Ready-to-use therapeutic food with elevated n-3 polyunsaturated fatty acid content, with or without fish oil, to treat severe acute malnutrition: a randomized controlled trial.

Kelsey Jones ,Steve Collins,Peter Akomo,Johnstone Thitiri,Kenneth Omollo,Rehema Ali,Anne Ndungu,Grielof Koster,Paluku Bahwere,Said Ndoro,Moses Ngari,Dennis Odera,Greg Fegan,Alison Talbert ,Maureen Khasira ,Philip C Calder ,Miguel Garcia-Knight ,Annette L West ,Musa Mulongo ,Victoria Goss ,John O Warner ,Anthony D Postle ,James A Berkley

doi:10.1186/s12916-015-0315-6

Abstract

BackgroundReady-to-use therapeutic foods (RUTF) are lipid-based pastes widely used in the treatment of acute malnutrition. Current specifications for RUTF permit a high n-6 polyunsaturated fatty acid (PUFA) content and low n-3 PUFA, with no stipulated requirements for preformed long-chain n-3 PUFA. The objective of this study was to develop an RUTF with elevated short-chain n-3 PUFA and measure its impact, with and without fish oil supplementation, on children’s PUFA status during treatment of severe acute malnutrition.MethodsThis randomized controlled trial in children with severe acute malnutrition in rural Kenya included 60 children aged 6 to 50 months who were randomized to receive i) RUTF with standard composition; ii) RUTF with elevated short chain n-3 PUFA; or iii) RUTF with elevated short chain n-3 PUFA plus fish oil capsules. Participants were followed-up for 3 months. The primary outcome was erythrocyte PUFA composition.ResultsErythrocyte docosahexaenoic acid (DHA) content declined from baseline in the two arms not receiving fish oil. Erythrocyte long-chain n-3 PUFA content following treatment was significantly higher for participants in the arm receiving fish oil than for those in the arms receiving RUTF with elevated short chain n-3 PUFA or standard RUTF alone: 3 months after enrolment, DHA content was 6.3% (interquartile range 6.0–7.3), 4.5% (3.9–4.9), and 3.9% (2.4–5.7) of total erythrocyte fatty acids (P <0.001), respectively, while eicosapentaenoic acid (EPA) content was 2.0% (1.5–2.6), 0.7% (0.6–0.8), and 0.4% (0.3–0.5) (P <0.001). RUTF with elevated short chain n-3 PUFA and fish oil capsules were acceptable to participants and carers, and there were no significant differences in safety outcomes.ConclusionsPUFA requirements of children with SAM are not met by current formulations of RUTF, or by an RUTF with elevated short-chain n-3 PUFA without additional preformed long-chain n-3 PUFA. Clinical and growth implications of revised formulations need to be addressed in large clinical trials.Trial registrationClinicaltrials.gov NCT01593969. Registered 4 May 2012.Electronic supplementary materialThe online version of this article (doi:10.1186/s12916-015-0315-6) contains supplementary material, which is available to authorized users.

Highlights

Ready-to-use therapeutic foods (RUTF) are lipid-based pastes widely used in the treatment of acute malnutrition
Randomization, and blinding Sample size was calculated with reference to changes over time in erythrocyte membrane fatty acids amongst a group of Thai schoolchildren provided with n-3 LC-PUFAfortified milk for 6 months [14]
Between May 30, 2012, and April 30, 2013, 236 children admitted to, or attending, the outpatient therapeutic feeding program (OTP) and inpatient malnutrition bay at Kilifi County Hospital (KCH) were assessed for eligibility; 61 children were enrolled in the trial, one of whom was withdrawn as ineligible within 24 hours of enrolment and is not included in any of the analyses (Figure 1)

Summary

Introduction

Ready-to-use therapeutic foods (RUTF) are lipid-based pastes widely used in the treatment of acute malnutrition. The global prevalence of severe wasting in children less than 5 years of age is 2.9% and, whilst the global burden of kwashiorkor is undefined, in some settings it contributes up to 50% of SAM cases [1,2]. Both syndromes are associated with greatly increased mortality from common infectious diseases such as pneumonia and diarrhea via mechanisms that are not fully understood [3,4]. A key enabling factor in the implementation of community management of acute malnutrition has been the development of lipidbased ready-to-use therapeutic foods (RUTF), which aim to provide a nutritionally complete diet for rehabilitation of SAM. There have been no major changes to the compositional specifications of F-100 or RUTF since they were originally designed [8]

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