FrameworkandSpecificationsfortheNutritionalCompositionofaFoodSupplementforPregnantandLactatingWomen(PLW)inUndernourishedandLow-IncomeSettings

ReportofanExpertConsultationheldatthe

Bill&MelindaGatesFoundation

September19&20,2016Seattle,WA

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Preface:RationalefortheExpertConsultationandConsensusProcess

Maternal undernutrition (low body mass index, short stature and micronutrient deficiency), which remains aproblemofpublichealthsignificance inmany lowandmiddle incomecountries (LMIC),particularlySub-SaharanAfrica and South Asia, has negative consequences for the health of both the mother and child. Nutritionalinadequacyduringpregnancyresults inpoorfetaldevelopmentandincreasestheriskofadversebirthoutcomesandmortality.Whilesignificantprogresshasbeenmade,itisestimatedthatapproximately32millionbabiesareborn too small (small for gestational age [SGA]). About 6million SGAbirths are associatedwithmaternal shortstatureinpregnancy.Reachingnutritional requirementsduringpregnancyand lactation isoftenunattainable formanywomen in lowincomesettings.Adequateenergy,micronutrients,essentialaminoacids(protein)andfattyacidsarerequiredtopromoteadequatematernalweightgainandhealthymaternalandinfantoutcomes.ThenewWHOantenatalcareguidelinehasacontext-specificrecommendationofbalancedenergy-proteinsupplementationinundernourishedpopulations to reduce the risk of stillbirths and SGA. Programmatic experience around food supplementationduringpregnancysuggestssomebenefitintermsofbirthweight,butnetincreaseinnutrientintakeislimiteddueto problems of accessibility, sharing and substitution. Ideally, a pregnancy supplement would fill theenergy/nutrient gap and yet there are fewproducts that havebeendesignedandmadeavailable for suchuse.Thereisanurgentneedforaffordable,nutritiousfoodsupplementsforpregnantwomenthataredesignedtobeready-to-use andmeet specified levels of macro- andmicronutrients. Targets for product design are required,includingnutrient content,product type(s),packagingandpromotion,andcost.Although recommendationsarefor pregnant women and requirements are different during lactation, such a food supplement could also beconsideredforusebypostpartumwomentosupportlactation.The Bill and Melinda Gates Foundation sponsored and organized an expert consultation for the purpose ofdeveloping nutrient content targets for affordable, nutritional supplements for use by pregnant and lactatingwomen (PLW) in low income and food insecure contexts. The consultation, which brought together experts(AppendixI)fromacademia,publicsector,privatesectorandthedonorcommunity,wasnotonlyagreatlyneededdiscussiononatopicthatwarrantedfurtherattention,butaneventthatwastimelyaswell,inviewoftherecentWHOantenatalcarerecommendations.

Theobjectiveoftheconsultationwastoi)sharelessonsfromthefieldfromvaryingcontextsonthedevelopmentofadailynutritiousfoodsupplementforPLW,ii)reachaconsensusonnutrientcontenttargetsandpossibletypesandformsforadailynutritiousfoodsupplementforPLWinlowincomeandfoodinsecuresettings,andiii)discussthe‘use-case’forsuchproducts.

This document is a report by the expert group capturing the considerations and consensus of the expertconsultationontheframeworkandspecificationsformacro-andmicronutrientcomposition,formandtype,anduse-casefornutritious,ready-to-usefoodsupplementsforPLWswhoareinadequatelynourished,and/orat-riskofsuboptimal nutrient intake related to food insecurity (e.g. residing in food insecure household or in an areaaffectedby(seasonalfoodinsecurity)inlowandmiddleincomecountrysettings.

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TableofContents

I. Background………………………………………………………………………………….……………………..………………………..03

II. NutrientSpecifications..………………………………………………………………………………………...……………..…..…05

§ Macronutrients……………………………………………………………………………………………….…...…...…………..05

§ Micronutrients…………………………………………………………………………………………….……….….………….…07

III. FormandType………………………………………………………………………………………………….…………....…………….11

IV. TargetPopulationandUse-Case..…..…………………………………………………………………………..…….............13

V. NextSteps………………………………………………………………………………………………………….……….………...........15

References………..………………………………………………………………………….………………………….……………....….16

AppendixI:ExpertGroup..………………………………………………………………………………………………....……....17

AppendixII:IOMandFAO/WHODRIs/RDA/RNIsforPLWformacroandmicronutrients…........18

AppendixIII:Typesofbalancedenergyandproteinsupplementsusedinstudies..…..................20

AppendixIV:WHOANCguidelineonenergyandproteindietarysupplementation.…………..……22

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I.Background

Itiswell-establishedthatpoormaternalnutritionhasmajorimplicationsforfetalgrowthanddevelopment,andlikelylongtermhealthconsequences.Despitetheexistingandmountingevidencefortheimportanceofmaternalnutrition,andglobaleffortsandinitiativesthathavebeenestablishedtopreventgrowthfalteringduringthefirstthousanddaysoflife(strivingtomeetWorldHealthAssemblyandSustainableDevelopmentGoalstargets),maternalnutritioncontinuestobeaneglectedarea.

Inlowandmiddleincomecountries,approximately32millionchildrenarebornsmallforgestationalage(SGA),causedinpartbythepoornutritionalwell-beingofthemotherbeforeandaroundconceptionandthroughoutpregnancy.Maternalnutrition,intermsofenergy/proteinbalanceandothermacroandmicronutrientdeficiency,hasbeenshowntoimpactfetalgrowth.Targetshavebeencreatedtodriveimpetustowardsaction.TheWHOGlobalTargetsfor2025forMaternalNutritionare:to1)reduceby50%(comparedto2010)anemiainwomenofreproductiveage(WRA)and2)reduceby30%theincidenceoflowbirthweight.

MaternalNutrition

Nutritionalrequirementsareincreasedduringpregnancy(AppendixII)andfrequentlyunmet,leadingtothehighburdenofmaternalundernutritionthatcontributestofetalgrowthrestrictioninmanysettings.Adequateenergy,micronutrientsandessentialaminoacidsandfattyacidsarerequiredtopromoteadequatematernalweightgainandhealthymaternalandinfantoutcomes.

Dataonweightgaininpregnancyarenotcommonlycollectedoravailableandinadequateenergyintakeduringpregnancymaybeaconcern,especiallyinsettingswheretheratesoflowbirthweightarehigh.Despiteincreasingoverweightandobesityglobally,andtherecognitionofa“dualburdenofmalnutrition,”maternalunderweightcontinuestobeamajorissueinmanyLMICcontexts.Forinstance,whileobesityaffected20millionwomeninIndiain2014,thenumberofwomenconsideredunderweightroseto100million(41.6%ofwomenunderweightglobally)from58.3millionin1975(NCDRiskFactorCollaboration,2016).Micronutrientdeficiencies(MND)duringpregnancyarealsocommon,resultinginpoorbirthandneonataloutcomes;iron-deficiencyanemiaprevalenceinpregnancyisatalmost20%globallyandiodinedeficiency,usinglowmedianurinaryiodineexcretioninschool-agechildrenasapopulationindicatorofiodinedeficiency,isatapproximately28%(Blacketal,2013).Thereisaprofoundneedtoaddresstheissueoffillingthenutrient/energygapforPLW,especiallyinfoodinsecureandlowincomesettings.

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Twometa-analysesofstudiesofbalancedenergy-proteinsupplementation(BEP)duringpregnancydemonstratedapositiveeffectofimprovedbirthweightamong‘malnourished’women(Imdad&Bhutta2013;Otaetal,2015).

ThedifferenttypesofformulationsthatwereusedintheexistingBEPtrialswereexaminedshowingawidevariationinboththeformsusedandtheenergyandproteincontent(AppendixIII).Evenso,theseheterogeneousstudieshavebeencombinedunderasimilarumbrellaofinterventionstermedasBEP.Programexperienceinsomesettingswherefoodsupplementationhasbeendoneexists.Programs,intheabsenceofspecificfoodproductsforPLW,haveusedfortifiedblendedfoods(cornandwheatsoyblends;CSB,WSB)forsupplementingPLW,however,sharingandsubstitutionareaproblemandthequalityofproteinmaybeanissue.DespitetheevidenceforabenefitofBEPsupplementation,therehavebeennopreviousWHOguidelinesforsupplementationinpregnancy(therewerenoneatthetimewhentheconveningwasheldinSept,2016),untilmostrecentlyinNovember2016whennewANCguidelinesfromWHOwereissuedthatincludematernalnutritionalcareinpregnancy(WHO,2016).Weighingtheevidencefromtrials,theWHOnowrecommendsBEPforpregnantwomeninundernourishedsettings(AppendixIV).Thus,thereexistsanexcitingopportunitytooperationalizethisnewrecommendation.Thedevelopmentofcompositionalguidanceforasuiteofproductscoulddriveapotentialpublic-privatepartnershiptodeliverthisinterventioninundernourishedpopulations.Belowisthesectiondescribingthespecificationsformacro-andmicronutrients,formsanduse-case,foraready-to-useaffordablefoodsupplementforpregnantwomeninlowincomesettings.

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II.NutrientSpecifications

MacronutrientRequirements

Whenconsideringmacronutrients,anumberofaspectsforthesupplementwerediscussedincluding:Amountofenergy,andcarbohydrates(%ofenergy);proteins(%ofenergyandtype);fats(fattyacids,%ofenergy,type)tobeprovided,andwhetherornotsugarandsaltshouldbeincluded.Theproposedmacronutrientcontentthatwasdevelopedwasintendedtobebroad,toallowfordifferenttypesoffood(e.g.withhigherorlowerfatcontent)andcompatibilitywithmicronutrientcontenttargets.Thefollowingwasproposedintermsofmacronutrientcontentandtypes:

• EnergyBalancefromMacronutrients:Oneportion/servingoftheproductshouldprovidebetween250and500kcals.Inahighriskpopulation,wheretheprevalenceoflowbirthweightishigher,orwhenlargeproteinandenergygapsexist(suchasinanemergencycontext,orwhenseasonalaccessislow),theportionsizecouldbedoubled.Alternately,inalow-to-moderateriskcontext,thesupplementcouldprovidethelowerdailyenergyvalue.

• Fat:Itwasagreedthefatcontentallowedwouldencompassabroadrangebetween10%and60%ofenergy,whichinturnwouldallowdevelopmentofproductsthatwerelipid-basedpastes,orthoseusingflours(e.g.thathavecorn,wheatorriceasabase)orlow-moistureproducts,whichmaybeimportantincertaincontextswhereproductstabilityisaconcern(e.g.inhumanitarianemergencieswherea24-monthshelflifeisoftenrequired).

• Protein:Withregardtoprotein,itisproposedthatthesupplementprovidesapproximately50%oftheadditionalproteinrequirementinthethirdtrimester,i.e.0.5*31.2=16g(range14-18g),andforthattohaveaDIAASof≥0.9,asthereisabodyofevidencethatsuggeststhataproportionofpregnantwomeninlow-incomesettinghavedifficultiesmeetingtherecommendedproteinintake(whicharesubstantiallyhigherinthethirdtrimesterofpregnancy)andachievingtherecommendedquality(Leeetal;2012).Giventherangefortheenergycontentofthesupplement,theproteincontenttargetisexpressedingrams,i.e.16g,ratherthanenergy%.Forexample,providing16gproteinin250kcalisequivalentto25.6energy%,in350kcalitis18.3energy%andin500kcalitis12.8energy%.Also,thisamountofproteinwithDIAASof≥0.9wouldbeexpectedtocovertheessentialaminoacid(AA)requirementsforpregnantwomenwhohavealowAAintakefromtheirregulardiet.Itwasdecidednottospecifythesourceortypeofprotein(i.e.notspecificallysuggestingdairyoranimalsource)inordertoallowthepotentialoptionofaddingaminoacids(albeitrecognizingthatthiswouldincreasethecost).Thegrouprecognizedthattheabove-mentionedproteinqualityrequirementscalledforanimalsourcefoodingredientsatleastpartially.

• Carbohydrate:Norecommendationsweremadefortheamountofcarbohydratesinthefoodproductasthiswoulddependonthechosenfatcontent.TheWHOrecommendationforlimitingtotaladdedsugarinthediettoamaximumof10%oftotalenergywasdiscussed,andwhilesavoryproducttypeswerepreferred,no‘must

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have’lowerorupperlimitforaddedsugarwasproposed.ItisimportanttonotethattheWHOrecommendationshouldbeappliedtothedailydietasawholeandindividualfoodscontributetoit.

• TransFats:Itwasrecommendedthattransfattyacidcontentshouldbe≤1%,asastandardrequirement.

• n-6:n-3ratio:Additionofn3-PUFAs,specificallyDHA,wasconsideredoptional.Therewasarichdiscussiononthen-6:n-3essentialfattyacidratio.Withthespecifiedfatcontentforthefoodsupplement,itwasassumedthataminimumof1.3gofn-3or200mgofDHAinsomesortofadditiveform,e.g.frommarinesources,wouldachieveahealthyn-6:n-3ratioof5-10:1.BecauseDHAisaverycostlynutrient,yetpotentiallyimportant,itsinclusionshouldbestbecontextspecific.DHAcouldalsobeusedinasupplementformwherepossible.Wherefishiscommonlyconsumedintakesmaybeadequate.

Furtherdiscussion:Forallmacronutrientrecommendations,everycontextwillbeoperatingundertheauspicesofanationalfoodsafetyagencywhichshouldguidethefoodsafetyandlabelingrequirements.

SummaryofMacronutrientTargets

Totalenergy:250-500kcalperdailyserving

FatContent:10-60%ofenergy

ProteinContent:16g(range14-18g)withaDigestibleIndispensableAminoAcidScore(DIAAS)of≥0.9

Carbohydrate(CHO)Content:Nospecificrecommendations,anddependsonthefatcontentofproducttypeTransFats:Nomorethan1%,asastandardsafetyrequirementFattyAcid(optional):Minof1.3gofn-3or300mgDHA+EPA(ofwhich200mgDHA)toachieveahealthyn-6:

nratioofthesupplementof5:1

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MicronutrientRequirements

Therewereseveralguidingprinciplesusedforthemicronutrientspecifications:

Itwasagreedthatspecificationsformicronutrientswouldbeprovidedasranges(minimumandmaximum).BothUSInstituteofMedicine’sDietaryReferenceIntakes(DRIs)andFAO/WHO’sRecommendedNutrientIntakes(RNIs)wereconsideredbuttheprobabilitybasedIOMDRIsprovideacommonframeworkthatallowedunifyingthespecificationsforasingledailyservingofthefoodsupplement.ItwasrecommendedthattheminimumdesiredintakefromafoodsupplementforPLWwouldbetheestimatedaveragerequirement(EAR),whichwhenprovided,wouldpushtheentirepopulationabovetheEAR.ItwasrecommendedthattheRDArecommendationbytheIOMwouldbethemaximumoftherange.Hence,asageneralguideline,theEARwassettobetheminimumdesiredtargetandtheRDAthemaximumallowedfromasingleservingofthefoodsupplement.AtargetofanEARinasingleservingwasdeemedappropriategiventhefactthattheremaybeconcurrentintakeofiron-folicacidormultiplemicronutrientsupplements.Also,insomesettingstwoservingsperdaymayberecommended,sothetotalamountprovidedwouldbeaminimumof2EARandamaximumof2RDA.Thereissomeevidencethatproviding2RDAforcertainnutrientsmayresultinimprovedbirthoutcomesinvulnerablepopulations(Kaesteletal.2005).

Otherconsiderationswereasfollows:

• Forsomenutrientsforwhichnutrientintakerecommendationsarebasedonanadequateintake(AI),theAIwouldbetheRDAequivalent(i.e.maximum),and80%oftherecommendationwasusedtosettheminimum.

• Differencesexistinthenutrientrequirementsofpregnantandoflactatingwomen.Itwasdecidedtousethehigherofthetwovaluesrecommended.

• Macromineralsandothernutrients:Forseveralmacrominerals(e.g.potassium,phosphorus,magnesium,

calcium)andcholine,itwouldbedifficulttoreachanEARintheportionsizeofthefoodproduct.Additionally,thereisadearthofdatalinkingtheintakesofthesenutrientstopregnancyspecificeffectswiththeexceptionofcalciumforwhichWHOguidelinesexist.Thus,theminimumforthesewassetat50%oftheEAR(whethertheEARwasahardnumberorderivedfromtheAdequateIntake).Itcannotberuledoutthatmacromineralsmayplayanimportantroleinimprovingpregnancyhealth,butthequantityofthesenutrientsshouldbemaximizedonlytotheextentthattheydonotnegativelyaffectthetasteoftheproduct,withcostconsiderationsalsotakenintoaccount.

Severalindividualnutrientspromptedfurtherconsideration:

• VitaminA:Becausethereisconcernwithhigh-dosepre-periconceptionalvitaminAintakeandtoremainprudent,thepregnancyvalue(lowerofthetwooptions)wasused.Commercialfortificationmustalsobetakenintoaccount,whichmayleadtocountry-specificorregionaladaptationofthedesiredvitaminAcontentofthefoodproduct.Beta-caroteneineitherasyntheticornaturalformcouldbeusedtopartiallyfulfilthevitaminAspecificationforthefood.

• VitaminE:TwoconsiderationsmustbetakenintoaccountwithvitaminEviz.thePUFAcontentinthedietandvegetableoilconsumption.PUFAcontentaffectsvitaminsE(alsoAandD)duetoperoxidation,andwhile

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vegetableoilintakeisrisinginLMICs,thereislimitedinformationabouthowthatoilisprocessedandhowitisstored,transportedandcooked,allofwhichimpactthevitaminElevelsinoil.Thus,thereislittleunderstandingofhowmuchofavitaminEgapexistsinthedietsofwomenandhowmuchvitaminEisneededtosupportthehighrequirementsduringthislifestage.

• VitaminK:Theremaybeaconcernaroundcost,whichmayneedtobetakenintoaccount.

• Folicacid:Itwasnotedthatiron-folicacid(IFA)supplementationanduseasrecommendedbyWHOmaybeprevalent,andthattheWHOrecommendsfolicacidlevelsat400µgdaily.Thus,theminimumamountforfolicacidinthesefoodproductsmaywarrantalowervaluethanthecurrentIOMEAR.TheRDAof600µgisusedforthemaximumamountaspertheIOMRDA.

• PantothenicAcid:BecauseonlyanAIisprovided,80%oftherecommendedIOMvaluewasused,butpantothenicacidwaslistedasanoptionalnutrient.

• Calcium:ThecurrentWHOguidelineistosupplementwomeninlowcalciumintakeareaswith1.5to2gcalciumdailyforreducingpreeclampsia.Asofyet,veryfewcountriesareimplementingcalciumsupplementationprograms,butthismaychange.Furthermore,therearelimitstotheamountofcalciumthatcanbeincludedinfoods,fortastereasons.Thus,theminimumamountforcalciumforthefoodsupplementisspecifiedtobedifferentfromtheIOMEAR.InsteadofthefoodsupplementfullyprovidingtheEARitisassumedthatabout300mgofcalciumwouldbederivedfromthediet,andthattheadditionof500mgwouldhelpachievethedailyEARof800mg.Thereisalsotheneedtotakethecalcium/phosphorusratiointoconsideration,whichshouldbebetween1.0-1.5.Thus,theminimumtargetissetat500mgandthemaximumat1000mg,whichistheRDAforpregnancy/lactation.

• Phosphorous:50%oftheEARwasused,andthenroundeduptoawholenumber.

• Iron:IFAsupplementationwastakenintoconsideration,aswellasintakefromothersourcesandenvironmentalaspects(ironingroundwater),whichiscontextspecific.TherecommendedIOMEARandRDAwereused,butitwasthoughtimportanttomaintainaniron/zincmolarratiothatwas1-2:1.Overconsumptionofironduringpregnancyisofconcern,thusa“middleoftheroad”valuewasusedtominimizetheconcernsofmakingspecificationstoohigh,andduetoorganolepticissues.ThesevaluescanthereforebeloweredinplaceswherethereishighIFAcoverage,orwheretherearebioavailabilityandfoodmatrixissuesinvolvedinthedesignoftheproduct.Whileironisessentialtobeincludedinthefoodsupplement,itisequallyimportanttominimizethepossibilityofapproachingvaluesthatcanleadtonegativeeffects.Concurrentfortificationoffoodsforthegeneralpopulation,e.g.offlour,mustalsobetakenintoaccount.

• Zinc:GiventhattheUNIMMAPsupplementformulationuses15-20mgofzinc(ULbeing40mg),itwasassumedthatthisamountwouldbeasaferecommendation.

• Iodine:TheIOMEARandRDAwereadopted,buttherewasarecognitionthatuniversalsaltiodizationmaybepresentandtherangemayneedtobeadaptedtothecontext.

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• Potassium:TheIOMrecommendationispresentedasanAI,thus80%oftherecommendation,andsubsequently50%ofthat,wasusedasthenutrientrecommendationforthesupplement.Itwasrecognizedthatpotassium’simpactontastewouldalsoplayaroleindeterminingthespecificamountandthechemicalformandlevelwillneedtobecarefullyadjustedforproducttasteacceptability,especiallyinproductsforwhichaddedsugarcontentislimited.

SomeoftherecommendednutrientsarenotinUNIMMAP,howeverthefollowingnutrientsweredeemedmandatorytobeaddedtofoodsupplementsinadditiontothosealsoincludedinUNIMMAP:iodine,vitaminK,calcium,andphosphorus(largelytoachieveabalancedCa:Pratio).ThefollowingnutrientsweredeemedoptionallargelybecausetheyareuntestedandnotpartofthetestedUNIMMAPsupplement:pantothenicacid,biotin,choline,manganese,potassium,magnesium.

Desirednutrientcontentcanbeadjustedbasedonknowledgeoftheprevailingdietinthetargetgroup.However,itisimportanttonotethatdownwardadjustmentsofnutrientcontentareonlyrecommendedwhenthepopulationsubsetwiththelowestnutrientintakeswillalsostillhaveanadequateintakewhenthecontributionfromthesupplementisreduced.

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TableI:MicronutrientTargetsperDailySingleServingof250-500KCAL

Micronutrient

Unit

Minimum/Target(EAR)*

Maximum(RDA)*

Comments

Required

FatSolubleVitamins

VitaminA µgRE 550 770IOMEARandRDAvaluesused.BecausethereisconcernthathighpericonceptualvitaminAintakeisharmful,thelowerpregnancyvalueswereused

VitaminD µg 10 15 IOMEARandRDAvaluesused.Valuesforpregnancyandlactationareequal

VitaminE mg 16 19 IOMEARandRDAvalueswereused.Thelactationvalueswereusedastheyarehigher

VitaminK µg 72 90BecauseonlyanAIisprovided,80%oftherecommendedvalueispresentedastheminimumamount.ThemaximumvalueistheAI.AIvaluesarethesameforpregnancyandlactation

WaterSolubleVitamins

Thiamin,B1 mg 1.2 1.4 IOMEARandRDAvaluesareused.Thelactationandpregnancyvaluesarethesame

Riboflavin,B2 mg 1.3 1.6 IOMEARandRDAvaluesareused.Thelactationvalueswereusedastheyarehigher

Niacin,B3 mg 14 18 IOMEARandRDAvaluesareused.Thepregnancyvalueswereusedastheyarehigher

Vitamin,B6 mg 1.7 2 IOMEARandRDAvaluesareused.Thelactationvalueswereusedastheyarehigher

Folate#,B9 µg 400 600

IronFolicAcidsupplementationmaybewidespread,andgiventheWHO/FAOrecommendationof400µg,theminimumwarrantsalowervaluethantheIOMEAR.However,theIOMRDAwasusedforthemaximum(600µg),basedonpregnancyvalue,whichishigher

VitaminB12 µg 2.4 2.8 IOMEARandRDAvalueswereused.Thelactationvalueswereusedastheyarehigher

VitaminC mg 100 120 IOMEARandRDAvalueswereused.Thelactationvalueswereusedastheyarehigher

Minerals

Iron mg 22 27 IOMEARandRDAvalueswereused.Thepregnancyvalueswereusedastheyarehigher

Zinc mg 15 20TheUNIMAPrecommendationandotherstudieshaveused15-20mgofzincperday(ULbeing40mg),itwasassumedthat15-20mgwouldbeasaferecommendationasaminimumandmaximumvalue

Iodine µg 209 290 IOMEARandRDAvalueswereused.Thelactationvalueswereusedastheyarehigher

Calcium mg 500 1000Theminimumvalueassumesthat300mgofcalciumwouldbederivedfromthediet,andthatanadditional500mginthefoodsupplementwouldprovideanEARof800mg.Themaximumvalueis1000mgbasedontheRDAforpregnancyandlactation

Phosphorus mg 300 700

Phosphorouscouldbeoptional,butisincludedgiventhatcalciumisincludedandtheratioofCa:Pneedstobebetween1.0-1.5.Becauseitisamacromineral,thevalueis50%oftheEARandroundedto300andtheIOMAIistheRDA.Thepregnancyandlactationvaluesareequal

Copper mg 1.0 1.3 IOMEARandRDAvalueswereused.Thelactationvalueswereusedastheyarehigher

Selenium µg 60 70 IOMEARandRDAvalueswereused.Thelactationvalueswereusedastheyarehigher

Optional

PantothenicAcid,B5 mg 5.6 7.0BecauseonlyanAIisprovided,80%oftherecommendedvalueispresentedastheminimumamount.ThemaximumvalueistheAI.AIvaluesforlactationwereused

Manganese mg 2.1 2.6 BecauseonlyanAIwasprovided,80%oftherecommendedvaluewasusedtodeterminetheEAR.TheMaximumvalueistheAI.AIvaluesforlactationwereused

Potassium g 2.0 5.1BecauseonlyanAIisprovided,80%oftherecommendedvaluewasused.Theminimumvaluewas50%ofthisamount,whereasthemaximumvalueistheAI.AIvaluesforpregnancywereused

Magnesium mg 145 350BecauseonlyanAIisprovided,80%oftherecommendedvaluewasused.Theminimumvaluewas50%ofthisamount,whereasthemaximumvalueistheAI.AIvaluesforpregnancywereused

Biotin µg 28 35BecauseonlyanAIisprovided,80%oftherecommendedvalueispresentedastheminimumamount.ThemaximumvalueistheAI.AIvaluesforlactationwereused

Choline mg 220 550BecauseonlyanAIisprovided,80%oftherecommendedwasused.Theminimumvaluewas50%ofthisamount,whereasthemaximumvalueistheAI.AIvaluesforlactationwereused

*GenerallytheIOMEARwasusedfortheminimumvalue,andtheRDAwasusedasthemaximumvalue.Exceptionsareexplainedinthecommentscolumn.#Expressedasdietaryfolateequivalents(DTE).

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III.FormandType

Considerationsfortheformandtypeofthefoodsupplementinvolvedavarietyofproductsandadvantagesanddisadvantagesofeachtypebasedonexistingexperienceandknowledge.Solid,semi-solidandliquidproductswereconsideredandaspectssuchasconvenience,riskofmealreplacement,easeofpackaging,safetyandtransport,amongothers,wereevaluated.Someguidingprincipleswereagreeduponwhendevelopingandrecommendingtypesofproductsandforms.Theseincludeda)notconsideringstaplefoods,b)notconsideringcondiments,c)productsthatcouldbepackagedinindividualservings,d)foods(anddrinks)thatcanbeconsumedbetweenmeals,e)productsamenabletomodificationinthevarietyofflavortoreducemonotony,andf)havinganadequateshelflife.

Thefollowingready-to-usefoodswereprioritizedfordiscussion:

• Highenergybiscuits,e.g.ascurrentlyusedinhumanitariansupplychainsortwobiscuitlayerswithcreamin-between

• Brittle(cookedsugarwithsometypeofproteinorlegume)• Lipid-basedspreads• Extrudedsnacks(savory,puffycrispyproduct,withanoptiontohaveapasteinside)• Bar• Encapsulatedfoods(e.g.asweetorsavoryoutercoveringwithalegume-baseinside)• Liquiddrink/drinkpowder

Theconsiderationsforeachformincluded:

• Riskofoverconsumption:Thereisapotentialriskofoverconsumptionformostsolidproducts,althoughriskforadrinkwasconsideredlowasitisconstrainedbythevolume.Ifsolidsarepackagedinadailyservingsizeandwithclearinstructionsonthepackage,thismightmitigatetheriskofoverconsumption.

• Sharingrisk:Iftheproductisconsideredtobeatreat,sharingmayoccurtoagreaterextent.Savoryproductsmaybelesslikelytobesharedandmorepalatableforadultsvs.sweetonesespeciallywithchildreninthehousehold

• Stabilityonceopened:Drinksseemedtohavethehighestriskofbacterialgrowthduetheirhighwateractivity,especiallywhenleftoutoverthecourseofseveralhours.Humiditymaybeanissueforsolids,butwouldstillhavelowermicrobiologicalsafetyriskthandrinks.

• Packaginganddistributioncost:Thiswasparticularlyimportantforextrudedsnacks;whenthinkingaboutstorageandaproductthatneedsanair-tightpackage,themore-denseoptionsmaybebetterandmorecost-effective.Packagesshouldbeharderforchildrentoopen.

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• Taste:Theproductwouldneedtobetasty,butshouldnotpromotesharing.Considerationofwomen’spreferencesforconsumptiononadailybasis,andvarietyweredeemedimportant.

• Nutritionspecifications:Forexample,calciumintherecommendedamountswouldbemorefeasibletoincludeinspreadsthaninbrittleandextrudedsnacks.

• Salt:Thiswasnotdiscussedindepth,butitwasrecognizedthatamaximumamountmaybemoreimportanttospecifythanaminimum.

• Sugar:Usesugarsparinglyandnottoincreaseenergydensityasdoneinlipid-basedsupplementsforyoungchildren.

• Energydensitycriteria:Thevolumeofthefoodisimportanttoconsiderduringpregnancy;ashighervolumemaybehardertoconsume.Thus,these“snacktypefoods”shouldbedesignedtoprovidetherequiredenergycontentusingasmallservingsize,althoughconcomitantlybeingconsumableinsmallerpartsoverafewhours.

• Hotversuscold:Ahotsnackmaylikelyimpactthedesired“ready-to-use”natureofthefoodproduct,andalsomaycausemealreplacementinadditiontopackagingchallenges.Heatingwouldlikelydestroysomenutrients.Ready-to-usesoupproductsmaybeanoption,yettheneedforfuelandcookingtimemaybeconstraints.Yogurtrequiringacoldchainwasruledout.Also,itsenergydensityisquitelow,anditwouldbechallengingtoincreaseitsuchthatitwillbeabletofillthegapasrequiredforPLW.

Therewasthenaninformalvoteoneachparticipant’stop3preferredformstogetageneralrankingfromthegroup.TheresultsofthisrankingarecapturedbelowinTableII.

TableII:FormandType

*DenotesTopChoicesbyexpertconsultation

ReadytoUseFoods RankingsSpreads* 17

Biscuits* 12

Bar* 8

ExtrudedSnack* 7

InstantDrinkPowder* 7

CoatedBites 5

Liquiddrink 3

Brittle 0

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IV.TargetPopulationsandUse-Case

Thefollowingthreescenarioswerediscussedtodevelopa“Use-Case”foranutritiousfoodproductforPLW:1. Emergencysituations(environmentaldisasters,civilunrest,refugeecontexts,etc).2. Chronicandhighhouseholdfoodinsecuritysettings3. Lowfoodinsecuritysettings

Contextspecificconsiderationsarelikelytodrivetheuse-caseforthePLWfoodsupplementandeachcountry/settingwouldneedtomodifytheuse-casebasedonexistingpublicsectorprograms(e.g.antenatalcare,health-servicesandsocialprotection)andmarketaccess(physicalandpurchasingpower)andexperiences.Thefollowingweremainissuesthatwereconsideredanddiscussed:• Thegroupdidnotfocusonfooddistributioninahumanitarianemergencysituation,largelybecausethemechanismsfor

distributionarerelativelywell-definedandsoarethein-kindrations/foodofferingsthatarefeasibleinsuchcircumstances.Theexceptionisinprotractedemergencieswherewomenandchildrenmayexperiencefoodandnutritionaldeprivationforextendedperiodsoftime,inwhichcasesuchproductsforPLWcouldbewellsuitedfordistributionpurposes.Theuse-caseinsuchsituationswouldbefreedistributionsupportedbyhumanitarianorgovernmentagencies.

• GiventhenewWHOANCguidelines,discussionswithgovernmentswillbeneededbothforadoptingapolicythatincludesfortifiedbalancedenergyandproteinsupplementsasapregnancyinterventioninareaswithahighburdenofundernutritionandforstrengtheningtheANCplatforms.Theproposednutritiousfoodsupplementwillfillthegapvis-á-visaproductforimplementingthenewguidelinethroughANCorextendedcommunityplatforms,includingmarket-baseddistribution.

• Theproportionofthepopulationthatisaffectedbyfoodinsecurityvariesbysettingandbycircumstancesandthisdeterminesthedifferentdistributionstrategiesthatcanbeused.Inmostcontexts,PLWsoffoodinsecurehouseholdsarelikelytoneedpublicsectorsupporttoaccessafoodsupplement.

o InacontextwherePLWfacehighfoodinsecurityorundernutrition,e.g.relatedtopovertyandhouseholdfoodinsecurity,thesupplementscouldbedistributedfreeduringANCvisitsorthroughcommunityoutreach.

o Inmoderatefoodinsecuritysituations,otherstrategiessuchasofferingvouchersystemsorothermeansofsubsidizedpurchasecouldbeused.

o Insettingswhereself-purchasingbyPLWthatwanttoaddabalanced,nutrient-denseproducttotheirdietmaybepossibleasahybrid(or‘blended’)distributionmodelcanbeconsidered.Thus,thedesignedproduct(s)couldbepromotedusingablendedor“layered”approachthatcombinesamarket-basedstrategywithpublicdistribution.Similarconceptsarebeingdevelopedandtestedforcomplementaryfoodsandhome-fortificationproductssuchasmicronutrientpowderforchildrenaged6-23months.

• The“market”problem:Itisimportanttonotethatthereisnoviablecommercialmodelforapreventivenutritioninterventionthatcanworkentirelyonitsown.Thereasonisthatthecommunicationneedsaboutwhythisisagoodproducttoconsumeduringpregnancyarequitecomplicated,especiallywhencomparedtopromotionof‘general’foodproducts.Furthermore,thecostofingredients,manufacturingandpackagingoftheproductarerelativelyhighcomparedtothepricetargetforaproductoflow-incomeconsumers,whichleaveslittlebudgetforinvestmentsandmarketing.

14

• Tohelpwomen,theirfamiliesandthewiderpublicunderstandwhatisneededinordertoreachnutritionaladequacyduringpregnancyandwhythatisimportant,demandgenerationandcommunicationarevital,andwouldrequiresupportfromthepublicsector,suchasthehealthsystemorotherplatforms(e.g.women’sself-helpgroups,others).

• Thespecificchallenge/needistocreateamarketanddesireforgoodnutrition,e.g.forPLWandchildrenaged6-23months,andthenofferspecificproductsassolutions.Inotherwords,itwouldnotberealistictojustadvertiseafoodsupplementforPLWalone,withoutraisingtheawarenessaboutaneedforsuchproducts,andexpectahighdemandfortheproduct.

• Beginningwithapublicapproachofpromotingbetternutritionandofferingspecificsolutionsmayworkinsomesettings,beforemarketingstrategiesarealsoadopted.Thisapproachdoesnotprecludeanopportunityforaprivatepublicpartnership,withthegovernmentplayingastrongerroleincreatingit.Furthermore,havingbothpublicsectorandcommercialdemandmaymakeitviableforacompanytodevelopandproducethesetypesofproducts.Agenciesthatprovidehumanitarianassistancemayalsoaddtothedemand,albeitlesspredictableandlessconsistent.

• Peer-to-peermarketingcanbeespeciallyeffective,asitcancombineeducationandfollowupinawaythatmanyretailoutletscannot.Also,itmaybepossibletoproposeasubscriptionmodelfortheuseofsuchaproduct.Thosewhodon’thavepurchasingpowercouldprocureitthroughavouchersystem,whilethosewhodohavepurchasingpowercouldpurchaseit.

• Itwassuggestedthatkeyenablingactivitieswouldneedtobeinitiatedthroughdemonstrationofthebenefitoftheproduct.Inotherwords,akeyfirststepwouldbetoshow,forinstancesomewhereinAsiaandinAfrica,theacceptabilityandefficacyofsuchanutritious,welldesignedfoodsupplementproduct.Thiswouldsecurethesupportofexperts,civilsocietyandthegovernment.Subsequently,specificmarketingandcommunicationofthefoodsupplementwouldbeneeded.Thiswouldneedtobeledbythemanufacturerswithsupportfromgovernmentanddonors.

• Importantly,underanyscenarioofdistributionorcombinationthereof,thereisaneedforbehaviorchangecommunicationanddemandgenerationtoensureadequateuptake/consumptionofthesupplementbyconsumersaswellasthewiderpopulation.Inaddition,thereisaneedtobetterunderstandwhymanywomeninlower-incomepopulationsdon’tgainadequateweightduringpregnancy,evenwhenfoodinsecurityisnotanissue.Helpingwomentoovercomeappetiteconstraints(e.g.nausea;infections;foodaversions)isalsoimportant.Inotherwords,simplyprovidingthefooddoesnotensurethatitwillbeconsumedinthedesiredamounts.

Summary

Therearemultipleelementsoftheuse-case;theconceptofafortifiedbalancedenergyproteinsupplementmaybesimple,yetgettingittothewomenwhoneeditandhavingthemconsumeitregularlyandintherequiredquantitiesisachallengethatneedstobeaddressedthroughacombinationofeffortsfromthepublicandprivate(commercial)sector,whichwouldbenefitfromasharedecosystem.

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V.NextSteps• Disseminatetheproposednutritionalcompositionandthenutrientcontenttargetsfor

anutritiousfoodsupplementforPLWinlow-incomeandunder-resourcedsettings

• Designanddevelopprototypesoffoodproducts

• Identifytwotothreesuitableprototypesthatcanspanacrossdifferentgeographies,culturesandcontexts

• Testacceptabilityandutilizationofafewtypesofproductsand,underprogrammaticcircumstances,testtheimpactonbirthoutcomes

• Createataskforcetoworkon“use-case”usingablendedmarketandpublicdistributionmodel(e.g.asdonewithcontraceptives)

16

References

BlackRE,VictoraCG,WalkerSP,BhuttaZA,ChristianP,deOnisM,EzzatiM,Grantham-McGregorS,KatzJ,MartorellR,UauyR;MaternalandChildNutritionStudyGroup.Maternalandchildundernutritionandoverweightinlow-incomeandmiddle-incomecountries.Lancet2013382:42-451.

ImdadAandBhuttaZ.EffectofBalancedProteinEnergysupplementationonbirthweight.PaediatrPeriEpi2012;26:178-90.

IOM.DietaryReferenceIntakes:TheEssentialGuidetoNutrientRequirements.TheNationalAcademiesPress,Washington,D.C.,2006.KaestelP,MichaelsenKF,AabyP,FriisH.Effectsofprenatalmultimicronutrientsupplementsonbirthweightandperinatalmortality:arandomized,controlledtrialinGuinea-Bissau.EJCN2005;59:1081-1089.

KozukiN,KatzJ,LeeAC,VogelJP,SilveiraMF,SaniaA,StevensGA,CousensS,CaulfieldLE,ChristianP,HuybregtsL,RoberfroidD,SchmiegelowC,AdairLS,BarrosFC,CowanM,FawziW,KolsterenP,MerialdiM,MongkolchatiA,SavilleN,VictoraCG,BhuttaZA,BlencoweH,EzzatiM,LawnJE,BlackRE;ChildHealthEpidemiologyReferenceGroupSmall-for-Gestational-Age/PretermBirthWorkingGroup.Shortmaternalstatureincreasesriskofsmall-for-gestational-ageandpretermbirthsinlow-andmiddle-incomecountries:individualparticipantdatameta-analysisandpopulationattributablefraction.JNutr2015;145:2542–50.

LeeSE,TalegawkarS,MerialdiM,CaulfieldLE.Dietaryintakesofwomenduringpregnancyinlow-andmiddleincomecountries.PubHlthNutr2012;16:1340-1353.

NCDRiskFactorCollaboration.Trendsinadultbody-massindexin200countriesfrom1975to2014:Apooledanalysisof1698population-basedmeasurementstudieswith19·2millionparticipants.Lancet2016;387:1377–1396.

OtaE,HoriH,MoriR,Tobe-GaiR,FarrarD.Antenataldietaryeducationandsupplementationtoincreaseenergyandproteinintake.CochraneDatabaseSystRev.2015;(6):CD000032. WorldHealthOrganization.WHOrecommendationsonantenatalcareforapositivepregnancyexperience.WHONov2016.http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/anc-positive-pregnancy-experience/en/

17

AppendixI:ExpertGroup

Name Organization

SaskiadePee WorldFoodProgramme(WFP),Rome

AshishDeo Children’sInvestmentFundFoundation(CIFF),London

KayDewey UniversityofCaliforniaDavis,Davis

EdwardFischer VanderbiltUniversity,Nashville

AlisonFleet UNICEF,NewYork

NicolleGötz DSMNutritionalProducts,Basel

SheilaIsanaka Epicenter,HarvardSchoolofPublicHealth,Boston

SarahJensenDeutscheGesellschaftfürInternationaleZusammenarbeit(GIZ)GmbH,Eschborn

RalphJerome Mars,Davis

KlausKraemer SightandLifeFoundation,Basel

KatharineKreis PATH,Seattle

MarkManary WashingtonUniversitySchoolofMedicine,St.Louis

ShahidMinhas WFP,Pakistan

SaskiaOsendarp Consultant,MI

WilliamPetri UniversityofVirginia,Virginia

KeithWestJr. JohnsHopkinsSchoolofPublicHealth,Baltimore

TahmeedAhmed(absent) icddr,b,Dhaka

ParulChristian BillandMelindaGatesFoundation,Seattle

18

AppendixII

IOMDRIs/RDAs/AIsandFAO/WHORNIsforPregnantandLactatingWomenforMacro-andMicronutrients

Pregnancy

IOMEnergyDRIsfor19-30yofage FAO/WHOEnergyDRIsfor19-30yofage

(additionalkcal/day)

1stTM 2ndTM 3rdTM 1stTM 2ndTM 3rdTM

None 340 452 85 285 475

Lactation

IOMEnergyDRIsfor19-30yofage FAO/WHOEnergyDRIsfor19-30yofage

(additionalkcal/day)

Lactating(≤6mo) Lactating(>6mo) Lactating(≤6mo) Lactating(>6mo)

330 400 505 675

(Continuedonthefollowingpage)

19

IOM1DRIsfor19-30y FAO/WHO2RNIsfor19-30y

Pregnant Lactating Pregnant Lactating

CHO(g) RDA 175 210

Protein(g)3

RDA

71

71Additional1,9and31gin1st,2ndand

3rdtrimester

Rangeofadditional14.3to16.2gin1st

6mo

Lipidstotal(g) - ND ND

Linoleicacid(g) AI 13 13

LinolenicAcid(g) AI 1.4 1.3

Fiber(g) AI 28 29

VitaminA(µgRE) RDA 770 1300370800

450850

RNISafeintake

VitaminD(µg) RDA 5 5 15 15

VitaminE(mg) RDA 15 19 *NR *NR

VitaminK(µg) AI 90 90 55 55

Thiamin(mg) RDA 1.4 1.4 1.4 1.5 RNI

Riboflavin(mg) RDA 1.4 1.6 1.4 1.6

Niacin(mg) RDA 18 17 18 17

VitaminB6(mg) RDA 1.9 2.0 1.9 2.0

Folate(µg) RDA 600 500 520(600) 450(500) EAR(RNI)

VitaminB12(µg) RDA 2.6 2.8 2.2(2.6) 2.4(2.8) EAR(RNI)

VitaminC(mg) RDA 85 120 55 70

Calcium(mg) RDA 1000 10001200

(lasttrimester)1000

Iron(mg) RDA 27 9 - 10-30Basedon%dietaryironbioavailability

Zinc(mg) RDA 11 125.5,7,10(1st,2nd3rd

trimester)

9.5,8.8,7.2(0-3,3-6,6-12mo)

Basedonmoderate

bioavailability

Iodine(µg) RDA 220 290 200 200

Biotin(µg) AI 30 35 30 35

Pantothenicacid(mg) AI 6 7 6.0 7.0

Choline(mg) AI 450 550

Phosphorus(mg) RDA 700 700

Magnesium(mg) RDA 350 310220forfemales>

19,NR**220forfemales>

19,NR**RNI

Manganese(mg) AI 2.6 2.6

Copper(µg) RDA 1000 1300

Selenium(µg) RDA 60 7028(2ndtrimester)30(3rdtrimester)

35(0-6mopp)42(7-12mopp)

Potassium(g) AI 4.7 5.1

1Source:https://fnic.nal.usda.gov/sites/fnic.nal.usda.gov/files/uploads/recommended_intakes_individuals.pdf2FAO/WHO2001,2004,20103Basedonperkgofbodyweightforreferencebodyweightat0.80g/kg/dor46gfora57kgreferencewoman;additional25gtheRDAforadultwoman*“NospecificrecommendationsconcerningthevitaminErequirementsinpregnancyandlactationhavebeenmadebyotheradvisorybodies(42,43)mainlybecausethereisnoevidenceofvitaminErequirementsdifferentfromthoseofotheradultsandpresumablyalsoastheincreasedenergyintakewouldcompensatefortheincreasedneedsforinfantgrowthandmilksynthesis.”**“Itisassumedthatduringpregnancythefoetusaccumulates8mgandfoetaladnexaaccumulate5mgmagnesium.Ifitisassumedthatthisdietarymagnesiumisabsorbedwith50percentefficiency,the26mgrequiredoverapregnancyof40weeks(0.09mg/day)canprobablybeaccommodatedbyadaptation.Alactationallowanceof50–55mg/dayfordietarymagnesiumismadeforthesecretionofmilkcontaining25–28mgmagnesium(21,64).”

20

AppendixIII

TypesofBalancedEnergyProteinSupplementsUsedinStudies

Study DescriptionofFoodSupplement Calories(kcal)

Protein(g)

Attonetal1990Flavoredmilkproductpackagedina200-mlTetrabrickcarton(withchoiceofflavors) 407 14.6

Blackwelletal1973 Protein-calorieliquidsupplement(milk-based)takendailyplusvitaminsandminerals

800 40

Campbelletal1983

Threedifferentsupplementoptionswereofferedbasedonsubjects’preference:• 0.5pintofflavoredmilkdrink• 1pintoffreshmilk• 75gcheddarcheese

300 14.6

Ceesayetal1997Highenergygroundnutbiscuits(2)containingroastedgroundnuts,riceflour,sugarandgroundnutoil

1017 22

Elwoodetal1981 Freetokenstopurchasemilkfortheirfamilies

Girijaetal1984 50gofsesamecake,40gjaggeryand10goil 417 30

Huybregtsetal200972gofaprenatalMMN-fortifiedspreadconsistingof33%peanutbutter,32%soyflour,15%vegetableoil,20%sugarandanMMNat1xRDA 372.6 14.7

Mardones-Santanderetal1988

Thereweretwointerventiongroups,PURandV-N• PURgroupreceivedpowderedmilk(anisocaloricsupplement)• V-Ngroupreceivedafortifiedformulamilk(abalancedprotein-energy

supplement);Inaddition,throughthesameprogramallwomenreceived2kgofricemonthly

PUR:498V-N:470

PUR:27.9

V-N:14.5

Metcoffetal1985 MonthlyWICvouchersforsupplementsofmilk,eggandcheese900–1000*

40-50*

Moraetal1978Supplementprovided60gofdryskimmilk,150gofenrichedbreadand20gofvegetablecookingoil;plus,avitaminmineralsupplement

856 38

Rushetal1980• Supplement:A16-ozbeverage(highprotein-energy)• Complement:A16-ozdrink(balancedenergyandprotein)

Supp:470Comp:322

Supp:40Comp:6

Viegasetal1982Flavoredcarbonateddietaryproteinenergysupplement(PrEnVit):containing1/3liquidglucosedrink,chocolateflavoredskimmilkpowder(26gprovideddaily)alongwithvitamins

273 30

21

References

AttonC,WatneyPJM.Selectivesupplementationinpregnancy:effectonbirthweight.JournalofHumanNutritionandDietetics1990;3:381–392.BlackwellR,ChowB,ChinnK,BlackwellB,HsuS.ProspectivematernalnutritionstudyinTaiwan:rationale,studydesign,feasibilityandpreliminaryfindings.NutritionReportsInternational1973;7:517–532.CampbellBrownM.Proteinenergysupplementsinprimigravidwomenatriskoflowbirthweight.In:CampbellDM,GillmerMDGeditor(s).Nutritioninpregnancy.Proceedingsofthe10thStudyGroupoftheRCOG.London:RoyalCollegeofObstetricsandGynecology,1983:85–98.CeesaySM,PrenticeAM,ColeTJ,FoordF,WeaverLT,PoskittEM,etal.EffectsonbirthweightandperinatalmortalityofmaternaldietarysupplementsinruralGambia:5yearrandomisedcontrolledtrial.BritishMedicalJournal(ClinicalResearchEd.)1997;315:786–790.GirijaA,GeervaniP,RaoGN.Influenceofdietarysupplementationduringpregnancyonlactationperformance.JournalofTropicalPediatrics1984;30:79–83HuybregtsL,RoberfroidD,LanouH,MentenJ,MedaN,VanCampJ,etal.Prenatalfoodsupplementationfortifiedwithmultiplemicronutrientsincreasesbirthlength:arandomizedcontrolledtrialinruralBurkinaFaso.AmericanJournalofClinicalNutrition2009;90:1593–1600.ImdadA,BhuttaZA.Maternalnutritionandbirthoutcomes:effectofbalancedprotein-energysupplementation.PaediatrPerinatEpidemiol.2012Jul;26Suppl1:178-90.Mardones-SantanderF,RossoP,StekelA,AhumadaE,LlagunoS,PizarroF,etal.Effectofamilk-basedfoodsupplementonmaternalnutritionalstatusandfetalgrowthinunderweightChileanwomen.AmericanJournalofClinicalNutrition1988;47:413–419.MetcoffJ,CostiloeP,CrosbyWM,DuttaS,SandsteadHH,MilneD,etal.Effectoffoodsupplementation(WIC)duringpregnancyonbirthweight.AmericanJournalofClinicalNutrition1985;41:933–947MoraJ,NavarroL,ClementJ,WagnerM,DeParedesB,HerreraMG.Theeffectofnutritionalsupplementationoncalorieandproteinintakeofpregnantwomen.NutritionReportsInternational1978;17:217–228.PrenticeAM,ColeTJ,FoordFA,LambWH,WhiteheadRG.IncreasedbirthweightafterprenataldietarysupplementationofruralAfricanwomen.AmericanJournalofClinicalNutrition1987;46:912–925.RushD,SteinZ,SusserM.ArandomizedcontrolledtrialofprenatalnutritionalsupplementationinNewYorkCity.Pediatrics1980;65:683–697.ViegasOA,ScottPH,ColeTJ,MansfieldHN,WhartonP,WhartonBA.DietaryproteinenergysupplementationofpregnantAsianmothersatSorrento,Birmingham.I:Unselectiveduringsecondandthirdtrimesters.BritishMedicalJournal(ClinicalResearchEd.)1982;285:589–592.

22

AppendixIV

WHOANCGuidelinesonEnergyandProteinDietarySupplementation

http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/anc-positive-pregnancy-experience/en/

WHORecommendationA.1.3:EnergyandProteinDietarySupplements

Inundernourishedpopulations,balancedenergyandproteindietarysupplementationisrecommendedforpregnantwomentoreducetheriskofstillbirthsandsmall-for-gestational-ageneonates.(Context-specificrecommendation)SelectedRemarks:

•TheGDGstressedthatthisrecommendationisforpopulationsorsettingswithahighprevalenceofundernourishedpregnantwomen,andnotforindividualpregnantwomenidentifiedasbeingundernourished.

•UndernourishmentisusuallydefinedbyalowBMI(i.e.beingunderweight).Foradults,a20–39%prevalenceofunderweightwomenisconsideredahighprevalenceofunderweightand40%orhigherisconsideredaveryhighprevalence(46).MUACmayalsobeusefultoidentifyprotein–energymalnutritioninindividualpregnantwomenandtodetermineitsprevalenceinthispopulation.However,theoptimalcut-offpointsmayneedtobedeterminedforindividualcountriesbasedoncontext-specificcost-benefitanalyses.

•Acontinual,adequatesupplyofsupplementsisrequiredforprogramsuccess.Thisrequiresaclearunderstandingandinvestmentinprocurementandsupplychainmanagement.

•Programsshouldbedesignedandcontinuallyimprovedbasedonlocallygenerateddataandexperiences.Examplesrelevanttothisguidelineinclude:

–Improvingdelivery,acceptabilityandutilizationofthisinterventionbypregnantwomen(i.e.overcomingsupplyandutilizationbarriers).

–DistributionofbalancedenergyandproteinsupplementsmaynotbefeasibleonlythroughthelocalscheduleofANCvisits;additionalvisitsmayneedtobescheduled.Thecostsrelatedtotheseadditionalvisitsshouldbeconsidered.Intheabsenceofantenatalvisits,toofewvisits,orwhenthefirstvisitcomestoolate,considerationshouldbegiventoalternativeplatformsfordelivery(e.g.communityhealthworkers,taskshiftinginspecificsettings).

–Valuesandpreferencesrelatedtothetypesandamountsofbalancedenergyandproteinsupplementsmayvary.

•Eachcountrywillneedtounderstandthecontext-specificetiologyofundernutritionatthenationalandsub-nationallevels.Forinstance,whereseasonalityisapredictoroffoodavailability,theprogramshouldconsiderthisandadapttotheconditionsasneeded(e.g.provisionofmoreorlessfoodofdifferenttypesindifferentseasons).Inaddition,abetterunderstandingisneededofwhetheralternativestoenergyandproteinsupplements–suchascashorvouchers,orimprovedlocalandnationalfoodproductionanddistribution–canleadtobetterorequivalentresults.

•Anthropometriccharacteristicsofthegeneralpopulationarechanging,andthisneedstobetakenintoaccounttoensurethatonlythosewomenwhoarelikelytobenefit(i.e.onlyundernourishedwomen)areincluded.

GDG:GuidelineDevelopmentGroup