Acceptability and Effectiveness of a Locally-Produced Ready-to-Use Supplementary Food (RUSF) for Prevention of Undernutrition in Children Under Two Years in Cambodia

Introduction The acceptability and efficacy of existing ready-to-use supplementary and therapeutic foods has been low in Cambodia, thus limiting success in preventing and treating malnutrition among Cambodian children. In that context, UNICEF and IRD have developed a locally produced, multiple micronutrient fortified lipid-based nutrient supplement. This food is innovative, in that it uses fish instead of milk as the animal source food. Very few supplementary foods have non-milk animal source foods, and in addition they have not been widely tested. This trial will assess the novel food’s acceptability to children and caregivers. Methods and analysis This is a cluster-randomised, incomplete block, 4×4 crossover design with no blinding. It will take place in four sites in a community setting in periurban Phnom Penh. Healthy children aged 9–23 months (n=100) will eat each of four foods for 3 days at a time. The amount they consume will be measured, and at the end of each 3-day set, caregivers will assess how well their child liked the food. After 12 days, caregivers themselves will do a sensory test of the 4 foods and will rank them in terms of preference. Ethics and dissemination Ethical clearance was received from the University of Queensland Medical Research Ethics Committee (2014001070) and from Cambodia’s National Ethics Committee for Health Research (03/8 NECHR). registration ClinicalTrials. gov, identifier: LNS-CAMBINFANTS; NCT02257437. Pre-results. bAckground And rAtIonAlE It is estimated that undernutrition is implicated in some 45% of deaths in children under 5 years. In Cambodia, progress in combatting malnutrition has stalled. In 2014, 32% of all children under 5 years (and 40% of children aged 3–4 years old) were stunted, 10% were wasted and 24% were underweight indicating, respectively, chronic and acute malnutrition, and a combination of the two. This malnutrition may be attributed in large part to poor complementary feeding, which remains inadequate for achieving optimal growth outcomes and micronutrient status. Adequate complementary feeding can reduce and prevent malnutrition. In Cambodia, the traditional weaning food is borbor, white rice porridge with added salt or sugar, which is low in nutrient density. Improvements to complementary feeding may be achieved with supplements, such as micronutrient powders, and supplementary foods. The latter include fortified blended products that are mixed with water to make a porridge (eg, corn-soy blend++ or CSB++, now called Supercereal Plus), biscuits that can be eaten directly (such as BP100) or ready-to-use supplementary foods (RUSFs). RUSFs are usually lipid-based nutrient supplements (LNSs), which are often pastes such as the peanut-based Plumpy'Nut. Although until fairly recently, prevention of malnutrition has relied on fortified blended products, these new LNSs are proving very effective, both as RUSFs and ready-to-use therapeutic foods (RUTFs). Compared with the existing products, LNSs are higher in energy, Crossover trial to test the acceptability of a locally produced lipid-based nutrient supplement (LNS) for children under 2 years in Cambodia: a study protocol Bindi Borg, Seema Mihrshahi, Mark Griffin, Chhoun Chamnan, Arnaud Laillou, Frank T Wieringa To cite: Borg B, Mihrshahi S, Griffin M, et al. Crossover trial to test the acceptability of a locally produced lipid-based nutrient supplement (LNS) for children under 2 years in Cambodia: a study protocol. BMJ Open 2017;0:e015958. doi:10.1136/ bmjopen-2017-015958 ► Prepublication history for this paper is available online. To view these files please visit the journal online (http:// dx. doi. org/ 10. 1136/ bmjopen2017015958). Received 13 January 2017 Revised 13 June 2017 Accepted 15 June 2017 School of Public Health, University of Sydney, Sydney, New South Wales, Australia School of Public Health, University of Queensland, Brisbane, Queensland, Australia DFPTQ, Fisheries Administration, Ministry of Agriculture, Forestry and Fisheries, Phnom Penh, Cambodia UNICEF, Phnom Penh, Cambodia UMR-204 Nutripass, Institut de Recherche pour le Développement, IRD/UM/ SupAgro, Montpellier, France correspondence to Bindi Borg; bindi_ borg@ yahoo. com. au Protocol strengths and limitations of this study ► This trial will contribute to the literature comparing supplementary foods using animal source foods other than milk. ► It will also provide information on the kinds of supplementary foods acceptable to a Southeast Asian population. ► Testing over 3 days in an unfamiliar setting may not be an indication of how caregivers and children would accept the food over a longer period. However, should the food prove acceptable in trial, a 6-month efficacy trial will follow. The latter trial will give additional information on long-term acceptability. group.bmj. com on September 7, 2017 Published by http://bmjopen.bmj. com/ Downloaded from