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BackgroundDietary supplements, like small-quantity lipid-based nutrient supplements (SQ-LNS), are used in intervention programs to prevent undernutrition among women and young children in low-income countries. An objective marker is needed to track consumption of supplements to evaluate the effectiveness of these programs.ObjectiveThe aim of this study was to evaluate saccharin and resveratrol as potential adherence markers for tracking recent consumption of a single serving of SQ-LNS in women.MethodsForty-seven healthy nonpregnant women 18-45 y of age were assigned to consume a single dose of SQ-LNS (20 g) containing either 10 mg sodium saccharin or 5 mg trans-resveratrol, under supervision. On the day before and for 2 d following SQ-LNS consumption, urine samples were collected each day for 24 h as 3 consecutive 4-h collections and one 12-h overnight collection. Urinary concentrations of saccharin and trans-resveratrol-3-O-sulfate, a resveratrol metabolite, were measured by ultra-high-performance liquid chromatography interfaced to a mass spectrometer with electrospray ionization [UHPLC-(ESI-)MS/MS]. Urinary concentrations (μmol/L urine) of saccharin and trans-resveratrol-3-O-sulfate were plotted against time, and receiver operating characteristic (ROC) curves were used to determine the discriminative capacity of each compound, at each post-consumption time point compared with baseline, to detect recent consumption of SQ-LNS. Cutoff values to differentiate supplement consumption from nonconsumption of each marker were developed using the closest-to-(0,1)-corner cut-point approach.ResultsForty-five participants were included in the analysis. Urinary concentrations of saccharin and trans-resveratrol-3-O-sulfate increased within 4 h of SQ-LNS consumption. Urinary concentration cutoff values for saccharin (13.4 µmol/L) and trans-resveratrol-3-O-sulfate (0.7 µmol/L) allowed for 78% and 89% sensitivity, respectively, and 100% specificity in detecting consumption of SQ-LNS within the first 12 h after consumption.ConclusionsUrinary concentrations of saccharin and trans-resveratrol-3-O-sulfate reflect consumption of SQ-LNS containing those compounds during the first 12 h post-consumption with high sensitivity and specificity in healthy women and may be useful objective adherence markers for tracking consumption of SQ-LNS.

Saccharin and trans-resveratrol were incorporated into small quantity lipid-based nutritional supplements (SQ-LNS) to be evaluated as the markers of consumption for nutritional intervention studies. Forty-seven healthy women consumed a single supplement with either 8.6 mg of saccharin or 5 mg of trans-resveratrol, and urine was collected for 4 h. A rapid 11 min method employing multiple reaction monitoring and ultrahigh performance liquid chromatography coupled to a triple quadrupole mass spectrometer was developed to measure saccharin and resveratrol metabolites in urine simultaneously. The linear dynamic range of the method was from 3 to 1000 ng mL-1, with the correlation coefficient of 0.999 and limits of quantification from 15.28 to 53.03 ng mL-1. Sample preparation was simple dilution with an average recovery of 97.8%. Ion suppression was observed with urine concentrations >10%. Mean levels of saccharin and resveratrol-3-O-sulfate in urine were 5.481 ± 4.359 and 3.440 ± 4.160 nmol L-1, respectively. We developed and validated a method to measure saccharin and trans-resveratrol metabolites in urine to objectively corroborate the consumption of SQ-LNS for the first time in nutrition intervention studies.

More than 20 million babies are born with low birthweight annually. Small newborns have an increased risk for mortality, growth failure, and other adverse outcomes. Numerous antenatal risk factors for small newborn size have been identified, but individual interventions addressing them have not markedly improved the health outcomes of interest. We tested a hypothesis that in low-income settings, newborn size is influenced jointly by multiple maternal exposures and characterized pathways associating these exposures with newborn size. This was a prospective cohort study of pregnant women and their offspring nested in an intervention trial in rural Malawi. We collected information on maternal and placental characteristics and used regression analyses, structural equation modelling, and random forest models to build pathway maps for direct and indirect associations between these characteristics and newborn weight-for-age Z-score and length-for-age Z-score. We used multiple imputation to infer values for any missing data. Among 1,179 pregnant women and their babies, newborn weight-for-age Z-score was directly predicted by maternal primiparity, body mass index, and plasma alpha-1-acid glycoprotein concentration before 20 weeks of gestation, gestational weight gain, duration of pregnancy, placental weight, and newborn length-for-age Z-score (p

There is little information on whether prenatal multiple micronutrient (MMN) supplements containing iodine affect women's iodine status. In the International Lipid-based Nutrient Supplements DYAD-Ghana trial, we aimed to assess women's urinary iodine concentration (UIC, μg/L) during pregnancy, as one of the planned secondary outcomes. Women (n = 1,320)

Background: It is unclear whether maternal supplementation with small-quantity lipid-based nutrient supplements (SQ-LNSs; 118 kcal/d) affects maternal weight.Objective: We compared several secondary anthropometric measures between 3 groups of women in the iLiNS (International Lipid-based Nutrient Supplements)-DYAD trial in Ghana.Methods: Women (n = 1320;

We examined hemoglobin (Hb, g/L), iron status (zinc protoporphyrin, ZPP, µmol/mol heme, and transferrin receptor, TfR, mg/L) and inflammation (C-reactive protein, CRP and alpha-1 glycoprotein, AGP) in pregnant Ghanaian women who participated in a randomized controlled trial. Women (n = 1320) received either 60 mg Fe + 400-µg folic acid (IFA); 18 micronutrients including 20-mg Fe (MMN) or small-quantity lipid-based nutrient supplements (SQ-LNS, 118 kcal/d) with the same micronutrient levels as in MMN, plus four additional minerals (LNS) daily during pregnancy. Intention-to-treat analysis included 349, 354 and 354 women in the IFA, MMN and LNS groups, respectively, with overall baseline mean Hb and anemia (Hb 60) [9.4% vs. 18.6% and 19.2%; P = 0.003] and elevated TfR (>6.0) [9.0% vs. 19.2% and 15.1%; P = 0.004]. CRP and AGP concentrations did not differ among groups. We conclude that among pregnant women in a semi-urban setting in Ghana, supplementation with SQ-LNS or MMN containing 20 mg iron resulted in lower Hb and iron status but had no impact on inflammation, when compared with iron (60 mg) plus folic acid (400 µg). The amount of iron in such supplements that is most effective for improving both maternal Hb/iron status and birth outcomes requires further evaluation. This trial was registered at ClinicalTrials.gov as: NCT00970866.

BackgroundSupplementing pregnant and lactating mothers with small quantity lipid-based nutrient supplements (SQ-LNS) has resulted in improvements in birth outcomes in some low-income settings. In order to be effective, SQ-LNS must be consumed regularly over sustained periods.MethodsThe objective was to assess and compare acceptability of and adherence to SQ-LNS consumption among pregnant and lactating women in Ghana and Malawi throughout 12 months of supplementation. We enrolled women before 20 gestation weeks into randomized trials in Ghana (n = 1320) and Malawi (n = 869). In the SQ-LNS group participants received a 20 g sachet of supplement per day during pregnancy and the first 6 months of lactation. In the control groups participants received multiple micronutrients (MMN) during pregnancy and lactation or iron and folic acid (IFA) during pregnancy and calcium during lactation. We used questionnaires to collect data on self-reported adherence to daily use of supplements and conducted in-depth interviews with women in the SQ-LNS group to examine acceptability.ResultsThe mean self-reported adherence during the supplementation period was lower in Ghana (79.9 %) than in Malawi (91.7 %) for all supplements (difference 11.8 %, P

BackgroundChildhood stunting usually begins in utero and continues after birth; therefore, its reduction must involve actions across different stages of early life.ObjectiveWe evaluated the efficacy of small-quantity, lipid-based nutrient supplements (SQ-LNSs) provided during pregnancy, lactation, and infancy on attained size by 18 mo of age.DesignIn this partially double-blind, individually randomized trial, 1320 women at ≤20 wk of gestation received standard iron and folic acid (IFA group), multiple micronutrients (MMN group), or SQ-LNS (LNS group) daily until delivery, and then placebo, MMNs, or SQ-LNS, respectively, for 6 mo postpartum; infants in the LNS group received SQ-LNS formulated for infants from 6 to 18 mo of age (endline). The primary outcome was child length by 18 mo of age.ResultsAt endline, data were available for 85% of 1228 infants enrolled; overall mean length and length-for-age z score (LAZ) were 79.3 cm and -0.83, respectively, and 12% of the children were stunted (LAZ

The International Lipid-Based Nutrient Supplements (iLiNS) Project began in 2009 with the goal of contributing to the evidence base regarding the potential of lipid-based nutrient supplements (LNS) to prevent undernutrition in vulnerable populations. The first project objective was the development of acceptable LNS products for infants 6-24 months and for pregnant and lactating women, for use in studies in three countries (Burkina Faso, Ghana and Malawi). This paper shares the rationale for a series of decisions in supplement formulation and design, including those related to ration size, ingredients, nutrient content, safety and quality, and packaging. Most iLiNS supplements have a daily ration size of 20 g and are intended for home fortification of local diets. For infants, this ration size is designed to avoid displacement of breast milk and to allow for dietary diversity including any locally available and accessible nutrient-dense foods. Selection of ingredients depends on acceptability of flavour, micronutrient, anti-nutrient and essential fatty acid contents. The nutrient content of LNS designed to prevent undernutrition reflects the likelihood that in many resource-poor settings, diets of the most nutritionally vulnerable individuals (infants, young children, and pregnant and lactating women) are likely to be deficient in multiple micronutrients and, possibly, in essential fatty acids. During ingredient procurement and LNS production, safety and quality control procedures are required to prevent contamination with toxins or pathogens and to ensure that the product remains stable and palatable over time. Packaging design decisions must include consideration of product protection, stability, convenience and portion control.

Introduction: Reversing malnutrition-induced impairment of cognition and emotional regulation is a critical global gap. We hypothesize that brain-targeted micronutrient supplemented nutritional rehabilitation in children with moderate acute malnutrition, followed by 2 years micronutrient supplementation will impact on the cognition and emotion regulation of these children. Methods: The primary outcome of this prospective, randomized controlled trial is to study the development of executive functions (EFs) and emotion regulation (ER) in this cohort. Moderate acute malnourished (MAM; WLZ/WHZ <-2 and ≥-3 z-score, and/or 11.5 cm ≤ MUAC < 12.5cm; n = 140)children aged around one year (11m-13m) in Mirpur, Dhaka, Bangladesh will be randomized (1:1) to receive either locally produced Ready to Use Supplementary Food (RUSF) or Enhanced Ready to Use Supplementary Food (E-RUSF) until anthropometric recovery (WLZ/WHZ > -1SD), or for 3 months after enrollment (whichever is earlier). The randomized MAMs groups will be given either Small Quantity Lipid Based Nutrient Supplement (SQLNS) or Enhanced Small Quantity Lipid Based Nutrient Supplement (E-SQLNS), respectively until the end of the 2-year follow up period. Standard psychosocial stimulation will be provided to the MAMs intervention groups. Biological samples will be collected, anthropometric and neurocognitive assessments will be performed at 2 (22m-26m) and 3 (34m-38m) years of age. Two control groups will be recruited: 1), non-malnourished one-year (11m-13m) old children (WLZ/WHZ score>-1SD; n = 70); and 2) three—year (34m-38m) old children (n = 70) with untreated MAM (WHZ <-2 and ≥-3 z-score, and/or 11.5≤MUAC<12.5 cm). The 3-year-old MAM reference group will be assessed once and provided with 2 months of nutritional rehabilitation support (RUSF Nutriset's Plumpy'Sup™). [ABSTRACT FROM AUTHOR]

Abstract: More than 20 million babies are born with low birthweight annually. Small newborns have an increased risk for mortality, growth failure, and other adverse outcomes. Numerous antenatal risk factors for small newborn size have been identified, but individual interventions addressing them have not markedly improved the health outcomes of interest. We tested a hypothesis that in low‐income settings, newborn size is influenced jointly by multiple maternal exposures and characterized pathways associating these exposures with newborn size. This was a prospective cohort study of pregnant women and their offspring nested in an intervention trial in rural Malawi. We collected information on maternal and placental characteristics and used regression analyses, structural equation modelling, and random forest models to build pathway maps for direct and indirect associations between these characteristics and newborn weight‐for‐age Z‐score and length‐for‐age Z‐score. We used multiple imputation to infer values for any missing data. Among 1,179 pregnant women and their babies, newborn weight‐for‐age Z‐score was directly predicted by maternal primiparity, body mass index, and plasma alpha‐1‐acid glycoprotein concentration before 20 weeks of gestation, gestational weight gain, duration of pregnancy, placental weight, and newborn length‐for‐age Z‐score (p < .05). The latter 5 variables were interconnected and were predicted by several more distal determinants. In low‐income conditions like rural Malawi, maternal infections, inflammation, nutrition, and certain constitutional factors jointly influence newborn size. Because of this complex network, comprehensive interventions that concurrently address multiple adverse exposures are more likely to increase mean newborn size than focused interventions targeting only maternal nutrition or specific infections. [ABSTRACT FROM AUTHOR]

Background: With a prevalence of 3.1%, approximately, 450 000 children in Bangladesh are having severe acute malnutrition (SAM). There is currently no national community-based program run by government to take care of these children, one of the reasons being lack of access to ready-to-use therapeutic food (RUTF).Objective: To develop RUTF using locally available food ingredients and test its acceptability.Methods: A checklist was prepared for all food ingredients available and commonly consumed in Bangladesh that have the potential of being used for developing a RUTF. Linear programming was used to identify the combinations of nutrients that would result in an ideal RUTF. To test the acceptability of 2 local RUTFs compared to the prototype RUTF, Plumpy'Nut, a clinical trial with a crossover design was conducted among 30 children in the Dhaka Hospital of International Centre for Diarrhoeal Disease Research, Bangladesh. The acceptability was determined by using the mean proportion of offered food consumed by the children themselves.Results: Two RUTFs were developed, one based on chickpea and the other on rice-lentils. The total energy content of 100 g of chickpea and rice-lentil-based RUTF were 537.4 and 534.5 kcal, protein 12.9 and 13.5 g, and fat 31.8 and 31.1 g, respectively, without any significant difference among the group. On an average, 85.7% of the offered RUTF amount was consumed by the children in 3 different RUTF groups which implies that all types of RUTF were well accepted by the children.Conclusion: Ready-to-use therapeutic foods were developed using locally available food ingredients-rice, lentil, and chickpeas. Chickpea-based and rice-lentil-based RUTF were well accepted by children with SAM. [ABSTRACT FROM AUTHOR]

Background: Vitamin A deficiency remains a global public health problem. Daily supplementation with a lipid-based nutrient supplement (LNS) has potential for increasing milk vitamin A concentrations.Objective: The objective of this study was to determine whether daily supplementation with approximately the recommended daily intake of vitamin A in an LNS or a multiple-micronutrient supplement (MMN) during pregnancy and the first 6 mo postpartum has an effect on breast milk retinol concentration at 6 mo postpartum.Methods: Women ≤20 wk pregnant (n = 1320) were randomly assigned to receive either the MMN providing 18 micronutrients, including 800 μg retinol equivalents of vitamin A, or the LNS with the same nutrients as the MMN group, plus 4 minerals and macronutrients, until 6 mo postpartum; a control group received iron and folic acid during pregnancy and a placebo (calcium tablet) during the first 6 mo postpartum. Breast milk samples collected at 6 mo postpartum were analyzed for retinol and fat concentrations by HPLC and creamatocrit, respectively, in a subsample of 756 women.Results: The breast milk retinol concentration was (mean ± SD) 56.3 ± 2.1 nmol/g fat, with no significant differences between groups [iron and folic acid (n = 243): 59.1 ± 2.8; MMN (n = 260): 55.4 ± 2.5; LNS (n = 253): 54.7 ± 2.5 nmol/g fat; P = 0.45], regardless of whether the woman had or had not received a high-dose vitamin A supplement (200,000 IU) soon after childbirth. Around 17% of participants had low milk retinol (≤28 nmol/g fat). We estimated that 41% of infants were potentially receiving vitamin A at amounts above the Tolerable Upper Intake Level (600 μg retinol activity equivalents/d), with no group differences in percentages with low or high milk retinol concentration.Conclusion: Daily consumption of approximately the recommended intake of vitamin A did not increase breast milk retinol concentrations in this sample of Ghanaian women. This trial was registered at clinicaltrials.gov as NCT00970866. [ABSTRACT FROM AUTHOR]

Ready-to-use foods are one of the available strategies for the treatment of moderate acute malnutrition (MAM), but challenges remain in the use of these products in programs at scale. This paper focuses on two challenges: the need for cheaper formulations using locally available ingredients that are processed in a safe, reliable, and financially sustainable local production facility; and the effective use of these products in large-scale communitybased programs. Linear programming tools can be used successfully to design local compositions that are in line with international guidelines, low in cost, and acceptable, and the efficacy of these local formulations in the treatment of MAM was recently demonstrated in Malawi. The production of local formulations for programs at scale relies on the existence of a reliable and efficient local production facility. Technical assistance may be required in the development of sustainable business models at an early stage in the process, taking into account the stringent product quality and safety criteria and the required investments. The use of ready-to-use products, as of any food supplement, in programs at scale will be affected by the practice of household sharing and diversion of these products for other uses. Additional measures can be considered to account for sharing. These products designed for the treatment and prevention of MAM are to be used in community-based programs and should therefore be used in conjunction with other interventions and designed so that they do not replace the intake of other foods and breastmilk. Remaining challenges and implications for the (operations) research agenda are discussed. [ABSTRACT FROM AUTHOR]

Undernutrition is a major public health problem leading to 1 in 5 of all deaths in children under 5 years. Undernutrition leads to growth stunting and/or wasting and is often associated with environmental enteric dysfunction (EED). EED mechanisms leading to growth failure include intestinal hyperpermeability, villus blunting, malabsorption and gut inflammation. As non-invasive methods for investigating gut function in undernourished children are limited, pre-clinical models are relevant to elucidating the pathophysiological processes involved in undernutrition and EED, and to identifying novel therapeutic strategies. In many published models, undernutrition was induced using protein or micronutrient deficient diets, but these experimental models were not associated with EED. Enteropathy models mainly used gastrointestinal injury triggers. These models are presented in this review. We found only a few studies investigating the combination of undernutrition and enteropathy. This highlights the need for further developments to establish an experimental model reproducing the impact of undernutrition and enteropathy on growth, intestinal hyperpermeability and inflammation, that could be suitable for preclinical evaluation of innovative therapeutic intervention. [ABSTRACT FROM AUTHOR]

Objectives: Ready-to-use therapeutic food (RUTF) is the preferred treatment for uncomplicated severe acute malnutrition. It contains large amounts of linoleic acid and little α-linolenic acid, which may reduce the availability of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) to the recovering child. A novel high-oleic RUTF (HO-RUTF) was developed with less linoleic acid to determine its effect on DHA and EPA status., Methods: We conducted a prospective, randomized, double-blind clinical effectiveness trial treating rural Malawian children with severe acute malnutrition. Children were treated with either HO-RUTF or standard RUTF. Plasma phospholipid fatty acid status was measured on enrollment and after 4 weeks and compared between the 2 intervention groups., Results: Among the 141 children enrolled, 48 of 71 receiving HO-RUTF and 50 of 70 receiving RUTF recovered. Plasma phospholipid samples were analyzed from 43 children consuming HO-RUTF and 35 children consuming RUTF. The change in DHA content during the first 4 weeks was +4% and -25% in the HO-RUTF and RUTF groups, respectively (P = 0.04). For EPA, the change in content was 63% and -24% in the HO-RUTF and RUTF groups, respectively (P < 0.001). For arachidonic acid, the change in content was -3% and 13% in the HO-RUTF and RUTF groups, respectively (P < 0.009)., Conclusions: The changes in DHA and EPA seen in the children treated with HO-RUTF warrant further investigation because they suggest that HO-RUTF support improved polyunsaturated fatty acid status, necessary for neural development and recovery.