The Effects of One Egg Per Day on Vitamin A Status Among Young Malawian Children: A Secondary Analysis of a Randomized Controlled Trial.

Background: Vitamin A deficiency (VAD) is common in populations with limited dietary diversity and access to vitamin A-rich foods. Objectives: This analysis aimed to determine the impact of supplementing children's diets with 1 egg/d on the concentration of plasma retinol and RBP and the prevalence of VAD. Methods: Children age 6-9 mo living in the Mangochi district of Malawi were individually randomly assigned to receive 1 egg/d for 6 mo (n = 331) or continue their usual diet (n = 329) in the Mazira trial (clinicaltrials.gov; NCT03385252). This secondary analysis measured plasma retinol by HPLC and RBP, CRP, and α-1-acid glycoprotein (AGP) by ELISA techniques at enrollment and 6 mo follow-up. Retinol and RBP were adjusted for inflammation, and mean concentrations were compared between groups using linear regression models. In addition, prevalence ratios of VAD (retinol <0.7 µmol/L) were compared between groups using log-binomial or modified Poisson regression models. Results: After 6 mo of study participation, 489 were assessed for retinol (egg: n = 238; control: n = 251), and 575 (egg: n = 281; control: n = 294) were assessed for RBP. Prevalence of inflammation (CRP >5 mg/L or AGP >1 g/L: 62%) and inflammation-adjusted VAD (7%) at enrollment did not differ between groups. At follow-up, the egg intervention group did not differ from the control in inflammation-adjusted retinol [geometric mean (95% CI); egg: 1.10 µmol/L (1.07, 1.13); control: 1.08 (1.05, 1.12)], RBP [egg: 0.99 µmol/L (0.96, 1.02); control: 0.97 (0.94, 1.00)], or prevalence of VAD [egg: 6%; control: 3%; prevalence ratio: 1.87 (0.83, 4.24)]. Conclusions: Provision of 1 egg/d did not impact VAD, plasma retinol, or RBP among young children in rural Malawi, where the prevalence of VAD was low. Curr Dev Nutr 2023;x:xx.This trial was registered at [clinicaltrials.gov] as [NCT03385252].

The association between plasma choline, growth and neurodevelopment among Malawian children aged 6-15 months enroled in an egg intervention trial.

Choline is an essential micronutrient that may influence growth and development; however, few studies have examined postnatal choline status and children's growth and development in low- and middle-income countries. The aim of this observational analysis was to examine associations of plasma choline with growth and development among Malawian children aged 6-15 months enrolled in an egg intervention trial. Plasma choline and related metabolites (betaine, dimethylglycine and trimethylamine N-oxide) were measured at baseline and 6-month follow-up, along with anthropometric (length, weight, head circumference) and developmental assessments (the Malawi Developmental Assessment Tool [MDAT], the Infant Orienting with Attention task [IOWA], a visual paired comparison [VPC] task and an elicited imitation [EI] task). In cross-sectional covariate-adjusted models, each 1 SD higher plasma choline was associated with lower length-for-age z-score (-0.09 SD [95% confidence interval, CI -0.17 to -0.01]), slower IOWA response time (8.84 ms [1.66-16.03]) and faster processing speed on the VPC task (-203.5 ms [-366.2 to -40.7]). In predictive models, baseline plasma choline was negatively associated with MDAT fine motor z-score at 6-month follow-up (-0.13 SD [-0.22 to -0.04]). There were no other significant associations of plasma choline with child measures. Similarly, associations of choline metabolites with growth and development were null except higher trimethylamine N-oxide was associated with slower information processing on the VPC task and higher memory scores on the EI task. In this cohort of children with low dietary choline intake, we conclude that there were no strong or consistent associations between plasma choline and growth and development.

The Effects of 1 Egg per Day on Iron and Anemia Status among Young Malawian Children: A Secondary Analysis of a Randomized Controlled Trial.

Background: Young children with diets lacking diversity with low consumption of animal source foods are at risk of iron deficiency anemia (IDA). Objectives: Our objectives were to determine the impact of supplementing diets with 1 egg/d on 1) plasma ferritin, soluble transferrin receptor (sTfR), body iron index (BII), and hemoglobin concentrations and 2) the prevalence of iron deficiency (ID), anemia, and IDA. Methods: Malawian 6-9-mo-old infants in the Mazira trial (clinicaltrials.gov; NCT03385252) were individually randomly assigned to receive 1 egg/d for 6 mo (n = 331) or continue their usual diet (n = 329). In this secondary analysis, hemoglobin, plasma ferritin, sTfR, C-reactive protein (CRP), and α-1-acid glycoprotein (AGP) were measured at enrollment and 6-mo follow-up. Iron biomarkers were corrected for inflammation. Ferritin, sTfR, BII, and hemoglobin were compared between groups using linear regression. Prevalence ratios (PRs) for anemia (hemoglobin <11 g/dL) and ID (ferritin <12 µg/L, sTfR >8.3 mg/L, or BII <0 mg/kg) between groups were compared using log binomial or modified Poisson regression. Results: A total of 585 children were included in this analysis (Egg: n = 286; Control: n = 299). At enrollment, the total prevalence of anemia was 61% and did not differ between groups. At 6-mo follow-up, groups did not differ in geometric mean concentration of hemoglobin [mean (95% CI); Egg: 10.9 (10.7, 11.1) g/dL; Control: 11.1 (10.9, 11.2) g/dL] and inflammation-adjusted ferritin [Egg: 6.52 (5.98, 7.10) µg/L; Control: 6.82 (6.27, 7.42) µg/L], sTfR [Egg: 11.34 (10.92, 11.78) mg/L; Control: 11.46 (11.04, 11.89) mg/L] or BII [Egg: 0.07 (0.06, 0.09) mg/kg; Control: 0.07 (0.05, 0.08) mg/kg]. There were also no group differences in anemia [Egg: 46%; Control 40%; PR: 1.15 (95% CI: 0.96, 1.38)], ID [PR: 0.99 (0.94, 1.05)], or IDA [PR: 1.12 (0.92, 1.36)]. Conclusions: Providing eggs daily for 6 mo did not affect iron status or anemia prevalence in this context. Other interventions are needed to address the high prevalence of ID and anemia among young Malawian children. This trial is registered at http://www.clinicaltrials.gov as NCT03385252.

Plasma Choline Concentration Was Not Increased After a 6-Month Egg Intervention in 6-9-Month-Old Malawian Children: Results from a Randomized Controlled Trial.

BACKGROUND: Eggs are a rich source of choline, an essential nutrient important for child growth and development. In a randomized trial of 1 egg/d in young children in Ecuador, an egg intervention led to significant improvements in growth, which were partially mediated by increased plasma choline concentration. A similar trial in Malawi (clinicaltrials.gov: NCT03385252) found little improvement in child growth or development. OBJECTIVES: We aimed to evaluate the effect of 1 egg/d for 6 mo on plasma choline concentrations in Malawian children enrolled in a randomized trial. METHODS: Infants aged 6-9 mo in rural Malawi were randomly assigned to receive 1 egg/d (n = 331) or serve as a nonintervention control (n = 329) for 6 mo. Anthropometric, developmental, and dietary data were collected at baseline and 6-mo follow-up, along with a blood draw. Plasma choline, betaine, dimethylglycine, trimethylamine N-oxide (TMAO), and DHA were measured at both time points using ultrahigh performance liquid chromatography-tandem MS (n = 200 per group). Linear regression analysis was used to determine the difference in plasma choline and related metabolites between groups after 6 mo of intervention. RESULTS: Plasma choline, betaine, dimethylglycine, and DHA concentrations did not differ between groups at 6-mo follow-up. Plasma TMAO was significantly (26%; 95% CI: 7%, 48%) higher in the egg intervention group in a fully adjusted model. CONCLUSIONS: Provision of 1 egg/d for 6 mo did not result in increases in plasma choline or related metabolites, except TMAO. This could partially explain the lack of effect on growth and development. Additional interventions are needed to improve choline status, growth, and development in this population.

Impacts of an egg intervention on nutrient adequacy among young Malawian children.

Eggs are a rich source of multiple nutrients that support child growth and development. Provision of eggs as a complementary food may improve dietary adequacy among young children at risk for undernutrition. Our objective was to test the impact of an egg intervention on the adequacy of total nutrient intakes and micronutrient density among 6- to 15-month-old Malawian children. Children 6 to 9 months old, living in Mangochi District, Malawi, were randomly assigned to the intervention group (n = 331) receiving an egg per day or a control group (n = 329) consuming their usual diet. Dietary intakes of macronutrients, vitamins and minerals were assessed using 24-h recalls at baseline, 3-month midline and 6-month endline, with repeat recalls in a subsample. Usual nutrient intake and micronutrient density distributions were modelled to estimate group means and prevalence of inadequacy. Group differences at midline and endline were tested using unequal variance t tests with bootstrapped standard errors. The egg intervention resulted in higher intakes of fat and protein and lower intakes of carbohydrates. The egg group had lower prevalence of inadequacy for selenium, vitamin A, riboflavin, vitamin B5 , vitamin B12 and choline. Micronutrient density inadequacy was lower in the egg group for vitamin A and choline at midline and endline, riboflavin at midline and vitamin B5 at endline. Inadequacy of nutrient intakes or density remained highly prevalent in both groups for multiple micronutrients. Though the egg intervention increased intakes of protein and several micronutrients, total intakes and micronutrient density of multiple micronutrients remained far below recommendations.

Supplementation With Lactoferrin and Lysozyme Ameliorates Environmental Enteric Dysfunction: A Double-Blind, Randomized, Placebo-Controlled Trial.

INTRODUCTION: Environmental enteric dysfunction (EED) predisposes children throughout the developing world to high rates of systemic exposure to enteric pathogens and stunting. Effective interventions that treat or prevent EED may help children achieve their full physical and cognitive potential. The objective of this study is to test whether 2 components of breast milk would improve a biomarker of EED and linear growth during the second year of life. METHODS: A prospective, randomized, double-blind, placebo-controlled clinical trial among children aged 12-23 months was conducted in rural Malawi. The experimental group received a daily supplement of 1.5 g of lactoferrin and 0.2 g of lysozyme for 16 weeks. The primary outcome was an improvement in EED, as measured by the change in the percentage of ingested lactulose excreted into the urine (Δ%L). RESULTS: Among 214 children who completed the study, there was a significant difference in Δ%L between the control and experimental groups over 8 weeks (an increase of 0.23% vs 0.14%, respectively; P = 0.04). However, this relative improvement was not as strongly sustained over the full 16 weeks of the study (an increase of 0.16% vs 0.11%, respectively; P = 0.17). No difference in linear growth over this short period was observed. The experimental intervention group had significantly lower rates of hospitalization and the development of acute malnutrition during the course of the study (2.5% vs 10.3%, relative risk 0.25; P < 0.02). DISCUSSION: Supplementation with lactoferrin and lysozyme in a population of agrarian children during the second year of life has a beneficial effect on gut health. This intervention also protected against hospitalization and the development of acute malnutrition, a finding with a significant clinical and public health importance. This finding should be pursued in larger studies with longer follow-up and optimized dosing.

Consumption of Animal-Source Protein is Associated with Improved Height-for-Age z Scores in Rural Malawian Children Aged 12⁻36 Months.

Linear growth faltering, caused by insufficient diet, recurrent infections and environmental enteric dysfunction (EED), continues to plague young children in low- and middle-income countries (LMICs). Diets in LMICs are primarily plant based, and thus have poor-quality protein and low levels of essential micronutrients. The aim of this study was to assess the association of the type and protein quality of food consumed with stunting, EED and acute malnutrition in children aged 6⁻36 months in Limera and Masenjere, two rural Southern Malawian communities. This is a secondary analysis of two randomized controlled trials that tested the effects of common bean and cowpea flour on stunting in children aged 6⁻36 months. We used data from two interactive 24-h dietary recalls conducted 12 weeks after enrolment into each trial. Food intakes were compared between the regions using Chi-square and Student's t-test. There were 355 children that participated in the dietary recalls. The diets of children were of poor quality, but the children from Limera consumed more fish (54% vs. 35%, p = 0.009) and more bioavailable protein (26.0 ± 10.3 g/day vs. 23.1 ± 8.1 g/day, p = 0.018, respectively) than children in Masenjere. Food type and protein quality were not associated with any of the outcomes except an association between animal protein consumption and improvement in height-for-age z scores in children aged 12⁻36 months (p = 0.047). These findings support the notion that animal-source food (ASF) consumption in this vulnerable population promotes linear growth.

Effect of cowpea flour processing on the chemical properties and acceptability of a novel cowpea blended maize porridge.

Childhood growth stunting is a pervasive problem in Malawi and is in large part due to low quality complementary foods and chronic gut inflammation. Introducing legumes such as cowpea (Vigna unguiculata) into the complementary diet has the potential to improve childhood growth by improving diet quality through improvements in macro- and micronutrients and also by reducing gut inflammation. However, cowpea is relatively underutilized in complementary feeding in Malawi due to its strong taste, long processing time, and high energy requirements for processing. Effective utilization of cowpea in complementary feeding requires processing which may affect chemical composition as well as sensory quality. The present study evaluated the effect of processing on the retention of zinc, crude fibre, and flavonoid in roasted, boiled, and dehulled cowpea flours, and assessed the acceptability of maize porridge (70%) enriched with one of the three cowpea flours (30%). Roasting, dehulling, and boiling did not have any effect on zinc content. Crude fibre content increased after processing by all methods. Processing had no effect on measurable flavonoids. Roasted, boiled, and dehulled cowpea blended maize porridges were acceptable to children with mean quantities of leftover food of less than 3g from the given 100g. Caregivers also rated the blended flours to be highly acceptable to them as well, with maize porridge blended with dehulled cowpea flour the most acceptable to both children and caregivers. These results demonstrate that cowpea flour, processed by any of these three different methods, could serve as a useful addition to maize porridge for complementary feeding of children in sub-Saharan Africa.

Lactoferrin and lysozyme to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for a randomized controlled trial.

BACKGROUND: Chronic childhood malnutrition, as manifested by stunted linear growth, remains a persistent barrier to optimal child growth and societal development. Environmental enteric dysfunction (EED) is a significant underlying factor in the causal pathway to stunting, delayed cognitive development, and ultimately morbidity and mortality. Effective therapies against EED and stunting are lacking and further clinical trials are warranted to effectively identify and operationalize interventions. METHODS/DESIGN: A prospective randomized placebo-controlled parallel-group randomized controlled trial will be conducted to determine if a daily supplement of lactoferrin and lysozyme, two important proteins found in breast milk, can decrease the burden of EED and stunting in rural Malawian children aged 12-23 months old. The intervention and control groups will have a sample size of 86 subjects each. All field and laboratory researchers will be blinded to the assigned intervention group, as will the subjects and their caregivers. The percentage of ingested lactulose excreted in the urine (Δ%L) after 4 h will be used as the biomarker for EED and linear growth as the measure of chronic malnutrition (stunting). The primary outcomes of interest will be change in Δ%L from baseline to 8 weeks and to 16 weeks. Intention-to-treat analyses will be used. DISCUSSION: A rigorous clinical trial design will be used to assess the biologically plausible use of lactoferrin and lysozyme as dietary supplements for children at high risk for EED. If proven effective, these safe proteins may serve to markedly reduce the burden of childhood malnutrition and improve survival. TRIAL REGISTRATION: Clinicaltrials.gov, NCT02925026 . Registered on 4 October 2016.

Low serum ω-3 and ω-6 polyunsaturated fatty acids and other metabolites are associated with poor linear growth in young children from rural Malawi.

Background: Stunting affects ∼25% of children <5 y of age and is associated with impaired cognitive and motor development and increased morbidity and mortality. The pathogenesis of stunting is poorly understood.Objective: The purpose of this study was to identify altered metabolic pathways associated with child stunting.Design: We measured 677 serum metabolites using liquid chromatography-tandem mass spectrometry in a cross-sectional study of 400 Malawian children aged 12-59 mo, of whom 62% were stunted.Results: A low height-for-age z score (HAZ) was associated with lower serum concentrations of 1) ω-3 (n-3) and ω-6 (n-6) polyunsaturated fatty acids (PUFAs), 2) sulfated neurosteroids, which play a role in brain development, 3) carnitine, a conditionally essential nutrient with an important role in the carnitine shuttle for the metabolism of fatty acids and energy production, and 4) γ-glutamyl amino acids, which represent an altered γ-glutamyl cycle of glutathione metabolism. A low HAZ was associated with significantly higher serum concentrations of 5 biomarkers related to cigarette smoke exposure.Conclusions: This metabolomics study shows a cross-sectional association between stunting and low serum ω-3 and ω-6 long-chain PUFAs, which are essential for growth and development; low sulfated neurosteroids, which play a role in brain development; low carnitine, which is essential for ß-oxidation of fatty acids; alterations in glutathione metabolism; and increased serum metabolites that are associated with secondhand tobacco smoke exposure. This trial was registered at www.controlled-trials.com as ISRCTN14597012.

Maternal and Child Supplementation with Lipid-Based Nutrient Supplements, but Not Child Supplementation Alone, Decreases Self-Reported Household Food Insecurity in Some Settings.

Background: It is unknown whether self-reported measures of household food insecurity change in response to food-based nutrient supplementation.Objective: We assessed the impacts of providing lipid-based nutrient supplements (LNSs) to women during pregnancy and postpartum and/or to their children on self-reported household food insecurity in Malawi [DOSE and DYAD trial in Malawi (DYAD-M)], Ghana [DYAD trial in Ghana (DYAD-G)], and Bangladesh [Rang-Din Nutrition Study (RDNS) trial].Methods: Longitudinal household food-insecurity data were collected during 3 individually randomized trials and 1 cluster-randomized trial testing the efficacy or effectiveness of LNSs (generally 118 kcal/d). Seasonally adjusted Household Food Insecurity Access Scale (HFIAS) scores were constructed for 1127 DOSE households, 732 DYAD-M households, 1109 DYAD-G households, and 3671 RDNS households. The impact of providing LNSs to women during pregnancy and the first 6 mo postpartum and/or to their children from 6 to 18-24 mo on seasonally adjusted HFIAS scores was assessed by using negative binomial models (DOSE, DYAD-M, and DYAD-G trials) and mixed-effect negative binomial models (RDNS trial).Results: In the DOSE and DYAD-G trials, seasonally adjusted HFIAS scores were not different between the LNS and non-LNS groups. In the DYAD-M trial, the average household food-insecurity scores were 14% lower (P = 0.01) in LNS households than in non-LNS households. In the RDNS trial, compared with non-LNS households, food-insecurity scores were 17% lower (P = 0.02) during pregnancy and the first 6 mo postpartum and 15% lower (P = 0.02) at 6-24 mo postpartum in LNS households.Conclusions: The daily provision of LNSs to mothers and their children throughout much of the "first 1000 d" may improve household food security in some settings, which could be viewed as an additional benefit that may accrue in households should policy makers choose to invest in LNSs to promote child growth and development. These trials were registered at clinicaltrials.gov as NCT00945698 (DOSE) NCT01239693 (DYAD-M), NCT00970866 (DYAD-G) and NCT01715038 (RDNS).

Trial of ready-to-use supplemental food and corn-soy blend in pregnant Malawian women with moderate malnutrition: a randomized controlled clinical trial.

Background: Malnutrition during pregnancy in sub-Saharan Africa is associated with poor birth outcomes. Objective: This study compared maternal and offspring anthropometry for moderately malnourished pregnant women receiving ready-to-use supplemental food (RUSF), a fortified corn-soy blend (CSB+) with a daily multiple micronutrient antenatal supplement [United Nations International Multiple Micronutrient Preparation (UNIMMAP)], or standard of care comprising CSB+ and iron and folic acid (IFA). Design: A single-blind randomized controlled clinical trial was conducted in southern Malawi among 1828 pregnant women with moderate malnutrition, defined as a midupper arm circumference (MUAC) ≥20.6 and ≤23.0 cm. Women received 1 of 3 dietary treatment regimens that provided ∼900 kcal/d and 33-36 g protein/d. Maternal and infant anthropometry were followed until the child was 3 mo old. Results: Newborns had a mean length-for-age z score of -1.3 ± 1.2 and 22% were stunted at birth. Mothers receiving RUSF had the highest weight gain during supplementation (3.4 ± 2.6, 3.0 ± 2.2, and 3.2 ± 2.4 kg for the RUSF, CSB+ with UNIMMAP, and CSB+ with IFA groups, respectively; P = 0.03). Newborn birth weights and lengths were similar across intervention groups, but the incidence of newborns with a birth weight <2.4 kg (weight-for-age z score <-2) was higher in the CSB+ with UNIMMAP group than the other groups (17%, 18%, and 24% for the CSB+ with IFA, RUSF, and CSB+ with UNIMMAP groups, respectively; P = 0.02). At birth, HIV-exposed newborns had a similar length and weight as newborns without HIV exposure, but their head circumference was smaller (34.0 ± 1.5 and 34.3 ± 1.6 cm, respectively; P = 0.02). At 3 mo of age, HIV-exposed infants had smaller weights, lengths, and head and arm circumferences than infants without HIV exposure. Conclusions: RUSF improved maternal weight gain compared with CSB+ with UNIMMAP. The large amount of food given and the modest effect on linear growth in newborns suggests that stunting in utero is unlikely to be reduced by supplemental food alone. This trial was registered at clinicaltrials.gov as NCT02120599.

Effect of a package of health and nutrition services on sustained recovery in children after moderate acute malnutrition and factors related to sustaining recovery: a cluster-randomized trial.

Background: Children who recover from moderate acute malnutrition (MAM) have high rates of relapse in the year after nutritional recovery. Interventions to decrease these adverse outcomes are needed to maximize the overall effectiveness of supplemental feeding programs (SFPs).Objective: We evaluated the effectiveness of a package of health and nutrition interventions on improving the proportion of children who sustained recovery for 1 y after MAM treatment. We further explored factors related to sustained recovery.Design: We conducted a cluster-randomized clinical effectiveness trial involving rural Malawian children aged 6-62 mo who were enrolled on discharge from an SFP for MAM. We enrolled 718 children at 10 control sites and 769 children at 11 intervention sites. In addition to routine health and nutrition counseling, the intervention group received a package of health and nutrition interventions that consisted of a lipid nutrient supplement, deworming medication, zinc supplementation, a bed net, and malaria chemoprophylaxis. A survival analysis was used to determine the effectiveness of the intervention as well as to identify factors associated with sustained recovery.Results: Of 1383 children who returned for the full 12-mo follow-up period, 407 children (56%) and 347 children (53%) sustained recovery in the intervention and control groups, respectively. There was no significant difference in relapse-free survival curves between the treatment and control groups (P = 0.380; log-rank test). The risk factors for relapse or death after initial recovery were a smaller midupper arm circumference on SFP admission (P = 0.01) and discharge (P < 0.001), a lower weight-for-height z score on discharge (P < 0.01), and the receipt of ready-to-use supplementary food as opposed to ready-to-use therapeutic food during treatment (P < 0.05).Conclusion: The provision of a package of health and nutrition services in addition to traditional SFP treatment has no significant effect on improving sustained recovery in children after treatment of MAM. This trial was registered at clinicaltrials.gov as NCT02351687.

The Nutrient and Metabolite Profile of 3 Complementary Legume Foods with Potential to Improve Gut Health in Rural Malawian Children.

Background: Environmental enteric dysfunction (EED), frequently seen in rural Malawian children, causes chronic inflammation and increases the risk of stunting. Legumes may be beneficial for improving nutrition and reducing the risk of developing EED in weaning children. Objective: The objectives of this study were to determine the nutritional value, verify the food safety, and identify metabolite profiles of 3 legume-based complementary foods: common bean (CB), cowpea (CP), and traditional corn-soy blend (CSB). Methods: Foods were prepared by using local ingredients and analyzed for nutrient composition with the use of Association of Official Analytical Chemists (AOAC) standards (950.46, 991.43, 992.15, 996.06, and 991.36) for macro- and micronutrient proximate analysis. Food safety analysis was conducted in accordance with the Environmental Protection Agency (7471B) and AOAC (2008.02) standards. The metabolite composition of foods was determined with nontargeted ultra-performance LC-tandem mass spectrometry metabolomics. Results: All foods provided similar energy; CB and CP foods contained higher protein and dietary fiber contents than did the CSB food. Iron and zinc were highest in the CSB and CP foods, whereas CB and CP foods contained higher amounts of magnesium, phosphorus, and potassium. A total of 652 distinct metabolites were identified across the 3 foods, and 23, 14, and 36 metabolites were specific to the CSB, CB, and CP foods, respectively. Among the potential dietary biomarkers of intake to distinguish legume foods were pipecolic acid and oleanolic acid for CB; arabinose and serotonin for CSB; and quercetin and α- and γ-tocopherol acid for CP. No heavy metals were detected, and aflatoxin was measured only in the CSB (5.2 parts per billion). Conclusions: Legumes in the diet provide a rich source of protein, dietary fiber, essential micronutrients, and phytochemicals that may reduce EED. These food metabolite analyses identified potential dietary biomarkers of legume intake for stool, urine, and blood detection that can be used in future studies to assess the relation between the distinct legumes consumed and health outcomes. This trial was registered at clinicaltrials.gov as NCT02472262 and NCT02472301.

Including whey protein and whey permeate in ready-to-use supplementary food improves recovery rates in children with moderate acute malnutrition: a randomized, double-blind clinical trial.

BACKGROUND: The utility of dairy ingredients in the supplementary foods used in the treatment of childhood moderate acute malnutrition (MAM) remains unsettled. OBJECTIVE: We evaluated the effectiveness of a peanut-based ready-to-use supplementary food (RUSF) with soy protein compared with a novel RUSF containing dairy ingredients in the form of whey permeate and whey protein concentrate in the treatment of children with MAM. DESIGN: We conducted a randomized, double-blind clinical effectiveness trial involving rural Malawian and Mozambican children 6-59 mo of age with MAM treated with either soy RUSF or a novel whey RUSF treatment of ~75 kcal · kg(-1) · d(-1) for up to 12 wk. RESULTS: The proportion of children that recovered from MAM was significantly higher in the group that received whey RUSF (960 of 1144; 83.9%) than in the group that received soy RUSF (874 of 1086; 80.5%; P < 0.04; risk difference 3.4%, 95% CI: 0.3%, 6.6%). Children who consumed whey RUSF also demonstrated better growth markers, with a higher mean midupper arm circumference (MUAC) at the time of discharge (P < 0.009), greater MUAC gain during the course of treatment (P < 0.003), higher mean weight-for-height z score at discharge (P < 0.008), and greater weight gain (P < 0.05). No significant differences were identified in length gain or time to recovery between the 2 groups. CONCLUSION: This study highlights the importance of milk protein in the treatment of MAM, because the use of a novel whey RUSF resulted in higher recovery rates and improved growth than did soy RUSF, although the whey RUSF supplement provided less total protein and energy than the soy RUSF. This study was registered at clinicaltrials.gov as NCT01790048.

Provision of 10-40 g/d Lipid-Based Nutrient Supplements from 6 to 18 Months of Age Does Not Prevent Linear Growth Faltering in Malawi.

BACKGROUND: Complementing infant diets with lipid-based nutrient supplements (LNSs) has been suggested to improve growth and reduce morbidity, but the daily quantity and the milk content of LNSs affect their cost. OBJECTIVE: We tested the hypotheses that the change in mean length-for-age z score (LAZ) for infants provided with 10-40 g LNSs/d from ages 6 to 18 mo would be greater than that for infants receiving no dietary intervention at the same age and that provision of LNSs that did not contain milk would be as good as milk-containing LNSs in promoting linear growth. METHODS: We enrolled in a randomized single-blind trial 6-mo-old infants who were allocated to 1 of 6 groups to receive 10, 20, or 40 g LNSs/d containing milk powder; 20 or 40 g milk-free LNSs/d; or no supplement until 18 mo of age. The primary outcome was change in LAZ. RESULTS: Of the 1932 enrolled infants, 78 (4.0%) died and 319 (16.5%) dropped out during the trial. The overall reported supplement consumption was 71.6% of days, with no difference between the groups (P = 0.26). The overall mean ± SD length and LAZ changes were 13.0 ± 2.1 cm and -0.45 ± 0.77 z score units, respectively, which did not differ between the groups (P = 0.66 for length and P = 0.74 for LAZ). The difference in mean LAZ change in the no-milk LNS group compared with the milk LNS group was -0.02 (95% CI: -0.10, 0.06; P = 0.72). CONCLUSION: Our results do not support the hypothesis that LNS supplementation during infancy and childhood promotes length gain or prevents stunting between 6 and 18 mo of age in Malawi. This trial was registered at clinicaltrials.gov as NCT00945698.

Impact of lipid-based nutrient supplements and corn-soy blend on energy and nutrient intake among moderately underweight 8-18-month-old children participating in a clinical trial.

Nutrition interventions have an effect on growth, energy and nutrient intake, and development, but there are mixed reports on the effect of supplementation of energy-dense foods on dietary intake. This substudy aimed at assessing the effect of supplementation with corn-soy blend (CSB) or lipid-based nutrient supplement (LNS) on energy and nutrient intake in moderately underweight children participating in a clinical trial. A total of 188 children aged 8-18 months participated and received daily either 284 kcal from CSB or 220 kcal from LNS and no supplements (control). An interactive 24-h recall method was used to estimate energy and nutrient intakes in the groups. Total mean energy intake was 548 kcal, 551 kcal and 692 kcal in the control, CSB and LNS groups, respectively (P = 0.011). The mean (95% confidence interval) intake of energy and protein were 144 (37-250; P < 0.001) and 46 (1.5-7.6; P < 0.001) larger, respectively, in the LNS group than among the controls. No significant differences were observed between the control and CSB groups. Energy intake from non-supplement foods was significantly lower in the CSB group compared with the control group, but not in the LNS group, suggesting a lower displacement of non-supplement foods with LNS. Both CSB and LNS supplementation resulted in higher intakes of calcium, iron, zinc and vitamin C compared with controls (all P ≤ 0.001). This study indicates that LNS might be superior to CSB to supplement underweight children as it results in higher energy intake, but this requires confirmation in other settings.

An effectiveness trial showed lipid-based nutrient supplementation but not corn-soya blend offered a modest benefit in weight gain among 6- to 18-month-old underweight children in rural Malawi.

OBJECTIVE: To determine if supplementation with corn-soya blend (CSB) or lipid-based nutrient supplement (LNS) improved the weight gain of moderately underweight infants and children when provided through the national health service. DESIGN: A randomised, controlled, assessor-blinded clinical trial. Infants and children were randomised to receive for 12 weeks an average daily ration of 71 g CSB or 43 g LNS, providing 1188 kJ and 920 kJ, respectively, or no supplement (control). Main outcome was weight gain. Secondary outcomes included changes in anthropometric indices and incidence of serious adverse events. Intention-to-treat analyses were used. SETTING: Kukalanga, Koche, Katema and Jalasi health centres in Mangochi District, rural Malawi. SUBJECTS: Underweight (weight-for-age Z-score <-2) infants and children aged 6-15 months (n 299). RESULTS: Mean weight gain was 630 g, 680 g and 750 g in control, CSB and LNS groups, respectively (P = 0·21). When adjusted for baseline age, children receiving LNS gained on average 90 g more weight (P = 0·185) and their weight-for-length Z-score increased 0·22 more (P = 0·049) compared with those receiving no supplementation. No statistically significant differences were observed between the CSB and control groups in mean weight and length gain. CONCLUSIONS: LNS supplementation provided during the lean season via through the national health service was associated with a modest increase in weight. However, the effect size was lower than that previously reported under more controlled research settings.

The validity of a structured interactive 24-hour recall in estimating energy and nutrient intakes in 15-month-old rural Malawian children.

This study aimed to compare the nutritional intake values among 15-month-old rural Malawian children obtained by weighed food record (WFR) with those obtained by modified 24-hour recall (mod 24-HR), and to develop algorithm for adjusting mod 24-HR values so as to predict mean intake based on WFRs. The study participants were 169 15-month-old children who participated in a clinical trial. Food consumption on one day was observed and weighed (established criterion) by a research assistant to provide the estimates of energy and nutrient intakes. On the following day, another research assistant, blinded to the direct observation, conducted the structured interactive 24-hour recall (24-HR) interview (test method). Paired t-tests and scatter-plots were used to compare intake values of the two methods. The structured interactive 24-HR method tended to overestimate energy and nutrient intakes (each P < 0.001). The regression-through-the-origin method was used to develop adjustment algorithms. Results showed that multiplying the mean energy, protein, fat, iron, zinc and vitamin A intake estimates based on the test method by 0.86, 0.80, 0.68, 0.69, 0.72 and 0.76, respectively, provides an approximation of the mean values based on WFRs.