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The impact of quality complementary food products on infant growth and body composition has not been adequately investigated. This study evaluated the effect on fat‐free mass (FFM) accrual, linear growth, and iron status of locally produced complementary food products comparing to a standard product. In a randomized, double‐blind trial, 499 infants at 6 months received nine monthly rations of (a) WinFood Classic (WFC) comprising germinated amaranth (71%), maize (10.4%), small fish (3%), and edible termites (10%); (b) WinFood Lite (WFL) comprising germinated amaranth (82.5%), maize (10.2%), and multimicronutrient premix; or (c) fortified corn–soy blend plus (CSB+). Primary outcomes were changes in FFM, length, and plasma ferritin and transferrin receptors (TfR). FFM was determined using deuterium dilution. Analysis was by intention to treat, based on available cases. Compared with CSB+, there were no differences in change from 6 to 15 months in FFM for WFC 0.0 kg (95% CI [−0.30, 0.29]) and WFL 0.03 kg (95% CI [−0.25, 0.32]) and length change for WFC −0.3 cm (95% CI [−0.9, 0.4]) and WFL −0.3 cm (95% CI [−0.9, 0.3]). TfR increased in WFC group 3.3 mg L−1 (95% CI [1.7, 4.9]) and WFL group 1.7 mg L−1 (95% CI [0.1, 3.4]) compared with CSB+. Compared with the increase in Hb in CSB+ group, there was a reduction in Hb in WFC of −0.9 g dl−1 (95% CI [−1.3, −0.5]) and a lower increase in WFL −0.4 g dl−1 (95% CI [−0.8, 0.0]). In conclusion, the tested WinFoods had the same effect on FFM and length as CSB+, whereas Hb and iron status decreased, suggesting inhibited iron bioavailability from the amaranth‐based WinFoods. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background. Researchers face myriad challenges in the design and implementation of randomized, controlled trials. Apart from summaries on limitations, these challenges are rarely documented in detail to inform future research projects. Objective. To describe methodological challenges encountered during randomized, controlled trials (Win-Food Study) designed to assess the efficacy of locally produced complementary foods based on traditional animal-source foods (edible termites and spiders) to support growth and nutritional status in Kenyan and Cambodian infants. Methods. In a randomized, controlled design, infants received WinFood or corn-soy blend (CSB) for 9 months from 6 to 15 months of age. Lean mass accrual and blood nutrition indicators (lipid profile, iron and zinc status) were measured cross-sectionally at 9 and 15 months of age, respectively. Lean mass was determined by measuring deuterium oxide enrichment in saliva samples following a standard dose of deuterium solution (0.5 g/kg body weight) to infants. Blood nutrition indicators were determined following the drawing of 3 mL of blood by venipuncture. Results. Challenges included rapid depletion of food rations, high rate of loss to follow-up, delayed ethical approval, lack of local food-processing capacity, low capacity among staff to draw blood, and lack of laboratory capacity to perform both deuterium oxide and micronutrient status measurements. Spillage of deuterium oxide solution during dosing was a major challenge in the Kenya context. A high rate of morbidity among infants made some assessments very difficult, especially drawing of blood and saliva samples. Conclusions. The challenges were largely contextual. Improvement of local laboratory capacity, training of staff, and sensitization of the communities and the Ethics Review Committee are highly recommended. [ABSTRACT FROM AUTHOR]

The cost of ready-to-use therapeutic food ( RUTF) used in community-based management of acute malnutrition has been a major obstacle to the scale up of this important child survival strategy. The current standard recipe for RUTF [peanut-based RUTF ( P- RUTF )] is made from peanut paste, milk powder, oil, sugar, and minerals and vitamins. Milk powder forms about 30% of the ingredients and may represent over half the cost of the final product. The quality of whey protein concentrates 34% ( WPC34) is similar to that of dried skimmed milk ( DSM) used in the standard recipe and can be 25-33% cheaper. This blinded, parallel group, randomised, controlled non-inferiority clinical trial tested the effectiveness in treating severe acute malnutrition ( SAM) of a new RUTF formulation WPC- RUTF in which WPC34 was used to replace DSM. Average weight gain (non-inferiority margin Δ = −1.2 g kg−1 day−1) and recovery rate (Δ = −10%) were the primary outcomes, and length of stay ( LOS) was the secondary outcome (Δ = +14 days). Both per-protocol ( PP) and intention-to-treat ( ITT) analyses showed that WPC- RUTF was not inferior to P- RUTF for recovery rate [difference and its 95% confidence interval ( CI) of 0.5% (95% CI -2.7, 3.7) in PP analysis and 0.6% (95% CI -5.2, 6.3) in ITT analysis] for average weight gain [0.2 (−0.5; 0.9) for both analyses] and LOS [−1.6 days (95% CI, −4.6, 1.4 days) in PP analysis and −1.9 days (95% CI, −4.6, 0.8 days) for ITT analysis]. In conclusion, whey protein-based RUTF is an effective cheaper alternative to the standard milk-based RUTF for the treatment of SAM. [ABSTRACT FROM AUTHOR]

Objective: To develop a method for determining the acceptability and safety of ready-to-use therapeutic foods (RUTF) before clinical trialing. Acceptability was defined using a combination of three consumption, nine safety, and six preference criteria. These were used to compare a soy/maize/sorghum RUTF (SMS-RUTFh), designed for the rehabilitation of human immunodeficiency virus/tuberculosis (HIV/TB) wasted adults, with a peanut-butter/milk-powder paste (P-RUTF; brand: Plumpy'nut) designed for pediatric treatment. Methods: A cross-over, randomized, controlled trial was conducted in Kenya. Ten days of repeated measures of product intake by 41 HIV/TB patients, >18 y old, body mass index (BMI) 18-24 kg · m-2, 250 g were offered daily under direct observation as a replacement lunch meal. Consumption, comorbidity, and preferences were recorded. Results: The study arms had similar age, sex, marital status, initial BMI, and middle upper-arm circumference. No carryover effect or serious adverse events were found. SMS-RUTFh energy intake was not statistically different from the control, when adjusted for BMI on day 1, and the presence of throat sores. General preference, taste, and sweetness scores were higher for SMS-RUTFh compared to the control (P < 0.05). Most consumption, safety, and preference criteria for SMS-RUTFh were satisfied except for the average number of days of nausea (0.16 versus 0.09 d) and vomiting (0.04 versus 0.02 d), which occurred with a higher frequency (P < 0.05). Conclusion: SMS-RUTFh appears to be acceptable and can be safely clinically trialed, if close monitoring of vomiting and nausea is included. The method reported here is a useful and feasible approach for testing the acceptability of ready-to-use foods in low income countries. [ABSTRACT FROM AUTHOR]