Effects of food supplementation on cognitive function, cerebral blood flow, and nutritional status in young children at risk of undernutrition: randomized controlled trial.

OBJECTIVE: To assess the effects of food supplementation on improving working memory and additional measures including cerebral blood flow in children at risk of undernutrition. DESIGN: Randomized controlled trial. SETTING: 10 villages in Guinea-Bissau. PARTICIPANTS: 1059 children aged 15 months to 7 years; children younger than 4 were the primary population. INTERVENTIONS: Supervised isocaloric servings (≈1300 kJ, five mornings each week, 23 weeks) of a new food supplement (NEWSUP, high in plant polyphenols and omega 3 fatty acids, within a wide variety and high fortification of micronutrients, and a high protein content), or a fortified blended food (FBF) used in nutrition programs, or a control meal (traditional rice breakfast). MAIN OUTCOME MEASUREMENTS: The primary outcome was working memory, a core executive function predicting long term academic achievement. Additional outcomes were hemoglobin concentration, growth, body composition, and index of cerebral blood flow (CBFi). In addition to an intention-to-treat analysis, a predefined per protocol analysis was conducted in children who consumed at least 75% of the supplement (820/925, 89%). The primary outcome was assessed by a multivariable Poisson model; other outcomes were assessed by multivariable linear mixed models. RESULTS: Among children younger than 4, randomization to NEWSUP increased working memory compared with the control meal (rate ratio 1.20, 95% confidence interval 1.02 to 1.41, P=0.03), with a larger effect in the per protocol population (1.25, 1.06 to 1.47, P=0.009). NEWSUP also increased hemoglobin concentration among children with anemia (adjusted mean difference 0.65 g/dL, 95% confidence interval 0.23 to 1.07, P=0.003) compared with the control meal, decreased body mass index z score gain (-0.23, -0.43 to -0.02, P=0.03), and increased lean tissue accretion (2.98 cm2, 0.04 to 5.92, P=0.046) with less fat (-5.82 cm2, -11.28 to -0.36, P=0.04) compared with FBF. Additionally, NEWSUP increased CBFi compared with the control meal and FBF in both age groups combined (1.14 mm2/s×10-8, 0.10 to 2.23, P=0.04 for both comparisons). Among children aged 4 and older, NEWSUP had no significant effect on working memory or anemia, but increased lean tissue compared with FBF (4.31 cm2, 0.34 to 8.28, P=0.03). CONCLUSIONS: Childhood undernutrition is associated with long term impairment in cognition. Contrary to current understanding, supplementary feeding for 23 weeks could improve executive function, brain health, and nutritional status in vulnerable young children living in low income countries. Further research is needed to optimize nutritional prescriptions for regenerative improvements in cognitive function, and to test effectiveness in other vulnerable groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT03017209.

Higher Levels of Dairy Result in Improved Physical Outcomes: A Synthesis of 3 Randomized Controlled Trials in Guinea-Bissau Comparing Supplements with Different Levels of Dairy Ingredients Among Children 6 to 59 Months, 5 to 19 Year Olds, and Mothers in Preschools, Primary Schools, and Villages, and the Implications for Programs.

BACKGROUND: This article synthesizes the results of 3 cluster randomized controlled trials of dairy-containing ready-to-use supplementary foods (RUSFs) to address malnutrition in primary schools, preschools and villages in Guinea-Bissau, one of the world's poorest countries. Together, these studies document widespread malnutrition across infants, young children, adolescents, and pregnant and lactating women and point to intervention options that were not previously presented. OBJECTIVE: To combine the evidence from the United States Department of Agriculture-funded pilot studies in Guinea-Bissau on the effects of dairy protein supplementation to gain a broader perspective on the role of dairy containing RUSFs in various age-groups, the importance of the mother-child dyad and family food dynamics for infant and child growth. Translate the results into action and the next generation of effective products. METHODS: A comparative analysis of data and synthesis of evidence from 3 published studies and ongoing research conducted by our team in Guinea-Bissau. RESULTS AND CONCLUSIONS: Higher dairy supplements have the potential to achieve broad benefits for malnutrition, especially in mothers and early childhood (first 1000 days and 36-59 months). Higher levels of dairy protein also can prevent moderate acute malnutrition in children younger than 2 years, independent of the family food dynamic. Community-level nutrition behavior change education should target older children and adolescents at the community level and through the preschool/school platform.

A Randomized Controlled Trial of Two Ready-to-Use Supplementary Foods Demonstrates Benefit of the Higher Dairy Supplement for Reduced Wasting in Mothers, and Differential Impact in Infants and Children Associated With Maternal Supplement Response.

BACKGROUND: There is no consensus over best approaches to reliably prevent malnutrition in rural communities in low-income countries. OBJECTIVE: We compared the effectiveness of 2 lipid-based ready-to-use supplementary foods (RUSFs) differing in dairy protein content to improve the nutritional status of mothers and at-risk infants and young children in rural Guinea-Bissau. METHODS: A 3-month cluster-randomized controlled pilot trial of 2 RUSFs was conducted with 692 mothers and 580 mildly or moderately malnourished infants (6-23 months) and children (24-59 months) from 13 villages. The RUSFs contained either 478 (mothers, children) or 239 kcal/d (infants) with 15% or 33% of protein from dairy and were distributed at community health centers 5 d/wk. Controls were wait-listed to receive RUSF. Primary outcomes were mid-upper arm circumference (MUAC) in mothers, and weight-for-age and height-for-age z-scores (WAZ and HAZ) in infants and children. RESULTS: There was a significant effect of the RUSF-33% on MUAC in mothers ( P = .03). The WAZ and HAZ increased substantially, by ≈1 z-score, in infants and children ( P < .01) independent of group randomization. In children, but not infants, baseline WAZ and change in maternal MUAC were associated with change in WAZ (ß = .07, P = .02). CONCLUSION: Ready-to-use supplementary foods with higher dairy protein content had a significant benefit in village mothers, supporting a comparable recent finding in preschool children. In addition, supplementation of children <2 years resulted in improved growth independent of family nutritional status, whereas success in older children was associated with change in maternal nutrition, suggesting the need for community-level education about preventing malnutrition in older, as well as younger, children.

Nutrition Status of Primary School Students in Two Rural Regions of Guinea-Bissau.

BACKGROUND: The nutrition status of primary schoolchildren in Africa has received relatively little attention in comparison to that of younger children. We surveyed primary school students in Guinea-Bissau, a nation that is among the poorest in the world. OBJECTIVE: Anthropometry and prevalence of anemia and vitamin A deficiency were assessed in schoolchildren participating in International Partnership for Human Development's school feeding program in 2 regions of Guinea-Bissau. METHODS: A cross-sectional survey of 32 schools in the regions of Cacheu and Oio was conducted in November 2011. Variables included age, gender, weight, height, hemoglobin, and retinol-binding protein concentrations. Z scores for height for age (HAZ), body mass index for age (BAZ), and weight for age were calculated using World Health Organization reference data. RESULTS: Anthropometric assessment of 4784 students revealed stunting (HAZ < -2) in 15.5%, thinness (BAZ < -2) in 13.2%, and anemia in 42.0%. Stunting, thinness, and anemia were significantly more common in males, in students from Oio, and in older students. Vitamin A deficiency, detected in 21.5% of the population, was the only assessment that did not demonstrate significant differences between genders or regions. About 61.1% of all children had 1 or more indicators of undernutrition. CONCLUSION: There are substantial rates of stunting, thinness, underweight, anemia, and vitamin A deficiency in primary schoolchildren in Guinea-Bissau, even among those participating in a school lunch program and particularly among males and older students. The results suggest the need for evaluating feeding programs and other methods to improve nutrition status in primary school students, especially in older students.

A Pilot Randomized Controlled Trial of a New Supplementary Food Designed to Enhance Cognitive Performance during Prevention and Treatment of Malnutrition in Childhood.

BACKGROUND: Cognitive impairment associated with childhood malnutrition and stunting is generally considered irreversible. OBJECTIVE: The aim was to test a new nutritional supplement for the prevention and treatment of moderate-acute malnutrition (MAM) focused on enhancing cognitive performance. METHODS: An 11-wk, village-randomized, controlled pilot trial was conducted in 78 children aged 1-3 or 5-7 y living in villages in Guinea-Bissau. The supplement contained 291 kcal/d for young children and 350 kcal/d for older children and included 5 nutrients and 2 flavan-3-ol-rich ingredients not present in current food-based recommendations for MAM. Local bakers prepared the supplement from a combination of locally sourced items and an imported mix of ingredients, and it was administered by community health workers 5 d/wk. The primary outcome was executive function abilities at 11 wk. Secondary outcomes included additional cognitive measures and changes in z scores for weight (weight-for-age) and height (height-for-age) and hemoglobin concentrations at 11 wk. An index of cerebral blood flow (CBF) was also measured at 11 wk to explore the use of this measurement as a biological index of cognitive impairment. RESULTS: There were no significant differences in any outcome between groups at baseline. There was a beneficial effect of random assignment to the supplement group on working memory at 11 wk in children aged 1-3 y (P < 0.05). This difference contrasted with no effect in older children and was not associated with faster growth rate. In addition, CBF correlated with task-switching performance (P < 0.05). CONCLUSIONS: These preliminary data suggest that cognitive impairment can be monitored with measurement of CBF. In addition, the findings provide preliminary data that suggest that it may be possible to improve poor cognitive performance in young children through changes in the nutritional formulation of supplementary foods used to prevent and treat MAM. Powered studies of the new supplement formulation are needed. This trial was registered at clinicaltrials.gov as NCT03017209.

Delivering Improved Nutrition: Dairy Ingredients in Food Aid Products.

The United States has a long history of food assistance for humanitarian need. The Food for Peace Act of 1954 established the United States' permanent food assistance program which has fed over 3 billion people in 150 countries worldwide through thousands of partner organizations. In 60 years, the program has evolved and will continue to do so. Recently, the program has gone from a focus on quantity of food shipped to quality food assistance from improved products, programs, and processes to effectively meet the needs of different vulnerable groups. The current debate focuses on the appropriateness of using fortified blended foods to prevent and treat malnutrition during the first 1000 days of life. Dairy ingredients have been at the center of this debate; they were included initially in fortified blended, removed in the 1980s, and now reincorporated into fortified therapeutic and supplemental foods. Improved quality food baskets and effective nutrition programming to prevent and treat malnutrition were developed through multisectoral collaboration between government and nongovernment organizations. The US Agency for International Development has focused on improving nutrition through development programs often tied to health, education, and agriculture. The years since 2008 have been a particularly intense period for improvement. The Food Aid Quality Review was established to update current food aid programming products, program implementation, cost-effectiveness, and interagency processes. Trials are underway to harmonize the areas of multisectoral nutrition programming and gather more evidence on the effects of dairy ingredients in food aid products.

A Randomized Controlled Trial Offering Higher- Compared with Lower-Dairy Second Meals Daily in Preschools in Guinea-Bissau Demonstrates an Attendance-Dependent Increase in Weight Gain for Both Meal Types and an Increase in Mid-Upper Arm Circumference for the Higher-Dairy Meal.

BACKGROUND: Controversy remains over the most effective approaches to prevent childhood malnutrition. OBJECTIVES: We tested the feasibility and effectiveness of delivering ready-to-use supplementary foods (RUSFs) as a second daily meal in preschool children aged 3-5 y in Guinea-Bissau, and compared RUSFs with different levels of dairy protein. METHODS: This study was a 3 mo cluster-randomized controlled pilot trial of 2 RUSFs differing in dairy protein in 533 boys and girls from 9 preschools. Children receiving RUSFs were compared with wait-listed controls, and all students received a daily school lunch. The RUSFs were delivered 5 d/wk for 3 mo and contained 478 kcal and 11.5 g protein per 92-g daily serving. Deliveries included a ready-to-use supplementary food with 15% of protein from dairy sources (RUSF-15%) or one with 33% of protein from dairy sources (RUSF-33%). Intention-to-treat (ITT) and per-protocol analyses (>50 d of RUSF consumption) were conducted. Changes in the weight-for-age z score (WAZ) and height-for-age z score were primary outcomes. Additional outcomes included changes in mid-upper arm circumference (MUAC), hemoglobin, and retinol binding protein. RESULTS: Baseline anthropometry was not different between groups (WAZ, -0.48 ± 1.04) and increased significantly over time (P < 0.01) with no effects of the RUSFs in ITT analyses. However, children consuming RUSFs for >50 d had a significantly greater increase in WAZ relative to the increase in controls (+0.40 and +0.32 for RUSF-15% and RUSF-33%, respectively, compared with +0.24 in controls, P < 0.01 and P < 0.05, respectively). RUSF-33%, but not RUSF-15%, also eliminated a decrease in MUAC observed in controls (-0.01 cm in RUSF-33% compared with -0.34 cm in controls, P < 0.05). The only difference between RUSF-15% and RUSF-33% was a mean decrease in hemoglobin in children receiving RUSF-15% (-0.5 compared with -0.002 g/dL, P = 0.05). CONCLUSIONS: Implementation of 2-meal preschool feeding programs is feasible in low-income countries, and there are measurable benefits relative to 1-meal programs in children attending preschool regularly. In addition, MUAC and hemoglobin measurements indicate that meals with 33% compared with 15% of protein from dairy may help prevent wasting and anemia.

Nutritional enhancement of US Title II food aid products.

BACKGROUND: Food aid provided by the United States has saved the lives of the vulnerable for many years. Recognizing the need for a thorough review of product formulations and specifications, the US Agency for International Development (USAID) commissioned a 2-year assessment of quality issues relating to Title II food aid products. This article presents findings and recommendations of that review relating to product enhancements. OBJECTIVE: The core question addressed was: Are current commodity specifications for enriched FBFs appropriate in light of evolving nutritional science and food fortification technology, or do they need to be updated? METHODS: Empirical data were derived from a number of sources, including a survey of Title II implementing partners focusing on procurement and logistics, and uses of FBFs and other foods. Input of implementing partners, civil society, and donor organizations was obtained through individual consultations, international and small group meetings. More than 400 individuals accessed the project's website. The project convened a panel of experts in food technology and science, food policy, law, industry, medicine, development and humanitarian work, and the maritime industry, and held regular joint meetings with USDA and USAID. The draft report was widely disseminated and posted on the website. RESULTS AND CONCLUSIONS: The findings of this research led to the following broad areas of improvement in US Title II food aid products: 1) Improve the formulation of existing FBF products used in Title II programming. This includes the addition of a dairy source of protein to products targeted to children 6 to 24 months of age, pregnant and lactating women, wasted children, and wasted individuals undergoing HIV/AIDS treatment. 2) Upgrade the vitamin and mineral mixes used and diversify approaches to addressing micronutrient needs. Enhance the composition of premixes used to fortify blended foods as well as milled grains and vegetable oil; facilitate shipping offortificant premix with bulk cereals for in-country fortification; and develop micronutrient powders (sachets) and other point-of-use fortification options. 3) Develop or adopt non-cereal-based (e.g., lipid-based) products for the management of nutritional deficiencies. This is an argument for more choice among appropriate tools, not for discarding products that have already shown their value over many years. It also does not reduce the need to maintain a focus on supplying high volumes of quality grains as the main staple in food aid baskets.

Selection and use of US Title II food aid products in programming contexts.

BACKGROUND: Food aid provided by the United States has saved lives for almost two centuries. Delivering the right products is important, but of equal concern are the ways in which products are delivered and to whom. OBJECTIVE: The study addresses how food products are currently used, whether interventions are appropriate to achieve nutrition objectives, and whether nutrition targets could be met more cost-effectively with a different mix of products or programs. METHODS: The team conducted consultations with a broad range of stakeholders. A survey of Title II implementing partners was conducted, focusing on procurement and logistics, and uses of FBFs and other foods. Input of implementing partners, civil society, and donor organizations was obtained through individual consultations, international and small group meetings. More than 400 individuals accessed the project's website. The project convened a panel of experts in food technology and science, food policy, law, industry, medicine, development and humanitarian work, and the maritime industry, and held regular joint meetings with USDA and USAID. The draft report was widely disseminated and posted on the website. RESULTS AND CONCLUSIONS: There is wide variation in the quantities of fortified blended foods provided to target populations. Most of these foods are used in health/nutrition programs, but they are also used in general family rations or as an incentive or pay. Clearer programming guidance and improved decision tools are needed to match products to nutrition goals, and programs should consider delivering nutrients across a basket of commodities, not single products. The evidence base for the effectiveness and cost-effectiveness of specific foods and programs needs to be strengthened and should be supported by FFP Research is needed to provide guidance on nutrition support for HIV/AIDS. Additional investments are needed in effective behavior change communication.

Enhancing processes for introduction, production, quality assurance, and delivery of US Title II food aid products.

BACKGROUND: Enacted in 1950, Public Law 480 (PL480) dramatically increased the volume of U.S.food aid and the scope of interventions it supports. Billions of dollars have been invested, both to enhance the diets of chronically undernourished people in development settings, and to support nutritional needs during conflicts and natural disasters. OBJECTIVE: Review the institutional processes-from procurement to delivery-that support this programming. METHODS: We examined the systems that govern and oversee the many components of food aid programming and the extent to which they support a whole-of-government, multi-agency food aid agenda. We conducted consultations with US government employees and contractors, academics, industry representatives, donor agency staff United Nations personnel, and field-level food aid programming technical staff from many countries. A survey of USAID implementing partners conducted among 64 responding offices in 40 countries provided data on the use and effectiveness of enriched, fortified, or blended Title II commodities, the use of new commodities, and related procurement or logistics aspects. Expert panels provided input and feedback throughout the process. RESULTS: We identified potential improvements to overall delivery and cost-effectiveness of USAID programming to better meet the nutrition needs of beneficiaries. Options include changes in product formulation, the range of products provided, and/or the modes of product approval, processing, procurement, and distribution. This research points to several improvements in processes related to food aid: 1) Establish an interagency committee to oversee all government interests in the food aid agenda through an ongoing review process. 2) Enhance processes and quality assurance along the product value chain including the importance of effective interaction with the private sector to incorporate industry best practices and create public-private partnerships to promote product innovations. 3) Strengthen the evidence base for innovations in products, programming approaches, and institutional processes. CONCLUSION: Successful programming requires knowledge and understanding of the unit cost of impact, not simply tonnage and "numbers of hungry people fed". Empirical rigor is essential; any significant program changes, including those recommended here, should be tested and monitored.