| Summary: | Background: Managing child and adult undernutrition is a global public health priority. In poor settings, improved specialised products are needed for treatment and prevention, including for chronic disease/HIV. Objective: To develop a method for the design and pre-clinical testing of novel, low-cost Ready-to-Use Therapeutic Foods (RUTF), to be also applied to supplementary/complementary feeding interventions. A method was developed and tested, using four sequential studies, with HIV-positive Kenyan adults with severe acute malnutrition (case-study). A qualitative study explored adherence and consumption barriers with the current UN standard peanut/milk-powder-based therapeutic formulation (P‐RUTF). A study using Linear Programming (LP) designed an improved, cheaper formulation soy/maize/sorghum-based (SMS-RUTF), considered accurate if: its manufactured prototype, compared to calculated values; it had a measured energy density difference (EDD) < 10%; a protein or lipid difference (P/LD) < 5g/100g. An acceptability study (4-weeks-cross-over design; washout one-week) compared use of SMS-RUTF against P-RUTF (n=41), using 18 consumption/safety/preference criteria. Based on a literature review (28 randomized controlled trials of micronutrient supplementation; outcomes: increased survival and CD4 cell count, reduced viral load), four criteria to determine micronutrient specifications for the SMS-RUTF fortification were developed and applied. The reported compliance with the prescribed RUTF was relatively low, and informed the necessary formulation improvements. The LP-determined formulation was accurate (EDD: 7%; PD and LD: 2.3 and 1.0g/100g). The LP-based prototype was acceptable and safe, but with an average number of days of nausea and vomit (0.16 and 0.04 d) occurred with a higher frequency (P < 0.05) than in the control (0.09 and 0.02 d). The existing evidence for determining micronutrient specifications for SMS-RUTF posed some challenges for the development of manufacturing specifications. Twelve of the micronutrient specifications developed for SMS-RUTF fortificant premix were equivalent to the UN minimum standards; eleven were 2 to 10 times higher. Conclusions: The proposed set of methods can be used to design and pre-clinically test improved/cheaper RUTF products, targeting malnourished adults. Novel formulations should be clinically trialled before widespread-use.
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