WO2015154259A1 - Gender specific synthetic nutritional compositions and nutritional systems comprising them - Google Patents

Gender specific synthetic nutritional compositions and nutritional systems comprising them Download PDF

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Publication number
WO2015154259A1
WO2015154259A1 PCT/CN2014/075001 CN2014075001W WO2015154259A1 WO 2015154259 A1 WO2015154259 A1 WO 2015154259A1 CN 2014075001 W CN2014075001 W CN 2014075001W WO 2015154259 A1 WO2015154259 A1 WO 2015154259A1
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Prior art keywords
infant
gender
concentration
synthetic nutritional
age
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PCT/CN2014/075001
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French (fr)
Inventor
Michael Affolter
Sagar THAKKAR
Carlos Antonio DE CASTRO
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Nestle China Ltd
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Nestle China Ltd
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Priority to PCT/CN2014/075001 priority Critical patent/WO2015154259A1/en
Priority to MX2016012340A priority patent/MX388551B/en
Priority to AU2015101946A priority patent/AU2015101946A4/en
Priority to RU2016143828A priority patent/RU2709988C2/en
Priority to US15/301,557 priority patent/US20170172194A1/en
Priority to CN201580018729.4A priority patent/CN106455657A/en
Priority to PCT/CN2015/076058 priority patent/WO2015154667A1/en
Priority to EP15776083.6A priority patent/EP3128857A4/en
Priority to AU2015245736A priority patent/AU2015245736A1/en
Publication of WO2015154259A1 publication Critical patent/WO2015154259A1/en
Priority to PH12016501921A priority patent/PH12016501921A1/en
Anticipated expiration legal-status Critical
Priority to AU2018102083A priority patent/AU2018102083A6/en
Priority to AU2018102079A priority patent/AU2018102079A6/en
Priority to AU2018102085A priority patent/AU2018102085A6/en
Priority to AU2018102086A priority patent/AU2018102086A6/en
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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/175—Amino acids
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients

Definitions

  • the invention relates to gender specific synthetic nutritional compositions,to nutritional systems comprising them and,to their use to provide optimised nutrition and/or one or more health benefit to an infant.
  • compositions of the aforementioned synthetic nutritional compositions are modeled on those of human milk.However,the composition of HM is extremely dynamic and these dynamic changes remain largely unexplored and uncharacterized.Whilst it is known that components and/or their quantities may vary depending on a variety of factors including the stage of lactation,circadian rhythms and even gender,it is not known which of the numerous components vary and if so how they vary e.g.by stage of lactation and/or gender.
  • Alanine,histidine,isoleucine,proline,and valine are amino acids.An optimum intake of amino acids helps to ensure optimum growth and development in infants.
  • Optimum growth and development may be immediate and/or long term.Long term may only be evident in months or years e.g.6months,9months,12months,5years,10years,or20 years.
  • the invention is set out in the claims.
  • the inventors have found that the concentration range of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine in HM varies up to1 month,more particularly2weeks to1month,postpartum depending on the gender of the mother’s infant.In light of this finding the inventors have developed gender specific nutritional compositions,and nutritional systems comprising them,that reflect these identified gender differences.Prior to aforementioned findings the skilled person has not incentive to develop such gender specific synthetic nutritional compositions or to include them in nutritional systems.
  • HM is considered optimal with respect to infant nutrition,they can provide an optimized amount of alanine,and/or histidine, and/or isoleucine,and/or proline,and/or valine to an infant of up to1month of age,more particularly2weeks to1month of age.
  • the gender specific synthetic nutritional compositions can be prepared from a gender neutral synthetic nutritional composition by measuring out an appropriate amount of said gender neutral synthetic nutritional composition and mixing it with an additive and/or diluent.
  • the gender specific synthetic nutritional composition is selected from the group consisting of:infant formula,and a composition for infants that is intended to be added or diluted to human milk e.g.HM fortifier.
  • the inventors have also found that the mean concentration of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine in HM does not vary by gender1month or later postpartum.
  • the nutritional systems disclosed herein may optionally also comprise synthetic nutritional compositions for infants more than1 month of age wherein,the concentration of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine does not differ by gender for infants of the same age.
  • the nutritional systems of the invention may also provide optimized nutrition,and thereby be used to treat,prevent or mitigate sub optimal growth e.g.obesity of an infant,to an infant up to12 months of age,up to9months of age,up to8months of age,up to6months of age.
  • FIG.1 is a graphical representation of the identified difference in the mean concentration of alanine in HM by gender at up to2weeks(5-11days),2weeks to1month(12-30days),1to2 months(31to60days),2to4months(61to120days)and,4to8months(121to240days) postpartum.
  • FIG.2 is a graphical representation of the identified difference in the mean concentration of histidine in HM by gender at up to2weeks(5-11days),2weeks to1month(12-30days),1to2 months(31to60days),2to4months(61to120days)and,4to8months(121to240days) postpartum.
  • FIG.3 is a graphical representation of the identified difference in the mean concentration of isoleucine in HM by gender at up to2weeks(5-11days),2weeks to1month(12-30days),1to 2months(31to60days),2to4months(61to120days)and,4to8months(121to240days) postpartum.
  • FIG.4 is a graphical representation of the identified difference in the mean concentration of proline in HM by gender at up to2weeks(5-11days),2weeks to1month(12-30days),1to2 months(31to60days),2to4months(61to120days)and,4to8months(121to240days) postpartum.
  • FIG.5 is a graphical representation of the identified difference in the mean concentration of valine in HM by gender at up to2weeks(5-11days),2weeks to1month(12-30days),1to2 months(31to60days),2to4months(61to120days)and,4to8months(121to240days) postpartum.
  • the inventors performed a cross sectional study evaluating the nutrient composition of HM collected from mothers at various stages of lactation(up to2weeks(5-11 days),2weeks to1month(12-30days),1to2months(31to60days),2to4months(61to120 days)and,4to8months(121to240days)postpartum).
  • the study indicated different min and max ranges for the concentration of alanine,histidine,isoleucine,proline,and valine by gender.
  • the inventors have designed gender specific synthetic nutritional compositions for infants up to1month,more particularly2weeks to1month,of age wherein,the concentration of alanine,and/or histidine,and/or isoleucine,and/or proline, and/or valine is adapted based on that found in HM produced for an infant of the same gender and age.
  • gender specific synthetic nutritional composition refers to any synthetic nutritional composition,intended to be consumed by an infant that is specifically adapted to the nutritional needs of either a female or male ieri.
  • gender specific synthetic nutritional compositions for infants from birth to4months include; infant formulae,and a composition for infants that is intended to be added or diluted with HM e.g.HM fortifier.
  • gender specific synthetic nutritional compositions for infants from4months to12months include infant formulae,a composition for infants that is intended to be added or diluted with HM e.g.HM fortifier,or food stuffs intended for consumption by infants either alone or in combination with HM e.g.complementary foods.
  • infant refers to a human infant of12months of age or less.
  • a gender specific synthetic nutritional composition for an infant up to1month of age wherein,the concentration of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine is adapted based on that found in HM produced for an infant of the same gender and age.
  • the concentration of alanine,histidine,isoleucine,proline,or valine is a measure of the total concentration of both the D and L forms of said amino acids,whether free or bound i.e.protein bound.
  • the gender specific synthetic nutritional composition can be a male specific synthetic nutritional composition or a female specific synthetic nutritional composition for an infant up to1month of age,more particularly2weeks to1month of age.
  • the gender specific synthetic nutritional composition is a female specific synthetic nutritional composition for an infant of up to1month of age,more particularly2 weeks to1month of age,and comprises alanine in a concentration of32.7to111.9,32.7to 87.61,32.7to60.90,43.66to72.96,or58.31,mg/100g and/or,histidine in a concentration of 28.2to80.8,28.2to48,28.2to69.39,34.2to57.66,or45.93,mg/100g and/or,isoleucine in a concentration of50.5to103.3,50.5to72,50.5to94.84,58.87to82.85,or70.86,mg/100g and/or,proline in a concentration of81.1to182.8,81.1to163.04,81.1to121,95.21to140.43, or117.82,mg/100g and/or valine in a concentration of56.9to149.9,56.9
  • the gender specific synthetic nutritional composition is a male specific synthetic nutritional composition for an infant of up to1month of age,more particularly2 weeks to1month of age,and comprises alanine in a concentration of32.7to193.1,32.7to 111.33,60.92to193.1,39.63to87.43,or63.53,mg/100g and/or,histidine in a concentration of 29.4to110.3,48.055to110.3,29.4to83.4,33.57to66.79,or50.18,mg/100g and/or, isoleucine in a concentration of51.1to155.5,51.1to108.24,72.95to155.5,58.44to91.64,or 75.04,mg/100g and/or,proline in a concentration of87.5to290.8,121.54to290.8,87.5to 188.14,93.82to156.7,or125.26,mg/100g and/or valine in a concentration of51.5to249.
  • concentration of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine can be measured by methods well known in the art.
  • concentration of alanine, and/or histidine,and/or isoleucine,and/or proline,and/or valine can be measured by an amino acid analyzer(using post-column derivatisation with ninhydrin)or by a pre-column derivatisation method(i.e.using PITC or OPA/FMOC chemistry as described in Blankenship D.T. et al.(1989)Analytical Biochemistry178:227)followed by HPLC separation and quantification.
  • Any source of Alanine,and/or Histidine,and/or Isoleucine,and/or Proline,and/or Valine known to be employed in the types of synthetic nutritional compositions disclosed herein may be comprised within in the gender specific synthetic nutritional compositions of the invention,in particular,they may be pure synthetic amino acids obtained through synthesis or fermentation, or liberated from any food-grade protein source such as animal or plant proteins through hydrolysis.
  • the Alanine,and/or Histidine,and/or Isoleucine,and/or Proline,and/or Valine may be intact, hydrolysed,partially hydrolysed,or any combination thereof.
  • the gender specific synthetic nutritional compositions of the invention can also comprise any other ingredients or excipients known to be employed in synthetic nutritional compositions.
  • Non limiting examples of such ingredients include:other amino acids,proteins,carbohydrates, oligosaccharides,lipids,prebiotics or probiotics,essential fatty acids,nucleotides,nucleosides, vitamins,minerals and other micronutrients.
  • Non limiting examples of other amino acids include,cysteine,glutamine,glutamic acid,glycine, serine,leucine,threonine,tyrosine,arginine,lysine,methionine,phenylalanine,tryptophane, asparagine,aspartic acid,and combinations thereof.
  • Non limiting examples of proteins include,caseins,alpha-lactalbumin,lactoferrin,serum albumin,whey,soy protein,rice protein,corn protein,oat protein,barley protein,wheat protein,rye protein,pea protein,egg protein,sunflower seed protein,potato protein,fish protein,meat protein,immunoglobins,and combinations thereof.
  • Non limiting examples of carbohydrates include lactose,saccharose,maltodexirin,starch,and mixtures thereof
  • Non limiting examples of lipids include:palm olein,high oleic sunflower oil,high oleic safflower oil,canola oil,fish oil,coconut oil,bovine milk fat,or mixtures thereof.
  • Non limiting examples of essential fatty acids include:linoleic acid(LA), ⁇ -linolenic acid(ALA) and polyunsaturated fatty acids(PUFAs).
  • the nutritional compositions of the invention may further contain gangliosides monosialoganglioside-3(GM3)and disialogangliosides3(GD3), phospholipids such as sphingomyelin,phospholipids phosphatidylcholine, phosphatidylethanolamine,phosphatidylinositol,phosphatidylserine,and combinations of the foregoing.
  • prebiotics include:oligosaccharides optionally containing fructose, galactose,mannose;dietary fibers,in particular soluble fibers,soy fibers;inulin;or mixtures thereof.
  • Preferred prebiotics are fructo-oligosaccharides(FOS),galacto-oligosaccharides(GOS), isomalto-oligosaccharides(IMO),xylo-oligosaccharides(XOS),arabino-xylo oligosaccharides (AXOS),mannan-oligosaccharides(MOS),oligosaccharides of soy,glycosylsucrose(GS), lactosucrose(LS),lactulose(LA),palatinose-oligosaccharides(PAO),malto-oligosaccharides, gums and/or hydrolysates thereof,pectins and/or hydrolysates thereof,and combinations of the foregoing.
  • FOS fructo-oli
  • oligosaccharide is described in Wrodnigg,T.M.;Stutz,A.E.(1999)Angew. Chem.Int.Ed.38:827-828and in WO2012/069416which is incorporated herein by reference.
  • Non limiting examples of probiotics include:Bifidobacterium,Lactobacillus,Lactococcus, Enterococcus,Streptococcus,Kluyveromyces,Saccharoymces,Candida,in particular selected from the group consisting of Bifidobacterium longum,Bifidobacterium lactis,Bifidobacterium animalis,Bifidobacterium breve,Bifidobacterium infantis,Bifidobacterium adolescentis, Lactobacillus acidophilus,Lactobacillus casei,Lactobacillus paracasei,Lactobacillus salivarius, Lactobacillus lactis,Lactobacillus rhamnosus,Lactobacillus johnsonii,Lactobacillus plantarum, Lactobacillus salivarius,Lactococcus lactis,Enterococcus faecium,Sacchar
  • Nucleotides include:cytidine monophosphate(CMP),uridine monophosphate(UMP),adenosine monophosphate(AMP),guanosine monophosphate(GMP), or any mixtures thereof.
  • vitamins and minerals include:vitamin A,vitamin B1,vitamin B2, vitamin B6,vitamin Bi2,vitamin E.vitamin K.vitamin C,vitamin D,folic acid,inositol,niacin, biotin,pantothenic acid,choline,calcium,phosphorous,iodine,iron,magnesium,copper,zinc, manganese,chloride,potassium,sodium,selenium,chromium,molybdenum,taurine,and L- carnitine,and mixtures thereof.Minerals are usually added in salt form.
  • compositions of the invention may be prepared by methods well known in the art for preparing that type of synthetic nutritional composition e.g.infant formulae,follow on formulae,a composition for infants that is intended to be added or diluted with HM e.g.HM fortifier,and food stuffs intended for consumption by infants either alone or in combination with HM e.g.complementary foods.
  • synthetic nutritional composition e.g.infant formulae,follow on formulae,a composition for infants that is intended to be added or diluted with HM e.g.HM fortifier,and food stuffs intended for consumption by infants either alone or in combination with HM e.g.complementary foods.
  • An exemplary method for preparing a gender specific powdered infant formula is as follows. Amino acids(including alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine),and/or protein source(comprising bound alanine,and/or histidine,and/or isoleucine, and/or proline,and/or valine),carbohydrate source,and fat source may be blended together in appropriate proportions.Emulsifiers maybe included in the blend.Vitamins and minerals may be added at this point but are usually added later to avoid thermal degradation. Any lipophilic vitamins,emulsifiers and the like may be dissolved into the fat source prior to blending. Water, preferably water which has been subjected to reverse osmosis,may then be mixed in to form a liquid mixture.
  • the liquid mixture may then be thermally treated to reduce bacterial loads.
  • the liquid mixture may be rapidly heated to a temperature in the range of about800C to about1 100C for about5seconds to about5minutes.This may be carried out by steam injection or by heat exchanger;for example a plate heat exchanger.
  • the liquid mixture may then be cooled to about600C to about850C;for example by flash cooling.
  • the liquid mixture may then be homogenised;for example in two stages at about7MPa to about40MPa in the first stage and about2MPa to about14MPa in the second stage.
  • the homogenised mixture may then be further cooled to add any heat sensitive components such as vitamins and minerals.
  • the pH and solids concentration in the homogenised mixture is conveniently standardised at this point.
  • the homogenised mixture can be transferred to a suitable drying apparatus such as a spray drier or freeze drier and converted to powder.
  • a suitable drying apparatus such as a spray drier or freeze drier and converted to powder.
  • the powder should have a moisture concentration in less than about3%by weight.
  • probiotic(s) can be added, they may be cultured according to any suitable method and prepared for addition to the infant formula by freeze-drying or spray-drying for example.
  • bacteria preparations can be bought from specialist suppliers such as Christian Hansen and Morinaga already prepared in a suitable form for addition to food products such as infant formula.Such bacterial preparations may be added to the gender specific powdered infant formula by dry mixing.
  • the gender specific compositions of the invention may also be prepared from a gender neutral synthetic nutritional composition in a method comprising;measuring out an appropriate amount of said gender neutral synthetic nutritional composition and mixing it with an additive and/or diluent e.g.water so as to arrive at a gender specific nutritional composition in accordance with the invention.
  • the additive may be a gender specific additive comprising caseins in a particular concentration so that when mixed with the gender neutral synthetic nutritional composition,and optionally a diluent,the resulting mixture is a gender specific synthetic nutritional composition of the invention.
  • the gender neutral synthetic nutritional composition can be prepared by methods well known in the art.For example,as laid out above for infant formula.
  • One or more of the gender specific synthetic nutritional compositions of the invention can be included in a nutritional system.
  • the term“nutritional system”as used herein refers to a collection of more than one synthetic nutritional composition advertised or sold as part of the same product range e.g. a collection of infant formulas sold under the same brand and adapted to the nutritional needs of infants of differing genders and/or ages.
  • the synthetic nutritional compositions making up the nutritional system may be packaged individually e.g.in capsules or boxes.Said packages can be sold individually,grouped together e.g.wrapped by plastic film or combined in a box or,in a combination of these two ways.
  • the nutritional system may comprise only gender specific synthetic nutritional compositions,or, it may comprise a mix of gender specific and gender neutral synthetic nutritional compositions.
  • a nutritional system comprising at least one of the gender specific synthetic nutritional compositions of the invention.
  • the nutritional system comprises a gender specific synthetic nutritional composition for a male infant of up to1month of age,more particularly2weeks to1month of age,and, a gender specific synthetic nutritional composition for a female infant of up to1 month of age,more particularly2weeks to1month of age.
  • concentration of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine in said male gender specific synthetic nutritional composition is higher than that of said female gender specific synthetic nutritional composition.
  • concentration of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine in the male gender synthetic nutritional compositions may be higher by any amount.
  • the ratio of the concentration of alanine between the female gender specific nutritional composition and male gender specific synthetic nutritional composition is1:5.08to 1:1.0003,1:5.18to1:1.08;or1:1.7to1:1.08.
  • the ratio of the concentration of histidine between the female gender specific nutritional composition and male gender specific synthetic nutritional composition is 1:3.9to1:1.001,1:3.9to1:1.04,or1:3.6to1:1.09.
  • the ratio of the concentration of Isoleucine between the female gender specific nutritional composition and male gender specific synthetic nutritional composition is 1:3.07to1:1.01,1:3.07to1:1.01,or1:1.5to1:1.05.
  • the ratio of the concentration of proline between the female gender specific nutritional composition and male gender specific synthetic nutritional composition is1:3.6to 1:1.004,1:3.6to1:1.06,or1:1.5to1:1.07.
  • the ratio of the concentration of valine between the female gender specific nutritional composition and male gender specific synthetic nutritional composition is1.4.4to 1:1.001,1:4.4to1:1.07,or1:1.6to1:1.07.
  • the male gender specific synthetic nutritional composition contains0.001to 155.8,5.22to155.8,or5.22to81.2,mg/100g more alanine than the female gender specific synthetic nutritional composition.
  • the male gender specific synthetic nutritional composition contains0.001to 82.1,1.2to82.1,or4.25to29.5,mg/100g more histidine than the female gender specific synthetic nutritional composition.
  • the male gender specific synthetic nutritional composition contains0.001to 105,0.6to105,or4.18to52.2,mg/100g more Isoleucine than the female gender specific synthetic nutritional composition.
  • the male gender specific synthetic nutritional composition contains0.001to 209.7,6.4to209.7,or7.44to108,mg/100g more proline than the female gender specific synthetic nutritional composition.
  • the male gender specific synthetic nutritional composition contains0.001to 197.7,6.4to192.7,or6.47to99.7,mg/100g more valine than the female gender specific synthetic nutritional composition.
  • the referenced study further indicated that between 31days and240days postpartum there is no difference in the mean concentration of alanine, and/or histidine,and/or isoleucine,and/or proline,and/or valine in HM depending on the gender of the mother’s infant.
  • the nutritional system further comprises gender specific synthetic nutritional compositions for infants more than1month of age wherein,the concentration of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine does not differ by gender for infants of the same age.
  • the nutritional system further comprises gender neutral specific synthetic nutritional compositions for infants more than1month of age.
  • the nutritional system may further comprise nutritional compositions for children older than 12months.
  • a gender specific synthetic nutritional composition and/or nutrition system according to the invention is particularly suitable for use in a method of preparing single servings of infant formula using capsules,each capsule of which contains a unit dose of a synthetic nutritional composition in concentrated form,and which is equipped with opening means contained within the capsule to permit draining of the reconstituted synthetic nutritional composition directly from the capsule into a receiving vessel such as a baby bottle.Such a method is described in WO2006/077259.
  • the different synthetic nutritional compositions including gender specific and gender neutral synthetic nutritional compositions,which may be comprised within a nutrition system,may be packed into individual capsules and presented to the consumer in multipacks containing a sufficient number of capsules to meet the requirements of an infant of a particular age or range for one week for example.
  • suitable capsule constructions are disclosed in WO2003/059778.
  • the capsules can contain the synthetic nutritional compositions,(gender specific and gender neutral)in the form of powders or concentrated liquids in both cases for reconstitution by an appropriate amount of water.Both the composition and the quantity of infant formula in the capsules may vary according to the gender and/or age of the infant.If necessary,different sizes of capsules may be provided for the preparation of infant formulas for infants of different genders and/or ages.
  • the gender specific synthetic nutritional compositions,or nutritional systems comprising them better reflect the differences in the concentration of alanine,and/or histidine,and/or isoleucine, and/or proline,and/or valine in HM found by gender at one or more stages of lactation.As stated herein,optimum alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine intake is necessary to ensure the optimum growth and development of an infant.
  • a gender specific synthetic nutritional composition and/or nutritional system as disclosed herein for use to treat,prevent or mitigate sub optimal growth of an infant e.g.obesity.
  • a gender specific synthetic nutritional composition may provide an optimum amount of alanine, and/or histidine,and/or isoleucine,and/or proline,and/or valine,to an infant up to1month of age,more particularly2weeks to1month of age.
  • the nutritional system may provide an optimum amount of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valineto an infant up to12months of age,up to9months of age,up to8months of age,up to6months of age,up to1month of age,up to2weeks of age.
  • the gender specific synthetic nutritional compositions may be prepared from gender neutral synthetic nutritional compositions.
  • a kit for providing an optimized amount of alanine,and/or histidine, and/or isoleucine,and/or proline,and/or valine,to an infant e.g.obesity,to a male or female infant of up to1month of age,more particularly2weeks to1month of age the kit comprising:
  • the dosage requirements may be with respect to the quantity of the gender neutral synthetic nutritional employed and/or consumption frequency e.g.4times per day.
  • Subjects included in the survey referenced herein were recruited from4provinces across China. Accordingly,the gender specific synthetic nutritional compositions and/or nutritional systems disclosed herein can be particularly relevant for Chinese infants,and or infants born in populations having common genetic origins and/or ethnic origins and/or common dietary habits thereto e.g.Asian,Indian,and/or Mongoloid populations.
  • HM samples collected from mothers to either male or females were analysed at various stages postpartum.
  • the HM samples were collected as part of a cross sectional survey of HM. The study criteria is set out below:
  • compositional analysis was then subject to a statistical analysis employing the following statistical model:
  • Table VI,VII,VIII,IX,X shows the estimates for gender differences per timeframe along with the corresponding Pvalues for alanine,histidine,isoleucine,proline and,valine respectively.
  • a P-value inferior to0.1for a particular timeframe suggests that there is a statistically significant difference in the concentration of alanine,histidine,isoleucine,proline,or valine in HM produced for males and females infants at that specific timeframe.

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Abstract

Gender specific synthetic nutritional compositions for female or male infants up to 1 month of age wherein, the concentration of alanine, and/or histidine, and/or isoleucine, and/or proline, and/or valine is adapted based on that found in HM produced for an infant of the same gender and age, and nutritional systems comprising them.

Description

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Title:Gender specific synthetic nutritional compositions and nutritional systems comprising  them.
Technical field:The invention relates to gender specific synthetic nutritional compositions,to  nutritional systems comprising them and,to their use to provide optimised nutrition and/or one  or more health benefit to an infant.
Background of the invention
Even though breastfeeding is optimal for infants,existence of certain conditions may not be in  the best interests of the infant and it may contraindicate breastfeeding(AAP,2012;Lawrence, 2013).In such cases,where the sole source of nutrition is not available to the infant,alternative  strategies to feed them have to be devised.Feeding infants with Synthetic nutritional  compositions e.g.Infant formula is one such strategy.
The compositions of the aforementioned synthetic nutritional compositions are modeled on  those of human milk.However,the composition of HM is extremely dynamic and these dynamic  changes remain largely unexplored and uncharacterized.Whilst it is known that components  and/or their quantities may vary depending on a variety of factors including the stage of  lactation,circadian rhythms and even gender,it is not known which of the numerous  components vary and if so how they vary e.g.by stage of lactation and/or gender.
Surprisingly it has now been identified that up to1month,more particularly2weeks to1  month,postpartum,there is a difference in the concentration range of alanine,and/or histidine, and/or isoleucine,and/or proline,and/or valine found in HM produced by mother’s to girls in  comparison to mother’s to boys.This finding stems from a cross-sectional study of HM wherein, HM samples from mothers to either boys or girls were collected at various stages postpartum  and analysed.Further,it was also surprisingly found that up to1month,more particularly2  weeks to1month,postpartum,the mean concentration of alanine,and/or histidine,and/or  isoleucine,and/or proline,and/or valine in HM produced by mothers to boys was higher than  that produced for mothers to girls.
Because these gender differences in the concentration of alanine,and/or histidine,and/or  isoleucine,and/or proline,and/or valine in HM have never been previously identified,they are  not reflected in the compositions of synthetic nutritional compositions available today.
Alanine,histidine,isoleucine,proline,and valine are amino acids.An optimum intake of amino  acids helps to ensure optimum growth and development in infants.
Optimum growth and development may be immediate and/or long term.Long term may only  be evident in months or years e.g.6months,9months,12months,5years,10years,or20  years.
Accordingly,there remains a need for gender specific synthetic nutritional compositions,and  nutritional systems comprising them,having compositions within which the identified gender  differences,with respect to the concentration of alanine,and/or histidine,and/or isoleucine, and/or proline,and/or valine,found in HM up to1month,more particularly2weeks to1month, postpartum are more accurately reflected and thereby optimised.
Summary of the invention
The invention is set out in the claims.The inventors have found that the concentration range of  alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine in HM varies up to1  month,more particularly2weeks to1month,postpartum depending on the gender of the  mother’s infant.In light of this finding the inventors have developed gender specific nutritional  compositions,and nutritional systems comprising them,that reflect these identified gender  differences.Prior to aforementioned findings the skilled person has not incentive to develop  such gender specific synthetic nutritional compositions or to include them in nutritional systems.
The concentration of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine  in the gender specific synthetic nutritional compositions of the invention,and the nutritional  systems comprising them,more accurately reflect their concentration in HM produced for  infants of the same gender and age.In light of this and,because HM is considered optimal with  respect to infant nutrition,they can provide an optimized amount of alanine,and/or histidine, and/or isoleucine,and/or proline,and/or valine to an infant of up to1month of age,more  particularly2weeks to1month of age.
The gender specific synthetic nutritional compositions can be prepared from a gender neutral  synthetic nutritional composition by measuring out an appropriate amount of said gender  neutral synthetic nutritional composition and mixing it with an additive and/or diluent.
Since optimized alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine  intake helps to ensure the optimum growth and development of an infant,the gender specific  synthetic nutritional compositions,and nutritional systems of the invention,can also be used to  treat,prevent or mitigate sub optimal growth e.g.obesity of an infant..
Optionally the gender specific synthetic nutritional composition is selected from the group  consisting of:infant formula,and a composition for infants that is intended to be added or  diluted to human milk e.g.HM fortifier.
In addition to that set out above,the inventors have also found that the mean concentration of  alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine in HM does not vary  by gender1month or later postpartum.In light of this,in addition to comprising the gender  specific synthetic nutritional compositions of the invention,the nutritional systems disclosed  herein may optionally also comprise synthetic nutritional compositions for infants more than1  month of age wherein,the concentration of alanine,and/or histidine,and/or isoleucine,and/or  proline,and/or valine does not differ by gender for infants of the same age.Accordingly,the  nutritional systems of the invention may also provide optimized nutrition,and thereby be used  to treat,prevent or mitigate sub optimal growth e.g.obesity of an infant,to an infant up to12  months of age,up to9months of age,up to8months of age,up to6months of age.
Drawings
FIG.1is a graphical representation of the identified difference in the mean concentration of  alanine in HM by gender at up to2weeks(5-11days),2weeks to1month(12-30days),1to2  months(31to60days),2to4months(61to120days)and,4to8months(121to240days) postpartum.
FIG.2is a graphical representation of the identified difference in the mean concentration of  histidine in HM by gender at up to2weeks(5-11days),2weeks to1month(12-30days),1to2  months(31to60days),2to4months(61to120days)and,4to8months(121to240days) postpartum.
FIG.3is a graphical representation of the identified difference in the mean concentration of  isoleucine in HM by gender at up to2weeks(5-11days),2weeks to1month(12-30days),1to  2months(31to60days),2to4months(61to120days)and,4to8months(121to240days) postpartum.
FIG.4is a graphical representation of the identified difference in the mean concentration of  proline in HM by gender at up to2weeks(5-11days),2weeks to1month(12-30days),1to2  months(31to60days),2to4months(61to120days)and,4to8months(121to240days) postpartum.
FIG.5is a graphical representation of the identified difference in the mean concentration of  valine in HM by gender at up to2weeks(5-11days),2weeks to1month(12-30days),1to2  months(31to60days),2to4months(61to120days)and,4to8months(121to240days) postpartum.
Detailed Description
As stated herein,the inventors performed a cross sectional study evaluating the nutrient  composition of HM collected from mothers at various stages of lactation(up to2weeks(5-11  days),2weeks to1month(12-30days),1to2months(31to60days),2to4months(61to120  days)and,4to8months(121to240days)postpartum).The study indicated different min and  max ranges for the concentration of alanine,histidine,isoleucine,proline,and valine by gender. Surprisingly,the results of this study also indicated that that up to1month,more particularly2  weeks to1month,postpartum,there is a difference in the concentration of alanine,and/or  histidine,and/or isoleucine,and/or proline,and/or valine in HM depending on the gender of the  mother’s infant.Further details of the study,analysis techniques and results are given in  example1.
Based on the findings of the study,the inventors have designed gender specific synthetic  nutritional compositions for infants up to1month,more particularly2weeks to1month,of age  wherein,the concentration of alanine,and/or histidine,and/or isoleucine,and/or proline, and/or valine is adapted based on that found in HM produced for an infant of the same gender  and age.
The term“gender specific synthetic nutritional composition”as used herein refers to any  synthetic nutritional composition,intended to be consumed by an infant that is specifically  adapted to the nutritional needs of either a female or male enfant.Non limiting examples of  gender specific synthetic nutritional compositions for infants from birth to4months include; infant formulae,and a composition for infants that is intended to be added or diluted with HM  e.g.HM fortifier.Non limiting examples of gender specific synthetic nutritional compositions for  infants from4months to12months include infant formulae,a composition for infants that is  intended to be added or diluted with HM e.g.HM fortifier,or food stuffs intended for  consumption by infants either alone or in combination with HM e.g.complementary foods.
The term“infant”as used herein refers to a human infant of12months of age or less.
In a first aspect of the invention there is provided a gender specific synthetic nutritional  composition for an infant up to1month of age wherein,the concentration of alanine,and/or  histidine,and/or isoleucine,and/or proline,and/or valine is adapted based on that found in HM  produced for an infant of the same gender and age.
The concentration of alanine,histidine,isoleucine,proline,or valine is a measure of the total  concentration of both the D and L forms of said amino acids,whether free or bound i.e.protein  bound.
The gender specific synthetic nutritional composition can be a male specific synthetic nutritional  composition or a female specific synthetic nutritional composition for an infant up to1month  of age,more particularly2weeks to1month of age.
In an embodiment the gender specific synthetic nutritional composition is a female specific  synthetic nutritional composition for an infant of up to1month of age,more particularly2  weeks to1month of age,and comprises alanine in a concentration of32.7to111.9,32.7to  87.61,32.7to60.90,43.66to72.96,or58.31,mg/100g and/or,histidine in a concentration of  28.2to80.8,28.2to48,28.2to69.39,34.2to57.66,or45.93,mg/100g and/or,isoleucine in a  concentration of50.5to103.3,50.5to72,50.5to94.84,58.87to82.85,or70.86,mg/100g  and/or,proline in a concentration of81.1to182.8,81.1to163.04,81.1to121,95.21to140.43, or117.82,mg/100g and/or valine in a concentration of56.9to149.9,56.9to85,56.9to119.61, 63to100.74,or81.87mg/100g.
In an embodiment the gender specific synthetic nutritional composition is a male specific  synthetic nutritional composition for an infant of up to1month of age,more particularly2  weeks to1month of age,and comprises alanine in a concentration of32.7to193.1,32.7to  111.33,60.92to193.1,39.63to87.43,or63.53,mg/100g and/or,histidine in a concentration of  29.4to110.3,48.055to110.3,29.4to83.4,33.57to66.79,or50.18,mg/100g and/or, isoleucine in a concentration of51.1to155.5,51.1to108.24,72.95to155.5,58.44to91.64,or  75.04,mg/100g and/or,proline in a concentration of87.5to290.8,121.54to290.8,87.5to  188.14,93.82to156.7,or125.26,mg/100g and/or valine in a concentration of51.5to249.6, 85.105to290.8,51.5to145.84,59.59to117.09,or88.34,mg/100g.
The concentration of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine  can be measured by methods well known in the art.In particular the concentration of alanine, and/or histidine,and/or isoleucine,and/or proline,and/or valine can be measured by an amino  acid analyzer(using post-column derivatisation with ninhydrin)or by a pre-column  derivatisation method(i.e.using PITC or OPA/FMOC chemistry as described in Blankenship D.T. et al.(1989)Analytical Biochemistry178:227)followed by HPLC separation and quantification.
Any source of Alanine,and/or Histidine,and/or Isoleucine,and/or Proline,and/or Valine known  to be employed in the types of synthetic nutritional compositions disclosed herein may be  comprised within in the gender specific synthetic nutritional compositions of the invention,in  particular,they may be pure synthetic amino acids obtained through synthesis or fermentation, or liberated from any food-grade protein source such as animal or plant proteins through  hydrolysis.
The Alanine,and/or Histidine,and/or Isoleucine,and/or Proline,and/or Valine may be intact, hydrolysed,partially hydrolysed,or any combination thereof.
The gender specific synthetic nutritional compositions of the invention can also comprise any  other ingredients or excipients known to be employed in synthetic nutritional compositions.
Non limiting examples of such ingredients include:other amino acids,proteins,carbohydrates, oligosaccharides,lipids,prebiotics or probiotics,essential fatty acids,nucleotides,nucleosides, vitamins,minerals and other micronutrients.
Non limiting examples of other amino acids include,cysteine,glutamine,glutamic acid,glycine, serine,leucine,threonine,tyrosine,arginine,lysine,methionine,phenylalanine,tryptophane, asparagine,aspartic acid,and combinations thereof.
Non limiting examples of proteins include,caseins,alpha-lactalbumin,lactoferrin,serum  albumin,whey,soy protein,rice protein,corn protein,oat protein,barley protein,wheat  protein,rye protein,pea protein,egg protein,sunflower seed protein,potato protein,fish  protein,meat protein,immunoglobins,and combinations thereof.
Non limiting examples of carbohydrates include lactose,saccharose,maltodexirin,starch,and  mixtures thereof
Non limiting examples of lipids include:palm olein,high oleic sunflower oil,high oleic safflower  oil,canola oil,fish oil,coconut oil,bovine milk fat,or mixtures thereof.
Non limiting examples of essential fatty acids include:linoleic acid(LA),α-linolenic acid(ALA) and polyunsaturated fatty acids(PUFAs).The nutritional compositions of the invention may  further contain gangliosides monosialoganglioside-3(GM3)and disialogangliosides3(GD3), phospholipids such as sphingomyelin,phospholipids phosphatidylcholine, phosphatidylethanolamine,phosphatidylinositol,phosphatidylserine,and combinations of the  foregoing.
None limiting examples of prebiotics include:oligosaccharides optionally containing fructose, galactose,mannose;dietary fibers,in particular soluble fibers,soy fibers;inulin;or mixtures  thereof.Preferred prebiotics are fructo-oligosaccharides(FOS),galacto-oligosaccharides(GOS), isomalto-oligosaccharides(IMO),xylo-oligosaccharides(XOS),arabino-xylo oligosaccharides  (AXOS),mannan-oligosaccharides(MOS),oligosaccharides of soy,glycosylsucrose(GS), lactosucrose(LS),lactulose(LA),palatinose-oligosaccharides(PAO),malto-oligosaccharides, gums and/or hydrolysates thereof,pectins and/or hydrolysates thereof,and combinations of  the foregoing.
Further examples of oligosaccharide are described in Wrodnigg,T.M.;Stutz,A.E.(1999)Angew. Chem.Int.Ed.38:827-828and in WO2012/069416which is incorporated herein by reference.
Non limiting examples of probiotics include:Bifidobacterium,Lactobacillus,Lactococcus, Enterococcus,Streptococcus,Kluyveromyces,Saccharoymces,Candida,in particular selected  from the group consisting of Bifidobacterium longum,Bifidobacterium lactis,Bifidobacterium  animalis,Bifidobacterium breve,Bifidobacterium infantis,Bifidobacterium adolescentis, Lactobacillus acidophilus,Lactobacillus casei,Lactobacillus paracasei,Lactobacillus salivarius, Lactobacillus lactis,Lactobacillus rhamnosus,Lactobacillus johnsonii,Lactobacillus plantarum, Lactobacillus salivarius,Lactococcus lactis,Enterococcus faecium,Saccharomyces cerevisiae, Saccharomyces boulardii or mixtures thereof,preferably selected from the group consisting of  Bifidobacterium longum NCC3001(ATCC BAA-999),Bifidobacterium longum NCC2705(CNCM I- 2618),Bifidobacterium longum NCC490(CNCM I-2170),Bifidobacterium lactis NCC2818(CNCM  I-3446),Bifidobacterium breve strain A,Lactobacillus paracasei NCC2461(CNCM I-2116), Lactobacillus johnsonii NCC533(CNCM I-1225),Lactobacillus rhamnosus GG(ATCC53103), Lactobacillus rhamnosus NCC4007(CGMCC1.3724),Enterococcus faecium SF68(NCC2768; NCIMB10415),and mixtures thereof.
Non limiting examples of Nucleotides include:cytidine monophosphate(CMP),uridine  monophosphate(UMP),adenosine monophosphate(AMP),guanosine monophosphate(GMP), or any mixtures thereof.
Non limiting examples of vitamins and minerals include:vitamin A,vitamin B1,vitamin B2, vitamin B6,vitamin Bi2,vitamin E.vitamin K.vitamin C,vitamin D,folic acid,inositol,niacin, biotin,pantothenic acid,choline,calcium,phosphorous,iodine,iron,magnesium,copper,zinc, manganese,chloride,potassium,sodium,selenium,chromium,molybdenum,taurine,and L- carnitine,and mixtures thereof.Minerals are usually added in salt form.
Other suitable and desirable ingredients of synthetic nutritional compositions,that may be  employed in the gender specific nutritional compositions of the invention,are described in  guidelines issued by the Codex Alimentarius with respect to the type of synthetic nutritional  composition in question e.g.Infant formula,HM fortifier,follow on formula,and food stuffs  intended for consumption by infants e.g.complementary foods.
The gender specific compositions of the invention may be prepared by methods well known in  the art for preparing that type of synthetic nutritional composition e.g.infant formulae,follow  on formulae,a composition for infants that is intended to be added or diluted with HM e.g.HM  fortifier,and food stuffs intended for consumption by infants either alone or in combination  with HM e.g.complementary foods.
An exemplary method for preparing a gender specific powdered infant formula is as follows. Amino acids(including alanine,and/or histidine,and/or isoleucine,and/or proline,and/or  valine),and/or protein source(comprising bound alanine,and/or histidine,and/or isoleucine, and/or proline,and/or valine),carbohydrate source,and fat source may be blended together in  appropriate proportions.Emulsifiers maybe included in the blend.Vitamins and minerals may  be added at this point but are usually added later to avoid thermal degradation.Any lipophilic  vitamins,emulsifiers and the like may be dissolved into the fat source prior to blending.Water, preferably water which has been subjected to reverse osmosis,may then be mixed in to form a  liquid mixture.
The liquid mixture may then be thermally treated to reduce bacterial loads.For example,the  liquid mixture may be rapidly heated to a temperature in the range of about800C to about1  100C for about5seconds to about5minutes.This may be carried out by steam injection or by  heat exchanger;for example a plate heat exchanger.
The liquid mixture may then be cooled to about600C to about850C;for example by flash cooling. The liquid mixture may then be homogenised;for example in two stages at about7MPa to  about40MPa in the first stage and about2MPa to about14MPa in the second stage.The  homogenised mixture may then be further cooled to add any heat sensitive components such as  vitamins and minerals.The pH and solids concentration in the homogenised mixture is  conveniently standardised at this point.
The homogenised mixture can be transferred to a suitable drying apparatus such as a spray  drier or freeze drier and converted to powder.The powder should have a moisture  concentration in less than about3%by weight.
If it is desired probiotic(s)can be added,they may be cultured according to any suitable method  and prepared for addition to the infant formula by freeze-drying or spray-drying for example.
Alternatively,bacterial preparations can be bought from specialist suppliers such as Christian  Hansen and Morinaga already prepared in a suitable form for addition to food products such as  infant formula.Such bacterial preparations may be added to the gender specific powdered  infant formula by dry mixing.
The gender specific compositions of the invention may also be prepared from a gender neutral  synthetic nutritional composition in a method comprising;measuring out an appropriate  amount of said gender neutral synthetic nutritional composition and mixing it with an additive  and/or diluent e.g.water so as to arrive at a gender specific nutritional composition in  accordance with the invention.
The additive may be a gender specific additive comprising caseins in a particular concentration  so that when mixed with the gender neutral synthetic nutritional composition,and optionally a  diluent,the resulting mixture is a gender specific synthetic nutritional composition of the  invention.
The gender neutral synthetic nutritional composition can be prepared by methods well known  in the art.For example,as laid out above for infant formula.
One or more of the gender specific synthetic nutritional compositions of the invention can be  included in a nutritional system.
The term“nutritional system”as used herein refers to a collection of more than one synthetic  nutritional composition advertised or sold as part of the same product range e.g.a collection of  infant formulas sold under the same brand and adapted to the nutritional needs of infants of  differing genders and/or ages.The synthetic nutritional compositions making up the nutritional  system may be packaged individually e.g.in capsules or boxes.Said packages can be sold  individually,grouped together e.g.wrapped by plastic film or combined in a box or,in a  combination of these two ways.
The nutritional system may comprise only gender specific synthetic nutritional compositions,or, it may comprise a mix of gender specific and gender neutral synthetic nutritional compositions.
The term“gender neutral”as used herein is synonymous with unisex.
In a further aspect of the present invention there is provided a nutritional system comprising at  least one of the gender specific synthetic nutritional compositions of the invention.
In an embodiment the nutritional system comprises a gender specific synthetic nutritional  composition for a male infant of up to1month of age,more particularly2weeks to1month of  age,and,a gender specific synthetic nutritional composition for a female infant of up to1  month of age,more particularly2weeks to1month of age.
In an embodiment the concentration of alanine,and/or histidine,and/or isoleucine,and/or  proline,and/or valine in said male gender specific synthetic nutritional composition is higher  than that of said female gender specific synthetic nutritional composition.
The concentration of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine  in the male gender synthetic nutritional compositions may be higher by any amount.
In an embodiment the ratio of the concentration of alanine between the female gender specific  nutritional composition and male gender specific synthetic nutritional composition is1:5.08to  1:1.0003,1:5.18to1:1.08;or1:1.7to1:1.08.
In an embodiment the ratio of the concentration of histidine between the female gender  specific nutritional composition and male gender specific synthetic nutritional composition is  1:3.9to1:1.001,1:3.9to1:1.04,or1:3.6to1:1.09.
In an embodiment the ratio of the concentration of Isoleucine between the female gender  specific nutritional composition and male gender specific synthetic nutritional composition is  1:3.07to1:1.01,1:3.07to1:1.01,or1:1.5to1:1.05.
In an embodiment the ratio of the concentration of proline between the female gender specific  nutritional composition and male gender specific synthetic nutritional composition is1:3.6to  1:1.004,1:3.6to1:1.06,or1:1.5to1:1.07.
In an embodiment the ratio of the concentration of valine between the female gender specific  nutritional composition and male gender specific synthetic nutritional composition is1.4.4to  1:1.001,1:4.4to1:1.07,or1:1.6to1:1.07.
In an embodiment the male gender specific synthetic nutritional composition contains0.001to  155.8,5.22to155.8,or5.22to81.2,mg/100g more alanine than the female gender specific  synthetic nutritional composition.
In an embodiment the male gender specific synthetic nutritional composition contains0.001to  82.1,1.2to82.1,or4.25to29.5,mg/100g more histidine than the female gender specific  synthetic nutritional composition.
In an embodiment the male gender specific synthetic nutritional composition contains0.001to  105,0.6to105,or4.18to52.2,mg/100g more Isoleucine than the female gender specific  synthetic nutritional composition.
In an embodiment the male gender specific synthetic nutritional composition contains0.001to  209.7,6.4to209.7,or7.44to108,mg/100g more proline than the female gender specific  synthetic nutritional composition.
In an embodiment the male gender specific synthetic nutritional composition contains0.001to  197.7,6.4to192.7,or6.47to99.7,mg/100g more valine than the female gender specific  synthetic nutritional composition.
In addition to that disclosed hereinabove,the referenced study further indicated that between  31days and240days postpartum there is no difference in the mean concentration of alanine, and/or histidine,and/or isoleucine,and/or proline,and/or valine in HM depending on the  gender of the mother’s infant.
In another embodiment the nutritional system further comprises gender specific synthetic  nutritional compositions for infants more than1month of age wherein,the concentration of  alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine does not differ by  gender for infants of the same age.
In another embodiment the nutritional system further comprises gender neutral specific  synthetic nutritional compositions for infants more than1month of age.
Non limiting examples of ages,or ranges thereof,more than1month,include:1-2mths,2mth, 2-4mths,3-6mths,4-6mths,4-8mths6-12mths,7-12mths.
The nutritional system may further comprise nutritional compositions for children older than  12months.
A gender specific synthetic nutritional composition and/or nutrition system according to the  invention is particularly suitable for use in a method of preparing single servings of infant  formula using capsules,each capsule of which contains a unit dose of a synthetic nutritional  composition in concentrated form,and which is equipped with opening means contained within  the capsule to permit draining of the reconstituted synthetic nutritional composition directly  from the capsule into a receiving vessel such as a baby bottle.Such a method is described in  WO2006/077259.
The different synthetic nutritional compositions,including gender specific and gender neutral  synthetic nutritional compositions,which may be comprised within a nutrition system,may be  packed into individual capsules and presented to the consumer in multipacks containing a  sufficient number of capsules to meet the requirements of an infant of a particular age or range  for one week for example.Suitable capsule constructions are disclosed in WO2003/059778.
The capsules can contain the synthetic nutritional compositions,(gender specific and gender  neutral)in the form of powders or concentrated liquids in both cases for reconstitution by an  appropriate amount of water.Both the composition and the quantity of infant formula in the  capsules may vary according to the gender and/or age of the infant.If necessary,different sizes  of capsules may be provided for the preparation of infant formulas for infants of different  genders and/or ages.
The gender specific synthetic nutritional compositions,or nutritional systems comprising them, better reflect the differences in the concentration of alanine,and/or histidine,and/or isoleucine, and/or proline,and/or valine in HM found by gender at one or more stages of lactation.As  stated herein,optimum alanine,and/or histidine,and/or isoleucine,and/or proline,and/or  valine intake is necessary to ensure the optimum growth and development of an infant.In  another aspect of the present invention there is provided a gender specific synthetic nutritional  composition and/or nutritional system as disclosed herein for use to treat,prevent or mitigate  sub optimal growth of an infant e.g.obesity.
A gender specific synthetic nutritional composition may provide an optimum amount of alanine, and/or histidine,and/or isoleucine,and/or proline,and/or valine,to an infant up to1month of  age,more particularly2weeks to1month of age.
The nutritional system may provide an optimum amount of alanine,and/or histidine,and/or  isoleucine,and/or proline,and/or valineto an infant up to12months of age,up to9months of  age,up to8months of age,up to6months of age,up to1month of age,up to2weeks of age.
In another aspect of the present invention there is provided a method for providing an optimum  amount of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine,and  thereby treating,to an infant of up to1month of age,more particularly2weeks to1month of  age,comprising:
a)Optionally preparing a gender specific synthetic nutritional compositions according to  the invention from a gender neutral synthetic nutritional composition;
b)Feeding a gender specific synthetic nutritional compositions according to the invention  to an infant up to1month of age,more particularly2weeks to1month of age.
As stated herein.The gender specific synthetic nutritional compositions may be prepared from  gender neutral synthetic nutritional compositions.Accordingly,in another aspect of the present  invention there is provided a kit for providing an optimized amount of alanine,and/or histidine, and/or isoleucine,and/or proline,and/or valine,to an infant e.g.obesity,to a male or female  infant of up to1month of age,more particularly2weeks to1month of age,the kit comprising:
a)A gender neutral synthetic nutritional composition
b)A label indicating dosage requirements for an infant so as to arrive at a gender specific  nutritional composition in accordance with the invention.
The dosage requirements may be with respect to the quantity of the gender neutral synthetic  nutritional employed and/or consumption frequency e.g.4times per day.
Subjects included in the survey referenced herein were recruited from4provinces across China. Accordingly,the gender specific synthetic nutritional compositions and/or nutritional systems  disclosed herein can be particularly relevant for Chinese infants,and or infants born in  populations having common genetic origins and/or ethnic origins and/or common dietary habits  thereto e.g.Asian,Indian,and/or Mongoloid populations.
It should be appreciated that all features of the present invention disclosed herein can be freely  combined and that variations and modifications may be made without departing from the scope  of the invention as defined in the claims.Furthermore,where known equivalents exist to  specific features,such equivalents are incorporated as if specifically referred to in this  specification.
There now follows a series of non-limiting examples that serve to illustrate the invention.
Examples
Example1
The concentration of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine  in HM samples collected from mothers to either male or females was analysed at various stages  postpartum.The HM samples were collected as part of a cross sectional survey of HM.The  study criteria is set out below:
Study population
·Number of subjects
Total540healthy subjects were enrolled,allowing a drop-out rate of10percent.They were  comprised of:
–480Lactating mothers in3cities(Beijing,Suzhou and Guangzhou)
–30mothers per city for each of the5time points(5to11days,2weeks to1month,1to2  months,2to4months and,4to8months)
Inclusion/Exclusion criteria
·Inclusion:Healthy Chinese lactating mothers without history of acute and chronic diseases; exclusively breast feeding mothers during4months after delivery were enrolled.
·Exclusion:Chinese lactating mothers having history of psychopathic tendencies and having no dietary memory.
The concentration of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or valine  in the HM samples collected as part of the above detailed study were analyzed using firstly acid  hydrolysis in6M hydrochloric acid at110℃ for22hrs with phenol antioxidant in the absence of  oxygen to liberate all protein-bound amino acids,followed secondly by high-sensitivity amino  acid analysis using derivatisation with o-Phthalaldehyde(OPA)and9-Fluorenylmethyl  Chloroformate(FMOC),and fluorescence detection(Blankenship D.T.et al.(1989)Analytical  Biochemistry178:227).
The results of the compositional analysis of the HM survey,with respect to the concentration of  Alanine,histidine,isoleucine,proline and,valine are shown in tables I,II,III,IV and,V  respectively.
Figure PCTCN2014075001-appb-000001
TableI
Figure PCTCN2014075001-appb-000002
Figure PCTCN2014075001-appb-000003
TableII
Figure PCTCN2014075001-appb-000004
Figure PCTCN2014075001-appb-000005
TableIII
Figure PCTCN2014075001-appb-000006
TableIV
Figure PCTCN2014075001-appb-000007
Figure PCTCN2014075001-appb-000008
TableV
The results of the compositional analysis were then subject to a statistical analysis employing  the following statistical model:
Concentration=sex+timeframe+timeframe+sex:timeframe–city+ε
εreferring to the residual error and sex:timeframe referring to the interaction between these2  variables.
Table VI,VII,VIII,IX,X shows the estimates for gender differences per timeframe along with the  corresponding Pvalues for alanine,histidine,isoleucine,proline and,valine respectively.
Figure PCTCN2014075001-appb-000009
Figure PCTCN2014075001-appb-000010
TableVI
Figure PCTCN2014075001-appb-000011
Figure PCTCN2014075001-appb-000012
TableVII
Figure PCTCN2014075001-appb-000013
TableVIII
Figure PCTCN2014075001-appb-000014
Figure PCTCN2014075001-appb-000015
TableIX
Figure PCTCN2014075001-appb-000016
Figure PCTCN2014075001-appb-000017
TableX
A P-value inferior to0.1for a particular timeframe suggests that there is a statistically significant  difference in the concentration of alanine,histidine,isoleucine,proline,or valine in HM  produced for males and females infants at that specific timeframe.
As can be seen from the results in table II,a statistically significant difference in the mean  alanine,histidine,isoleucine,proline,and valine concentration between HM produced for male  and female infants was identified at2weeks to1month postpartum.No statistically significant  difference was identified in the mean concentration between HM produced for male and  female infants older than30days postpartum Viz.1to2months,2to4months and4to8  months.
Example2
Examples of gender specific infant formulas are given in table XI
Figure PCTCN2014075001-appb-000018
Figure PCTCN2014075001-appb-000019
Figure PCTCN2014075001-appb-000020
TableXI
Example3
An example of a nutritional system in accordance with the invention is given in table XII.
Figure PCTCN2014075001-appb-000021
Figure PCTCN2014075001-appb-000022
TableXII

Claims (13)

  1. A gender specific synthetic nutritional composition for an infant up to1month of age  wherein,the concentration of alanine,and/or histidine,and/or isoleucine,and/or  proline,and/or valine is adapted based on that found in human milk produced for an  infant of the same gender and age.
  2. A gender specific synthetic nutritional composition according to claim1wherein,if the  concentration of alanine is adapted to a male infant it is32.7to193.1,mg per100g and, if the concentration of alanine is adapted to a female infant it is32.7to111.9,mg per  100g;if the concentration of histidine is adapted to a male infant it is29.4to110.3,mg  per100g and,if the concentration of histidine is adapted to a female infant it is28.2to  80.8,mg per100g;if the concentration of isoleucine is adapted to a male infant it is51.1  to155.5,mg per100g and,if the concentration of isoleucine is adapted to a female  infant it is50.5to103.3,mg per100g;if the concentration of proline is adapted to a  male infant it is87.5to290.8,mg per100g and,if the concentration of proline is  adapted to a female infant it is81.1to182.8,mg per100g;if the concentration of valine  is adapted to a male infant it is51.5to249.6,mg per100g and,if the concentration of  valine is adapted to a female infant it is56.9to149.9,mg per100g.
  3. A composition according to claim1or2wherein,the gender specific synthetic  nutritional composition is selected from the groups consisting of:infant formula,and a  composition for infants that is intended to be added to or diluted with human milk.
  4. A method of preparing a composition as defined in any one of claims1to3comprising: measuring out an appropriate amount of a gender neutral synthetic nutritional  composition and mixing it with an additive and/or diluent.
  5. A nutritional system comprising a gender specific synthetic nutritional composition as  defined in any one of claims1to3.
  6. A nutritional system according to claim5comprising one gender specific synthetic  nutritional composition for a male infant of up to1month of age as defined in claim1or  2and,one gender specific nutritional composition for a female infant of up to1month  as defined in claim1or2wherein,the concentration of alanine,and/or histidine,and/or  isoleucine,and/or proline,and/or valine in the synthetic nutritional composition for a  male infant is higher than in that for the female infant.
  7. A nutritional system according to claim5or6further comprising gender specific  synthetic nutritional compositions for infants more than1month of age wherein,the  concentration of alanine,and/or histidine,and/or isoleucine,and/or proline,and/or  valine in said gender specific synthetic nutritional compositions does not differ by  gender for infants of the same age.
  8. A nutritional system according to any one of claims5to7further comprising gender  neutral synthetic nutritional compositions for infants of more than1month of age.
  9. Use of a gender specific synthetic nutritional composition as defined in anyone of claims  1to3to provide an optimum amount of alanine,and/or histidine,and/or isoleucine, and/or proline,and/or valine to aninfant of up to1month of age.
  10. A gender specific synthetic nutritional composition as defined in anyone of claims1to3  for use to treat,protect or mitigate sub optimal growth and development of an infant.
  11. A method for providing an optimum amount of alanine,and/or histidine,and/or  isoleucine,and/or proline,and/or valine to an infant of up to1month of age comprising:
    a.Optionally preparing a gender specific nutritional compositions as defined in any  one of claims1to3from a gender neutral synthetic nutritional composition;
    b.Feeding a gender specific nutritional compositions as defined in any one of claims  1to3to an infant of up to1month of age.
  12. A nutritional system as defined in anyone of claims5to8for use to treat,protect or  mitigate sub optimal growth and development of a male or female infant.
  13. A kit for providing an optimized amount of alanine,and/or histidine,and/or isoleucine, and/or proline,and/or valine to aninfant of up to1month of age,the kit comprising:
    a.A gender neutral synthetic nutritional composition
    b.A label indicating dosage requirements for an infant so as to arrive at a gender  specific nutritional composition as defined in any one of claims1to3.
PCT/CN2014/075001 2014-04-09 2014-04-09 Gender specific synthetic nutritional compositions and nutritional systems comprising them Ceased WO2015154259A1 (en)

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PCT/CN2014/075001 WO2015154259A1 (en) 2014-04-09 2014-04-09 Gender specific synthetic nutritional compositions and nutritional systems comprising them
EP15776083.6A EP3128857A4 (en) 2014-04-09 2015-04-08 Gender specific synthetic nutritional compositions and nutritional systems comprising them
AU2015245736A AU2015245736A1 (en) 2014-04-09 2015-04-08 Gender specific synthetic nutritional compositions and nutritional systems comprising them
RU2016143828A RU2709988C2 (en) 2014-04-09 2015-04-08 Gender specific synthetic nutritional compositions and nutritional systems comprising them
US15/301,557 US20170172194A1 (en) 2014-04-09 2015-04-08 Gender specific synthetic nutritional compositions and nutritional systems comprising them
CN201580018729.4A CN106455657A (en) 2014-04-09 2015-04-08 Gender specific synthetic nutritional compositions and nutritional systems comprising them
PCT/CN2015/076058 WO2015154667A1 (en) 2014-04-09 2015-04-08 Gender specific synthetic nutritional compositions and nutritional systems comprising them
MX2016012340A MX388551B (en) 2014-04-09 2015-04-08 GENDER-SPECIFIC SYNTHETIC NUTRITIONAL COMPOSITIONS AND SYSTEMS THAT COMPRISE THEM.
AU2015101946A AU2015101946A4 (en) 2014-04-09 2015-04-08 Gender specific synthetic nutritional compositions and nutritional systems comprising them
PH12016501921A PH12016501921A1 (en) 2014-04-09 2016-09-28 Gender specific synthetic nutritional compositions and nutritional systems comprising them
AU2018102083A AU2018102083A6 (en) 2014-04-09 2018-12-18 Gender specific synthetic nutritional compositions and nutritional systems comprising them
AU2018102079A AU2018102079A6 (en) 2014-04-09 2018-12-18 Gender specific synthetic nutritional compositions and nutritional systems comprising them
AU2018102085A AU2018102085A6 (en) 2014-04-09 2018-12-18 Gender specific synthetic nutritional compositions and nutritional systems comprising them
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Publication number Priority date Publication date Assignee Title
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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1358067A (en) * 1999-04-29 2002-07-10 雀巢制品公司 Compositions for infant formulas with low threonine content
EP2382874A1 (en) * 2003-06-23 2011-11-02 Nestec S.A. Amino acid supplementation for a healthy microbiota ecosystem
CN103260437A (en) * 2010-10-14 2013-08-21 阿莎营养科学公司 Optimized nutritional formulations, methods for selection of tailored diets therefrom, and methods of use thereof

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5132113A (en) * 1990-10-26 1992-07-21 Maurizio Luca Nutritional composition containing essential amino acids
CN1280788A (en) * 1999-07-01 2001-01-24 葆婴有限公司 Health-care food for baby and its application method
US6511696B2 (en) * 2000-12-13 2003-01-28 Novartis Nutrition Ag Infant formula with free amino acids and nucleotides
EP1638415B1 (en) * 2003-06-23 2010-12-15 Nestec S.A. Infant or follow-on formula
EP1634599A1 (en) * 2004-08-20 2006-03-15 N.V. Nutricia Iimmune stimulatory infant nutrition
EP1787114A1 (en) * 2004-09-10 2007-05-23 Medela Holding AG Method for analysing and treating human milk and system therefore
ES2525223T3 (en) * 2006-08-04 2014-12-19 Shs International Ltd. Protein free formula
CN101313721B (en) * 2008-07-09 2012-06-27 内蒙古蒙牛乳业（集团）股份有限公司 Liquid milk with additive serum albumin suitable for baby of birth time to 6 months ages
WO2011119023A1 (en) * 2010-03-26 2011-09-29 N.V. Nutricia Low protein infant formula with increased essential amino acids
CN103458890A (en) * 2011-04-12 2013-12-18 雀巢产品技术援助有限公司 Nutritional compositions including branched chain fatty acids and methods of using same
CN103404595B (en) * 2013-07-29 2015-04-15 北安宜品努卡乳业有限公司 Dedicated infant formula for infant boys
ES2743206T3 (en) * 2013-12-12 2020-02-18 Nestle Sa Synthetic milk compositions for optimal growth and development and prevention of obesity in infants and children, male and female

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1358067A (en) * 1999-04-29 2002-07-10 雀巢制品公司 Compositions for infant formulas with low threonine content
EP2382874A1 (en) * 2003-06-23 2011-11-02 Nestec S.A. Amino acid supplementation for a healthy microbiota ecosystem
CN103260437A (en) * 2010-10-14 2013-08-21 阿莎营养科学公司 Optimized nutritional formulations, methods for selection of tailored diets therefrom, and methods of use thereof

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