Abstract

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Background and objective Globally, around 20 million children sufer from severe acute malnutrition (SAM). Identifying a more economical treatment for those afected has the potential to make treatment more available and improve prognosis for recovery and future health. Design/methods The double-blind randomized study compared taste acceptability (measured by the eagerness to eat) and efcacy of soy-based RUTF (S-RUTF) with milk-based RUTF (M-RUTF) in 6- to 59-month-old children sufering from SAM (WHZ<−3) at icddr,b, in Bangladesh. These SAM children were enrolled in the study after completion of their stabilization phase of treatment. Tolerance of test-RUTF was also tested during the efcacy trial. Results The cross-over taste acceptability study, conducted in 36 children, revealed similar results between products and an absence of side efects. The efcacy trial enrolled 260 children (130, each group) with similar baseline characteristics, including mean±SD age 15.0±8.0 months, WHZ −3.41±0.40 and mid-upper arm circumference (MUAC) 11.1±0.7 cm. The features at the end of study by RUTF group were (in S-RUTF vs. M-RUTF, respectively): total days from enrollment: 44±34 versus 39±30; weight gain (kg): 0.698±0.438 versus 0.741±0.381 and rate of weight gain (g/kg/d): 3.9±3.2 versus 5.2±4.6; MUAC gain (cm): 0.9±0.7 versus 0.9±0.6; and improvement of WHZ: 1.12±0.82 versus 1.22±0.68 (all data were man±SD and none were signifcantly diferent between the groups). At enrollment and the end of intervention, the body composition [total body water (TBW): 70.3±3.2 vs. 69.9±3.5%, and fat: 11.0±4.0 vs.11.5±4.3% at baseline; and TBW: 65.5±4.1 vs. 65.9±4.6%; and fat: 16.8±5.2 vs. 16.2±5.8% in S-RUTF and M-RUTF group, respectively] was found similar. Moreover, the increment of total TBW, FM, and FFM was also observed similar between the groups. Conclusions This is the frst randomized trial comparing S-RUTF using soy protein isolate with milk-based RUTF includ- ing comparison of body composition. S-RUTF was found equally acceptable as of milk-based RUTF without any adverse event. Children receiving S-RUTF showed similar pattern of changes in anthropometric indices, and body composition as of milk-based RUTF. Greater number of SAM children can be managed in the community with comparatively low-cost soy-based RUTF.