powder. Design: This nonblinded, 3-arm, parallel-group, simple randomized controlled trial enrolled Malawian children with severe acute malnutrition. Results: In intention-to-treat analyses, FSMS-RUTF showed noninferiority for recovery rates in children aged 24–59 mo (D: 21.9%; 95% CI: 29.5%, 5.6%) and 6–23 mo (D: 20.2%; 95% CI: 27.5%, 7.1%) compared with PM-RUTF. MSMS-RUTF also showed noninferiority for recovery rates in children aged 24–59 mo (D: 0.0%; 95% CI: 27.3%, 7.4%) and 6–23 mo (D: 0.6%; 95% CI: 24.3%, 5.5%). Noninferiority in recovery rates was also observed in per-protocol analyses. For length of stay in the program (time to cure), both FSMS-RUTF in children aged 24–59 mo (D: 2.8 d; 95% CI: 20.8, 6.5 d) and 6–23 mo (D: 3.4 d; 95% CI: 21.2, 8.0 d) and MSMS-RUTF in children aged 24–59 mo (D: 0.2 d; 95% CI: 23.1, 3.6 d) and 6–23 mo (D: 1.2 d; 95% CI: 23.4, 5.8 d) were not inferior to PM-RUTF. FSMS-RUTF was also significantly better than PM-RUTF at increasing hemoglobin and body iron stores in anemic children, with mean hemoglobin increases of 2.1 (95% CI: 1.6, 2.6) and 1.3 (95% CI: 0.9, 1.8) and mean body iron store increases of 2.0 (95% CI: 0.8, 3.3) and 0.1 (95% CI: 21.1, 1.3) for FSMS-RUTF and PM-RUTF, respectively. Conclusions: FSMS-RUTF without milk is efficacious in the treatment of severe acute malnutrition in children aged 6–23 and 24–59 mo. It is also better at correcting iron deficiency anemia than PM-RUTF. This trial was registered at, SCOPUS: ar.j, info:eu-repo/semantics/published