Ready-to-use Supplementary Food Research Articles

Investigating the Effects of Dietary Supplementation and High-Intensity Motor Learning on Nutritional Status, Body Composition, and Muscle Strength in Children with Moderate Thinness in Southwest Ethiopia: A Cluster-Randomized Controlled Trial.

In Ethiopia, moderate thinness (MT) is a persistent issue among children. Yet, evidence on the effects of dietary supplementation and motor skills training in these children is limited. This study aimed to assess the effect of Ready-to-Use Supplementary Food (RUSF), whether or not combined with high-intensity motor learning (HiML), on weight, height, body composition, and muscle strength in children 5-7 years old with MT living in Jimma Town, Ethiopia. A cluster-randomized controlled trial was carried out among 69 children (aged 5-7) with MT assigned to receive RUSF (n = 23), RUSF + HiML (n = 25), or no intervention (control group, n = 21). A multivariable Generalized Estimating Equations model was used and the level of significance was set at alpha < 0.05. At baseline, there were no significant differences in the outcome measurements between the RUSF, RUSF + HiML, and control groups. However, after 12 weeks of intervention, there were significant mean differences in differences (DIDs) between the RUSF group and the control arm, with DIDs of 1.50 kg for weight (p < 0.001), 20.63 newton (N) for elbow flexor (p < 0.001), 11.00 N for quadriceps (p = 0.023), 18.95 N for gastrocnemius sup flexor of the leg (p < 0.001), and 1.03 kg for fat-free mass (p = 0.022). Similarly, the mean difference in differences was higher in the RUSF + HiML group by 1.62 kg for weight (p < 0.001), 2.80 kg for grip strength (p < 0.001), 15.93 for elbow flexor (p < 0.001), 16.73 for quadriceps (p < 0.001), 9.75 for gastrocnemius sup flexor of the leg (p = 0.005), and 2.20 kg for fat-free mass (p < 0.001) compared the control arm. RUSF alone was effective, but combining it with HiML had a synergistic effect. Compared to the control group, the RUSF and RUSF + HiML interventions improved the body composition, height, weight, and muscle strength of the studied moderately thin children. The findings of this study suggest the potential that treating moderately thin children with RUSF and combining it with HiML has for reducing the negative effects of malnutrition in Ethiopia. Future research should explore these interventions in a larger community-based study. This trial has been registered at the Pan African Clinical Trials Registry (PACTR) under trial number PACTR202305718679999.

A microbiome-directed therapeutic food for children recovering from severe acute malnutrition.

Severe acute malnutrition (SAM), defined anthropometrically as a weight-for-length z-score more than 3 standard deviations below the mean (WLZ<-3), affects 19 million children under 5-years-old worldwide. Complete anthropometric recovery after standard inventions is rare with children often left with moderate acute malnutrition (MAM; WLZ -2 to -3). Here we conduct a randomized controlled trial (RCT), involving 12-18-month-old Bangladeshi children from urban and rural sites, who after hospital-based treatment for SAM received a 3-month intervention with a microbiota-directed complementary food (MDCF-2) or a ready-to-use supplementary food (RUSF) as they transitioned to MAM. The rate of WLZ improvement was significantly greater with MDCF-2 than the more calorically-dense RUSF, as we observed in a previous RCT of Bangladeshi children with MAM without antecedent SAM. A correlated meta-analysis of aptamer-based measurements of 4,520 plasma proteins in this and the prior RCT revealed 215 proteins positively-associated with WLZ (prominently those involved in musculoskeletal and CNS development) and 44 negatively-associated proteins (related to immune activation), with a significant enrichment in levels of the positively WLZ-associated proteins in the MDCF-2 arm. Characterizing changes in 754 bacterial metagenome-assembled genomes in serially collected fecal samples disclosed the effects of acute rehabilitation for SAM on the microbiome, its transition as each child achieves a state of MAM, and how specific strains of Prevotella copri function at the intersection between MDCF-2 glycan metabolism and the rescue of growth faltering. These results provide a rationale for further testing the generalizability of the efficacy of MDCF and identify biomarkers for defining treatment responses.

A microbiota-directed complementary food intervention in 12–18-month-old Bangladeshi children improves linear growth

Globally, stunting affects ∼150 million children under five, while wasting affects nearly 50 million. Current interventions have had limited effectiveness in ameliorating long-term sequelae of undernutrition including stunting, cognitive deficits and immune dysfunction. Disrupted development of the gut microbiota has been linked to the pathogenesis of undernutrition, providing potentially new treatment approaches. 124 Bangladeshi children with moderate acute malnutrition (MAM) enrolled (at 12-18 months) in a previously reported 3-month RCT of a microbiota-directed complementary food (MDCF-2) were followed for two years. Weight and length were monitored by anthropometry, the abundances of bacterial strains were assessed by quantifying metagenome-assembled genomes (MAGs) in serially collected fecal samples and levels of growth-associated proteins were measured in plasma. Children who had received MDCF-2 were significantly less stunted during follow-up than those who received a standard ready-to-use supplementary food (RUSF) [linear mixed-effects model, βtreatment group x study week (95% CI)=0.002 (0.001, 0.003); P=0.004]. They also had elevated fecal abundances of Agathobacter faecis, Blautia massiliensis, Lachnospira and Dialister, plus increased levels of a group of 37 plasma proteins (linear model; FDR-adjusted P<0.1), including IGF-1, neurotrophin receptor NTRK2 and multiple proteins linked to musculoskeletal and CNS development, that persisted for 6-months post-intervention. MDCF-2 treatment of Bangladeshi children with MAM, which produced significant improvements in wasting during intervention, also reduced stunting during follow-up. These results suggest that the effectiveness of supplementary foods for undernutrition may be improved by including ingredients that sponsor healthy microbiota-host co-development. This work was supported by the BMGF (Grants OPP1134649/INV-000247).

Effect of a simplified approach on recovery of children 6-59 months with wasting in Ethiopia: A noninferiority, cluster randomized controlled trial.

Worldwide, nearly 45 million children under the age of 5 years were affected by wasting in 2022. Ethiopia has been challenged by disasters increasing the caseload of children with wasting. This study aimed to determine the effect of a simplified approach on recovery of children with acute malnutrition as compared with the standard protocol. A cluster randomized, controlled, noninferiority trial was carried out in three regions of Ethiopia from December 4, 2021, to July 30, 2022. A total of 58 clusters (health posts) were randomized into intervention and control groups. Children with SAMin the intervention groups received two sachets of Ready-to-Use Therapeutic Food (RUTF),whereas children in the control groups received RUTF based on their body weight. Children with moderate acute malnutrition (MAM)received one sachet of RUTF and one sachet of Ready-to-Use Supplementary Food (RUSF)daily in the intervention and control groups, respectively. Per protocol (PP) andintention-to-treatanalysis were used to compare recovery at a noninferiority margin of 15%. Data were collected from 55 health posts and 1032 children. In the PP analysis, the recovery rate of children with wasting amongthe simplified group (97.8%) was noninferior to the standard protocol group (97.7%), p = 0.399. The RUTF cost per treatment of child with SAM was 56.55 USD for the standard versus 42.78 USD for the simplified approach. The simplified approach is noninferior to the standard protocol in terms of recovery and has a lower cost of RUTF. Further study is recommended to assess the effectiveness of the simplified approach in emergency contexts.

Effect of Gut Microbiota-Directed Complementary Food Supplementation on Fecal and Plasma Biomarkers of Gut Health and Environmental Enteric Dysfunction in Slum-Dwelling Children with Moderate Acute Malnutrition.

Dietary supplementation with a gut microbiota-directed complementary food (MDCF-2) significantly improved weight gain and repaired gut microbiota, as reported in a recent randomized controlled trial on Bangladeshi children with moderate acute malnutrition (MAM). Environmental enteric dysfunction (EED) is a small bowel disorder, and recent evidence shows that it is linked to growth failure in children. Therefore, we intended to investigate whether supplementation with MDCF-2 has any role in modifying gut health by changing the levels of biomarkers of EED and gut inflammation in children with MAM. We randomly assigned 124 children aged 12-18 months to one of two intervention diets, either MDCF-2 or ready-to-use supplementary food (RUSF). Approximately 50 g of the diet was administered in two feeding sessions daily for 12 weeks. Stool and plasma biomarkers were assessed to evaluate intestinal health. Results showed that the average change in citrulline concentration (µmol/L) significantly increased among children who consumed MDCF-2 compared to those who consumed RUSF (mean difference-in-differences: 123.10; 95% CI: 3.60, 242.61; p = 0.044). The research findings demonstrated that MDCF-2 might have a beneficial effect on improving the gastrointestinal health of malnourished children.

The Outcome of the Treatment of Malnourished Children Treated by Ready To Use Therapeutic Food and Ready to Use Supplementary Food in Wad ElBashir Heath Cente 2021

introduction: Malnutrition includes both undernutrition and overnutrition. Child undernutrition is a major global health problem that is more common in low-income countries like Sudan, it can cause childhood morbidity, mortality, and impaired intellectual development. Objective: This study was conducted to assess the outcome of malnourished children treated with ready to-Use Therapeutic Food (RUTF), and ready to-Use Supplementary Food (RUSF) in Wad Elbasheir Health Centre in Ombada Locality Methods: This is an analytical Cross-Sectional facility-based Study conducted at Wad Elbasheir Health Centre. A convenient nonprobability sampling technique was used in this study. Data were collected using a datasheet after being pretested. Data were collected from secondary data from the records of malnourished children treated by the RTUF and RUSF. Results: The majority of the participants of this study were aged between 6 to 23 months (84%) and most of the participants were females (56%). This study showed that 70 (24%) of the participants were classified as severe Acute Malnutrition (SAM), while 218 (76%) were classified as moderate Acute malnutrition (MAM). This study showed that having a smaller number of children in the family and middle Upper Arm Circumference (MUAC) between 11.5-12.5 cm were more associated with recovery. Moreover, this study showed that children who use amoxicillin or anti-worms were more likely to be recovered from malnutrition. Conclusion: RUTF was designed for the nutritional management of children with uncomplicated acute malnutrition treated as outpatients. In this study, most of the children recovered. In addition, this study found that several factors were associated with better outcomes including fewer children in the family, MUAC between 11.5-12.5 cm, having MAM (compared to having SAM), and using amoxicillin or anti-worms.

Standard RUTF vs. locally-made RUSF for acutely malnourished children: A quasi-experimental comparison of the impact on growth and compliance in a rural community of Pakistan.

The reduction in severe and moderate acute malnutrition (SAM and MAM) rates in Pakistan has been sub-optimal compared to other low-and middle-income countries (LMICs). Specially-formulated products have been designed globally to manage SAM and MAM, such as ready-to-use therapeutic food (RUTF) and ready-to-use supplementary food (RUSF), with variable efficacies. RUTF is primarily produced and patented in industrialized countries, raising supply challenges in resource-constrained regions with a high burden of acute malnutrition. RUSF minimizes costs by using locally-available ingredients while providing similar nutritional value. In this study, we compared the efficacy, side effects, and compliance of two months of supplementation with either RUTF or RUSF. Children aged nine months in the rural district of Matiari, Pakistan, with a weight-for-height z-score (WHZ) <-2 received either RUTF (500 kcal sachet) for two months in 2015 or RUSF (520 kcal sachet) for two months in 2018. The RUSF group had a higher height gain and mid-upper arm circumferences (MUAC) score. Higher compliance was noted with lower side effects in the RUSF group. A higher compliance rate did correlate with the growth parameters in respective groups. Our study found that both RUTF and RUSF partially improve the anthropometric status of acutely malnourished children, with neither being superior to the other.

Effects of complementary food formulated from millet, soybean, and grasshopper on hematological parameters of malnourished weanling albino rats

Background: Malnutrition in under-five children remains an issue of public health, especially in low and middle-income countries, and is associated with inadequate child development and poor survival. Recent public health intervention strategies for malnourished children allow for localized targeted supplementation with locally available materials to replace the imported Ready-to-Use-Supplementary-Food (RUSF) for the target group. Aims: The aim of the study was to develop a local supplementary food and determine its effects on hematological parameters of weanling rats. Material and Methods: The experimental study involved thirty weanling albino rats, grouped into groups A, B, and C, each consisting of ten rats. All the groups were acclimatized for fourteen days, thereafter, groups A and B were induced with moderate acute malnutrition (MAM) by feeding with only corn starch for fourteen days. Weight, tail length, and hematological parameters (hemoglobin level, white blood cell count) of all the weanling albino rats were determined and recorded as baseline values on the fourteenth day. Therapeutic food made from millet, soybean, and grasshopper blends was produced and fed to group A as the intervention, Group B was fed with corn starch only and group C was fed on normal rat pellets for twenty-eight days. Weight, tail length, and hematological parameters were determined and recorded at the end of the intervention. Results: Experimental group A had the lowest packed cell volume (PCV) value with a difference of 2.20 ± 0.56 %, the lowest hemoglobin (Hb) level with a difference of 0.58 ± 0.02 g/dL, the control group had the highest PCV, Hb, and RBC with values of 4.10 ± 0.5 %, 1.58 ± 0.21 g/dL, and 0.9 ± 0.05 x 106 µ/L respectively. Conclusions: With the evidence provided by the parameters assessed in the study, it can be concluded that the developed therapeutic food is efficacious in the treatment of malnutrition especially in weanling albino rats. Keywords: Moderate Acute Malnutrition (MAM), Ready-to-Use-Supplementary-Food (RUSF) Malnutrition, Complementary feeding, Animal studies.

Current evidence on the effectiveness of Ready-to-Use Supplementary Foods in children with moderate acute malnutrition: a systematic review and meta-analysis.

Moderate acute malnutrition (MAM) is defined by a weight-for-height Z-score (WHZ) between -3 and -2 of the WHO reference or by a mid-upper arm circumference (MUAC) of ≥11⋅5 and <12⋅5 cm. This study aimed to synthesise the evidence for the effectiveness of Ready-to-Use Supplementary Food (RUSF) compared to other dietary interventions or no intervention on functioning at different levels of the International Classification of Functioning, Disability, and Health (ICF) among children with MAM between 2 and12 years old. Three databases (PubMed, Scopus, and Web of Science) were systematically searched (last update: 20 November 2022). Pooled estimates of effect were calculated using random-effects meta-analyses. The level of evidence was estimated with the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) method. Seven studies were included. RUSF had a significant small-sized better effect (pooled mean: 0⋅38; 95 % CI = [0⋅10, 0⋅67], P = 0⋅01, I² = 97 %) on different anthropometric measurements compared to other dietary interventions among MAM children (n 6476). Comparing RUSF with corn-soy blend Plus Plus (CSB++) showed that RUSF had a small-sized but significantly better effect on the children's anthropometric measures compared to children who received CSB++ (pooled mean: 0⋅16; 95 % CI = [0⋅05, 0⋅27], P = 0⋅01; I2 = 35 %). MAM children treated with RUSF had a better recovery rate compared to those treated with CSB++ (pooled risk difference: 0⋅11; 95 % CI = [0⋅06, 0⋅11], P < 0⋅001; I2 = 0 %). The RUSF intervention seems promising in improving MAM children's nutritional outcomes and recovery rate compared to other dietary interventions.

Developing shelf-stable Microbiota Directed Complementary Food (MDCF) prototypes for malnourished children: study protocol for a randomized, single-blinded, clinical study

BackgroundChildhood undernutrition is a major public health concern that needs special attention to achieve 2025 global nutrition targets. Moderate acute malnutrition (MAM), manifest as wasting (low weight-for-height), affects 33 million children under 5, yet there are currently no global guidelines for its treatment. We recently performed a randomized-controlled clinical study of a microbiota-directed complementary food formulation (MDCF-2) in 12-18-month-old Bangladeshi children with MAM. The results revealed that MDCF-2, freshly prepared each day, produced a significantly greater improvement in ponderal growth than a standard ready-to-use supplementary food (RUSF), an effect that is associated with repair of the disrupted gut microbial community development that occurs in children with MAM. To test the generalizability of these results in acutely malnourished children at other sites, there is a pressing need for a packaged, shelf-stable, organoleptically-acceptable formulation that is bioequivalent to MDCF-2. This report describes the protocol for a clinical study to evaluate candidate formulations designed to meet these criteria.MethodsA randomized single-blind study will be conducted in 8-12-month-old Bangladeshi children with MAM to compare the efficacy of alternative shelf-stable MDCF prototypes versus the current MDCF-2 formulation that is produced fresh each day. V4-16S rDNA amplicon and shotgun sequencing datasets will be generated from faecal DNA samples collected from each child enrolled in each group prior to, during, and after treatment to determine the abundances of MDCF-2-responsive bacterial taxa. Efficacy will be assessed by quantifying the change in representation of MDCF-2-responsive gut bacterial taxa after 4-weeks of treatment with freshly prepared MDCF-2 compared to their changes in abundance after treatment with the prototype MDCFs. Equivalence will be defined as the absence of a statistically significant difference, after 4-weeks of treatment, in the representation of faecal bacterial taxa associated with the response to MDCF-2 in participants receiving a test MDCF.DiscussionThis trial aims to establish acceptability and equivalence with respect to microbiota repair, of scalable, shelf-stable formulations of MDCF-2 in 8-12-month-old Bangladeshi children with moderate acute malnutrition.Trial registrationClinicalTrials.gov (NCT05094024). The trial has been registered before starting enrolment on 23 October 2021.

Ready to-Use Supplementary Food in the Outpatient Management of Children with Acute Malnutrition in Basrah

Summary Background Ready-to-use supplementary foods are high-energy, lipid-based provide energy, protein, fat, vitamins and minerals to treat acute malnutrition in children aged 6 -59 months. Aim To evaluate the effect of ready-to-use supplement foods on the outpatient management of children with acute malnutrition. Methods A prospective appropriate study was carried out on children with acute malnutrition who were referred to the nutritional rehabilitation center at Basra Teaching Hospital; were received ready-to- use supplementary foods at a quantity sufficient to meet their nutrient requirements for full catch- up growth and followed at two subsequent visits Results Moderate wasting and underweight recorded in (66.7 %) and severe wasting in (33.33%) of the patients. Mean weight gain at the first and second follow-up visit was (5.78 ±2.43) and (6.52 ±2.75) g/kg/day respectively. There was a significant improvement in the weight for height Z score at the first and second follow-up visits after the administration of ready-to-use supplementary foods (P value < 0.05). Approximately 32% of the children aged 12-18-month experienced moderate weight gain. Bottle feeding with complementary feeding was reported in 24.19% of the children with moderate weight gain, and 9.52% and 34.68% of the children of illiterate parents and unemployed fathers respectively, showed moderate weight gain. Children belong to families with low income group accounted for 37.09% of those with moderate weight gain. Family income was the only variable that depend on the weight gain results (P value < 0.05). Conclusion: Ready-to-use supplementary food is significantly effective for outpatient management of acute malnutrition. Key words: Acute Malnutrition, Ready-to-Use Supplementary Food, Outpatients

Composite Flour from Indonesian Local Food Resources to Develop Cereal/Tuber Nut/Bean-Based Ready-to-Use Supplementary Foods for Prevention and Rehabilitation of Moderate Acute Malnutrition in Children.

Undernourishment is a threat to human health. The prevalence of undernourishment remains alarming, especially among children under five years old in many countries, including Indonesia. Nowadays, the handling of undernourishment has shifted to treatment outside the hospital, utilizing local nutrient-rich foods. At the national level, the utilization of local food resources is a part of the promotion of dietary diversification and the bioeconomy. Ready-to-use supplementary food (RUSF) refers to supplementary foods aimed at improving the nutrition of moderate acute malnutrition (MAM) children under five years old. RUSF biscuit recipes were made using local food resources available in Banten province, Indonesia. To optimize the nutritional profile of the developed RUSF, taro/talas banten were mixed with ground-nut/peanut (Arachis hypogaea L.) and mungbean (Vigna radiata) as protein and lipid sources and red rice (Oryza longistaminata) and maize (Zea mays) as carbohydrate sources, and enriched by the local banana Nangka (Musa textilia). Two formulations were selected for the pilot testing, namely the taro-peanut and taro-peanut/mungbean RUSF biscuits, made from taro Banten, cereal, peanut and/or mungbean, and local banana. The RUSF biscuit showed promising results, presenting a high level of acceptance and a macronutrient composition that meets the standards for MAM children. However, the RUSF biscuits should be fortified with micronutrient premix to fulfill the dietary requirement for the MAM children. The results of this study provide further development opportunities.

Effects of a supplementary feeding program on the nutritional status of children in Daynile District Hospital Mogadishu, Somalia

Infant growth is an important variable that determines the nutritional and health status of children and during growth faltering supplementary feeding is very essential and saves a child’s life. The overall purpose of this study was to establish the association between dietary intake of supplementary foods on recovery and growth of children attending Daynile district hospital in Mogadishu, Somalia. A one month follow-up period longitudinal study with 28 participants was pulled from a baseline study that included 196 children (6-59 months) attending Daynile District Hospital. Children with global acute malnutrition (z-score less than minus two (-2)) were selected for the follow up study. Data was collected using digitized questionnaires in the Open Data Kit (ODK). Baseline data was analyzed using SPSS v20 software, nutrient intake and follow up data were analyzed using Python version 3.7 while Ena-For-SMART version 2015 was used for analysis of anthropometric data. P-value less than 0.05 were considered significant. From the baseline study, majority (90.3%) of the children had eaten food prepared from dairy products. Carbohydrates such as grains, tubers, and roots were also among the highest (88.8%) consumed foods. The study children had a high prevalence of stunting (18.4%), wasting (17.3%), and underweight (27%). A significant association (p=0.032) between mother’s complementary feeding practices, household income and minimum meal frequency was observed. From the longitudinal study, the feeding regime indicated that 9 out of 28 children (32%) transitioned from Ready to Use Supplementary Foods (RUSF) to Lipid based Nutrient Supplement (LNS), 7 out of 28 (25%) did not transition from RUSF while the remaining 12 (43%) children received LNS all through the entire one month of monitoring. At the end of the follow up, 56% (16 children) improved and were transitioned to LNS. The overall mean height, weight, and mid upper arm circumference differences for all the children who took RUSF and LNS slightly increased throughout the assessment period though the mean difference was not statistically significant. Treatment of moderate acute malnutrition with RUSF and LNS resulted in recovery of children. Therefore, there’s need to introduce effective and sustainable supplemental feeding programmes as a stop-gap solution in an effort to address the high malnutrition rates among these children. Keywords: child growth, nutrition status, supplementary foods, dietary intake

A novel intervention combining supplementary food and infection control measures to improve birth outcomes in undernourished pregnant women in Sierra Leone: A randomized, controlled clinical effectiveness trial.

BackgroundInnovations for undernourished pregnant women that improve newborn survival and anthropometry are needed to achieve the Sustainable Development Goals 1 and 3. This study tested the hypothesis that a combination of a nutritious supplementary food and several proven chemotherapeutic interventions to control common infections would increase newborn weight and length in undernourished pregnant women.Methods and findingsThis was a prospective, randomized, controlled clinical effectiveness trial of a ready-to-use supplementary food (RUSF) plus anti-infective therapies compared to standard therapy in undernourished pregnant women in rural Sierra Leone. Women with a mid-upper arm circumference (MUAC) ≤23.0 cm presenting for antenatal care at one of 43 government health clinics in Western Rural Area and Pujehun districts were eligible for participation. Standard of care included a blended corn/soy flour and intermittent preventive treatment for malaria in pregnancy (IPTp). The intervention replaced the blended flour with RUSF and added azithromycin and testing and treatment for vaginal dysbiosis. Since the study involved different foods and testing procedures for the intervention and control groups, no one except the authors conducting the data analyses were blinded. The primary outcome was birth length. Secondary outcomes included maternal weight gain, birth weight, and neonatal survival. Follow-up continued until 6 months postpartum. Modified intention to treat analyses was undertaken. Participants were enrolled and followed up from February 2017 until February 2020.Of the 1,489 women enrolled, 752 were allocated to the intervention and 737 to the standard of care. The median age of these women was 19.5 years, of which 42% were primigravid. Twenty-nine women receiving the intervention and 42 women receiving the standard of care were lost to follow-up before pregnancy outcomes were obtained. There were 687 singleton live births in the intervention group and 657 in the standard of care group. Newborns receiving the intervention were 0.3 cm longer (95% confidence interval (CI) 0.09 to 0.6; p = 0.007) and weighed 70 g more (95% CI 20 to 120; p = 0.005) than those receiving the standard of care. Those women receiving the intervention had greater weekly weight gain (mean difference 40 g; 95% CI 9.70 to 71.0, p = 0.010) than those receiving the standard of care. There were fewer neonatal deaths in the intervention (n = 13; 1.9%) than in the standard of care (n = 28; 4.3%) group (difference 2.4%; 95% CI 0.3 to 4.4), (HR 0.62 95% CI 0.41 to 0.94, p = 0.026). No differences in adverse events or symptoms between the groups was found, and no serious adverse events occurred. Key limitations of the study are lack of gestational age estimates and unblinded administration of the intervention.ConclusionsIn this study, we observed that the addition of RUSF, azithromycin, more frequent IPTp, and testing/treatment for vaginal dysbiosis in undernourished pregnant women resulted in modest improvements in anthropometric status of mother and child at birth, and a reduction in neonatal death. Implementation of this combined intervention in rural, equatorial Africa may well be an important, practical measure to reduce infant mortality in this context.Trial registrationClinicalTrials.gov NCT03079388.

Effectiveness and cost-effectiveness of 4 supplementary foods for treating moderate acute malnutrition: results from a cluster-randomized intervention trial in Sierra Leone

ABSTRACTBackgroundModerate acute malnutrition (MAM) affects 33 million children annually. Investments in formulations of corn-soy blended flours and lipid-based nutrient supplements have effectively improved MAM recovery rates. Information costs and cost-effectiveness differences are still needed.ObjectivesWe assessed recovery and sustained recovery rates of MAM children receiving a supplementary food: ready-to-use supplementary food (RUSF), corn soy whey blend with fortified vegetable oil (CSWB w/oil), or Super Cereal Plus with amylase (SC + A) compared to Corn Soy Blend Plus with fortified vegetable oil (CSB+ w/oil). We also estimated differences in costs and cost effectiveness of each supplement.MethodsIn Sierra Leone, we randomly assigned 29 health centers to provide a supplement containing 550 kcal/d for ∼12 wk to 2691 children with MAM aged 6–59 mo. We calculated cost per enrollee, cost per child who recovered, and cost per child who sustained recovery each from 2 perspectives: program perspective and caregiver perspective, combined.ResultsOf 2653 MAM children (98.6%) with complete data, 1676 children (63%) recovered. There were no significant differences in the odds of recovery compared to CSB+ w/oil [0.83 (95% CI: 0.64–1.08) for CSWB w/oil, 1.01 (95% CI: 0.78–1.3) for SC + A, 1.05 (95% CI: 0.82–1.34) for RUSF]. The odds of sustaining recovery were significantly lower for RUSF (0.7; 95% CI 0.49–0.99) but not CSWB w/oil or SC + A [1.08 (95% CI: 0.73–1.6) and 0.96 (95% CI: 0.67–1.4), respectively] when compared to CSB+ w/oil. Costs per enrollee [US dollars (USD)/child] ranged from $105/child in RUSF to $112/child in SC + A and costs per recovered child (USD/child) ranged from $163/child in RUSF to $179/child in CSWB w/oil, with overlapping uncertainty ranges. Costs were highest per sustained recovery (USD/child), ranging from $214/child with the CSB+ w/oil to $226/child with the SC + A, with overlapping uncertainty ranges.ConclusionsThe 4 supplements performed similarly across recovery (but not sustained recovery) and costed measures. Analyses of posttreatment outcomes are necessary to estimate the full cost of MAM treatment. This trial was registered at clinicaltrials.gov as NCT03146897.

A Microbiota-Directed Food Intervention for Undernourished Children

BackgroundMore than 30 million children worldwide have moderate acute malnutrition. Current treatments have limited effectiveness, and much remains unknown about the pathogenesis of this condition. Children with moderate acute malnutrition have perturbed development of their gut microbiota.MethodsIn this study, we provided a microbiota-directed complementary food prototype (MDCF-2) or a ready-to-use supplementary food (RUSF) to 123 slum-dwelling Bangladeshi children with moderate acute malnutrition between the ages of 12 months and 18 months. The supplementation was given twice daily for 3 months, followed by 1 month of monitoring. We obtained weight-for-length, weight-for-age, and length-for-age z scores and mid–upper-arm circumference values at baseline and every 2 weeks during the intervention period and at 4 months. We compared the rate of change of these related phenotypes between baseline and 3 months and between baseline and 4 months. We also measured levels of 4977 proteins in plasma and 209 bacterial taxa in fecal samples.ResultsA total of 118 children (59 in each study group) completed the intervention. The rates of change in the weight-for-length and weight-for-age z scores are consistent with a benefit of MDCF-2 on growth over the course of the study, including the 1-month follow-up. Receipt of MDCF-2 was linked to the magnitude of change in levels of 70 plasma proteins and of 21 associated bacterial taxa that were positively correlated with the weight-for-length z score (P<0.001 for comparisons of both protein and bacterial taxa). These proteins included mediators of bone growth and neurodevelopment.ConclusionsThese findings provide support for MDCF-2 as a dietary supplement for young children with moderate acute malnutrition and provide insight into mechanisms by which this targeted manipulation of microbiota components may be linked to growth. (Supported by the Bill and Melinda Gates Foundation and the National Institutes of Health; ClinicalTrials.gov number, NCT04015999.)

Nutritional perspectives on sickle cell disease in Africa: a systematic review

BackgroundSickle cell disease (SCD) is an inherited blood disorder that predominantly affects individuals in sub-Saharan Africa. However, research that elucidates links between SCD pathophysiology and nutritional status in African patients is lacking. This systematic review aimed to assess the landscape of studies in sub-Saharan Africa that focused on nutritional aspects of SCD, and highlights gaps in knowledge that could inform priority-setting for future research.MethodsThe study was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Inclusion criteria comprised original, peer-reviewed research published between January 1995 and November 2020 involving individuals in Africa with any phenotypic variant of SCD and at least one nutritional status outcome. Nutritional status outcomes were defined as those that assessed dietary intakes, growth/anthropometry, or nutritional biomarkers. Databases used were Ovid Embase, Medline, Biosis and Web of Science.ResultsThe search returned 526 articles, of which 76 were included in the final analyses. Most investigations (67%) were conducted in Nigeria. Studies were categorized into one of three main categories: descriptive studies of anthropometric characteristics (49%), descriptive studies of macro- or micronutrient status (41%), and interventional studies (11%). Findings consistently included growth impairment, especially among children and adolescents from sub-Saharan Africa. Studies assessing macro- and micronutrients generally had small sample sizes and were exploratory in nature. Only four randomized trials were identified, which measured the impact of lime juice, long-chain fatty acids supplementation, ready-to-use supplementary food (RUSF), and oral arginine on health outcomes.ConclusionsThe findings reveal a moderate number of descriptive studies, most with small sample sizes, that focused on various aspects of nutrition and SCD in African patients. There was a stark dearth of interventional studies that could be used to inform evidence-based changes in clinical practice. Findings from the investigations were generally consistent with data from other regional settings, describing a significant risk of growth faltering and malnutrition among individuals with SCD. There is an unmet need for clinical research to better understand the potential benefits of nutrition-related interventions for patients with SCD in sub-Saharan Africa to promote optimal growth and improve health outcomes.

Effect of a newly developed ready-to-use supplementary food on growth indicators in children with mild to moderate malnutrition

ObjectivesMalnutrition is one of the leading causes of death among children younger than five years. In this study, we aimed to formulate a ready-to-use supplementary food (RUSF), based on local food products, and investigate its efficacy on growth indicators in children with mild to moderate malnutrition. Study designThis is a randomized controlled clinical trial. MethodsThis study was performed in six health centers in Shahr-e-Rey, Tehran, Iran, between April and October 2017. One hundred children, aged 24–59 months, with mild to moderate malnutrition (weight-for-height Z-score [WHZ] between −3 and −1) were randomly assigned to two groups to receive either 1–3 sachets of RUSF or normal diet for 8 weeks. All mothers and caregivers received nutrition education. Growth indicators including weight and height, WHZ, and body mass index (BMI), along with clinical outcomes, were assessed. ResultsChildren who received RUSF had a significant increase in weight (1.44 ± 0.38 vs 0.7 ± 0.32 kg, respectively, P < 0.001), and BMI (1.2 ± 0.47 vs 0.35 ± 0.33 kg/m2, respectively, P < 0.001) compared with the control group. There was a greater daily weight gain during the first 4 weeks (P < 0.001) and throughout the study (P = 0.013) in the RUSF group. Daily height gain was considerably higher in the RUSF group during the first 4 weeks (P = 0.027). Children in the RUSF group had more improvement in WHZ (1.18 ± 0.41 vs 0.41 ± 0.31, P < 0.001) after supplementation. Besides, 92% of the RUSF and 12% of the control group reached to WHZ > −1 at the end of the study (P < 0.001). There was lower prevalence of diarrhea (12% vs 28.6%, respectively, P = 0.01) and marginally lower fever (16% vs 36.7%, respectively, P = 0.05) in the intervention than in the control group. ConclusionsA newly developed RUSF improved growth indicators and clinical outcomes in children with mild to moderate malnutrition. Clinical Trial Registry numberIRCT2017021315536N6 (registered at www.irct.ir)

A simplified, combined protocol versus standard treatment for acute malnutrition in children 6-59 months (ComPAS trial): A cluster-randomized controlled non-inferiority trial in Kenya and South Sudan.

Malnutrition underlies 3 million child deaths worldwide. Current treatments differentiate severe acute malnutrition (SAM) from moderate acute malnutrition (MAM) with different products and programs. This differentiation is complex and costly. The Combined Protocol for Acute Malnutrition Study (ComPAS) assessed the effectiveness of a simplified, unified SAM/MAM protocol for children aged 6-59 months. Eliminating the need for separate products and protocols could improve the impact of programs by treating children more easily and cost-effectively, reaching more children globally. A cluster-randomized non-inferiority trial compared a combined protocol against standard care in Kenya and South Sudan. Randomization was stratified by country. Combined protocol clinics treated children using 2 sachets of ready-to-use therapeutic food (RUTF) per day for those with mid-upper arm circumference (MUAC) < 11.5 cm and/or edema, and 1 sachet of RUTF per day for those with MUAC 11.5 to <12.5 cm. Standard care clinics treated SAM with weight-based RUTF rations, and MAM with ready-to-use supplementary food (RUSF). The primary outcome was nutritional recovery. Secondary outcomes included cost-effectiveness, coverage, defaulting, death, length of stay, and average daily weight and MUAC gains. Main analyses were per-protocol, with intention-to-treat analyses also conducted. The non-inferiority margin was 10%. From 8 May 2017 to 31 March 2018, 2,071 children were enrolled in 12 combined protocol clinics (mean age 17.4 months, 41% male), and 2,039 in 12 standard care clinics (mean age 16.7 months, 41% male). In total, 1,286 (62.1%) and 1,202 (59.0%), respectively, completed treatment; 981 (76.3%) on the combined protocol and 884 (73.5%) on the standard protocol recovered, yielding a risk difference of 0.03 (95% CI -0.05 to 0.10, p = 0.52; per-protocol analysis, adjusted for country, age, and sex). The amount of ready-to-use food (RUTF or RUSF) required for a child with SAM to reach full recovery was less in the combined protocol (122 versus 193 sachets), and the combined protocol cost US$123 less per child recovered (US$918 versus US$1,041). There were 23 (1.8%) deaths in the combined protocol arm and 21 (1.8%) deaths in the standard protocol arm (adjusted risk difference 95% CI -0.01 to 0.01, p = 0.87). There was no evidence of a difference between the protocols for any of the other secondary outcomes. Study limitations included contextual factors leading to defaulting, a combined multi-country power estimate, and operational constraints. Combined treatment for SAM and MAM is non-inferior to standard care. Further research should focus on operational implications, cost-effectiveness, and context (Asia versus Africa; emergency versus food-secure settings). This trial is complete and registered at ISRCTN (ISRCTN30393230). The trial is registered at ISRCTN, trial number ISRCTN30393230.

Behavioral Factors Related to Use of Specialized Nutritious Foods in a MAM Treatment Program in Sierra Leone

Abstract Objectives This analysis describes differences in household-level use of four specialized nutritious foods (SNFs) for treatment of moderate acute malnutrition (MAM) in children 6–59 months of age in Sierra Leone and explores whether these behaviors influenced recovery. Methods From 4/2017 to 11/2018, sub-samples of caregivers whose children were enrolled in a supplemental feeding program (SFP) for a MAM treatment study were randomly selected for in-depth interviews and in-home observations. This was a cluster-randomized trial of 2653 children with MAM in Sierra Leone evaluating cost-effectiveness of 4 SNFs: Super Cereal Plus w/amylase (SC + A), Corn-soy Blend Plus w/oil (CSB + w/oil), Corn-soy-whey Blend w/oil (CSWB w/oil), and Ready-to-Use Supplementary Food (RUSF). Caregivers received bi-weekly isocaloric distributions of 1 of the 4 SNFs until recovery or up to 12 weeks. The purpose of the in-depth interviews was to understand caregivers’ experiences with the SFP and the SNF which they received. In-home observations gathered information about observed behaviors related to SNF use over 5 consecutive days. Descriptive statistics were calculated and stratified by study arm and by outcome to explore: consumption of the SNF by the target child, sharing and selling, and diversion of other household foods. Results A total of n = 949 caregivers completed an in-depth interview. Of these, n = 323 also had an in-home observation. Observed consumption of the SNF was high in all study arms (&amp;gt;60%), with no discernible differences among arms. Consumption of the study food by anyone other than the beneficiary child (i.e., sharing) was similar across arms (9–12% reported, 19–27% observed), with the lowest reported and highest observed in RUSF. Very few reported giving the SNF away or selling it to others (&amp;lt;1%). Sharing and displacement did not differ by recovery status, but children who recovered were observed consuming the SNF more often than those who failed (82% vs. 46%). Conclusions Sharing of the SNF was common among all arms but did not affect likelihood of recovery. Ensuring adequate consumption of the SNF by the beneficiary child is critical for effectiveness. Qualitative data can expand on these findings. Funding Sources Office of Food for Peace, United States Agency for International Development.