Framework and Specifications for the Nutritional Composition of … · 2019-10-29 · nutrition, in...
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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.
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• 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
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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).”
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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