Research protocol local ingredients-based supplementary food as an alternative to corn-soya blends plus for treating moderate acute malnutrition among children aged 6 to 59 months: a randomized controlled non-inferiority trial in Wolaita.

BACKGROUND: In Ethiopia, 12.5% of children below 5 years are wasted, and 9.7% are moderately wasted. The present strategy for the management of moderate acute malnutrition (MAM) is a supplementary feeding program; however, this is only provided to chronically food-insecure areas. This randomized controlled non-inferiority trial examines if Local ingredients-based supplement (LIBS) is as effective as corn-soya blends plus (CSB+) in treating moderate acute malnutrition among children aged 6-59 months. METHODS: A randomized controlled non-inferiority trial will be conducted with moderately wasted children aged 6 to 59 months in Wolaita, Ethiopia. The calculated sample size is 324 (i.e. with 162 children in each of two arms, to be assigned by randomization). The daily ration will be: 100 g of LIBS plus 25.2 g of sugar with 8 ml oil in the intervention group, and 150 g of CSB+ with 16 ml of oil in the control group. These interventions will be provided for a maximum period of 12 weeks, with follow-up performed on a weekly basis. Data analysis will be done using SPSS and STATA software. Both intention-to-treat and per protocol analyses will be done. Hazard ratio and Kaplan-Meier (log rank) curves of survival analysis will be done to predict the probability of recovery rate. Logistic regression will be used to test for interactions between independent and dependent variables. Analysis of variances, t-tests, fisher's exact test and chi-square tests will be used to assess baseline characteristics. CONCLUSIONS: This paper will introduce to the existing research locally available nutritious foods which have the potential to enhance recovery from moderate acute malnutrition and to reduce the burden of malnutrition. The perceptions of mothers on feeding children with local ingredient-based supplementary food to assist recovery from moderate acute malnutrition will be the focus of in a qualitative study to follow; this will provide a further contribution in an evolving area of research. TRIAL REGISTRATION: Pan-African Clinical Trial Registration number: PACTR201809662822990, retrospectively registered on 11/09/2018.

Factors affecting the acceptability and consumption of Corn Soya Blend Plus as a prenatal dietary supplement among pregnant women in rural Cambodia.

OBJECTIVE: Undernutrition is prevalent among pregnant women in Cambodia. The provision of fortified dietary supplements is one strategy to help pregnant women meet their nutritional needs. Corn Soya Blend Plus (CSBP) is a widely used prenatal dietary supplement in areas with high rates of undernutrition and food insecurity. However, little is known about its acceptability during pregnancy. The present study aimed to identify factors that affected the acceptability and consumption of CSBP supplements among pregnant women. DESIGN: Women completed a structured interview designed to provide information on facilitators of and barriers to utilization. In addition, six focus groups were conducted with a subset of women (n 70) to further explore attitudes, perceptions and experiences related to CSBP use. SETTING: Two districts in Kampong Chhnang Province, Cambodia. SUBJECTS: Pregnant women (n 288) participating in a cluster-randomized trial of CSBP. RESULTS: The acceptability of CSBP was influenced by sensory attributes, family support, peer influences, and attitudes related to diet, nutritional status and weight gain in pregnancy. Attaining adequate nutrition was considered less important than other concerns during pregnancy, particularly anxiety related to the costs of delivery and postpartum care. Acceptance was lower among new mothers due to fears of weight gain. Health benefits were common reasons for continued use and minor side-effects, such as nausea, were not major barriers to consumption. CONCLUSIONS: CSBP was generally well accepted in this population. However, organoleptic factors and perceptions regarding nutrition and weight gain in pregnancy, particularly for first-time mothers, were barriers to increasing acceptance among Cambodian women.

Recovery rate of children with moderate acute malnutrition treated with ready-to-use supplementary food (RUSF) or improved corn-soya blend (CSB+): a randomized controlled trial.

OBJECTIVE: To compare an improved corn-soya blend (CSB+) with a ready-to-use supplementary food (RUSF) to test the hypothesis that satisfactory recovery rate will be achieved with CSB+ or RUSF when these foods provide 50 % of the child's energy requirement, the 50 % remaining coming from usual diet. DESIGN: A comparative efficacy trial study was conducted with moderately wasted children, using a controlled randomized design, with parallel assignment for RUSF or CSB+. Every child received a daily ration of 167 kJ (40 kcal)/kg body weight during 56 d with a follow-up performed every 14 d. Every caregiver received nutrition counselling at enrolment and at each follow-up visit. SETTING: Health districts of Mvog-Beti and Evodoula in the Centre region of Cameroon. SUBJECTS: Eight hundred and thirty-three children aged 6-59 months were screened and eighty-one malnourished children (weight-for-height Z-score between -3 and -2) aged 25-59 months were selected. RESULTS: Of children treated with CSB+ and RUSF, 73 % (95 % CI 59 %, 87 %) and 85 % (95 % CI 73 %, 97 %), respectively, recovered from moderate acute malnutrition, with no significant difference between groups. The mean duration of treatment required to achieve recovery was 44 d in the RUSF group and 51 d in the CSB+ group (log-rank test, P=0·0048). CONCLUSIONS: There was no significant difference in recovery rate between the groups. Both CSB+ and RUSF were relatively successful for the treatment of moderate acute malnutrition in children. Despite the relatively low ration size provided, the recovery rates observed for both groups were comparable to or higher than those reported in previous studies, a probable effect of nutrition education.

Newly formulated, protein quality-enhanced, extruded sorghum-, cowpea-, corn-, soya-, sugar- and oil-containing fortified-blended foods lead to adequate vitamin A and iron outcomes and improved growth compared with non-extruded CSB+ in rats.

Corn and soyabean micronutrient-fortified-blended foods (FBF) are commonly used for food aid. Sorghum and cowpeas have been suggested as alternative commodities because they are drought tolerant, can be grown in many localities, and are not genetically modified. Change in formulation of blends may improve protein quality, vitamin A and Fe availability of FBF. The primary objective of this study was to compare protein efficiency, Fe and vitamin A availability of newly formulated extruded sorghum-, cowpea-, soya- and corn-based FBF, along with a current, non-extruded United States Agency for International Development (USAID) corn and soya blend FBF (CSB+). A second objective was to compare protein efficiency of whey protein concentrate (WPC) and soya protein isolate (SPI) containing FBF to determine whether WPC inclusion improved outcomes. Eight groups of growing rats (n 10) consumed two white and one red sorghum-cowpea (WSC1 + WPC, WSC2 + WPC, RSC + WPC), white sorghum-soya (WSS + WPC) and corn-soya (CSB14 + WPC) extruded WPC-containing FBF, an extruded white sorghum-cowpea with SPI (WSC1 + SPI), non-extruded CSB+, and American Institute of Nutrition (AIN)-93G, a weanling rat diet, for 4 weeks. There were no significant differences in protein efficiency, Fe or vitamin A outcomes between WPC FBF groups. The CSB+ group consumed significantly less food, gained significantly less weight, and had significantly lower energy efficiency, protein efficiency and length, compared with all other groups. Compared with WSC1 + WPC, the WSC1 + SPI FBF group had significantly lower energy efficiency, protein efficiency and weight gain. These results suggest that a variety of commodities can be used in the formulation of FBF, and that newly formulated extruded FBF are of better nutritional quality than non-extruded CSB+.

Prenatal supplementation with Corn Soya Blend Plus reduces the risk of maternal anemia in late gestation and lowers the rate of preterm birth but does not significantly improve maternal weight gain and birth anthropometric measurements in rural Cambodian women: a randomized trial.

BACKGROUND: Corn Soya Blend (CSB) Plus is a fortified dietary supplement used to help Cambodian women meet their nutritional requirements in pregnancy, although little is known about its ability to improve pregnancy outcomes. OBJECTIVE: This study assessed the effect of prenatal CSB Plus supplementation on birth weight and secondary outcomes of low birth weight (<2500 g), small for gestational age, birth length and head circumference, preterm birth (<37 wk), maternal weight gain, and anemia at 24-28 wk, 30-32 wk, and 36-38 wk of gestation among rural Cambodian women. DESIGN: A cluster-randomized trial was conducted in 75 villages in Kampong Chhnang Province, in which 547 women received CSB Plus (treatment) during the first trimester until delivery or continued their normal diet (control) based on their village residence. All women received routine daily iron folic acid tablets and were treated with additional iron folic acid if they were anemic (hemoglobin <11 g/dL). Cluster-adjusted linear mixed-effect and logistic regression models were used to examine group differences. RESULTS: There was no significant difference in birth weight between the CSB Plus and control group (46 g; 95% CI: -31, 123 g; P = 0.24). Significant reductions were observed in preterm birth (OR = 0.33; 95% CI: 0.12, 0.89) and anemia at 36-38 wk (OR = 0.51; 95% CI: 0.34, 0.77). There were no significant differences in low birth weight, small for gestational age, birth length, head circumference, or maternal weight gain. A higher rate of fetal loss was observed in the treatment group (10.2% compared with 3.7%; P < 0.01). CONCLUSIONS: In Cambodian women, CSB Plus consumed during pregnancy did not significantly increase maternal weight gain or improve birth size but did reduce maternal anemia in late gestation and preterm birth in comparison with women consuming a normal diet. The unexpectedly higher rate of fetal loss in the treatment group is concerning and warrants further investigation. This trial was registered at clinicaltrials.gov as NCT01413776.

Food supplementation among HIV-infected adults in Sub-Saharan Africa: impact on treatment adherence and weight gain.

Sub-Saharan Africa has the highest proportion of undernourished people in the world, along with the highest number of people living with HIV and AIDS. Thus, as a result of high levels of food insecurity many HIV patients are also undernourished. The synergism between HIV and undernutrition leads to poor treatment adherence and high mortality rates. Undernutrition has a debilitating effect on the immune system due to key nutrient deficiencies and the overproduction of reactive species (oxidative stress), which causes rapid HIV progression and the onset of AIDS. Therapeutic food supplementation used in the treatment of severe acute malnutrition is being applied to HIV palliative care; however, little biochemical data exist to highlight its impact on oxidative stress and immune recovery. In addition, as most food supplements are imported by donor agencies, efforts are being put into local therapeutic food production such as the Food Multi-Mix concept to ensure sustainability. The purpose of this review is to highlight studies that examine the effectiveness of food supplementation in undernourished HIV patients in Sub-Saharan Africa; noting the parameters used to measure efficacy, as well as the long-term feasibility of supplementation.