Leucine Supplementation in the Management of Moderate Wasting in Children Aged 6 – 24 Months

Abstract

Wasting in children is a serious form of acute malnutrition that affects approximately 370,000 children under five years of age in Kenya. While guidelines for treatment of severe wasting are available, moderate wasting has no standardized treatment protocol. Studies have established that when leucine (an amino acid), is administered in a large dose in catabolic conditions in humans, it functions as a nutraceutical that accelerates muscle protein synthesis. The main objective of the study was thus to establish the effectiveness of leucine supplementation in treating moderate wasting in children and formulate a leucine-rich composite flour (TheraPEM) from locally available foods. This study had two phases: Phase One was a double blind placebo controlled trial at Mbagathi Level IV Hospital that established the effectiveness of leucine supplementation in treating moderate wasting. Data on the risk factors and dietary intake of children with moderate wasting was also collected. Children, while under observation, were either supplemented with leucine capsules at a dose of 150 mg/kg bodyweight/day or given a placebo for 28 days. Phase Two involved formulation of a leucine-rich composite flour from locally available foods beans, millet and groundnuts) for use in management of moderate wasting. Ethical approval to conduct the study was obtained from the University of Nairobi – Kenyatta National Hospital Ethics and Research Committee (P 519/7/2016). At the end of Phase One, it was observed that energy intake among 134 (92.7 %) of the study children was below 50 % of their daily requirement. In addition, their mean energy intake was 250.6 ± 59.3 kcal/day which represented 31.3 % of their daily energy requirement. Factors that were independently associated with moderate wasting were: daily frequency of meal consumption (r=0.7; p=0.00), female-headed households (r=-0.6; p=0.02), polygamous households (r=-0.4; p=0.02) and a high household dependency ratio (r=-0.4; p=0.03). On completion of the clinical trial, there was a significant difference (p = 0.00) in the proportion of children who recovered from moderate wasting between the study group receiving 150 mg/kg/day leucine capsules (93.1 %) and the placebo group (40.3 %). It was therefore concluded that leucine supplementation is effective in treatment of moderate wasting and its usage should be scaled up in the treatment of moderate wasting. For this to occur, a policy brief should be formulated from this study and submitted to the Ministry of Health in support of adoption of leucine supplementation in the management of moderate wasting including the recovery phase after treatment of severe wasting. It was also concluded that the frequency of feeding in the majority of moderately wasted children is adequate however the meals are of a low energy density and therefore result in undernutrition and wasting in children. It is thus recommended that recurrent nutrition education to mothers on complementary feed preparation should be implemented during the growth monitoring clinics they attend. In addition, the study recommends adoption of nutrient-optimized combinations of affordable and locally available foods in the preparation of child complementary feeds. In Phase Two, six leucine-rich composite flours branded TheraPEM were formulated. All six met the Codex Alimentarius food standards for minimum energy density (80 kcal/100g) and maximum fat content (27 %). All flours delivered above 1050 mg leucine per 100 grams of flour. Formulations 2 (Beans 300g +Groundnuts 200g + Millet 500g), 3 (Beans 400g +Groundnuts 200g+ Millet 400g) and 5 (Beans 300g +Groundnuts 150g+ Millet 550g) had the most preferred sensory attributes, hence was subjected to accelerated shelf-life evaluation. All three flours had a significant change in the Total Viable Count from the pre-storage counts by the third day of storage. The results led to the conclusion that all six formulations meet the minimum leucine requirement (1050 g/100g) in moderate wasting and that formulation 2, 3 and 5 are the most acceptable based on sensory attributes. It is recommended that these three flours be subjected to a feeding trial to further validate their effectiveness in treating moderate wasting