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.

Efficacy of ready-to-use therapeutic food in malnourished children with cancer: Results of a randomized, open-label phase 3 trial.

BACKGROUND: The adverse influence of undernutrition in children with cancer may be remediated by early nutritional intervention. This study assessed the efficacy of ready-to-use therapeutic food (RUTF) in improving nutritional status and reducing treatment-related toxicities (TRTs) in such children. METHODS: In a randomized controlled phase-3 open-label trial, severely and moderately undernourished children with cancer were randomized 1:1 to receive standard nutritional therapy (SNT) or SNT+RUTF for 6 weeks. The primary outcome (weight gain >10%) and secondary outcomes (improved/maintained nutritional status, improved body composition) were assessed after 6 weeks. TRTs were assessed over 6 months. RESULTS: Between July 2015 and March 2018, 260 subjects were enrolled, 126 were analyzable in both arms at 6 weeks. More children on RUTF had weight gain (98 [77.8%] vs. 81 [64.2%], p = .025) with a greater increase in fat mass as a percentage of body mass (median 2% [IQR -0.12 to 4.9] vs. 0.5% [IQR -1.45 to 2.27, p = .005]) but a greater loss of lean mass (median -1.86% [IQR -4.4 to 0.50] vs. -0.4% [IQR -2.4 to 1.4, p = .007]) compared to the SNT arm. Fewer subjects on the RUTF arm had episodes of severe infection (10.6% vs. 31%, p < .0001), treatment delays (17.7% vs. 39%, p < .0001), and severe mucositis (11% vs. 23.8%, p = .006) compared to the SNT arm. The odds of developing TRTs on the RUTF arm were lower even after adjusting for improvement in nutritional status. CONCLUSIONS: RUTF is efficacious in improving weight gain and nutritional status in undernourished children with cancer and decreases TRTs. Incorporating RUTF into a healthy, balanced diet should be considered in undernourished children with cancer.

Treating high-risk moderate acute malnutrition using therapeutic food compared with nutrition counseling (Hi-MAM Study): a cluster-randomized controlled trial.

BACKGROUND: There is a lack of consensus on what is the most appropriate treatment of moderate acute malnutrition (MAM). OBJECTIVES: We aimed to determine if provision of ready-to-use-therapeutic food (RUTF) and antibiotics to "high-risk" MAM (HR-MAM) children in addition to nutritional counseling would result in higher recovery and less deterioration than nutrition counseling alone. METHODS: At the 11 intervention clinics, HR-MAM children were given RUTF and amoxicillin along with standard nutrition counseling, for 2-12 wk. All others received 6 wk of nutrition counseling alone. HR-MAM was defined as midupper arm circumference (MUAC) <11.9 cm, weight-for-age z score (WAZ) <-3.5, mother not the main caregiver, or a child <2 y old not being breastfed. Outcomes were compared using intention-to-treat analysis. RESULTS: Analysis included 573 children at the intervention sites and 714 children at the control sites. Of the intervention group, 317 (55%) were classified as HR-MAM. Short-term recovery was greater at the intervention sites [48% compared with 39% at week 12; risk difference (rd): 0.08; 95% CI: 0.03, 0.13]. The intervention group had lower risk of deteriorating to severe acute malnutrition (SAM) (18% compared with 24%; rd: -0.07; 95% CI: -0.11, -0.04), lower risk of dying (1.8% compared with 3.1%; rd: -0.02; 95% CI: -0.03, -0.00), and greater gains in MUAC and weight than did children at the control sites. However, by 24 wk, the risk of SAM was similar between the 2 arms (31% compared with 34%; rd: -0.03; 95% CI: -0.09, 0.02). Control group data identified recent illness, MUAC <12.0 cm, WAZ <-3, dropping anthropometry, age <12 mo, being a twin, and a history of previous SAM as risk factors for deterioration. CONCLUSIONS: Provision of RUTF and antibiotics to HR-MAM children improved short-term recovery and reduced short-term risk of deterioration. However, recovery rates were still suboptimal and differences were not sustained by 6 mo post enrollment.This trial was registered at clinicaltrials.gov as NCT03647150.

Report of a Pilot Program Using a Milk-Free Ready-to-Use Therapeutic Food Made From Soya, Maize, and Sorghum to Treat Severe Acute Malnutrition.

BACKGROUND: Globally, ready-to-use therapeutic food (RUTF) with peanut and milk as the primary source of protein is used to treat children having severe acute malnutrition (SAM). Valid Nutrition in collaboration with Ajinomoto Co., Inc has developed a nonmilk RUTF from soybean, maize, and sorghum (SMS-RUTF) and demonstrated its efficacy. OBJECTIVE: To pilot SMS-RUTF in treatment of SAM within Community-Based Management of Acute Malnutrition (CMAM) program in Malawi, Africa. METHODS AND FINDINGS: This was implemented from January to July 2018 and its performance was based on the SPHERE criteria and Ministry of Health CMAM guidelines. A total of 742 children were treated with SMS-RUTF. Of these, 94.5% (95% CI: 92.6-96.0) were successfully discharged to supplementary feeding program (SFP) with middle upper arm circumference (MUAC) ≥115 mm or directly to their homes with MUAC ≥125 mm; 3.6% (95% CI: 2.4-5.3) defaulted, 1.9 % (95% CI: 1.0-2.1) died, and 0.0% nonresponders. Analysis of 222 children who were discharged home with MUAC ≥125 mm gave a recovery rate of 88.3% (95% CI: 88.3-92.2), a defaulter rate of 6.8 % (95% CI: 3.8-10.9), a mortality rate of 1.3% (95% CI: 0.3-3.9), and a nonresponders rate of 1.8% (95% CI: 0.5-4.5). These outcomes exceed SPHERE minimum performance standards. The mean (standard deviation) length of stay of children discharged to SFP and discharged directly home were 42.0 (20.9) and 46.1 (21.1) days, respectively. These outcomes are within the recommended average duration of <60 days. CONCLUSION: The pilot CMAM program using SMS-RUTF recipe that contains no milk or peanuts achieved SPHERE minimum standards. Based on this evidence, SMS-RUTF should be encouraged for treatment of SAM in children between 6 and 59 months in routine CMAM programs in Malawi and globally.

Acceptability and efficacy of ready-to-use therapeutic food using soy protein isolate in under-5 children suffering from severe acute malnutrition in Bangladesh: a double-blind randomized non-inferiority trial.

BACKGROUND AND OBJECTIVE: Globally, around 20 million children suffer from severe acute malnutrition (SAM). Identifying a more economical treatment for those affected has the potential to make treatment more available and improve prognosis for recovery and future health. DESIGN/METHODS: The double-blind randomized study compared taste acceptability (measured by the eagerness to eat) and efficacy of soy-based RUTF (S-RUTF) with milk-based RUTF (M-RUTF) in 6- to 59-month-old children suffering from SAM (WHZ < -3) at icddr,b, in Bangladesh. These SAM children were enrolled in the study after completion of their stabilization phase of treatment. Tolerance of test-RUTF was also tested during the efficacy trial. RESULTS: The cross-over taste acceptability study, conducted in 36 children, revealed similar results between products and an absence of side effects. The efficacy trial enrolled 260 children (130, each group) with similar baseline characteristics, including mean ± SD age 15.0 ± 8.0 months, WHZ - 3.41 ± 0.40 and mid-upper arm circumference (MUAC) 11.1 ± 0.7 cm. The features at the end of study by RUTF group were (in S-RUTF vs. M-RUTF, respectively): total days from enrollment: 44 ± 34 versus 39 ± 30; weight gain (kg): 0.698 ± 0.438 versus 0.741 ± 0.381 and rate of weight gain (g/kg/d): 3.9 ± 3.2 versus 5.2 ± 4.6; MUAC gain (cm): 0.9 ± 0.7 versus 0.9 ± 0.6; and improvement of WHZ: 1.12 ± 0.82 versus 1.22 ± 0.68 (all data were man ± SD and none were significantly different between the groups). At enrollment and the end of intervention, the body composition [total body water (TBW): 70.3 ± 3.2 vs. 69.9 ± 3.5%, and fat: 11.0 ± 4.0 vs.11.5 ± 4.3% at baseline; and TBW: 65.5 ± 4.1 vs. 65.9 ± 4.6%; and fat: 16.8 ± 5.2 vs. 16.2 ± 5.8% in S-RUTF and M-RUTF group, respectively] was found similar. Moreover, the increment of total TBW, FM, and FFM was also observed similar between the groups. CONCLUSIONS: This is the first randomized trial comparing S-RUTF using soy protein isolate with milk-based RUTF including comparison of body composition. S-RUTF was found equally acceptable as of milk-based RUTF without any adverse event. Children receiving S-RUTF showed similar pattern of changes in anthropometric indices, and body composition as of milk-based RUTF. Greater number of SAM children can be managed in the community with comparatively low-cost soy-based RUTF. TRIAL REGISTRATION: NCT01634009.

Development and testing of locally-produced ready-to-use therapeutic and supplementary foods (RUTFs and RUSFs) in Cambodia: lessons learned.

BACKGROUND: Rates of childhood undernutrition are persistently high in Cambodia. Existing ready-to-use supplementary and therapeutic foods (RUSFs and RUTFs) have had limited acceptance and effectiveness. Therefore, our project developed and trialled a locally-produced, multiple micronutrient fortified lipid-based nutrient supplement (LNS) with therapeutic and supplementary versions. This ready-to-use food (RUF) is innovative in that, unlike many RUFs, it contains fish instead of milk. Development began in 2013 and the RUF was finalised in 2015. From 2015 until the present, both the RUTF and the RUSF versions were trialled for acceptability and effectiveness. METHODS: This paper draws on project implementation records and semi-structured interviews to describe the partnership between the Cambodian Ministries of Health and Agriculture, Forestry and Fisheries, UNICEF, the French National Research Institute for Sustainable Development (IRD), universities, and Vissot factory. It discusses the project implementation and lessons learned from the development and trialling process, and insights into positioning nutrition on the health agenda in low and middle-income countries. RESULTS: The lessons learned relate to the importance of project planning, management, and documentation in order to seize opportunities in the research, policy, advocacy, and programming environment while ensuring adequate day-to-day project administration and resourcing. CONCLUSIONS: We conclude that projects such as ours, that collaborate to develop and test novel, locally-produced RUTFs and RUSFs, offer an exciting opportunity to respond to both local programmatic and broader research needs.

The food multimix concept: harnessing and promoting local composite complementary diets.

Over the past two decades, increasing efforts have been made to find suitable nutritional products for managing particularly moderate forms of malnutrition following acute phase treatment, including the adoption of ready-to-use therapeutic foods. The challenge in meeting nutrient needs of normal growing young children and other vulnerable population groups with scant food supply has led us to explore the use of local, traditional and culturally adaptable food-based complementary foods employing the food multimix (FMM) concept. The present paper examined FMM as a concept to demonstrate how locally available composite complementary recipes were used to create highly nutritious recipes at low cost and improve nutrition among vulnerable individuals. The method employed a food-to-food fortification approach for recipe development making use of the 'nutrient strengths' of candidate ingredients. A range of different food recipes had been developed using a stepwise approach and combinations of foods from different populations and communities and packaged as 100 g recipe powders. Proximate and micronutrient analyses have been undertaken, optimised and the nutrient compositions compared with reference nutrient intakes for target groups. Examples of recipes and their nutrient profiles had been highlighted for different formulations showing different ingredients. Theoretical nutrient values were translated into practice based on data from intervention studies. The FMM approach using locally available food has held promise, and published evidence did indicate that the concept can contribute significantly to long-term food-based solutions to meeting nutrient needs of vulnerable groups in poor communities.

Transition from F-75 to ready-to-use therapeutic food in children with severe acute malnutrition, an observational study in Uganda.

BACKGROUND: World Health Organization now recommends the transition from F-75 to ready-to-use therapeutic foods (RUTF) in the management of severe acute malnutrition (SAM). We described the transition from F-75 to RUTF and identified correlates of failed transition. METHODS: We conducted an observational study among children aged 6-59 months treated for SAM at Mulago hospital, Kampala, Uganda. Therapeutic feeding during transition phase was provided by first offering half of the energy requirements from RUTF and the other half from F-75 and then increasing gradually to RUTF as only energy source. The child was considered to have successfully transitioned to RUTF if child was able to gradually consume up to 135 kcal/kg/day of RUTF in the transition phase on first attempt. Failed transition to RUTF included children who failed the acceptance test or those who had progressively reduced RUTF intake during the subsequent days. Failure also included those who developed profuse diarrhoea or vomiting when RUTF was ingested. RESULTS: Among 341 of 400 children that reached the transition period, 65% successfully transitioned from F-75 to RUTF on first attempt while 35% failed. The median (IQR) duration of the transition period was 4 (3-8) days. The age of the child, mid-upper arm circumference, weight-for-height z-score and weight at transition negatively predicted failure. Each month increase in age reflected a 4% lower likelihood of failure (OR 0.96 (95% CI 0.93; 0.99). Children with HIV (OR 2.73, 95% CI 1.27; 5.85) and those rated as severely ill by caregiver (OR 1.16, 95% CI: 1.02; 1.32) were more likely to fail. At the beginning of the rehabilitation phase, the majority (95%) of the children eventually accepted RUTF while only 5% completed rehabilitation in hospital on F-100. CONCLUSION: Transition from F-75 to RUTF for hospitalized children with SAM by gradual increase of RUTF was possible on first attempt in 65% of cases. Younger children, severely wasted, HIV infected and those with severe illness as rated by the caregiver were more likely to fail to transit from F-75 to RUTF on first attempt.

The effect of lipids, a lipid-rich ready-to-use therapeutic food, or a phytase on iron absorption from maize-based meals fortified with micronutrient powders.

Background: Ready-to-use-therapeutic foods (RUTFs) high in lipid, protein, and iron are used to treat malnutrition. Lipids increase gastric residence time, which could increase iron absorption, particularly from poorly soluble iron compounds and in combination with phytase.Objectives: The objectives were to 1) assess the effect on iron absorption of a lipid emulsion given 20 min before or together with an iron-fortified maize meal and 2) assess iron absorption from a micronutrient powder (MNP) given with a nutrient-dense RUTF and/or a microbial phytase.Design: A total of 41 women participated in 3 studies. They consumed a maize meal fortified with isotopically labeled ferrous sulfate (FeSO4; study 1) or ferric pyrophosphate (FePP; study 2). In studies 1 and 2, a lipid emulsion was given with or 20 min before the meal. In study 3, with the use of a 2 × 2 factorial design, subjects consumed a maize meal fortified with an MNP containing labeled FeSO4 (MNP) given with an RUTF (MNP+RUTF), with a phytase (MNP+phytase), or both (MNP+RUTF+phytase). Iron absorption was assessed by isotope incorporation in erythrocytes 14 d after the test meals.Results: The lipid emulsion given either before or with the meal significantly increased iron absorption from FePP by 2.55-fold (95% CI: 1.48-, 4.37-fold; P = 0.001) but not from FeSO4 There was a trend to increase iron absorption with the MNP+RUTF meal, which did not reach significance (1.21-fold; 95% CI: 0.92-, 1.61-fold; P = 0.060). The addition of phytase to MNP and MNP+RUTF significantly increased iron absorption by 1.85-fold (95% CI: 1.49-, 2.29-fold; P < 0.001), with no interaction between phytase and RUTF.Conclusions: In iron-fortified maize-based meals, the addition of lipids more than doubles iron absorption from FePP. Our results suggest the possibility of an enhancing effect on iron absorption of lipid-rich RUTFs, but more research is needed to determine this. This trial was registered at clinicaltrials.gov as NCT01991626.

The Life Course Implications of Ready to Use Therapeutic Food for Children in Low-Income Countries.

The development of ready-to-use therapeutic food (RUTF) for the treatment of uncomplicated cases of severe acute malnutrition in young children from 6 months to 5 years old has greatly improved survival through the ability to treat large numbers of malnourished children in the community setting rather than at health facilities during emergencies. This success has led to a surge in demand for RUTF in low income countries that are frequently food insecure due to environmental factors such as cyclical drought. Worldwide production capacity for the supply of RUTF has increased dramatically through the expansion and development of new manufacturing facilities in both low and high income countries, and new business ventures dedicated to ready-to-use foods have emerged not only for emergencies, but increasingly, for supplementing caloric intake of pregnant women and young children not experiencing acute undernutrition. Due to the lack of evidence on the long term health impact these products may have, in the midst of global nutrition transitions toward obesity and metabolic dysfunction, the increased use of manufactured, commercial products for treatment and prevention of undernutrition is of great concern. Using a framework built on the life course health development perspective, the current research presents several drawbacks and limitations of RUTF for nutrition of mothers and young children, especially in non-emergency situations. Recommendations follow for potential strategies to limit the use of these products to the treatment of acute undernutrition only, study the longer term health impacts of RUTF, prevent conflict of interests arising for social enterprises, and where possible, ensure that whole foods are supported for life-long health and nutrition, as well as environmental sustainability.

Local versus offshore production of ready-to-use therapeutic foods and small quantity lipid-based nutrient supplements.

Manufacturers on four continents currently produce ready-to-use therapeutic foods (RUTF). Some produce locally, near their intended users, while others produce offshore and ship their product long distances. Small quantity lipid-based nutrient supplements (SQ-LNS) such as Nutriset's Enov'Nutributter are not yet in widespread production. There has been speculation whether RUTF and SQ-LNS should be produced primarily offshore, locally, or both. We analyzed The United Nations Children's Fund (UNICEF) Supply Division data, reviewed published literature, and interviewed local manufacturers to identify key benefits and challenges to local versus offshore manufacture of RUTF. Both prices and estimated costs for locally produced product have consistently been higher than offshore prices. Local manufacture faces challenges in taxation on imported ingredients, low factory utilization, high interest rates, long cash conversion cycle, and less convenient access to quality testing labs. Benefits to local economies are not likely to be significant. Although offshore manufacturers offer RUTF at lower cost, local production is getting closer to cost parity for RUTF. UNICEF, which buys the majority of RUTF globally, continues to support local production, and efforts are underway to narrow the cost gap further. Expansion of RUTF producers into the production of other ready-to-use foods, including SQ-LNS in order to reach a larger market and achieve a more sustainable scale, may further close the cost and price gap. Local production of both RUTF and SQ-LNS could be encouraged by a favorable tax environment, assistance in lending, consistent forecasts from buyers, investment in reliable input supply chains, and local laboratory testing.

Changes in whole-blood PUFA and their predictors during recovery from severe acute malnutrition.

Children with severe acute malnutrition (SAM) with complications require in-patient management including therapeutic feeding. Little attention has been given to the effects of these feeds on the essential fatty acid status of children with SAM. The objective of this study was to describe changes in the PUFA composition in whole blood in children with SAM during treatment and to determine predictors of change. This prospective study took place in a paediatric nutrition rehabilitation unit in Kampala, Uganda, and assessed whole-blood fatty acid composition of children with SAM at admission, transition, discharge and follow-up (8 and 16 weeks). ANCOVA was used to identify predictors of change in whole-blood PUFA. The study included 120 children with SAM and twenty-nine healthy control children of similar age and sex. Among the SAM children, 38 % were female and 64 % had oedema. Whole-blood n-6 PUFA proportions increased from admission to follow-up, except for arachidonic acid, which decreased by 0·79 (95 % CI 0·46, 1·12) fatty acid percentage (FA%) from admission to transition and 0·10 (95 % CI 0·23, 0·44) FA% at discharge. n-3 Long-chain (LC) PUFA decreased by 0·21 (95 % CI 0·03, 0·40) FA% at discharge and 0·22 (95 % CI 0·01, 0·42) FA% at 8 weeks of follow-up. This decrease was greater in children from families with recent fish intake and those with nasogastric tube feeding. Current therapeutic feeds do not correct whole-blood levels of LCPUFA, particularly n-3 LCPUFA, in children with SAM. Increased attention is needed to the contents of n-3 LCPUFA in therapeutic feeds.

Effectiveness And Acceptability Of Ready-To-Use Therapuetic Foods Among Malnourished Children In A Tertiary Care Hospital.

BACKGROUND: Ready-to-use-therapeutic foods (RUTF) are an important component of the effective outpatient treatment of severe wasting because most of the child deaths in the world especially in developing countries is due to malnutrition. The objective of the study was to evaluate the effectiveness and acceptability of ready to use therapeutic food among malnourished children in a tertiary care hospital. METHODS: An observational exploratory study based on sixty subjects with 3-120 months of age, malnourished children were chosen by universal sampling from Children Hospital Lahore, Pakistan, during the time period 1st September 2012 to 30th November 2012 with the approval of ethical committee. The study tool for investigation was a well-structured questionnaire. RESULTS: The highest proportion of malnourished children belonged to urban areas (71.67%) and age group <24 months (65%).The effect of RUTF on weight for height and weight for age Z score from baseline to the end of follow-up was statistically significant (Paired sample t-test) (p=0.000, 0.000) but there was no significant effect of RUTF on height for age (p-value=0.14).The acceptance of food among patients was good, the proportion of patient was higher who consumed ready to use therapeutic food easily (70%), percentage of vomiting (16.7%) and complaints of diarrhoea (46.7%) after taking RUTF was less in patients. All mothers were satisfied from ready to use therapeutic foods (100%). CONCLUSIONS: Malnourished children gained weight after the short term supplementation of ready to use therapeutic food but had no significant effect on height of the patients. Its acceptability in term of taste, amount consumes and demand was good. Mother's perception was also satisfactory regarding these foods.

Acceptability of Two Ready-to-Use Therapeutic Foods by HIV-Positive Patients in Vietnam.

BACKGROUND: Ready-to-use therapeutic food (RUTF) has been found effective in treating severe acute malnutrition. Vietnam's National Institute of Nutrition (NIN), the Institut de Recherche pour le Développement (IRD), and UNICEF collaborated to formulate a local RUTF called High-Energy Bar for Integrated Management of Acute Malnutrition (HEBI). RUTF might be useful to address malnutrition in HIV patients. OBJECTIVE: To compare the acceptability of the local RUTF and an imported RUTF among malnourished people with HIV in Vietnam Methods: The acceptability of HEBI and Plumpy'Nut was studied among 80 HIV-positive children and 80 HIV-positive adults. In a crossover design, participants were randomly assigned to receive either Plumpy'Nut or HEBI for 2 weeks and were switched to the other product for the subsequent 2 weeks. A third (control) group of about 40 HIV-positive participants in each study was randomly assigned to receive no RUTF. Nurses took anthropometric measurements weekly, and the subjects or their caregivers monitored daily RUTF intake. RESULTS: Children consumed 69% of HEBI and 65% of Plumpy'Nut (p = .13). Adults consumed 91% of HEBI and 81% of Plumpy'Nut (p = .059). Both children (p = .058) and adults (p ≤ .0001) preferred HEBI. Significant gains were observed in percent weight (p = .035), weight-for-age (p = .014), and body mass index (BMI)-for-age (p = .036) in children who received RUTF and in percent weight (p = .017) and BMI (p = .0048) in adults who received RUTF compared with the control groups. CONCLUSIONS: In this study in Vietnam, both HEBI and Plumpy'Nut were found acceptable by people with HIV.

Food supplementation among HIV-infected adults in Sub-Saharan Africa: impact on treatment adherence and weight gain.

Sub-Saharan Africa has the highest proportion of undernourished people in the world, along with the highest number of people living with HIV and AIDS. Thus, as a result of high levels of food insecurity many HIV patients are also undernourished. The synergism between HIV and undernutrition leads to poor treatment adherence and high mortality rates. Undernutrition has a debilitating effect on the immune system due to key nutrient deficiencies and the overproduction of reactive species (oxidative stress), which causes rapid HIV progression and the onset of AIDS. Therapeutic food supplementation used in the treatment of severe acute malnutrition is being applied to HIV palliative care; however, little biochemical data exist to highlight its impact on oxidative stress and immune recovery. In addition, as most food supplements are imported by donor agencies, efforts are being put into local therapeutic food production such as the Food Multi-Mix concept to ensure sustainability. The purpose of this review is to highlight studies that examine the effectiveness of food supplementation in undernourished HIV patients in Sub-Saharan Africa; noting the parameters used to measure efficacy, as well as the long-term feasibility of supplementation.

Comparison of the effectiveness of a milk-free soy-maize-sorghum-based ready-to-use therapeutic food to standard ready-to-use therapeutic food with 25% milk in nutrition management of severely acutely malnourished Zambian children: an equivalence non-blinded cluster randomised controlled trial.

Community-based Management of Acute Malnutrition using ready-to-use therapeutic food (RUTF) has revolutionised the treatment of severe acute malnutrition (SAM). However, 25% milk content in standard peanut-based RUTF (P-RUTF) makes it too expensive. The effectiveness of milk-free RUTF has not been reported hitherto. This non-blinded, parallel group, cluster randomised, controlled, equivalence trial that compares the effectiveness of a milk-free soy-maize-sorghum-based RUTF (SMS-RUTF) with P-RUTF in treatment of children with SAM, closes the gap. A statistician randomly assigned health centres (HC) either to the SMS-RUTF (n = 12; 824 enrolled) or P-RUTF (n = 12; 1103 enrolled) arms. All SAM children admitted at the participating HCs were enrolled. All the outcomes were measured at individual level. Recovery rate was the primary outcome. The recovery rates for SMS-RUTF and P-RUTF were 53.3% and 60.8% for the intention-to-treat (ITT) analysis and 77.9% and 81.8% for per protocol (PP) analyses, respectively. The corresponding adjusted risk difference (ARD) and 95% confidence interval, were -7.6% (-14.9, 0.6%) and -3.5% (-9,6., 2.7%) for ITT (P = 0.034) and PP analyses (P = 0.257), respectively. An unanticipated interaction (interaction P < 0.001 for ITT analyses and 0.0683 for PP analyses) between the study arm and age group was observed. The ARDs were -10.0 (-17.7 to -2.3)% for ITT (P = 0.013) and -4.7 (-10.0 to 0.7) for PP (P = 0.083) analyses for the <24 months age group and 2.1 (-10.3,14.6)% for ITT (P = 0.726) and -0.6 (-16.1, 14.5) for PP (P = 0.939) for the ≥24 months age group. In conclusion, the study did not confirm our hypothesis of equivalence between SMS-RUTF and P-RUTF in SAM management.

Development and acceptability of a novel milk-free soybean-maize-sorghum ready-to-use therapeutic food (SMS-RUTF) based on industrial extrusion cooking process.

Peanut milk-based ready-to-use therapeutic food (P-RUTF) primarily used to treat severe acute malnutrition at community setting is expensive. We developed an alternative milk-free soybean-maize-sorghum-based RUTF (SMS-RUTF) using locally grown ingredients that have the potential to support local economy and reduce the cost of RUTF. We describe the production process and results of acceptability of the new product. Acceptability and tolerance of SMS-RUTF was compared with P-RUTF among 45 children aged 4-11 years old based on a cross-over design. Each child consumed 250 g RUTF for 10 days followed by a five-day washout period and a subsequent 10-day period on the second RUTF. The SMS-RUTF was as acceptable as the P-RUTF among normal children aged 4-11 years of age with no associated adverse effects. SMS-RUTF was stable for at least 12 months without detectable microbiological or chemical deterioration. The major challenge encountered in SMS-RUTF development was the difficulty to accurately determine key nutrient composition due to its high oil content. Use of diversified locally available ingredients to produce RUTF is feasible. The SMS-RUTF meets expected standards and is acceptable to children aged 4-11 months old. Effectiveness and cost-effectiveness of SMS-RUTF is required.

Effectiveness of indigenous ready-to-use therapeutic food in community-based management of uncomplicated severe acute malnutrition: a randomized controlled trial from India.

A randomized controlled trial was conducted in Chandigarh, India (2011), to determine the effectiveness of indigenous ready-to-use therapeutic food (RUTF) in community-based management of uncomplicated severe acute malnutrition (SAM). Intervention was through outpatient therapeutic program site (OTP). Study and control group children (6 months-5 years) were followed up weekly for 12 weeks, in OTP and at home. All children received supplementary nutrition through anganwadis under integrated child development scheme. Study children, in addition, received therapeutic dose of RUTF in OTP. Primary outcome, 115% of baseline weight, was attained in 6 of 13 (46.2%) and 1 of 13 (7.7%) children among study and control group, respectively [odds ratio: 10.28, 95% confidence interval (CI): 1.02-103.95]. Compared with control group, addition of RUTF in study group resulted in average additional increase in weight by 13 g/kg of baseline weight/week/child (95% CI: 2-23). Indigenous RUTF was effective in community-based management of uncomplicated SAM.