An Alternative Oat-Containing, Ready-To-Use, Therapeutic Food Does Not Alter Intestinal Permeability or the 16S Ribosomal RNA Fecal Microbiome Configuration Among Children With Severe Malnutrition in Sierra Leone: A Randomized Controlled Trial.

BACKGROUND: Previously, a novel oat ready-to-use therapeutic food (o-RUTF) resulted in improved recovery from severe acute malnutrition (SAM) when compared to a standard RUTF (s-RUTF). The o-RUTF contained 18% oat, while the s-RUTF has no cereal ingredients. OBJECTIVES: We determined the effects of o-RUTF on intestinal permeability, as measured by lactulose permeability, and the 16S ribosomal RNA (rRNA) fecal microbiome configuration of children with SAM. METHODS: This was a prospective, randomized, double-blinded, controlled clinical trial. Sierra Leonean children aged 6-59 mo with SAM, defined by a midupper arm circumference < 11.5 cm, were randomized to receive o-RUTF or s-RUTF. All children received 7 d of amoxicillin per guidelines. Lactulose permeability testing and fecal 16S rRNA sequencing were performed at baseline and after 4 wk of therapy. The change in lactulose permeability was the primary outcome, while the fecal 16S rRNA configuration at 4 wk was a secondary outcome. RESULTS: Of the 129 children enrolled, lactulose permeability testing was completed by 100 at baseline and 82 at week 4. After 4 wk of therapeutic feeding, there were no differences in lactulose permeability between the o-RUTF and s-RUTF groups (P = 0.84), and over half of children had increased lactulose permeability (50% s-RUTF compared with 58% o-RUTF, mean difference = -7.5%; 95% CI: -29.2, 15.2; P = 0.50). After 4 wk of feeding, there were no differences in the 16S rRNA configurations between the o-RUTF and s-RUTF groups (Permanova, 999 permutations; P = 0.648; pseudo-F = 0.581), nor were there differences in α or ß diversity. CONCLUSIONS: Despite remarkably different compositions of o-RUTF and s-RUTF, no differences were identified in lactulose permeability or the fecal 16S rRNA configuration among children with SAM receiving these foods. These results suggest that the o-RUTF exerts its beneficial effects through mechanisms other than reducing intestinal permeability or altering the fecal 16S configuration. This trial was registered at clinicaltrials.gov as NCT04334538.

Supplementary Feeding of Moderately Wasted Children in Sierra Leone Reduces Severe Acute Malnutrition and Death When Compared with Nutrition Counseling: A Retrospective Cohort Study.

BACKGROUND: There is uncertainty about whether children with moderate wasting should receive supplementary feeding. OBJECTIVES: We examined whether supplementary feeding compared with counseling alone in children with moderate wasting prevented progression to severe acute malnutrition (SAM) or death. METHODS: This was a retrospective, dual-cohort study in which 1791 children with moderate wasting were drawn from 2 prior randomized controlled trials that took place in the same location in rural Sierra Leone. A total of 1077 children received supplementary feeding, whereas 714 children received counseling alone. Children in both cohorts were followed for ≥24 wk from enrollment. The primary outcome was time to SAM or death using Kaplan-Meier analysis. Secondary outcomes included time to death as well as proportions of children with healthy midupper arm circumference (MUAC), moderate wasting, SAM, or death at 6, 12, and 24 wk from enrollment. RESULTS: Children who received supplementary feeding were less likely to develop SAM or die across the entire follow-up period (HR: 0.53; 95% CI: 0.44, 0.65; P < 0.001). Time to event for death alone also revealed a lower risk for children who received supplementary feeding (HR: 0.52; 95% CI: 0.28, 0.94; P = 0.03). Children who received supplementary feeding were more likely to have a healthy MUAC at 6 wk (RR: 2.0; 95% CI: 1.7, 2.2) and 12 wk (RR: 1.3; 95% CI: 1.2, 1.5), were less likely to develop SAM at 6 (RR: 0.7; 95% CI: 0.6, 0.9), 12 (RR: 0.5; 95% CI: 0.3, 0.8), and 24 wk (RR: 0.2; 95% CI: 0.1, 0.5), and had higher rates of gain in weight and MUAC at 6 and 12 wk. CONCLUSIONS: Supplementary feeding of children with moderate wasting reduces risk of SAM and death across 24 wk of follow-up.

Supplementary Feeding of Moderately Wasted Children in Sierra Leone Reduces Severe Acute Malnutrition and Death When Compared with Nutrition Counseling: A Retrospective Cohort Study.

BACKGROUND: There is uncertainty about whether children with moderate wasting should receive supplementary feeding. OBJECTIVES: We examined whether supplementary feeding compared with counseling alone in children with moderate wasting prevented progression to severe acute malnutrition (SAM) or death. METHODS: This was a retrospective, dual-cohort study in which 1791 children with moderate wasting were drawn from 2 prior randomized controlled trials that took place in the same location in rural Sierra Leone. A total of 1077 children received supplementary feeding, whereas 714 children received counseling alone. Children in both cohorts were followed for ≥24 wk from enrollment. The primary outcome was time to SAM or death using Kaplan-Meier analysis. Secondary outcomes included time to death as well as proportions of children with healthy midupper arm circumference (MUAC), moderate wasting, SAM, or death at 6, 12, and 24 wk from enrollment. RESULTS: Children who received supplementary feeding were less likely to develop SAM or die across the entire follow-up period (HR: 0.53; 95% CI: 0.44, 0.65; P < 0.001). Time to event for death alone also revealed a lower risk for children who received supplementary feeding (HR: 0.52; 95% CI: 0.28, 0.94; P = 0.03). Children who received supplementary feeding were more likely to have a healthy MUAC at 6 wk (RR: 2.0; 95% CI: 1.7, 2.2) and 12 wk (RR: 1.3; 95% CI: 1.2, 1.5), were less likely to develop SAM at 6 (RR: 0.7; 95% CI: 0.6, 0.9), 12 (RR: 0.5; 95% CI: 0.3, 0.8), and 24 wk (RR: 0.2; 95% CI: 0.1, 0.5), and had higher rates of gain in weight and MUAC at 6 and 12 wk. CONCLUSIONS: Supplementary feeding of children with moderate wasting reduces risk of SAM and death across 24 wk of follow-up.

Development of Acute Malnutrition Despite Nutritional Supplementation in Malawi.

Malnutrition in children is most often attributed to inadequate nutrient intake. Utilizing data from 2 prospective, randomized controlled trials of complimentary feeding with supplemental legumes (n = 693, ages 6-24 months) in 2 Malawian villages, Masenjere, and Limera, we document a high rate 70/693 (10.1%) of acute malnutrition (AM). Risks for AM in this setting, as determined by Cox regression analysis, include study village (hazard ratio [HR] 3.0), prior malnutrition (HR 4.12), stunting (HR 2.87), and a marker of food insecurity (HR 1.89). Comparison of Masenjere to Limera demonstrate adequate and similar nutritional intake yet an increased rate of AM in Masenjere, 56 of 400 (14.0%) versus 14 of 293 (4.8%), and stunting, 140 of 400 (35%) versus 80 of 293 (27%), environmental enteric dysfunction 246 of 400 (71%) versus 181/293 (67%), and infectious symptoms (cough and diarrhea). Masenjere did have cleaner water and less food insecurity 200 of 399 (50.5%) versus 204 of 293 (69.6%). These findings suggest adequate complementary nutrient intake does not protect young children against AM.

Additional Common Bean in the Diet of Malawian Children Does Not Affect Linear Growth, but Reduces Intestinal Permeability.

Background: Chronic malnutrition, as manifested by linear growth faltering, is pervasive among rural African children. Improvements in complementary feeding may decrease the burden of environmental enteric dysfunction (EED) and thus improve growth in children during the critical first 1000 d of development. Objective: We tested the hypothesis that systematically including common bean or cowpea into complementary feeding would reduce EED and growth faltering among children in rural Malawi. Methods: This was a double-blind clinical trial in which children 12-23 mo of age were randomly assigned to receive complementary feeding with 1 of 3 foods: roasted cowpea or common bean flour, or an isoenergetic amount of corn-soy blend as a control food for 48 wk. Children aged 12-23 mo received 155 kcal/d and thereafter until 35 mo received 200 kcal/d. The primary outcomes were change in length-for-age z score (LAZ) and improvements in a biomarker of EED, the percentage of lactulose (%L) excreted as part of the lactulose:mannitol dual-sugar absorption test. Anthropometric measurements and urinary %L excretion were compared between the 2 intervention groups and the control group separately with the use of linear mixed model analyses for repeated measures. Results: A total of 331 children completed the clinical trial. Compliance with the study interventions was excellent, with >90% of the intervention flour consumed as intended. No significant effects on LAZ, change in LAZ, or weight-for-length z score were observed due to either intervention legume, compared to the control. %L was reduced with common bean consumption (effect estimate was -0.07 percentage points of lactulose, P = 0.0007). The lactulose:mannitol test was not affected by the legume intervention. Conclusion: The addition of common bean to complementary feeding of rural Malawian children during the second year of life led to an improvement in a biomarker of gut health, although this did not directly translate into improved linear growth. This trial was registered at clinicaltrials.gov as NCT02472301.

Zinc or albendazole attenuates the progression of environmental enteropathy: a randomized controlled trial.

BACKGROUND & AIMS: Environmental enteropathy (EE) is a subclinical condition among children in the developing world, characterized by T-cell infiltration of the small-bowel mucosa and diffuse villous atrophy. EE leads to macronutrient and micronutrient malabsorption and stunting, with a resultant increased risk for infection and reduced cognitive development. We tested the hypothesis that zinc and albendazole treatments would reduce the severity of EE in rural African children. METHODS: In a randomized, double-blind, placebo-controlled trial in rural southern Malawi, asymptomatic children, 1 to 3 years old and at high risk for EE, received either a single dose of albendazole, a 14-day course of 20 mg zinc sulfate, or a placebo. Subjects were given the dual-sugar absorption test, and the ratio of lactulose to mannitol (L:M) in urine was used to determine the severity of EE at baseline and 34 days after completion of the assigned regimen. The primary outcome was the change in the L:M. RESULTS: A complete set of urine samples was obtained from 222 of 234 children enrolled and analyzed. The mean baseline L:M was 0.32 ± 0.18 among all children and did not differ among groups (normal L:M range, <0.12). At the end of the study, the L:M ratio had increased more in the placebo group (0.12 ± 0.31) than in the zinc group (0.03 ± 0.20; P < .03) or the albendazole group (0.04 ± 0.22; P < .04). CONCLUSIONS: Treatment with zinc or albendazole protects against a significant increase in the L:M ratio, a biomarker for EE, in asymptomatic rural Malawian children. These findings could provide insight into the etiology and pathogenesis of EE. Clinicaltrials.gov Number: NCT01440608.

Multiple micronutrient supplementation transiently ameliorates environmental enteropathy in Malawian children aged 12-35 months in a randomized controlled clinical trial.

BACKGROUND: Environmental enteropathy (EE) is subclinical, diffuse villous atrophy characterized by T cell infiltration of the small intestinal mucosa associated with nutrient malabsorption and stunting. EE is assessed by the lactulose:mannitol (L:M) test, whereby nonmetabolized sugars are ingested and quantified in the urine. Multiple micronutrient (MN) deficiency morphologically mimics EE, and ω-3 (n-3) polyunsaturated fatty acids reduce mucosal inflammation in Crohn disease. OBJECTIVE: We tested the hypothesis that supplementary MNs, with or without fish oil (FO), would improve L:M in rural Malawian children aged 1-3 y compared with a control (C) group receiving a placebo. METHODS: The MNs and FO provided the Recommended Dietary Intake for 26 vitamins, minerals, eicosapentaenoic acid, and docosahexaenoic acid. This was a 3-arm, randomized, double-blind, placebo-controlled clinical trial, with the primary outcomes being the change in L:M (ΔL:M) after 12 and 24 wk of supplementation. Comparisons were made for ΔL:M after 12 and 24 wk within each group by using a Wilcoxon matched pairs signed rank test, because the data are not normally distributed. RESULTS: A total of 230 children had specimens adequate for analysis; all had an abnormal baseline L:M, defined as >0.10. After 12 wk, children who received MNs + FO had a ΔL:M [mean (95% CI)] of -0.10 (-0.04, -0.15; P = 0.001), and children receiving only MNs had ΔL:M of -0.12 (-0.03, -0.21; P = 0.002). After 24 wk, children who received MNs + FO had a ΔL:M of -0.09 (-0.03, -0.15; P = 0.001); children receiving only MNs had a ΔL:M of -0.11 (-0.02, -0.20; P = 0.001), and the C group had ΔL:M of -0.07 (0.02, -0.16); P = 0.002). Linear growth was similar in all groups, ∼4.3 cm over 24 wk. CONCLUSION: Although the effect was modest, these data suggest MNs can transiently ameliorate EE in rural African children. The trial was registered at clinicaltrials.gov as NCT01593033.

The Effect of Breastfeeding Practices of Undernourished Mothers in Rural Sierra Leone on Infant Growth and Mortality.

Breastfeeding provides optimal infant nutrition; however, <50% of infants are exclusively breastfed (EBF) for 6 months. We aimed to describe breastfeeding practices and their effects on growth and mortality among a high-risk mother-infant cohort in rural Sierra Leone. This was a secondary analysis of data from a randomized nutrition intervention trial among undernourished pregnant women. The study's primary outcomes were infant weight and length gains at 6 weeks of age. We included 1270 singleton infants in the analysis, with 1092 (85.6%) having 24-week outcome data. At 6 weeks, 88% were EBF, but the rate of EBF decreased to 17% at 24 weeks. The EBF infants at 6 weeks had improved length (difference of 0.9 mm/week; 95% CI 0.4 to 1.3; p < 0.001) and weight (difference of 40 g/week; 95% CI 24 to 53; p < 0.001) gains compared to the non-EBF infants. At 12 weeks, the EBF infants had improved weight (difference of 12 g/week; 95% CI 2 to 22; p = 0.024) gain. The EBF infants had lower mortality than the infants who were not EBF (hazard ratio of 0.39; 95% CI 0.18 to 0.84; p = 0.017). In summary, the infants who were EBF had greater weight and length gain and reduced mortality than those who were not EBF. Efforts to improve breastfeeding should thus be prioritized to improve infant health.

Effect of Peanut Paste-based Ready-to-use School Meals With and Without Milk on Fluid Cognition in Northern Ghana: A Randomized Controlled Trial.

BACKGROUND: Few studies have investigated the role of school feeding in low- and middle-income countries as a means of improving childhood cognition. Peanut/milk ready-to-use food (PM-RUF) or cowpea offers an affordable, scalable option that might improve cognition. OBJECTIVES: To determine whether micronutrient-fortified PM-RUF or peanut/cowpea ready-to-use food (PC-RUF) would improve fluid cognition as assessed by 4 tests from the National Institutes of Health Toolbox Cognitive Battery when compared with a micronutrient-fortified millet porridge (FP) after a year of school feeding. METHODS: An individually randomly assigned, investigator-blinded, controlled clinical trial was conducted at 6 schools in Mion District in rural northern Ghana. Eight hundred seventy-one school children aged 5-12 y were randomly assigned and allocated to receive PM-RUF (n = 282), PC-RUF (n = 292), or FP (n = 297), each providing ∼400 kcal/d. The primary outcomes were 4 fluid cognition test scores: Dimensional Change Card Sort test, Flanker Inhibitory Control and Attention test, Pattern Comparison Processing Speed test, and a modified List Sorting Working Memory test. Secondary outcomes included a composite median ranking of the 4 primary outcomes and anthropometry changes. RESULTS: Among the 871 participants (median age, 8.8 y; 47% female), 795 (91%) completed endline cognitive testing. Median attendance rates exceeded 87% in all groups. PM-RUF group demonstrated better fluid cognition on the Dimensional Change Card Sort test [odds ratio (OR): 1.5; 95% CI: 1.1, 2.0; P = 0.016] and Pattern Comparison Processing Speed test (OR: 1.4; 95% CI: 1.0, 1.9; P = 0.026) than FP, whereas there were no significant differences on Flanker Inhibitory Control and Attention or List Sorting Working Memory tests. PC-RUF group demonstrated no improvement over FP on any cognitive tests. PM-RUF group had superior fluid cognition composite median rankings (OR: 1.5; 95% CI: 1.1, 2.0; P = 0.007). CONCLUSIONS: Among rural Ghanaian children aged 5-12 y, PM-RUF compared with FP resulted in superior fluid cognition. This trial was registered at clinicaltrials.gov as NCT04349007.

An Optimized Dose of Therapeutic Feeding Results in Noninferior Growth in Midupper Arm Circumference Compared with a Standard Dose in Children in Sierra Leone Recovering from Acute Malnutrition.

BACKGROUND: Ready-to-use therapeutic food (RUTF) given at 175 kcal/kg per day throughout severe acute malnutrition (SAM) treatment is recommended. Some treatment programs have diverged from this paradigm in 2 ways: reducing the supplemental food dose to 75 kcal/kg per day when midupper arm circumference (MUAC) is >11.4 cm or simplifying to a fixed-dose regimen. OBJECTIVE: The objective was to determine if transitioning to an optimized, fixed-dose supplementary feeding regimen during SAM treatment when MUAC is >11.4 cm would result in noninferior gain in MUAC compared with standard treatment. METHODS: Using data from 2 clinical trials conducted in Sierra Leone, a retrospective dual-cohort study was performed. The 2 cohorts included children with SAM who had improved to meet criteria for moderate acute malnutrition (MAM). The standard dose cohort continued to receive weight-based RUTF at 175 kcal/kg per day, while the optimized dose cohort received fixed-dose, 500 kcal/d of supplementary feeding. The primary outcome was a noninferiority margin of 1 mm of MUAC after 4 wk of treatment, while secondary outcomes included rate of anthropometric changes as well as time-to-relapse to SAM or death. RESULTS: MUAC after 4 wk was noninferior (Δ: -0.1 mm; 95% CI: -0.05, 0.03; inferiority rejected P = 0.008). Rates of weight gain and MUAC gain were the same in the optimized-dose and standard-dose groups, whereas the rate of length gain was slower in the optimized-dose cohort. Time-to-relapse to SAM or death was not different (HR: 1.05; P = 0.71). CONCLUSIONS: This study supports the practice of treating children with SAM who have recovered to meet criteria for MAM with a reduced and fixed-dose regimen of RUTF. The results also raise the question of whether this strategy might adversely impact linear growth during SAM treatment.

Should the CIWA-Ar be the standard monitoring strategy for alcohol withdrawal syndrome in the intensive care unit?

BACKGROUND: The Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) is commonly used in hospitals to titrate medications for alcohol withdrawal syndrome (AWS), but may be difficult to apply to intensive care unit (ICU) patients who are too sick or otherwise unable to communicate. OBJECTIVES: To evaluate the frequency of CIWA-Ar monitoring among ICU patients with AWS and variation in CIWA-Ar monitoring across patient demographic and clinical characteristics. METHODS: The study included all adults admitted to an ICU in 2017 after treatment for AWS in the Emergency Department of an academic hospital that standardly uses the CIWA-Ar to assess AWS severity and response to treatment. Demographic and clinical data, including Richmond Agitation-Sedation Scale (RASS) assessments (an alternative measure of agitation/sedation), were obtained via chart review. Associations between patient characteristics and CIWA-Ar monitoring were tested using logistic regression. RESULTS: After treatment for AWS, only 56% (n = 54/97) of ICU patients were evaluated using the CIWA-Ar; 94% of patients had a documented RASS assessment (n = 91/97). Patients were significantly less likely to receive CIWA-Ar monitoring if they were intubated or identified as Black. CONCLUSIONS: CIWA-Ar monitoring was used inconsistently in ICU patients with AWS and completed less often in those who were intubated or identified as Black. These hypothesis-generating findings raise questions about the utility of the CIWA-Ar in ICU settings. Future studies should assess alternative measures for titrating AWS medications in the ICU that do not require verbal responses from patients and further explore the association of race with AWS monitoring.

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.

Complementary feeding with cowpea reduces growth faltering in rural Malawian infants: a blind, randomized controlled clinical trial.

Background: Growth faltering is common in rural African children and is attributed to inadequate dietary intake and environmental enteric dysfunction (EED).Objective: We tested the hypothesis that complementary feeding with cowpea or common bean flour would reduce growth faltering and EED in 6-mo-old rural Malawians compared with the control group receiving a corn-soy blend.Design: A prospective, double-blind, randomized controlled clinical trial was conducted in which children received daily feeding for 6 mo (200 kcal/d when 6-9 mo old and 300 kcal/d when 10-12 mo old). The primary outcomes were change in length-for-age z score (LAZ) and improvements in EED, as measured by percentage of lactulose excretion (%L). %L <0.2% was considered normal. Anthropometric measurements and %L through urine were compared between each legume group and the control group with Student's t test.Results: Of the 355 infants enrolled, 291 infants completed the trial, and 288 were breastfed throughout the duration of the study. Cowpea and common bean added 4.6-5.2 g protein/d and 4-5 g indigestible carbohydrate/d to the diet. LAZ and weight-for-height z score were reduced in all 3 groups from 6 to 12 mo of age. The changes in LAZ [mean (95% CI)] for the cowpea, common bean, and control groups from 6 to 9 mo were -0.14 (-0.24, -0.04), -0.27 (-0.38, -0.16), and -0.27 (-0.35, -0.19), respectively. LAZ was reduced less in infants receiving cowpea than in those receiving control food from 6 to 9 mo (P = 0.048). The absolute value of %L did not differ between the dietary groups at 9 mo of age (mean ± SD: 0.30 ± 0.43, 0.23 ± 0.21, and 0.26 ± 0.31 for cowpea, common bean, and control, respectively), nor did the change in %L from 6 to 9 mo.Conclusion: Addition of cowpea to complementary feeding in Malawian infants resulted in less linear growth faltering. This trial was registered at clinicaltrials.gov as NCT02472262.

Common beans and cowpeas as complementary foods to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for two randomized controlled trials.

BACKGROUND: Interventions to decrease the burden of childhood malnutrition are urgently needed, as millions of children die annually owing to undernutrition and hundreds of millions more are left cognitively and physically stunted. Environmental enteric dysfunction (EED), a pervasive chronic subclinical inflammatory condition among children that develops when complementary foods are introduced, places them at high risk of stunting, malabsorption, and poor oral vaccine efficacy. Improved interventions to reduce the burden of EED and stunting are expected to markedly improve the nutritional status and survival of children throughout resource-limited settings. METHODS/DESIGN: We will conduct, in parallel, two prospective randomized controlled clinical trials to determine whether common beans or cowpeas improve growth, ameliorate EED, and alter the intestinal microbiome during a high-risk period in the lives of rural Malawian children. Study 1 will enroll children at 6 months of age and randomize them to receive common beans, cowpeas, or a standard complementary food for 6 months. Anthropometry will be compared among the three groups; EED will be assessed using a dual-sugar absorption test and by quantifying human intestinal mRNA for inflammatory messages; and the intestinal microbiota will be characterized by deep sequencing of fecal DNA, to enumerate host microbial populations and their metabolic capacity. Study 2 will enroll children 12-23 months old and follow them for 12 months, with similar interventions and assessments as Study 1. DISCUSSION: By amalgamating the power of rigorous clinical trials and advanced biological analysis, we aim to elucidate the potential of two grain legumes to reduce stunting and EED in a high-risk population. Legumes have potential as an affordable and effective complementary food intervention, given their cultural acceptability, nutritional content, and agricultural feasibility in sub-Saharan Africa. TRIAL REGISTRATION: Clinicaltrials.gov NCT02472262 and NCT02472301 .