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Background In food insecure settings, it may be difficult for pregnant women to meet increased nutritional needs through traditional diets. A promising new strategy to fill nutrient gaps in pregnancy involves the provision of lipid-based nutrient supplements (LNS). We aimed to assess the acceptability and utilization of a 40 g LNS formulation (Epi-E) with increased micronutrient content relative to the recommended daily allowance among pregnant women in rural Niger. Methods We conducted a two-part, multi-methods study among pregnant women presenting to antenatal care in Madarounfa, Niger during two periods (Ramadan and non-Ramadan). Part 1 included two LNS test meals provided at the health center, and Part 2 included a 14-day home trial to simulate more realistic conditions outside of the health center. Open- and closed-ended questions were used to assess organoleptic properties of Epi-E using a 5-point hedonic scale after the test meals, as well as utilization and willingness to pay for Epi-E after the 14-day home trial. Results Participants consumed more than 90% of the test meal in both periods. Epi-E was rated highly in terms of overall liking, color, taste and smell during test meals in both periods (median 5/5 for all); only time, mode and frequency of consumption varied between Ramadan and non-Ramadan periods in observance of daily fasting during the holy month. Conclusion Epi- E, a 40 g LNS formulation with increased micronutrient content, was highly acceptable among pregnant women in rural Niger, and utilization was guided by household and individual considerations that varied by time period. This formulation can be further tested as a potential strategy to improve the nutritional status of pregnant women in this context. Trial registration ClinicalTrials.gov Identifier: NCT02145000. Registered 22 May 2014.

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 (20g) containing either 10mg sodium saccharin or 5mg 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 (13.4µmol/L) and trans-resveratrol-3-O-sulfate (0.7µmol/L) allowed for 78% and 89% sensitivity, respectively, and 100% specificity in detecting consumption of SQ-LNS within the first 12h after consumption.ConclusionsUrinary concentrations of saccharin and trans-resveratrol-3-O-sulfate reflect consumption of SQ-LNS containing those compounds during the first 12h 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.

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.

Undernutrition is a global health issue leading to 1 out 5 all deaths in children under 5 years. Undernutrition is often associated with environmental enteric dysfunction (EED), a syndrome associated with increased intestinal permeability and gut inflammation. We aimed to develop a novel murine model of undernutrition with these EED features. Post-weaning mice were fed with low-protein diet (LP) alone or combined with a gastrointestinal insult trigger (indomethacin or liposaccharides). Growth, intestinal permeability and inflammation were assessed. LP diet induced stunting and wasting in post-weaning mice but did not impact gut barrier. We therefore combined LP diet with a single administration of indomethacin or liposaccharides (LPS). Indomethacin increased fecal calprotectin production while LPS did not. To amplify indomethacin effects, we investigated its repeated administration in addition to LP diet and mice exhibited stunting and wasting with intestinal hyperpermeability and gut inflammation. The combination of 3-weeks LP diet with repeated oral indomethacin administration induced wasting, stunting and gut barrier dysfunction as observed in undernourished children with EED. As noninvasive methods for investigating gut function in undernourished children are scarce, the present pre-clinical model provides an affordable tool to attempt to elucidate pathophysiological processes involved in EED and to identify novel therapeutic strategies.

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.

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.

OBJECTIVES: An objective adherence marker is needed to track consumption of nutrient supplements in nutrition intervention trials and programs targeted to young children and women of reproductive age in low-income countries. Here, resveratrol and saccharin are evaluated as adherence markers for tracking short-term intermittent or daily consumption of a small-quantity lipid-based nutrient supplement (SQ-LNS) in US women in a ten-day controlled feeding study. METHODS: Sixty-three women were randomly assigned to receive daily for 10 d either: SQ-LNS containing trans-resveratrol (10 mg) and sodium saccharin (10 mg) (SQ-LNS/RS); 2) control SQ-LNS without the markers (SQ-LNS/C); or 3) alternating SQ-LNS/RS or SQ-LNS/C to simulate intermittent consumption. Urine concentrations of saccharin and trans-resveratrol-3-O-sulfate were measured in pooled urine samples collected 0–4 h post-consumption of the assigned SQ-LNS product on study days 4, 5, 9 and 10. Cutoff values were determined for urinary concentrations of each compound for classifying participants as consumers or non-consumers of SQ-LNS/RS. Then, participants were classified as daily, intermittent or non-consumers of SQ-LNS/RS based on their overall consumption pattern (number of days classified as a consumer during the 10-d period). RESULTS: The cutoff value for urinary trans-resveratrol-3-O-sulfate (0.80 µmol/L) classified participants correctly as consumers or non-consumers in 97% of samples; the cutoff value for urinary saccharin (6.92 µmol/L) classified participants correctly in 93% of samples. Overall, 95% of daily, 95% of intermittent, and 100% of control group participants were classified correctly into their consumption pattern based on urinary trans-resveratrol-3-O-sulfate concentrations during the 10-d period; and 75% of daily, 95% of intermittent, and 100% of control participants were classified correctly based on urinary saccharin concentrations. CONCLUSIONS: The results suggest that urinary concentrations of saccharin and trans-resveratrol-3-O-sulfate may be useful for qualitative assessment of daily vs. intermittent vs. non-consumption of SQ-LNS; further work is needed to assess the usefulness of the markers in the intended target populations. FUNDING SOURCES: Bill & Melinda Gates Foundation

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.

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

Background: Intrauterine growth restriction may be reduced by supplementing maternal diets during pregnancy, but few studies have assessed the impact of combined prenatal and postnatal interventions on child growth. Objective: We tested a hypothesis that provision of small-quantity lipid-based nutrient supplements (SQ-LNSs) to mothers in pregnancy and 6 mo postpartum and to their infants from 6 to 18 mo of age would promote infant and child growth in the study area in rural Malawi. Methods: We enrolled 869 pregnant women in a randomized trial in Malawi. During pregnancy and 6 mo thereafter, the women received daily 1 capsule of iron-folic acid (IFA), 1 capsule containing 18 micronutrients (MMN), or one 20-g sachet of SQ-LNS [lipid-based nutrient supplements (LNS), containing 21 MMN, protein, carbohydrates, essential fatty acids, and 118 kcal]. Children in the IFA and MMN groups received no supplementation; children in the LNS group received SQ-LNSs from 6 to 18 mo. Primary outcome was child length at 18 mo. Results: At 18 mo, the mean length in the IFA, MMN, and LNS groups was 77.0, 76.9, and 76.8 cm (P = 0.90), respectively, and the prevalence of stunting was 32.7%, 35.6%, and 37.9% (P = 0.54), respectively. No intergroup differenceswere found in the mean weight, head circumference, or midupper arm circumference or the proportions with low z scores for these variables (P > 0.05). Covariate adjustment did not change the analysis results, and the associations between the intervention and child length were not modified by maternal parity, age, or nutritional status (P > 0.10). Conclusions: The findings do not support a hypothesis that provision of SQ-LNSs to women in pregnancy and postpartum and to children from 6 to 18 mo of age would promote child growth in this Malawian study area. This trial was registered at clinicaltrials.gov as NCT01239693. JN utr2015;145:1345‐53.

BACKGROUND The International Lipid-Based Nutrient Supplements Project developed a small-quantity (20 g/d) lipid-based nutrient supplement (LNS) for pregnant and lactating women. OBJECTIVE We evaluated the effects of prenatal LNS supplementation on fetal growth. DESIGN In a community-based, partially double-blind, individually randomized controlled trial, 1320 women ≤20 wk pregnant received 60 mg Fe/400 μg folic acid (IFA), or 1-2 Recommended Dietary Allowances of 18 micronutrients, including 20 mg Fe (MMN), or LNS with the same micronutrients as the MMN group, plus 4 minerals and macronutrients contributing 118 kcal (LNS) daily until delivery. Fetal growth was compared across groups by using intention-to-treat analysis. The primary outcome was birth length. RESULTS This analysis included 1057 women (IFA = 349, MMN = 354, LNS = 354). Groups did not differ significantly in mean birth length, length-for-age z score (LAZ), head circumference, or percentage low birth length but differed in mean birth weight (P = 0.044), weight-for-age z score (WAZ; P = 0.046), and BMI-for-age z score (BMIZ; P = 0.040), with a trend toward differences in low birth weight (P = 0.069). In pairwise comparisons, the LNS group had greater mean birth weight (+85 g; P = 0.040), WAZ (+0.19; P = 0.045), and BMIZ (+0.21; P = 0.035) and a lower risk of low birth weight (RR: 0.61, 95% CI: 0.39, 0.96; P = 0.032) than did the IFA group. The other group differences were not significant. The effect of intervention was modified by mother's parity, age, height, baseline hemoglobin, household food insecurity, and child sex, with parity being the most consistent modifier. Among primiparous women (IFA = 131; MMN = 110; LNS = 128), the LNS group had greater mean birth length (+0.91 cm; P = 0.001), LAZ (+0.47; P = 0.001), weight (+237 g; P < 0.001), WAZ (+0.56; P < 0.001), BMIZ (+0.52; P < 0.001), head circumference (0.50 cm; P = 0.017), and head circumference-for-age z score (+0.40; P = 0.022) than did the IFA group; similar differences were found when comparing the LNS and MMN groups among primiparous women, and no group differences were found among multiparous women. CONCLUSION Prenatal LNS supplementation can improve fetal growth among vulnerable women in Ghana, particularly primiparous women. This trial was registered at clinicaltrials.gov as NCT00970866.

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 tested the acceptability of three new lipid-based nutrient supplements (LNSs) in two independent phases among 18 8-12-month-old healthy rural Malawians and their caregivers. In phase 1, acceptability was assessed by offering three new LNSs in random order, and an LNS already determined to be acceptable, Nutributter(®), each added to 30 g of warm maize porridge over three consecutive days. In phase 2, infants from each village were provided one of the new supplements for a 2-week home-use trial. Outcome measures included the amount consumed, time completion of the dose and the maternal rating of likeability on a 5-point scale. The supplements were rated acceptable if consumption was over 50% of the offered dose in phase 1. The mean (95% confidence interval) proportion of the LNS test meals consumed under direct observation was 88% (82-94%) for LNS-10gM, 90% (84-95%) for LNS-20gM, 87% (79-95%) for LNS-20gNoM, and 86% (83-90%) for Nutributter. The median (25th and 75th centile) time (minutes) for completing the offered test meal was 4 (2, 7) for LNS-10gM, 5 (3, 6) for LNS-20gM, 4 (3, 8) for LNS-20gNoM and 4 (2, 6) for Nutributter. During both phases, almost all caregivers rated all study foods very likeable for themselves and their children, with mean scores slightly lower among the caregivers than among the infants. In the home-use phase, the test foods were almost exclusively used by the study participants with minimal sharing with siblings and other household members. Some infants were reported to prefer the new investigational products over traditional complementary food. Considering that the novel LNS was largely acceptable. Efficacy trials are now needed to assess their impact on child growth and development.

Inadequate micronutrient intake during pregnancy, lactation and infancy is a major problem in many developing countries. Lipid-based nutrient supplements (LNS) can improve micronutrient status, growth and development of infants, and also have potential to improve nutritional status of pregnant and lactating women. The objective of the study was to test the acceptability of LNS designed for infants (LNS-20gM) and pregnant or lactating women (LNS-P&L). Participants were infants (n = 22, mean age = 8 months) and pregnant or lactating women (n = 24) attending routine services at a hospital in Ghana. Infants consumed 45 g of a test meal consisting of one part LNS-20gM and three parts fermented maize porridge, while women consumed 50 g of a similar test meal containing LNS-P&L instead. Participants also used their respective LNS at home for 14 days. Primary outcome was the proportion of the test meal consumed. On average, infants consumed 76.2% of the test meal [95% (confidence interval) CI: 65.7, 86.7], while women consumed 87.1% (95% CI: 82.6, 91.6). During the 14-day period, median daily consumption of LNS-20gM was 19.3 g, very close to the recommended 20 g d(-1), while that of LNS-P&L was one sachet, as recommended. We conclude that LNS-20gM and LNS-P&L were well accepted.

Micronutrient deficiencies are a public health concern among young children in low-income countries,and novel strategies are needed to improve the nutritional status of children at risk. One promising approach is the use of lipid-based nutrient supplements (LNS),which can be added to complementary food at the time of consumption. The optimal amount of zinc to include in LNS is uncertain, and concerns have been expressed about possible adverse effects of zinc on sensory characteristics of LNS.We conducted a series of acceptability studies of LNS containing either 0 or 10 mg of zinc per daily 20 g LNS dose among Burkinabe children 9-15 months old and their mothers.These acceptability studies included observations of children's consumption, maternal and child sensory reaction to the products using a 5-unit hedonic scale, a triangle test for detection of differences and a review of maternal reports of their child-feeding experiences during a 2-week home-feeding trial. The LNS products were well appreciated by the mothers and children during the sensory trials and the 2-week home- feeding trial. The addition of 10 mg zinc to LNS did not affect the consumed proportion of the offered porridge-LNS-mixture (P = 0.43). Results of the triangle test with mothers confirmed that there was no detect- able difference between products containing 0 or 10 mg zinc per 20 g LNS dose.Most importantly,interviews and focus groups following the 2-week home-feeding trial indicated good acceptability of the products by mothers and their children.

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

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 community-based 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.

Small birth size, often associated with insufficient maternal nutrition, contributes to a large share of global child undernutrition, morbidity, and mortality. We developed a small-quantity lipid-based nutrient supplement (SQ-LNS) to enrich the diets of pregnant women.The objective was to test a hypothesis that home fortification of pregnant women's diets with SQ-LNS would increase birth size in an African community.We enrolled 1391 women with uncomplicated pregnancies (20 gestational weeks) in a randomized controlled trial in Malawi. The women were provided with one daily iron-folic acid (IFA) capsule, one capsule containing multiple micronutrients (MMNs), or one 20-g sachet of SQ-LNS (LNS, containing 118 kcal, protein, carbohydrates, essential fatty acids, and 21 micronutrients). Primary outcomes were birth weight and newborn length. Secondary outcomes included newborn weight, head and arm circumference, and pregnancy duration. Analysis was by intention to treat.The mean ± SD birth weight and newborn length were 2948 ± 432, 2964 ± 460, and 3000 ± 447 g (P = 0.258) and 49.5 ± 2.4, 49.7 ± 2.2, and 49.9 ± 2.1 cm (P = 0.104) in the IFA, MMN, and LNS groups, respectively. For newborn weight-for-age, head circumference, and arm circumference, the point estimate for the mean was also highest in the LNS group, intermediate in the MMN group, and lowest in the IFA group, but except for midupper arm circumference (P = 0.024), the differences were not statistically significant. The prevalence of low birth weight (2500 g) was 12.7%, 13.5%, and 12.1% (P = 0.856), respectively; newborn stunting (length-for-age z score-2) was 19.2%, 14.0%, and 14.9% (P = 0.130), respectively; and newborn small head circumference (head circumference-for-age z score-2) was 5.8%, 3.0%, and 3.1% (P = 0.099), respectively. The associations between the intervention and the outcomes were not modified by maternal parity, age, or nutritional status (P0.100).The study findings do not support a hypothesis that provision of SQ-LNS to all pregnant women would increase the mean birth size in rural Malawi. The trial was registered at clinicaltrials.gov as NCT01239693.

BACKGROUND: Lipid-based nutrient supplements (LNSs) offer a vehicle to improve childrens diets in low-income countries where complementary foods are typically deficient in essential nutrients. Sustained acceptability by the intended users is essential for achieving growth-promoting effects. OBJECTIVE: We aimed to determine the sustained acceptability of LNSs among 6- to 18-mo-old children in Malawi. METHODS: In the context of a trial testing the growth-promoting effect of different formulations and doses of LNSs we delivered LNSs to the homes of the children biweekly according to the randomization protocol. We defined acceptability to include adherence to feeding recommendations and mothers experiences of feeding LNSs to their child. We conducted brief interviews each week with the mothers. At 2 time points we conducted knowledge attitudes and practices (KAP) interviews. In addition we conducted repeated in-depth interviews with a subset of mothers. RESULTS: Of the 1612 children who received the LNS intervention we analyzed adherence data from 1478 (91.7%) children and KAP data at 2 time points (childs age of 12 and 18 mo) from 839 (52.1%) of the children. The mean +/- SD overall adherence (proportion of days when the study child reportedly consumed LNSs considering only those weeks when the supplement had been successfully delivered to the home) was 92.4 +/- 9.6% and there was no difference between children receiving milk-containing or milk-free LNSs. There was also no increasing or decreasing trend over time in any of the groups. Sharing and deviation from other feeding recommendations were common. Maternal experiences were mostly very positive. CONCLUSIONS: The acceptability of LNS products was good and was sustained for 12 mo in this rural Malawian population. However sharing of the products with family members and deviation from other feeding recommendations were frequent which means that individually targeted children were likely to receive less than the intended dose of the LNS. This trial was registered at clinicaltrials.gov as NCT00945698. (c) 2015 American Society for Nutrition.

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. (c) 2015 American Society for Nutrition.

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.

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.

Inadequate micronutrient intake during pregnancy, lactation and infancy is a major problem in many developing countries. Lipid‐based nutrient supplements (LNS) can improve micronutrient status, growth and development of infants, and also have potential to improve nutritional status of pregnant and lactating women. The objective of the study was to test the acceptability of LNS designed for infants (LNS‐20gM) and pregnant or lactating women (LNS‐P&L). Participants were infants (n = 22, mean age = 8 months) and pregnant or lactating women (n = 24) attending routine services at a hospital in Ghana. Infants consumed 45 g of a test meal consisting of one part LNS‐20gM and three parts fermented maize porridge, while women consumed 50 g of a similar test meal containing LNS‐P&L instead. Participants also used their respective LNS at home for 14 days. Primary outcome was the proportion of the test meal consumed. On average, infants consumed 76.2% of the test meal [95% (confidence interval) CI: 65.7, 86.7], while women consumed 87.1% (95% CI: 82.6, 91.6). During the 14‐day period, median daily consumption of LNS‐20gM was 19.3 g, very close to the recommended 20 g d(−1), while that of LNS‐P&L was one sachet, as recommended. We conclude that LNS‐20gM and LNS‐P&L were well accepted.