Dibari, F; (2015) Design and pre-testing of lipid-based, ready-to-use foods for the prevention and treatment of malnutrition in low-resource settings. Doctoral thesis , UCL (University College London).

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Abstract

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 UNstandard 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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