TECHNICAL FIELD OF THE INVENTION
The present invention relates to a human milk fortifier composition, more specifically to a human milk fortifier composition comprising human milk oligosaccharides. In particular the present invention relates to a human milk fortifier composition specifically tailored to fortify the breastmilk of a primiparous woman, and for consumption by an infant or child born who is the offspring of a primiparous mother. The invention furthermore relates to the use of said human milk fortifier composition.
BACKGROUND OF THE INVENTION
Infants who are the offspring of primiparous woman are considered to be at an increased risk of suffering from a variety of health complaints in infancy, childhood, and later life. Infants born of primiparous mothers are more likely to be smaller and/or thinner at birth, and so at an increased risk of suffering from conditions associated with being small and/or underweight, and at the same time are also more likely to be larger children and suffer from conditions associated with being larger e.g. being overweight or obese—this is because of dramatic catch-up gains in weight and length that overcompensate for their initial size deficit.
The reasons for the increased health risks seen in infants who are the offspring of primiparous mothers is not clear. However, there is a need to identify factors that may contribute to this risk and to address them.
The inventors have now identified a factor that they believe may contribute to this risk. In particular the inventors have found that the concentration of one or more human milk oligosaccharides (herein after “HMOs”) found in human breast milk (hereinafter “HM”) produced by primiparous mothers, may differ from the concentration found in HM produced by multiparous mothers. More particularly the inventors have found that the concentration of an HMO found in HM produced by primiparous mothers may be lower than the concentration of the same HMO found in HM produced by multiparous mothers.
HMOs are, collectively, the third largest solid constituents in human milk, and a variety of benefits have been associated with them, in consequence, an optimal intake of these compounds in infancy and childhood is believed to be necessary to ensure optimum health and development. HMOs have for example been linked to a variety of biological functions including the establishment of gut microbiota. Some HMOs have also been linked to growth and body composition.
Accordingly, there is need for milk fortifiers comprising one or more HMO that can be used to fortify HM produced by primiparous mothers, and to optimise the intake of one or more HMO in infants consuming HM from a primiparous mother.
SUMMARY OF THE INVENTION
The invention is set out in the claims and in the detailed description included herein. The inventors have found that the concentration of an HMO found in HM produced by multiparous mothers may be higher than the concentration of the same HMO found in HM produced by primiparous mothers. In light of this finding, the inventors have developed a human milk fortifier composition comprising one or more HMOs.
Said human milk fortifier may be tailored to fortify the breast milk of a primiparous women.
The one or more HMO may be a sialylated oligosaccharide, a fucosylated oligosaccharide, an N-acetylated oligosaccharide, or any combination thereof. The one or more HMO may for example be selected from the group consisting of; 2′-Fucosyllactose, 3′-Fucosyllactose, 6′Galactosyllactose, Blood group A Tetrasaccharide, Difucosyllacto-N-Hexose-A, Lacto-N-Difucosylhexose, Lacto-N-Fucosylpentaose-I, Lacto-N-Fucosylpentaose-II, Lacto-N-Fucosylpentaose-III, Lacto-N-Fucosylpentaose-V, Lacto-N-hexaose A, Lacto-N-hexaose B, Lacto-N-Neodifucosylhexose, Lacto-N-Neofucosylpentaose, Lacto-N-Neotetraose, Lacto-N-Tetraose, Lactodifucosyllactose, Sialyllacto-N-Tetraose a, Sialyllacto-N-Tetraose b, and any combination thereof.
It may be particularly beneficial if the HMO is selected from the group consisting of; 3′-Fucosyllactose, Lacto-N-Fucosylpentaose, and any combination thereof.
The human milk fortifier composition may comprise an HMO in a range of 0.1 to 10000 mg/L.
The human milk fortifier may be specifically tailored for up an infant of an age selected from the group consisting of; up to 4 months of age, up to 3 months of age, up to 2 months of age, up to 1 months of age, up to 2 weeks of age, and up to 1 week of age. It may for example be specifically tailored to supplement breastmilk produced for up an infant of up to one month of age or up to 2 weeks of age. The infant may be an infant of a primiaparous woman.
The human milk fortifier may further comprise one or more ingredient selected from the group consisting of vitamins, minerals, protein, carbohydrates, and probiotics.
Further provided is a method of preparing a human milk fortifier composition tailored to fortify the breast milk of a primiparous women, said method comprising the steps of: measuring out an appropriate amount of a human milk fortifier composition and mixing it with a diluent and/or additive.
Also provided is a human milk fortifier as defined herein, for use in fortifying human breast milk and in particular human breastmilk from a primiparous woman.
The human milk fortifier as defined herein may to provide an optimised amount of one or more HMO to an infant. The infant may be selected from the group consisting of: preterm infants and term infants. The infant may be an infant who is the offspring of a primiparous mother.
Also provided is a nutritional system comprising:
a. a human milk fortifier composition tailored to fortify the breast milk of a primiparous women, and b. A human milk fortifier composition, wherein, said human milk fortifier composition tailored to fortify the breast milk of a primiparous women comprises one or more HMO in a concentration higher than in the human milk fortifier composition. The method may also comprise the step of determining whether the woman is a primiaparous woman.
DRAWINGS
FIG. 1 is a graphical representation of the 2′-fucosyllactose concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 2 is a graphical representation of the 3-Fucosyllactose concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 3 is a graphical representation of the 6′Galactosyllactose concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 4 is a graphical representation of the Blood group A Tetrasaccharide concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 5 is a graphical representation of the Difucosyllacto-N-Hexose-A concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 6 is a graphical representation of the Lacto-N-Difucosylhexose concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 7 is a graphical representation of the Lacto-N-Fucosylpentaose-I concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 8 is a graphical representation of the Lacto-N-Fucosylpentaose-II concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 9 is a graphical representation of the Lacto-N-Fucosylpentaose-III concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 10 is a graphical representation of the Lacto-N-Fucosylpentaose-V concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 11 is a graphical representation of the Lacto-N-hexaose A concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 12 is a graphical representation of the Lacto-N-hexaose B concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 13 is a graphical representation of the Lacto-N-Neodifucosylhexose concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 14 is a graphical representation of the Lacto-N-Neofucosylpentaose concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 15 is a graphical representation of the Lacto-N-Neotetraose concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 16 is a graphical representation of the Lacto-N-Tetraose concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 17 is a graphical representation of the Lactodifucosyllactose concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 18 is a graphical representation of the Sialyllacto-N-Tetraose a concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
FIG. 19 is a graphical representation of the Sialyllacto-N-Tetraose b concentration found in HM by delivery mode at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum.
DETAILED DESCRIPTION
In a first aspect of the present invention there is provided a human milk fortifier composition comprising one or more HMO.
The term “human milk fortifier composition” as used herein, refers to a nutritional composition for use in combination and in admixture with human breast milk. Unless otherwise specified, the term “human milk fortifier composition” specifically excludes conventional infant formulas that provide the sole or primary source of infant nutrition and that are not typically combined and admixed with human milk to supplement human milk feedings.
The term “fortifier” refers to a composition which comprises one or more nutrients having a nutritional benefit for infants, both preterm infants and term infants. The fortifier according to the present invention is rich in HMOs and may therefore be considered as an HMO fortifier, HMO supplement or the like.
In an embodiment of the invention, the human milk fortifier composition is tailored/adapted to fortify the breast milk of a primiparous women. A human milk fortifier, as disclosed herein, may be considered as specifically tailored/adapted to fortify the breast milk of a woman who is primaprous if it comprises one or more HMO as described herein. Said human milk fortifier may, for example, comprise said one or more HMO in an amount sufficient to address the deficiency of one or more HMO identified in the human breast milk of primiaparous mothers in comparison to multiparous mothers. A sufficient amount of an HMO may for example be an amount equal to or greater than an amount that an infant born to a multiparous woman would receive, or may for example, be any amount that is equal to or higher than the difference found in the concentration e.g. averages, in human milk produced by primparous women and multiparous women. Said human milk fortifier composition may be a parity specific human milk fortifier i.e. a milk fortifier sold specifically for use in primiparous women e.g. marketed as a being for use to fortify the breastmilk of primiparous women
The term “multiparous” as used herein refers to a woman who has given birth more than once or has more than 1 child.
The term “primiparous” as used herein refers to a woman who has given birth once, or has only 1 child.
The term “infant” as used herein, refers to humans of less than about 1 year of age. The term includes preterm infants, premature infants, small for gestational age (SGA) infants and/or infant with low birth weight (LBW).
The terms “preterm infants” or “premature infants” as used herein, refer to infants who were not born at term. Generally they refers to infants born alive prior to 37 weeks of gestation/pregnancy.
The term “small for gestational age infant” as used herein, refers to an infant who is smaller in size than normal for their gestational age at birth, most commonly defined as a weight below the 10th percentile for the gestational age. In some embodiments, SGA may be associated with intrauterine growth restriction (IUGR), which refers to a condition in which a foetus is unable to achieve its potential size.
The term “low birth weight infants” as used herein refers to an infant that has a body weight under 2500 g at birth. It therefore encompasses:
- infants who have/had a body weight from 1800 to 2500 g at birth (usually called “low birth weight” or LBW)
- infants who have/had a body weight from 1000 to 1800 g at birth (called “very low birth weight” or VLBW)
- infants who have/had a body weight under 1000 g at birth (called “extremely low birth weight” or ELBW) Infants or young children with low birth weight may or may not be preterm, and similarly, infants or young children who were small for gestational age may or may not be preterm.
The term “child” as used herein, refers to humans from about 1 to about 7 year of age, for example, between 1 and 3 years of age.
The human milk fortifier composition of the invention may comprise any type of HMO.
In an embodiment of the present invention the human milk fortifier comprise a HMO selected from the group consisting of a sialylated oligosaccharide, a fucosylated oligosaccharide, an N-acetylated oligosaccharide, or any combination of the foregoing.
The term “sialylated oligosaccharide” as used herein refers to an oligosaccharide having a sialic acid (such as N-acetylneuraminic acid and/or N-glycolylneuraminic acid) residue.
The term “N-acetylated” oligosaccharide as used herein refers to an oligosaccharide having at least one hexose carrying an N-acetyl residue.
The term “fucosylated oligosaccharide” as used herein refers to an oligosaccharide having a fucose residue.
In a more specific embodiment the human milk fortifier composition of the invention comprises an HMO selected from the group consisting of: 2′-Fucosyllactose, 3-Fucosyllactose, 6′Galactosyllactose, Blood group A Tetrasaccharide, Difucosyllacto-N-Hexose-A, Lacto-N-Difucosylhexose, Lacto-N-Fucosylpentaose-I, Lacto-N-Fucosylpentaose-II, Lacto-N-Fucosylpentaose-III, Lacto-N-Fucosylpentaose-V, Lacto-N-hexaose A, Lacto-N-hexaose B, Lacto-N-Neodifucosylhexose, Lacto-N-N eofucosylpentaose, Lacto-N-Neotetraose, Lacto-N-Tetraose, Lactodifucosyllactose, Sialyllacto-N-Tetraose a, Sialyllacto-N-Tetraose b, and any combination thereof.
In an even more specific embodiment the human milk fortifier composition of the invention comprises an HMO selected from the group consisting of: 3-Fucosyllactose, Lacto-N-Fucosylpentaose II, 2′-Fucosyllactose and any combination thereof.
The human milk fortifier composition of the invention may comprise an HMO in any concentration.
In particular the human milk fortifier composition may comprise one an HMO in a concentration of 0.1 to 10000 ring/L e.g. 0.1 to 6000 mg/L e.g. 0.1 to 350 mg/L.
The concentrations listed herein may refer to a concentration after a composition has been reconstituted or mixed with water or milk.
The human milk fortifier composition of the invention may for example comprise one or more of the HMOs listed in table I in a concentration range listed in table I.
TABLE I
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HMO
Concentration Range mg/L
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2′-Fucosyllactose
9-8500
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3-Fucosyllactose
1-3600
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6′Galactosyllactose
0.09-250
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Blood group A Tetrasaccharide
1-1000
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Difucosyllacto-N-Hexose-A
0.4-1100
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Lacto-N-Difucosylhexose
20-3000
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Lacto-N-Fucosylpentaose-I
0.4-4300
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Lacto-N-Fucosylpentaose-II
32-3600
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Lacto-N-Fucosylpentaose-III
13-800
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Lacto-N-Fucosylpentaose-V
1.5-500
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Lacto-N-hexaose A
0.15-200
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Lacto-N-hexaose B
0.3-120
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Lacto-N-Neodifucosylhexose
0.3-330
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Lacto-N-Neofucosylpentaose
0.1-65
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Lacto-N-Neotetraose
0.1-700
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Lacto-N-Tetraose
4-3400
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Lactodifucosyllactose
2-3300
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Sialyllacto-N-Tetraose a
1.5-1900
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Sialyllacto-N-Tetraose b
0.7-180
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In an embodiment of the present invention the human milk fortifier composition of the invention may comprise one or more of the HMOs listed in table II in the concentration range listed in table II.
TABLE II
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HMO
Concentration Range mg/L
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2′-Fucosyllactose
9-350
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3-Fucosyllactose
51-230
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6′Galactosyllactose
0.09-11
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Blood group A Tetrasaccharide
1.5-22
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Difucosyllacto-N-Hexose-A
0.4-9
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Lacto-N-Difucosylhexose
20-160
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Lacto-N-Fucosylpentaose-I
0.4-75
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Lacto-N-Fucosylpentaose-II
14-190
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Lacto-N-Fucosylpentaose-III
13-16
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Lacto-N-Fucosylpentaose-V
1.5-22
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Lacto-N-hexaose A
2-4
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Lacto-N-hexaose B
1-4.5
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Lacto-N-Neodifucosylhexose
1.1-9
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Lacto-N-Neofucosylpentaose
1.8-6
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Lacto-N-Neotetraose
0.1-6
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Lacto-N-Tetraose
23-125
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Lactodifucosyllactose
2-38
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Sialyllacto-N-Tetraose a
1.5-36
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Sialyllacto-N-Tetraose b
0.7-11
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The human milk fortifier of the invention may be tailored to fortify breastmilk produced for an infant or child of any age e.g. any age born to a primparous mother
In an embodiment of the present invention the human milk fortifier composition is tailored/adapted to fortify breastmilk produced for an infant of an age selected from the group consisting of; up to 4 months of age, up to 3 months of age, up to 2 months of age, up to 1 months of age, up to 2 weeks of age, up to 1 week of age. For example the human milk fortifier composition may be tailored/adapted to fortify breastmilk produced for an infant up to 1 month of age e.g. up to 2 weeks of age. The infant may be born to a primparous mother.
In an embodiment of the present invention the human milk fortifier is tailored/adapted for an infant of up to 1 month of age e.g. an infant up to 2 weeks of age, or an infant up to 1 week of age and said composition comprises one or more HMO selected from the group consisting of 3-Fucosyllactose, Lacto-N-Fucosylpentaose II, 2′-Fucosyllactose, and any combination thereof. In a more specific embodiment said HMOs, if present in said human milk fortifier tailored/adapted for an infant of up to 1 month of age, may be present in a concentration range as set out in table III.
TABLE III
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HMO
Concentration Range mg/L
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3-Fucosyllactose
51-230
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Lacto-N-Fucosylpentaose II
14-190
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2′-Fucosyllactose
9-350
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|
The human milk fortifier composition of the invention can also comprise any other ingredients or excipients known to be employed in human milk fortifier compositions.
Non limiting examples of such ingredients include: proteins, amino acids, carbohydrates, lipids, prebiotics or probiotics, essential fatty acids, nucleotides, nucleosides, vitamins, minerals and other micronutrients.
In an embodiment of the invention the human milk fortifier composition further comprises one or more ingredient selected from the group consisting of vitamins, minerals, protein, carbohydrates, and probiotics.
Non limiting examples of proteins include: casein, alpha-lactalbumin, 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, lactoferrin, serum albumin, immunoglobins, and combinations thereof.
Non limiting examples of amino acids include leucine, threonine, tyrosine, Isoleucine, arginine, alanine, histidine, isoleucine, proline, valine, cysteine, glutamine, glutamic acid, glycine, serine, arginine, lysine, methionine, phenylalanine, tryptophane, asparagine, aspartic acid, and combinations thereof.
Non limiting examples of carbohydrates include lactose, saccharose, maltodexirin, starch, and combinations 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, and combinations thereof.
Non limiting examples of essential fatty acids include: linoleic acid (LA), a-linolenic acid (ALA) and polyunsaturated fatty acids (PUFAs). The gender specific synthetic nutritional compositions of the invention may further contain gangliosides monosialoganglioside-3 (GM3) and disialogangliosides 3 (GD3), phospholipids such as sphingomyelin, phospholipids phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol, phosphatidylserine, and combinations thereof.
None limiting examples of prebiotics include: oligosaccharides (other than HMOs) optionally containing fructose, galactose, mannose; dietary fibers, in particular soluble fibers, soy fibers; inulin; and combinations 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.
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 (CGMCC 1.3724), Enterococcus faecium SF 68 (NCC2768; NCIMB10415), and combinations thereof.
Non limiting examples of Nucleotides include: cytidine monophosphate (CMP), uridine monophosphate (UMP), adenosine monophosphate (AMP), guanosine monophosphate (GMP), and combinations 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, L-carnitine, and combinations thereof. Minerals are usually added in salt form.
Other suitable and desirable ingredients of human milk fortifier compositions, that may be employed in the human milk fortifier compositions of the invention, are described in guidelines issued by the Codex Alimentarius.
The human milk fortifier composition of the invention may be prepared in any way known in the art to prepare human milk fortifier compositions. It is well within the purview of the skilled person to decide on a method depending on the type of human milk fortifier in question e.g. powder or liquid. An exemplary method for preparing a human milk fortifier in accordance with the invention is set out below.
A human milk fortifier may be prepared, for example, by blending together lipid, protein, HMOs, and carbohydrate in appropriate proportions. If used, emulsifiers may be included in the blend at this stage. The vitamins and minerals may be added at this stage but are usually added later to avoid thermal degradation. Any lipophilic vitamins, such as vitamin A, D, E and K, and emulsifiers 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 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 on the range of about 80° C. to about 110° C. for about 5 seconds to about 5 minutes. 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 about 60° C. to about 85° C., for example by flash cooling. The liquid mixture may then be homogenised, for example in two stages at about 7 MPa to about 40 MPa in the first stage and about 2 MPa to about 14 MPa in the second stage. The homogenised mixture may then be further cooled and any heat sensitive components, such as vitamins and minerals may be added. The pH of the homogenised mixture is conveniently standardised at this point.
The homogenized liquid mixture is then filled into suitable containers, preferably aseptically. However, the liquid composition may also be reported in the container. Suitable apparatus for carrying out filling of this nature is commercially available.
A human milk fortifier composition specifically tailored/adapted to fortify the breast milk of a primiparous women may be prepared from a human milk fortifier composition e.g. a human milk fortifier composition not specifically tailored to fortify the breast milk of a woman of a particularly parity e.g. primiparous or multiparous.
Accordingly, in another aspect of the present invention there is provided a method of preparing a human milk fortifier composition tailored to fortify the breast milk of a primiparous women, said method comprising the steps of: measuring out an appropriate amount of a human milk fortifier composition e.g. a human milk fortifier composition not specifically tailored to fortify the breast milk of a woman of a particular parity, and mixing it with an additive and/or a diluent e.g. one or more HMOs and/or water, so as to arrive at a human milk fortifier composition tailored to fortify the breast milk of a primiparous woman in accordance with the invention.
The additive may be a one or more HMO e.g. one or more HMO in a concentration such, that that when the additive is mixed with a human milk fortifier composition, and optionally a diluent, the resulting mixture is a human milk fortifier tailored to fortify the breast milk of a primiparous women, in accordance with the invention.
The additive may be a parity specific additive e.g. an additive marketed as specifically being for use by primiparous women.
In another aspect of the present invention there is provided a human milk fortifier in accordance with the invention, for use in fortifying human breast milk.
In an embodiment the human breastmilk is breastmilk from primiparous women.
In another aspect of the present invention there is provided a human milk fortifier composition in accordance with the invention, for use to provide an optimised amount of and/or to prevent a sub-optimal intake of one or more HMO to an infant or child who is the offspring of a primiparous mother.
An optimised amount of one or more HMO would be an amount equal to or greater than an amount e.g. the average amount, that an infant born to a multiparous woman would be considered to receive e.g. an amount of an HMO set out in table I, II or III included herein.
In another aspect of the present invention there is provided a human milk fortifier composition in accordance with the invention, for use in optimising the health and development and/or preventing the sub-optimal health and development e.g. growth and development of an infant or child who is the offspring of a primiparous mother.
The human milk fortifier compositions of the invention may not only optimise the health and development of an infant or child who is the offspring of a primiparous mother in the short term, but may also do so in the long term.
In another aspect of the present invention there is provided a human milk fortifier composition in accordance with the invention, for use in optimising the gut microbiota and/or preventing sub-optimal gut microbiota in an infant or child who is the offspring of a primiparous mother. HMOs are known to be important for the establishment of gut microbiota and therefore an optimal supply of HMOs may lead to an optimised gut microbiota.
In another aspect of the present invention there is provided the use of a human milk fortifier composition in accordance with the invention, in the manufacture of a composition for use in optimising the gut microbiota and/or health and development of an infant or child who is the offspring of a primiparous mother.
A non-optimal gut microbiota may be one showing presence of one or several pathobionts and/or opportunistic pathobionts and/or their toxins and/or virulence factors and/or antibiotic resistence genes. An optimal gut microbiota may be one not showing presence of one or several pathobionts and/or opportunistic pathobionts and/or their toxins and/or virulence factors and/or antibiotic resistence genes.
The human milk fortifier compositions of the invention may not only optimise gut microbiota composition and/or health and development short term, but may also do so in the long term.
Long term effects may only be evident in months or years e.g. 6 months, 9 months, 12 months, 5 years, 10 years, or 20 years
In another aspect of the present invention there is provided the use of a human milk fortifier composition in accordance with the invention, to fortify human breast milk and to improve/prevent sub-optimal breastmilk quality wherein, said breastmilk is from a primiparous women.
The quality of breastmilk in a primparous woman may be considered sub-optimal if it comprises one or more HMO in a concentration less than that found in breastmilk from a multiparous woman e.g. in a concentration less than the average found in multiparous women.
In another aspect of the present invention there is provided the use of a human milk fortifier according to the invention in optimising and/or preventing the sub-optimal health and development and/or the gut flora composition in an infant or child who is the offspring of a primiparous mother.
As stated previously, some HMOs have also been linked to growth and body composition. In particular the intake of some HMOs have been positively linked to weight, lean mass and fat mass. In particular Lacto-N-Fucosylpentaose-II has been linked to increased size and in particular increased fat mass.
In another aspect of the present invention there is provided a human milk fortifier according to the invention for use in optimising and/or preventing the sub-optimal growth of an infant or child who is the offspring of a primiparous mother. In an embodiment the human milk fortifier according to the invention comprises Lacto-N-Lacto-N-Fucosylpentaose-II. In a more specific embodiment the human milk fortifier is tailored/adapted to fortify the human breast milk produced for an infant of up to 4 months of age, more specifically up to 1 month of age e.g. up to 2 weeks of age.
An infants or child's growth and development may be optimised if for example said infants or child's weight and length is within growth curves developed by the WHO.
Optimized growth refers to the criteria set by the WHO and they are depicted as charts of the growth of breastfed infants with the appropriate age- and sex-specific weight, length and head circumference. The WHO growth charts are international standards that show how healthy infants should grow, describing the growth of infants living in environments believed to support optimal growth.
If an infant or child's weight and length is within the growth curves developed by the WHO, and he/she has an appropriate distribution of lean and fat mass, it may be assumed that this child/infant is growing and developing in a healthy way, and may have a lower risk for later adverse metabolic outcomes.
Health and development and/or gut flora composition and/or growth may be optimised short term or long term.
A human milk fortifier tailored to fortify the breastmilk of a primiparous woman may be included in a nutritional system.
The term “nutritional system” as used herein refers to a collection of more than one synthetic nutritional compositions advertised or sold as part of the same product range e.g. a collection of human milk fortifiers and/or infant formulas sold under the same brand and adapted/tailored to the nutritional needs of infants born to different parity mothers e.g. primiparous or multiparous mothers. 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 also comprise synthetic nutritional compositions for children older than 12 months.
In a further aspect of the present invention there is provided a nutritional system comprising:
- a. a human milk fortifier composition tailored to fortify the breast milk of a primiparous women, in accordance with the invention, and
- b. a human milk fortifier composition e.g. a human milk fortifier composition not specifically tailored to fortify the breast milk of a woman of a specific parity or specifically tailored to fortify the offspring of a multiparous woman,
wherein,
said human milk fortifier composition tailored to fortify the breast milk of a primiparous women comprises one or more HMO in a concentration higher than in the human milk fortifier composition e.g. human milk fortifier composition not specifically tailored to fortify the breast milk of a woman of a specific parity.
The concentration of one or HMO in the human milk fortifier tailored for a primiparous woman may be higher by any amount.
In an embodiment the human milk fortifier composition tailored for a primiparous woman comprises one or more HMO listed in table II in a higher amount. The higher amount may be an amount within the range given in table II for the HMO in question.
In a more specific embodiment the human milk fortifier composition tailored for a multiparous woman comprises one or more HMO listed in table III in a higher amount. The higher amount may be an amount within the range given in table III for the HMO in question.
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
Example 1
Longitudinal Clinical Trial:
The present inventors designed a longitudinal clinical trial with lactating mothers with milk sampling at 2 days (V1), 17 days (V2), 30 days (V3) 60 days (V4), 90 days (V5), and 120 days (V6) postpartum. The milk samples were quantitatively analyzed for HMOs.
The data presented here is from a multi-center, exploratory study with the primary objective of characterizing key nutrient components in human breast milk. Healthy women of any ethnicity having decided to exclusively breast-feed their new born infant from birth to 4 months of infant's age were recruited during the last 3 months of pregnancy, and their infants were followed up until 4 months of age.
Breast milk samples were collected from the mother at the following days postpartum: 0-3 (V1), 17±3 (V2), 30±3 (V3), 60±5 days (V4), 90±5 days (V5) and 120±5 days (v6). Samples were collected after full expression from one breast using a milk pump (Symphony Breastpump, Medela), while the baby was fed on the other breast to produce a satisfactory let-down. All efforts were made to collect complete feed that included fore-, mid-, and hind-milk as a representation of one feed and to avoid within feed variation of lipid and other nutrient contents. Approximately 30 mL aliquot was separated into two conical 15 mL polypropylene tubes for analysis and the rest was returned to the mother to feed the infant. Samples collected for research were stored at −80° C. and shipped on dry ice for analyses to the Nestlé Research Center, Lausanne, Switzerland.
Information on parity (primiparous versus multiparous) were collected along with other maternal sociodemographic and anthropometric characteristics. The concentrations of HMOs were measured in breast milk at all the time points as described below.
HMO were analysed by ulta high performance liquid chromatography (UHPLC) with fluorescence detection (FLD) after labelling with anthranilamide (2AB). Milk samples (50 μL) or HMO standard solutions (50 μL) were mixed with laminaritriose solution (0.5 μmol/mL; 50 μL) used as internal standard. 2AB labelling solution (2AB, 0.35 mol/L+sodium cyanoborohydride, 1.0 mol/L in DMSO containing 30% acetic acid; 200 μL) was added and the solution heated at 65° C. for 2 h. After 2 h the samples (and standards) were cooled to 4° C. for 10 min and diluted with a solution of acetonitrile/water (75/25; 600 μL). After mixing well, the solutions were placed in a centrifuge (10000×g; 5 min) to remove particulates and the supernatant transferred to vials suitable for the UHPLC autosampler. The HMO were separated on a Waters BEH Glycan column (2.1×150 mm, 1.7 μm), preceded by a Waters BEH Amide Pre-column (2.1×5.0 mm, 1.7 μm) plumbed in to the system in such a way to act as a trapping column for removal of the excess labelling reagents (previously described by Benet & Austin, 2011) using the gradient described below. The 2AB-labelled oligosaccharides were detected by monitoring their fluorescence using λex=330 nm and λem=420 nm.
Quantification was performed against standards of the genuine HMO for 2′FL, 3FL, A-tetrasaccharide, 3′SL, 6′SL, LNT, LNnT, LNFP-I, LNFP-V, and LNnFP. All other HMO were quantified against maltotriose assuming an equimolar response of the 2AB-labelled oligosaccharides.
The following conditions were used for Separation of HMO on a BEH Glycan Column:
|
Time
Mobile phase*
10 ports valve
|
(min)
Flow (mL/min)
% A
% B
position
Comment
|
|
0.0
0.5
95.0
5.0
10-1
Inject 5.0 μL
|
Sample loading on trapping col.
|
2.3
0.5
95.0
5.0
10-1
Switch valve - start acquisition
|
2.5
0.5
90.0
10.0
1-2
|
4.9
0.5
90.0
10.0
1-2
Elution
|
32.1
0.5
82.0
18.0
1-2
|
48.1
0.5
80.5
19.5
1-2
|
61.5
0.5
78.0
22.0
1-2
|
89.0
0.5
74.6
25.4
1-2
|
89.5
0.4
30.0
70.0
1-2
Washing analytical col.
|
92.0
0.4
30.0
70.0
1-2
|
93.0
0.4
90.0
10.0
1-2
Re-equilibrate analytical col.
|
98.0
0.5
90.0
10.0
10-1
Autozero/switch valve/
|
stop acquisition
|
99.0
0.5
95.0
5.0
10-1
Equilibrate trapping col.
|
99.5
0.5
95.0
5.0
10-1
End
|
|
Benet, T. & Austin, S. (2011) On-line clean-up for 2-aminobenzamide-labeled oligosaccharides, Anal. Chem. 414: 166-168. http://dx.doi.org/10.1016/j.ab.2011.03.002.
The results of the compositional analysis were then subject to a statistical analysis.
A linear mixed model was used to model each HMO in which visit, parity, country and interaction between visit and parity were used as fixed effects. The within subject variability due to longitudinal repeat measures were taken care of in the model by declaring subject as a random effect.
The following statistical model was employed:
HMO˜Timepoint*Parity+Country+e
Timepoint, Parity and Country refers to the fixed effects of the model and takes into consideration the interactions between timepoint and parity. e refers to the random effect of the model which controls for within subject variability.
The results of the Statistical analysis (statistical inference) are show in in tables IV-XXIV and FIGS. 1 to 19. P value tables are given in the table beneath the compound and results to which they refer.
TABLE IV
|
|
param
unit
DELITYP
visit
N
mean
sd
median
q1.25%
q3.75%
min
max
|
|
|
2′ -
mg/L
UNIQUE
V1
138
4006.75
1517.06
3767.15924
3080.24
4761.75
175.61
9589.39
|
Fucosyllactose
|
2′ -
mg/L
UNIQUE
V2
171
2715.34
976.99
2715.344
2018.57
3409.34
88.07
5848.58
|
Fucosyllactose
|
2′ -
mg/L
UNIQUE
V3
149
2517.85
873
2442.034
1959.83
3128.59
325.18
4409.01
|
Fucosyllactose
|
2′ -
mg/L
UNIQUE
V4
134
2122.26
813.22
2005.177885
1565.84
2658.09
189.51
4026.61
|
Fucosyllactose
|
2′ -
mg/L
UNIQUE
V5
129
1819.24
721.8
1706.086
1335.71
2347.2
125.08
3820.31
|
Fucosyllactose
|
2′ -
mg/L
UNIQUE
V6
122
1628.42
675.81
1526.19981
1188.35
2071.5
124.18
3608.3
|
Fucosyllactose
|
2′ -
mg/L
WITH
V1
48
4386.09
1736.73
4289.65
3228.69
5129.99
1100.93
9498.58
|
Fucosyllactose
SIBLINGS
|
2′ -
mg/L
WITH
V2
54
2587.29
918.13
2426.2
2041.13
3043.69
533.88
5307.33
|
Fucosyllactose
SIBLINGS
|
2′ -
mg/L
WITH
V3
52
2442.11
899.71
2320.87
1799.47
2927.19
399.74
4485.03
|
Fucosyllactose
SIBLINGS
|
2′ -
mg/L
WITH
V4
50
2110.74
738.82
2022.34
1553.69
2605.41
295.32
3824.97
|
Fucosyllactose
SIBLINGS
|
2′ -
mg/L
WITH
V5
48
1894.55
712.41
1817.36
1381.61
2359.19
295.69
3621.32
|
Fucosyllactose
SIBLINGS
|
2′ -
mg/L
WITH
V6
46
1651.26
625.97
1621.59
1210.65
2096.49
159.25
2986.33
|
Fucosyllactose
SIBLINGS
|
|
TABLE IVa
|
|
Visit
Estimate
SE
pvalue
|
|
|
V1
382.33277
163.9708
0.01989229
|
V2
-134.65750
159.1302
0.39761651
|
V3
-141.87577
161.5152
0.37991228
|
V4
-152.21420
163.7197
0.35271384
|
V5
-90.77581
165.3151
0.58312380
|
V6
-169.04976
166.9656
0.31152596
|
|
TABLE V
|
|
param
unit
DELITYP
visit
N
mean
sd
median
q1.25%
q3.75%
min
max
|
|
|
3 -
mg/L
UNIQUE
V1
172
385.4664991
415.5565524
237.86708
148.2090175
398.264
11.41228
2468.566
|
Fucosyl-
|
lactose
|
3 -
mg/L
UNIQUE
V2
214
553.0388569
521.3096535
354.48191
210.854
649.0720075
43.78025
2537.227
|
Fucosyl-
|
lactose
|
3 -
mg/L
UNIQUE
V3
189
674.7012092
574.5232909
478.311
275.97259
831.444
57.45987
2921.70036
|
Fucosyl-
|
lactose
|
3 -
mg/L
UNIQUE
V4
173
928.8239356
668.6906753
708.247
454.831
1209.657
81.083
3278.66994
|
Fucosyl-
|
lactose
|
3 -
mg/L
UNIQUE
V5
166
1086.633496
757.0840296
864.07916
571.399
1410.950658
93.05087
5715.55268
|
Fucosyl-
|
lactose
|
3 -
mg/L
UNIQUE
V6
158
1160.839661
682.5011962
998.615
621.92175
1606.707478
112.962
3443.91
|
Fucosyl-
|
lactose
|
3 -
mg/L
WITH
V1
64
519.4932994
531.8511225
289.8366
169.507215
728.1158025
32.664
2078.125
|
Fucosyl-
SIBLINGS
|
lactose
|
3 -
mg/L
WITH
V2
75
711.2907307
628.9001769
441.16265
299.365935
939.567185
40.313
2638.36113
|
Fucosyl-
SIBLINGS
|
lactose
|
3 -
mg/L
WITH
V3
71
839.9917762
678.0150354
633.44927
345.148815
1173.1234
58.9511
2670.76
|
Fucosyl-
SIBLINGS
|
lactose
|
3 -
mg/L
WITH
V4
69
1073.123048
742.4445881
937.19072
548.39844
1322.12
78.17999
2963.532
|
Fucosyl-
SIBLINGS
|
lactose
|
3 -
mg/L
WITH
V5
67
1271.12714
815.3119729
1038.34043
672.70648
1623.508555
84.97374
3499.62987
|
Fucosyl-
SIBLINGS
|
lactose
|
3 -
mg/L
WITH
V6
65
1327.515428
787.8852486
1196.455
757.36606
1674.172
109.34912
3653.15978
|
Fucosyl-
SIBLINGS
|
lactose
|
|
TABLE VI
|
|
Visit
Estimate
SE
pvalue
|
|
|
V1
1.304577
1.116104
0.01561971
|
V2
1.270724
1.114634
0.02742312
|
V3
1.249569
1.115363
0.04146459
|
V4
1.189985
1.1157696
0.11261200
|
V5
1.180027
1.116120
0.13207376
|
V6
1.169900
1.116435
0.15445449
|
|
TABLE VII
|
|
param
unit
DELITYP
visit
N
mean
sd
median
q1.25%
|
|
6′ -
mg/L
UNIQUE
V1
173
128.9940719
47.46982
126.3577251
100.3019356
|
Galactosyllactose
|
6′ -
mg/L
UNIQUE
V2
214
40.43950928
34.32453
34.93363996
27.84100032
|
Galactosyllactose
|
6′ -
mg/L
UNIQUE
V3
190
25.44688677
9.806509
23.17565201
19.42520304
|
Galactosyllactose
|
6′ -
mg/L
UNIQUE
V4
173
17.59295944
8.05038
15.74108242
12.47470354
|
Galactosyllactose
|
6′ -
mg/L
UNIQUE
V5
161
14.34098883
7.479945
12.4716807
10.16207027
|
Galactosyllactose
|
6′ -
mg/L
UNIQUE
V6
147
13.07171018
12.49064
10.80183408
8.87243724
|
Galactosyllactose
|
6′ -
mg/L
WITH
V1
64
138.9473035
46.10431
137.0616097
106.2274385
|
Galactosyllactose
SIBLINGS
|
6′ -
mg/L
WITH
V2
74
39.1280561
15.2604
35.89756199
29.57195798
|
Galactosyllactose
SIBLINGS
|
6′-
mg/L
WITH
V3
71
26.40557425
10.78379
24.87935762
20.45856916
|
Galactosyllactose
SIBLINGS
|
6′ -
mg/L
WITH
V4
67
18.19156281
9.872754
16.27389683
12.55895567
|
Galactosyllactose
SIBLINGS
|
6′ -
mg/L
WITH
V5
65
14.43524793
7.081825
12.01385773
9.826798342
|
Galactosyllactose
SIBLINGS
|
6′ -
mg/L
WITH
V6
61
12.24780197
5.723957
10.93564962
9.250831953
|
Galactosyllactose
SIBLINGS
|
|
param
unit
DELITYP
visit
q3.75%
min
max
|
|
6′ -
mg/L
UNIQUE
V1
154.0188447
11.28896522
288.7462236
|
Galactosyllactose
|
6′ -
mg/L
UNIQUE
V2
42.73797305
13.62127529
434.3117534
|
Galactosyllactose
|
6′ -
mg/L
UNIQUE
V3
29.16381402
7.291378016
88.87964314
|
Galactosyllactose
|
6′ -
mg/L
UNIQUE
V4
19.96432738
6.838216821
65.30491452
|
Galactosyllactose
|
6′ -
mg/L
UNIQUE
V5
16.09249333
6.514312709
60.46113641
|
Galactosyllactose
|
6′ -
mg/L
UNIQUE
V6
13.69842265
6.482990651
146.8862427
|
Galactosyllactose
|
6′ -
mg/L
WITH
V1
168.6023267
29.69176747
258.227941
|
Galactosyllactose
SIBLINGS
|
6′ -
mg/L
WITH
V2
44.46636476
14.16036621
98.52362497
|
Galactosyllactose
SIBLINGS
|
6′-
mg/L
WITH
V3
29.31283111
12.8653756
85.11500318
|
Galactosyllactose
SIBLINGS
|
6′ -
mg/L
WITH
V4
21.00367988
6.668169255
74.29089736
|
Galactosyllactose
SIBLINGS
|
6′ -
mg/L
WITH
V5
17.61023478
7.170486535
55.96674008
|
Galactosyllactose
SIBLINGS
|
6′ -
mg/L
WITH
V6
13.5930005
6.800981073
43.62702667
|
Galactosyllactose
SIBLINGS
|
|
TABLE VIII
|
|
param
unit
DELITYP
visit
N
mean
sd
median
q1.25%
q3.75%
min
max
|
|
|
BloodgroupA-
mg/L
UNIQUE
V1
62
218.3100965
199.91
137.645
96.501955
339.8993275
16.70496
1198.809
|
Tetrasaccharide
|
BloodgroupA-
mg/L
UNIQUE
V2
74
108.9752193
87.04024
73.80618
49.86775
153.6967025
20.571
406.27274
|
Tetrasaccharide
|
BloodgroupA-
mg/L
UNIQUE
V3
67
101.1101424
80.23
74.20433
44.016415
113.37141
18.04427
388.594
|
Tetrasaccharide
|
BloodgroupA-
mg/L
UNIQUE
V4
59
89.30594305
70.23909
58.313
39.61766
128.653605
15.067
338.339
|
Tetrasaccharide
|
BloodgroupA-
mg/L
UNIQUE
V5
53
85.24264679
64.13099
62.96622
35.832
119.28
17.93698
269.711
|
Tetrasaccharide
|
BloodgroupA-
mg/L
UNIQUE
V6
48
78.27483
59.40327
54.919015
32.0109175
113.239025
15.08493
214.554
|
Tetrasaccharide
|
BloodgroupA-
mg/L
WITH
V1
18
224.7452844
294.2047
120.82463
35.8747
284.1568725
16.98872
993.8064
|
Tetrasaccharide
SIBLINGS
|
BloodgroupA-
mg/L
WITH
V2
18
112.8672322
117.5963
75.509785
48.8410875
159.6912825
15.208
517.54089
|
Tetrasaccharide
SIBLINGS
|
BloodgroupA-
mg/L
WITH
V3
17
123.0597341
119.73
95.024
48.21369
146.4399
17.56554
529.36
|
Tetrasaccharide
SIBLINGS
|
BloodgroupA-
mg/L
WITH
V4
17
98.30965941
83.89327
77.95666
57.209
115.87755
16.361
376.29878
|
Tetrasaccharide
SIBLINGS
|
BloodgroupA-
mg/L
WITH
V5
15
85.03220533
69.04539
67.01464
40.436035
107.519645
19.39048
294.134
|
Tetrasaccharide
SIBLINGS
|
BloodgroupA-
mg/L
WITH
V6
15
70.211992
56.09551
51.54932
35.436115
88.07794
21.94559
246.20116
|
Tetrasaccharide
SIBLINGS
|
|
TABLE IX
|
|
param
unit
DELITYP
visit
N
mean
sd
median
q1.25%
|
|
Difucosyllacto-N-
mg/L
UNIQUE
V1
125
166.66388
100.4515893
150.4463936
98.1823431
|
Hexaose-a
|
Difucosyllacto-N-
mg/L
UNIQUE
V2
167
282.797729
161.029439
247.1195693
178.1422564
|
Hexaose-a
|
Difucosyllacto-N-
mg/L
UNIQUE
V3
144
234.3063825
147.4320416
200.969341
134.8599339
|
Hexaose-a
|
Difucosyllacto-N-
mg/L
UNIQUE
V4
118
119.7067972
96.5242152
94.42787799
52.25253247
|
Hexaose-a
|
Difucosyllacto-N-
mg/L
UNIQUE
V5
78
98.51640533
80.74105435
72.88240189
50.34510842
|
Hexaose-a
|
Difucosyllacto-N-
mg/L
UNIQUE
V6
58
74.99587394
51.32117734
59.0456174
42.88833806
|
Hexaose-a
|
Difucosyllacto-N-
mg/L
WITH
V1
48
148.346054
81.70434542
125.6285912
94.72884661
|
Hexaose-a
SIBLINGS
|
Difucosyllacto-N-
mg/L
WITH
V2
54
261.9050265
169.8874876
231.2689262
167.1776416
|
Hexaose-a
SIBLINGS
|
Difucosyllacto-N-
mg/L
WITH
V3
51
206.2678072
144.2391624
170.0672888
110.5643357
|
Hexaose-a
SIBLINGS
|
Difucosyllacto-N-
mg/L
WITH
V4
42
120.121861
100.4379777
102.9007162
56.84164741
|
Hexaose-a
SIBLINGS
|
Difucosyllacto-N-
mg/L
WITH
V5
29
97.3857747
77.50806012
71.724665
59.86775755
|
Hexaose-a
SIBLINGS
|
Difucosyllacto-N-
mg/L
WITH
V6
24
76.45717107
53.3864606
65.56011998
42.44962707
|
Hexaose-a
SIBLINGS
|
|
param
unit
DELITYP
visit
q3.75%
min
max
|
|
Difucosyllacto-N-
mg/L
UNIQUE
V1
208.71468
37.68514348
576.8930576
|
Hexaose-a
|
Difucosyllacto-N-
mg/L
UNIQUE
V2
355.9677629
33.08461539
856.5390082
|
Hexaose-a
|
Difucosyllacto-N-
mg/L
UNIQUE
V3
300.7426145
39.43414695
807.2575598
|
Hexaose-a
|
Difucosyllacto-N-
mg/L
UNIQUE
V4
149.7452022
33.55783812
538.5644379
|
Hexaose-a
|
Difucosyllacto-N-
mg/L
UNIQUE
V5
107.3617675
33.27717717
515.2208712
|
Hexaose-a
|
Difucosyllacto-N-
mg/L
UNIQUE
V6
82.61864327
33.45887998
270.1883637
|
Hexaose-a
|
Difucosyllacto-N-
mg/L
WITH
V1
188.3725375
33.04833329
412.2467197
|
Hexaose-a
SIBLINGS
|
Difucosyllacto-N-
mg/L
WITH
V2
307.2992152
41.111123
1086.897955
|
Hexaose-a
SIBLINGS
|
Difucosyllacto-N-
mg/L
WITH
V3
253.965274
42.14158522
747.7649157
|
Hexaose-a
SIBLINGS
|
Difucosyllacto-N-
mg/L
WITH
V4
127.1671806
34.70128067
606.8605662
|
Hexaose-a
SIBLINGS
|
Difucosyllacto-N-
mg/L
WITH
V5
89.40771747
33.00609983
393.74294
|
Hexaose-a
SIBLINGS
|
Difucosyllacto-N-
mg/L
WITH
V6
80.98116787
33.43153153
266.5264593
|
Hexaose-a
SIBLINGS
|
|
TABLE X
|
|
param
unit
DELITYP
visit
N
Mean
sd
median
|
|
Lacto-N-
mg/L
UNIQUE
V1
126
1234.406373
535.3466
1180.198793
|
Difucosylhexaose
|
Lacto-N-
mg/L
UNIQUE
V2
158
1255.755653
537.4429
1192.294603
|
Difucosylhexaose
|
Lacto-N-
mg/L
UNIQUE
V3
136
1091.823028
465.8642
995.3117755
|
Difucosylhexaose
|
Lacto-N-
mg/L
UNIQUE
V4
121
848.0091077
328.5295
802.3504693
|
Difucosylhexaose
|
Lacto-N-
mg/L
UNIQUE
V5
116
710.6302809
271.9261
681.6194012
|
Difucosylhexaose
|
Lacto-N-
mg/L
UNIQUE
V6
112
634.9542185
242.0775
624.6350378
|
Difucosylhexaose
|
Lacto-N-
mg/L
WITH
V1
46
1225.800254
477.4247
1169.458449
|
Difucosylhexaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V2
51
1336.18374
578.9028
1348.485217
|
Difucosylhexaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V3
48
1142.006226
411.3581
1114.291686
|
Difucosylhexaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V4
48
825.7560502
324.6839
788.8361782
|
Difucosylhexaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V5
45
739.1373379
317.1183
701.7743271
|
Difucosylhexaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V6
44
578.2746578
236.0452
567.1716751
|
Difucosylhexaose
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Lacto-N-
849.3209761
1495.918413
11.58325101
3346.954498
|
Difucosylhexaose
|
Lacto-N-
942.9128926
1550.664139
21.63261134
3582.842867
|
Difucosylhexaose
|
Lacto-N-
821.2656843
1344.286596
10.97928599
3501.352786
|
Difucosylhexaose
|
Lacto-N-
662.7755195
1023.609883
11.88700135
1649.120744
|
Difucosylhexaose
|
Lacto-N-
541.1164043
837.2962088
103.063301
1722.213919
|
Difucosylhexaose
|
Lacto-N-
471.4977544
756.5617445
111.6094256
1485.00214
|
Difucosylhexaose
|
Lacto-N-
878.4507667
1407.01817
462.8830063
2782.944079
|
Difucosylhexaose
|
Lacto-N-
1108.263831
1576.688066
12.29676207
3031.332599
|
Difucosylhexaose
|
Lacto-N-
884.4304615
1431.628644
169.4986155
1927.975206
|
Difucosylhexaose
|
Lacto-N-
631.0881501
1035.617596
74.64280102
1917.735932
|
Difucosylhexaose
|
Lacto-N-
536.5070919
882.8586901
221.5440208
1793.170075
|
Difucosylhexaose
|
Lacto-N-
413.7894666
739.2552491
60.80285161
1261.115824
|
Difucosylhexaose
|
|
TABLE XI
|
|
param
unit
DELITYP
visit
N
Mean
sd
median
|
|
Lacto-N-
mg/L
UNIQUE
V1
139
1953.405264
895.9388
1913.01447
|
Fucosylpentaose-I
|
Lacto-N-
mg/L
UNIQUE
V2
170
1442.925271
803.4876
1369.9995
|
Fucosylpentaose-I
|
Lacto-N-
mg/L
UNIQUE
V3
149
1080.473899
640.1305
933.32871
|
Fucosylpentaose-I
|
Lacto-N-
mg/L
UNIQUE
V4
133
610.916764
413.7517
503.48892
|
Fucosylpentaose-I
|
Lacto-N-
mg/L
UNIQUE
V5
127
470.6971887
378.858
376.267
|
Fucosylpentaose-I
|
Lacto-N-
mg/L
UNIQUE
V6
120
388.8400843
320.5121
315.61007
|
Fucosylpentaose-I
|
Lacto-N-
mg/L
WITH
V1
48
1855.27654
929.5294
1704.10064
|
Fucosylpentaose-I
SIBLINGS
|
Lacto-N-
mg/L
WITH
V2
54
1391.449066
788.47
1172.082955
|
Fucosylpentaose-I
SIBLINGS
|
Lacto-N-
mg/L
WITH
V3
52
1044.350567
593.307
1006.408885
|
Fucosylpentaose-I
SIBLINGS
|
Lacto-N-
mg/L
WITH
V4
50
611.3230378
451.9114
562.65468
|
Fucosylpentaose-I
SIBLINGS
|
Lacto-N-
mg/L
WITH
V5
48
465.4264017
359.7624
380.606735
|
Fucosylpentaose-I
SIBLINGS
|
Lacto-N-
mg/L
WITH
V6
45
370.5976704
304.8824
293.10456
|
Fucosylpentaose-I
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Lacto-N-
1330.993545
2520.18355
27.4573
4040.89442
|
Fucosylpentaose-I
|
Lacto-N-
781.2125
2003.57863
49.806
3756.06871
|
Fucosylpentaose-I
|
Lacto-N-
573.47716
1496.567
28.866
3306.848
|
Fucosylpentaose-I
|
Lacto-N-
283.029
832.54689
30.669
1970.645
|
Fucosylpentaose-I
|
Lacto-N-
185.98
617.2625
30.394
2062.94583
|
Fucosylpentaose-I
|
Lacto-N-
161.52072
501.8237575
27.51296
1913.34495
|
Fucosylpentaose-I
|
Lacto-N-
1202.36626
2417.197
304.92323
4311.24617
|
Fucosylpentaose-I
|
Lacto-N-
808.9399325
1909.67225
106.64425
3571.06665
|
Fucosylpentaose-I
|
Lacto-N-
594.47375
1446.30243
77.48494
2372.66273
|
Fucosylpentaose-I
|
Lacto-N-
285.0165
781.02097
36.497
2068.53637
|
Fucosylpentaose-I
|
Lacto-N-
194.196455
608.467225
28.33995
1643.26
|
Fucosylpentaose-I
|
Lacto-N-
153.08
490.82
43.879
1622.958
|
Fucosylpentaose-I
|
|
TABLE XII
|
|
param
unit
DELITYP
visit
N
mean
sd
median
|
|
Lacto-N-
mg/L
UNIQUE
V1
145
400.7219326
518.1076
192.6370398
|
Fucosylpentaose-II
|
Lacto-N-
mg/L
UNIQUE
V2
190
544.0406658
590.6689
327.9102556
|
Fucosylpentaose-II
|
Lacto-N-
mg/L
UNIQUE
V3
165
512.6256601
521.4556
320.0085042
|
Fucosylpentaose-II
|
Lacto-N-
mg/L
UNIQUE
V4
149
461.1191582
396.6782
331.221059
|
Fucosylpentaose-II
|
Lacto-N-
mg/L
UNIQUE
V5
146
420.9635001
326.0906
332.4659875
|
Fucosylpentaose-II
|
Lacto-N-
mg/L
UNIQUE
V6
138
383.5239207
276.9464
293.9566112
|
Fucosylpentaose-II
|
Lacto-N-
mg/L
WITH
V1
57
474.9349989
519.0685
248.5627023
|
Fucosylpentaose-II
SIBLINGS
|
Lacto-N-
mg/L
WITH
V2
70
732.4415102
712.1251
428.9741842
|
Fucosylpentaose-II
SIBLINGS
|
Lacto-N-
mg/L
WITH
V3
65
642.6995951
550.2848
458.7201961
|
Fucosylpentaose-II
SIBLINGS
|
Lacto-N-
mg/L
WITH
V4
64
504.6233294
416.96
327.235739
|
Fucosylpentaose-II
SIBLINGS
|
Lacto-N-
mg/L
WITH
V5
63
461.6140679
346.8066
347.3093904
|
Fucosylpentaose-II
SIBLINGS
|
Lacto-N-
mg/L
WITH
V6
61
416.7272357
300.1685
326.0899963
|
Fucosylpentaose-II
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Lacto-N-
103.6228597
323.2837721
37.04755787
2426.895823
|
Fucosylpentaose-II
|
Lacto-N-
182.5788937
568.883943
52.61106978
2856.419409
|
Fucosylpentaose-II
|
Lacto-N-
184.3943767
543.5270238
53.24693544
2488.674427
|
Fucosylpentaose-II
|
Lacto-N-
216.7351314
562.6200229
60.89431943
2274.458362
|
Fucosylpentaose-II
|
Lacto-N-
200.0765447
498.1834633
53.63244898
1714.785797
|
Fucosylpentaose-II
|
Lacto-N-
215.2587313
449.8741781
50.47498562
1554.445901
|
Fucosylpentaose-II
|
Lacto-N-
124.7083137
752.9452298
38.05551582
2146.380077
|
Fucosylpentaose-II
|
Lacto-N-
256.8757435
1123.163255
35.31341987
3602.345161
|
Fucosylpentaose-II
|
Lacto-N-
240.4601421
955.8715703
88.28875496
2623.432553
|
Fucosylpentaose-II
|
Lacto-N-
217.4510082
639.6884927
35.93501895
2091.202327
|
Fucosylpentaose-II
|
Lacto-N-
231.9723537
592.70929
41.55891583
1551.01748
|
Fucosylpentaose-II
|
Lacto-N-
214.4554786
547.9185395
44.29386143
1488.541991
|
Fucosylpentaose-II
|
|
TABLE XIII
|
|
Visit
Estimate
SE
pvalue
|
|
V1
1.276220
1.132216
0.04972522
|
V2
1.350333
1.130009
0.01412686
|
V3
1.337439
1.131037
0.01835975
|
V4
1.211846
1.131458
0.12001568
|
V5
1.191473
1.131706
0.15703207
|
V6
1.147623
1.132101
0.26730874
|
|
TABLE XIV
|
|
param
unit
DELITYP
visit
N
mean
sd
median
|
|
Lacto-N-
mg/L
UNIQUE
V1
172
440.7436567
162.9639
425.9454976
|
Fucosylpentaose-III
|
Lacto-N-
mg/L
UNIQUE
V2
214
324.5042397
155.5033
307.6437027
|
Fucosylpentaose-III
|
Lacto-N-
mg/L
UNIQUE
V3
189
313.7021468
104.9384
304.1777874
|
Fucosylpentaose-III
|
Lacto-N-
mg/L
UNIQUE
V4
173
361.8867399
117.8097
352.9061564
|
Fucosylpentaose-III
|
Lacto-N-
mg/L
UNIQUE
V5
166
355.1420518
92.17895
351.5526117
|
Fucosylpentaose-III
|
Lacto-N-
mg/L
UNIQUE
V6
158
345.2252395
93.83141
337.6224468
|
Fucosylpentaose-III
|
Lacto-N-
mg/L
WITH
V1
64
454.7211229
173.722
441.4279491
|
Fucosylpentaose-III
SIBLINGS
|
Lacto-N-
mg/L
WITH
V2
75
307.1033885
86.78954
304.261907
|
Fucosylpentaose-III
SIBLINGS
|
Lacto-N-
mg/L
WITH
V3
71
303.1843203
78.66454
293
|
Fucosylpentaose-III
SIBLINGS
|
Lacto-N-
mg/L
WITH
V4
69
348.8290902
89.00072
335.6039586
|
Fucosylpentaose-III
SIBLINGS
|
Lacto-N-
mg/L
WITH
V5
67
349.2434082
93.08592
345.6968971
|
Fucosylpentaose-III
SIBLINGS
|
Lacto-N-
mg/L
WITH
V6
65
323.8386581
87.5295
313.2473169
|
Fucosylpentaose-III
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Lacto-N-
326.9628144
523.1014552
117.4373288
1151.993123
|
Fucosylpentaose-III
|
Lacto-N-
231.1082286
388.025127
79.94840168
1751.020203
|
Fucosylpentaose-III
|
Lacto-N-
252.945844
378.3723403
97.1179054
951.8773833
|
Fucosylpentaose-III
|
Lacto-N-
289.4064649
414.3069494
80.61587114
1196.494936
|
Fucosylpentaose-III
|
Lacto-N-
281.5673515
416.9454623
166.2976602
635.2849534
|
Fucosylpentaose-III
|
Lacto-N-
284.583471
413.5865187
138.1858699
557.1545027
|
Fucosylpentaose-III
|
Lacto-N-
315.3262438
541.2156412
187.9371289
890.3129598
|
Fucosylpentaose-III
|
Lacto-N-
246.1138864
356.6258239
87.25376406
535.9760196
|
Fucosylpentaose-III
|
Lacto-N-
257.845359
348.19862
147.4060444
563.392227
|
Fucosylpentaose-III
|
Lacto-N-
292.1571655
405.4241552
160.7903865
543.5231017
|
Fucosylpentaose-III
|
Lacto-N-
278.5226687
399.4384528
126.2259899
679.9790614
|
Fucosylpentaose-III
|
Lacto-N-
251.2469262
383.3281509
134.2613528
567.5952348
|
Fucosylpentaose-III
|
|
TABLE XV
|
|
param
unit
DELITYP
visit
N
mean
sd
median
|
|
Lacto-N-
mg/L
UNIQUE
V1
112
109.4842732
107.2949
48.9985
|
Fucosylpentaose-V
|
Lacto-N-
mg/L
UNIQUE
V2
175
119.017012
114.1155
63.592
|
Fucosylpentaose-V
|
Lacto-N-
mg/L
UNIQUE
V3
155
109.9870335
101.3161
61.36453
|
Fucosylpentaose-V
|
Lacto-N-
mg/L
UNIQUE
V4
144
90.07381556
72.94248
58.491385
|
Fucosylpentaose-V
|
Lacto-N-
mg/L
UNIQUE
V5
135
87.41945786
70.56107
57.784
|
Fucosylpentaose-V
|
Lacto-N-
mg/L
UNIQUE
V6
129
76.81346488
59.9275
54.037
|
Fucosylpentaose-V
|
Lacto-N-
mg/L
WITH
V1
46
105.4405772
91.79857
57.939865
|
Fucosylpentaose-V
SIBLINGS
|
Lacto-N-
mg/L
WITH
V2
68
138.2168362
125.1875
84.83034
|
Fucosylpentaose-V
SIBLINGS
|
Lacto-N-
mg/L
WITH
V3
65
116.1223805
95.20984
75.977
|
Fucosylpentaose-V
SIBLINGS
|
Lacto-N-
mg/L
WITH
V4
62
91.59901602
71.28318
64.315775
|
Fucosylpentaose-V
SIBLINGS
|
Lacto-N-
mg/L
WITH
V5
60
79.1156255
55.1115
59.570785
|
Fucosylpentaose-V
SIBLINGS
|
Lacto-N-
mg/L
WITH
V6
57
73.00692544
49.32591
53.91017
|
Fucosylpentaose-V
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Lacto-N-
34.0883725
176.98825
24.098
393.23939
|
Fucosylpentaose-V
|
Lacto-N-
42.54693
172.5235
24.15465
495.7132
|
Fucosylpentaose-V
|
Lacto-N-
44.732165
132.402505
24.357
427.275
|
Fucosylpentaose-V
|
Lacto-N-
41.540815
120.62295
24.31422
412.37003
|
Fucosylpentaose-V
|
Lacto-N-
42.07251
105.3295
25.775
360.11687
|
Fucosylpentaose-V
|
Lacto-N-
39.65592
91.13553
24.172
325
|
Fucosylpentaose-V
|
Lacto-N-
36.8393575
165.8721925
24.184
309.94073
|
Fucosylpentaose-V
|
Lacto-N-
49.35551
224.66925
25.57568
515.4305
|
Fucosylpentaose-V
|
Lacto-N-
50.50503
148.75439
24.72194
414.4
|
Fucosylpentaose-V
|
Lacto-N-
41.231875
111.3105
24.48
360.47113
|
Fucosylpentaose-V
|
Lacto-N-
38.57574
101.87361
26.214
243.549
|
Fucosylpentaose-V
|
Lacto-N-
38.03945
97.496
24.586
232.777
|
Fucosylpentaose-V
|
|
TABLE XVI
|
|
param
unit
DELITYP
visit
N
Mean
Sd
median
|
|
Lacto-N-hexaose
mg/L
UNIQUE
V1
139
69.65726947
60.09699
58.2952622
|
(A)
|
Lacto-N-hexaose
mg/L
UNIQUE
V2
205
83.91299646
44.09424
72.90325819
|
(A)
|
Lacto-N-hexaose
mg/L
UNIQUE
V3
185
71.67837167
65.1411
60.20319698
|
(A)
|
Lacto-N-hexaose
mg/L
UNIQUE
V4
154
39.62268882
18.54261
34.7920641
|
(A)
|
Lacto-N-hexaose
mg/L
UNIQUE
V5
130
30.26720457
14.06454
25.06469316
|
(A)
|
Lacto-N-hexaose
mg/L
UNIQUE
V6
107
25.29538373
9.751377
21.98491257
|
(A)
|
Lacto-N-hexaose
mg/L
WITH
V1
53
69.44083736
43.31972
62.07164331
|
(A)
SIBLINGS
|
Lacto-N-hexaose
mg/L
WITH
V2
74
69.18762737
31.78699
60.56720348
|
(A)
SIBLINGS
|
Lacto-N-hexaose
mg/L
WITH
V3
70
62.49890449
31.54116
53.23506574
|
(A)
SIBLINGS
|
Lacto-N-hexaose
mg/L
WITH
V4
63
38.80460416
20.67884
34.70663487
|
(A)
SIBLINGS
|
Lacto-N-hexaose
mg/L
WITH
V5
52
33.10356562
20.12426
27.47100266
|
(A)
SIBLINGS
|
Lacto-N-hexaose
mg/L
WITH
V6
51
27.65797971
11.52966
24.0510901
|
(A)
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Lacto-N-hexaose
38.17826996
81.61276425
18.36222878
585.5330588
|
(A)
|
Lacto-N-hexaose
54.70601626
109.8055481
17.46965778
255.4484418
|
(A)
|
Lacto-N-hexaose
43.02753693
84.88738297
16.19895295
803.0893219
|
(A)
|
Lacto-N-hexaose
27.13590373
46.62997118
16.3928703
112.8544379
|
(A)
|
Lacto-N-hexaose
20.88531751
32.23440104
16.0313543
87.57130429
|
(A)
|
Lacto-N-hexaose
19.09685889
27.93809463
16.1076984
68.12521273
|
(A)
|
Lacto-N-hexaose
46.00691942
81.83799145
16.96457388
248.8007182
|
(A)
|
Lacto-N-hexaose
45.91588703
82.53308105
18.15175655
169.5397907
|
(A)
|
Lacto-N-hexaose
41.84623544
77.85927254
17.24348703
202.4682182
|
(A)
|
Lacto-N-hexaose
26.44253846
44.29626051
17.87155202
139.2964627
|
(A)
|
Lacto-N-hexaose
22.26315853
38.02796933
16.26681559
141.4095103
|
(A)
|
Lacto-N-hexaose
20.30278179
31.43146137
16.26239728
69.64415593
|
(A)
|
|
TABLE XVII
|
|
param
unit
DELITYP
Visit
N
mean
Sd
median
|
|
Lacto-N-hexaose
mg/L
UNIQUE
V1
134
44.73295024
34.32684
33.28233637
|
(B)
|
Lacto-N-hexaose
mg/L
UNIQUE
V2
145
43.11011358
23.31967
35.13295515
|
(B)
|
Lacto-N-hexaose
mg/L
UNIQUE
V3
133
38.50327162
21.12716
32.35290783
|
(B)
|
Lacto-N-hexaose
mg/L
UNIQUE
V4
91
33.26540708
18.18317
26.42650386
|
(B)
|
Lacto-N-hexaose
mg/L
UNIQUE
V5
59
31.002883
17.26554
24.99800181
|
(B)
|
Lacto-N-hexaose
mg/L
UNIQUE
V6
43
27.72187917
15.68486
22.97054189
|
(B)
|
Lacto-N-hexaose
mg/L
WITH
V1
40
41.5669005
25.93896
37.79728256
|
(B)
SIBLINGS
|
Lacto-N-hexaose
mg/L
WITH
V2
36
36.02515556
16.13595
30.58969053
|
(B)
SIBLINGS
|
Lacto-N-hexaose
mg/L
WITH
V3
43
34.28955775
15.68827
29.61018115
|
(B)
SIBLINGS
|
Lacto-N-hexaose
mg/L
WITH
V4
29
34.74970859
13.55697
31.13853753
|
(B)
SIBLINGS
|
Lacto-N-hexaose
mg/L
WITH
V5
22
28.51987306
13.09366
24.76177376
|
(B)
SIBLINGS
|
Lacto-N-hexaose
mg/L
WITH
V6
18
28.88319141
11.91772
27.2941175
|
(B)
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Lacto-N-hexaose
22.79344461
53.48647374
16.03905983
220.7927384
|
(B)
|
Lacto-N-hexaose
27.90776152
55.01012587
16.31270557
179.8286126
|
(B)
|
Lacto-N-hexaose
24.09883189
45.67418316
16.18714448
131.3072962
|
(B)
|
Lacto-N-hexaose
19.69922881
39.64344687
16.41060296
115.2056418
|
(B)
|
Lacto-N-hexaose
20.04178856
33.98491795
16.25904523
105.2379451
|
(B)
|
Lacto-N-hexaose
18.6143141
32.997549
16.02806725
99.84562336
|
(B)
|
Lacto-N-hexaose
24.8190705
44.77882074
16.60528968
135.9994959
|
(B)
|
Lacto-N-hexaose
23.74009313
46.45568574
17.15234171
84.77670516
|
(B)
|
Lacto-N-hexaose
23.11258219
45.36245075
16.5380127
85.67908288
|
(B)
|
Lacto-N-hexaose
24.25250318
43.6851328
16.78734358
76.04017383
|
(B)
|
Lacto-N-hexaose
18.2128352
33.18017398
16.04481676
63.3735739
|
(B)
|
Lacto-N-hexaose
20.37699792
31.56511312
16.83515397
62.67504542
|
(B)
|
|
TABLE XVIII
|
|
param
unit
DELITYP
Visit
N
mean
sd
median
|
|
Lacto-N-
mg/L
UNIQUE
V1
117
111.9565166
69.43106
94.19356953
|
Neodifucosylhexaose
|
Lacto-N-
mg/L
UNIQUE
V2
69
63.29788709
74.07394
43.4578365
|
Neodifucosylhexaose
|
Lacto-N-
mg/L
UNIQUE
V3
43
57.46798821
56.84744
46.51065959
|
Neodifucosylhexaose
|
Lacto-N-
mg/L
UNIQUE
V4
56
55.60053979
33.48608
41.85130914
|
Neodifucosylhexaose
|
Lacto-N-
mg/L
UNIQUE
V5
38
54.58027932
27.91287
45.11014515
|
Neodifucosylhexaose
|
Lacto-N-
mg/L
UNIQUE
V6
29
64.33423068
33.2452
56.79116124
|
Neodifucosylhexaose
|
Lacto-N-
mg/L
WITH
V1
46
114.8602548
82.49724
80.63002523
|
Neodifucosylhexaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V2
19
61.94019548
45.97203
45.4381543
|
Neodifucosylhexaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V3
15
58.61383439
39.13784
54.97433839
|
Neodifucosylhexaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V4
19
54.94306309
22.66628
48.37428768
|
Neodifucosylhexaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V5
18
63.29320064
32.14269
53.26006424
|
Neodifucosylhexaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V6
16
58.9507447
27.15766
45.11453324
|
Neodifucosylhexaose
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Lacto-N-
59.70978875
132.6595225
29.32389989
334.1268818
|
Neodifucosylhexaose
|
Lacto-N-
36.27672844
68.9398609
28.52752291
612.4524307
|
Neodifucosylhexaose
|
Lacto-N-
32.51100498
65.227353
28.13123604
398.4920634
|
Neodifucosylhexaose
|
Lacto-N-
34.6297264
73.17992495
28.10296364
224.0399443
|
Neodifucosylhexaose
|
Lacto-N-
34.29570779
63.77490019
28.12614506
141.5694861
|
Neodifucosylhexaose
|
Lacto-N-
35.66139704
82.82903182
28.64848952
151.8818948
|
Neodifucosylhexaose
|
Lacto-N-
57.15833441
153.8645579
31.26569753
350.3302321
|
Neodifucosylhexaose
|
Lacto-N-
35.75460343
68.64819832
29.95124997
226.4465075
|
Neodifucosylhexaose
|
Lacto-N-
34.52825063
66.41893776
29.35106887
187.0453095
|
Neodifucosylhexaose
|
Lacto-N-
40.02309424
65.92514047
28.49364998
114.5744313
|
Neodifucosylhexaose
|
Lacto-N-
38.88978245
79.91072693
30.09514734
140.8977209
|
Neodifucosylhexaose
|
Lacto-N-
39.24229995
73.74432573
32.02848488
111.8547311
|
Neodifucosylhexaose
|
|
TABLE XIX
|
|
param
unit
DELITYP
visit
N
mean
sd
median
|
|
Lacto-N-
mg/L
UNIQUE
V1
50
37.2525136
16.38068
33.67124
|
Neofucosylpentaose
|
Lacto-N-
mg/L
UNIQUE
V2
42
29.88595143
10.58937
26.92816
|
Neofucosylpentaose
|
Lacto-N-
mg/L
UNIQUE
V3
40
27.0749745
9.243692
23.80713
|
Neofucosylpentaose
|
Lacto-N-
mg/L
UNIQUE
V4
39
30.60720744
12.18325
27.47212
|
Neofucosylpentaose
|
Lacto-N-
mg/L
UNIQUE
V5
31
27.02506516
6.34542
25.69
|
Neofucosylpentaose
|
Lacto-N-
mg/L
UNIQUE
V6
23
26.7532187
7.552031
24.091
|
Neofucosylpentaose
|
Lacto-N-
mg/L
WITH
V1
22
35.40536864
16.21748
28.809265
|
Neofucosylpentaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V2
16
23.29734
3.547994
23.303695
|
Neofucosylpentaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V3
11
31.39661
8.042168
29.12481
|
Neofucosylpentaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V4
12
32.5542
11.27676
32.015775
|
Neofucosylpentaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V5
11
28.90526364
10.61775
25.04186
|
Neofucosylpentaose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V6
9
30.85879
15.08243
24.315
|
Neofucosylpentaose
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Lacto-N-
24.897
41.76092
19.73896
92.18025
|
Neofucosylpentaose
|
Lacto-N-
22.144305
30.94125
19.066
59.578
|
Neofucosylpentaose
|
Lacto-N-
21.4349075
28.11675
19.002
53.52264
|
Neofucosylpentaose
|
Lacto-N-
23.1454
32.614335
19.074
82.885
|
Neofucosylpentaose
|
Lacto-N-
22.51126
28.6975
19.037
42.33404
|
Neofucosylpentaose
|
Lacto-N-
20.97355
29.805
19.054
48.112
|
Neofucosylpentaose
|
Lacto-N-
26.059
39.3506325
20.14561
84.56933
|
Neofucosylpentaose
|
Lacto-N-
20.0572975
25.788
19.148
30.76332
|
Neofucosylpentaose
|
Lacto-N-
25.681345
36.948515
22.29
46.081
|
Neofucosylpentaose
|
Lacto-N-
23.654625
35.353345
22.437
60.886
|
Neofucosylpentaose
|
Lacto-N-
21.985635
31.76967
20.88696
57.46976
|
Neofucosylpentaose
|
Lacto-N-
20.677
29.41272
20.15457
64.87128
|
Neofucosylpentaose
|
|
TABLE XX
|
|
param
unit
DELITYP
visit
N
mean
sd
median
|
|
Lacto-N-
mg/L
UNIQUE
V1
173
307.7437813
131.4372
293.564
|
Neotetraose
|
Lacto-N-
mg/L
UNIQUE
V2
213
184.6575148
100.9842
173.50436
|
Neotetraose
|
Lacto-N-
mg/L
UNIQUE
V3
187
156.7024487
82.56116
146.70853
|
Neotetraose
|
Lacto-N-
mg/L
UNIQUE
V4
168
128.4345314
83.21485
107.724735
|
Neotetraose
|
Lacto-N-
mg/L
UNIQUE
V5
158
107.643116
69.56969
91.5955
|
Neotetraose
|
Lacto-N-
mg/L
UNIQUE
V6
146
98.41257377
60.79302
83.588435
|
Neotetraose
|
Lacto-N-
mg/L
WITH
V1
64
304.2184716
135.7726
298.56318
|
Neotetraose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V2
72
154.2337461
79.88463
141.929085
|
Neotetraose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V3
68
144.1930094
71.03133
132.30853
|
Neotetraose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V4
64
126.1508667
72.02305
112.7993
|
Neotetraose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V5
60
107.7504913
60.55004
93.494
|
Neotetraose
SIBLINGS
|
Lacto-N-
mg/L
WITH
V6
62
96.30362226
64.02489
79.572765
|
Neotetraose
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Lacto-N-
214.326
389.59097
47.75439
699.27383
|
Neotetraose
|
Lacto-N-
102.93676
246.335
25.73309
597.13727
|
Neotetraose
|
Lacto-N-
89.75674
205.208
26.64085
424.58858
|
Neotetraose
|
Lacto-N-
69.01625
167.72524
25.0473
463.904
|
Neotetraose
|
Lacto-N-
58.5215
136.18827
25.20536
398.9075
|
Neotetraose
|
Lacto-N-
52.0978825
121.5750225
25.22179
298.346
|
Neotetraose
|
Lacto-N-
219.730275
373.411605
64.40836
695.668
|
Neotetraose
|
Lacto-N-
96.1692475
202.7789125
32.626
407.85
|
Neotetraose
|
Lacto-N-
85.0371325
200.53189
31.748
333.83
|
Neotetraose
|
Lacto-N-
63.8390525
179.90584
25.575
309.45348
|
Neotetraose
|
Lacto-N-
62.7070925
147.2496125
31.655
257.58145
|
Neotetraose
|
Lacto-N-
47.7260275
118.86836
24.222
277.71054
|
Neotetraose
|
|
TABLE XXI
|
|
param
unit
DELITYP
visit
N
mean
Sd
median
|
|
Lacto-N-Tetraose
mg/L
UNIQUE
V1
173
941.3105777
869.2799
668.05
|
Lacto-N-Tetraose
mg/L
UNIQUE
V2
215
1198.301294
760.0552
1066.41302
|
Lacto-N-Tetraose
mg/L
UNIQUE
V3
190
1013.002805
642.5475
860.403755
|
Lacto-N-Tetraose
mg/L
UNIQUE
V4
174
710.5043052
451.1813
624.944005
|
Lacto-N-Tetraose
mg/L
UNIQUE
V5
167
617.336245
439.7945
499.74
|
Lacto-N-Tetraose
mg/L
UNIQUE
V6
159
541.9378956
396.6598
460.991
|
Lacto-N-Tetraose
mg/L
WITH
V1
64
833.6287748
579.2782
791.530885
|
SIBLINGS
|
Lacto-N-Tetraose
mg/L
WITH
V2
75
1255.222192
591.7982
1121.872
|
SIBLINGS
|
Lacto-N-Tetraose
mg/L
WITH
V3
71
1000.002187
425.3526
947.02993
|
SIBLINGS
|
Lacto-N-Tetraose
mg/L
WITH
V4
68
672.2036891
307.2625
647.973965
|
SIBLINGS
|
Lacto-N-Tetraose
mg/L
WITH
V5
67
552.031873
275.787
479.85205
|
SIBLINGS
|
Lacto-N-Tetraose
mg/L
WITH
V6
63
486.68108
230.7009
413.22725
|
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Lacto-N-Tetraose
389.089
1247.059
21.9529
6714.31284
|
Lacto-N-Tetraose
672.8633
1443.05473
125.055
5360.81507
|
Lacto-N-Tetraose
608.09198
1259.128325
119.024
4011.92765
|
Lacto-N-Tetraose
429.9219475
815.3775375
121.34189
2894.36631
|
Lacto-N-Tetraose
349.65877
738.019535
85.62092
2932.955
|
Lacto-N-Tetraose
300.9595
640.624545
101.62557
3026.125
|
Lacto-N-Tetraose
402.6631225
1063.8035
53.0063
2461.67215
|
Lacto-N-Tetraose
840.66133
1577.087795
161.241
3144.60141
|
Lacto-N-Tetraose
687.912885
1289.76172
147.76
2176.884
|
Lacto-N-Tetraose
424.3854625
893.4178375
125.368
1648.35178
|
Lacto-N-Tetraose
348.85265
767.16389
105.469
1182.654
|
Lacto-N-Tetraose
290.58641
641.668435
90.424
971.2455
|
|
TABLE XXII
|
|
param
unit
DELITYP
visit
N
mean
sd
median
|
|
Lactodifucosyllactose
mg/L
UNIQUE
V1
138
602.4483369
532.6734
420.450595
|
Lactodifucosyllactose
mg/L
UNIQUE
V2
168
356.5481879
418.4975
226.1571229
|
Lactodifucosyllactose
mg/L
UNIQUE
V3
146
276.3310824
241.1256
225.6436741
|
Lactodifucosyllactose
mg/L
UNIQUE
V4
132
276.9074259
155.7537
235.3399016
|
Lactodifucosyllactose
mg/L
UNIQUE
V5
127
262.4787906
105.0967
251.3244514
|
Lactodifucosyllactose
mg/L
UNIQUE
V6
122
271.2121321
118.9087
251.5873565
|
Lactodifucosyllactose
mg/L
WITH
V1
48
621.9134647
632.5672
446.7314741
|
SIBLINGS
|
Lactodifucosyllactose
mg/L
WITH
V2
53
324.4667808
207.8789
263.9484063
|
SIBLINGS
|
Lactodifucosyllactose
mg/L
WITH
V3
52
278.3663381
202.4931
229.1361688
|
SIBLINGS
|
Lactodifucosyllactose
mg/L
WITH
V4
50
288.8035427
153.0885
253.9644236
|
SIBLINGS
|
Lactodifucosyllactose
mg/L
WITH
V5
48
301.0084875
180.131
270.6795168
|
SIBLINGS
|
Lactodifucosyllactose
mg/L
WITH
V6
46
264.2267501
143.745
235.4535289
|
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Lactodifucosyllactose
252.9317593
740.5602398
79.7125399
2988.924526
|
Lactodifucosyllactose
150.8612583
382.6521639
45.93249331
2996.415918
|
Lactodifucosyllactose
153.9841793
302.7349125
54.62821152
1682.713383
|
Lactodifucosyllactose
189.679307
314.4043267
47.58249391
1108.712256
|
Lactodifucosyllactose
194.6646696
328.8925958
54.61609346
659.1978832
|
Lactodifucosyllactose
197.9919531
321.6287901
51.57284974
738.7201617
|
Lactodifucosyllactose
226.8209576
724.3811897
50.73247046
3297.275118
|
Lactodifucosyllactose
179.9819135
365.4112845
85.89288249
1006.992878
|
Lactodifucosyllactose
148.2192763
307.5226659
49.85838655
1155.744731
|
Lactodifucosyllactose
185.9829117
369.4069428
48.51975875
755.2157228
|
Lactodifucosyllactose
159.9668191
374.1570922
46.25256273
823.6766534
|
Lactodifucosyllactose
166.4023321
323.0766056
51.0670661
789.5430687
|
|
TABLE XXIII
|
|
param
unit
DELITYP
visit
N
mean
Sd
median
|
|
Sialyllacto-N-
mg/L
UNIQUE
V1
173
120.4946707
143.5211
79.38738266
|
Tetraose a
|
Sialyllacto-N-
mg/L
UNIQUE
V2
215
120.320383
174.7271
67.4387729
|
Tetraose a
|
Sialyllacto-N-
mg/L
UNIQUE
V3
190
102.3350203
162.4454
52.40591398
|
Tetraose a
|
Sialyllacto-N-
mg/L
UNIQUE
V4
174
93.13419276
147.0611
43.84859549
|
Tetraose a
|
Sialyllacto-N-
mg/L
UNIQUE
V5
167
94.31415999
147.0746
49.15530418
|
Tetraose a
|
Sialyllacto-N-
mg/L
UNIQUE
V6
159
87.10861153
104.4478
53.16420322
|
Tetraose a
|
Sialyllacto-N-
mg/L
WITH
V1
64
131.8621806
146.2816
82.78296339
|
Tetraose a
SIBLINGS
|
Sialyllacto-N-
mg/L
WITH
V2
75
156.1165221
252.4851
74.99139372
|
Tetraose a
SIBLINGS
|
Sialyllacto-N-
mg/L
WITH
V3
71
120.6949772
178.2896
53.99733714
|
Tetraose a
SIBLINGS
|
Sialyllacto-N-
mg/L
WITH
V4
69
107.0655282
131.3995
57.34829438
|
Tetraose a
SIBLINGS
|
Sialyllacto-N-
mg/L
WITH
V5
67
116.0504387
134.8519
60.29079818
|
Tetraose a
SIBLINGS
|
Sialyllacto-N-
mg/L
WITH
V6
65
104.5433758
111.7794
56.80548521
|
Tetraose a
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Sialyllacto-N-
47.18897931
124.0410768
0
837.4945131
|
Tetraose a
|
Sialyllacto-N-
38.1468268
107.9080843
0
1110.361583
|
Tetraose a
|
Sialyllacto-N-
27.44278706
92.1621572
0
1121.248141
|
Tetraose a
|
Sialyllacto-N-
23.94542777
89.71831532
0
1187.41635
|
Tetraose a
|
Sialyllacto-N-
26.76896814
90.56411096
0
1133.515897
|
Tetraose a
|
Sialyllacto-N-
27.54758109
103.3993222
0
613.7754102
|
Tetraose a
|
Sialyllacto-N-
51.7635368
141.5571605
0
744.0657752
|
Tetraose a
|
Sialyllacto-N-
47.88950453
132.3895992
0
1819.176794
|
Tetraose a
|
Sialyllacto-N-
35.99927184
100.647476
0
1092.717349
|
Tetraose a
|
Sialyllacto-N-
33.00046274
108.7613672
0
619.6592317
|
Tetraose a
|
Sialyllacto-N-
36.44169544
133.7701709
0
566.2366019
|
Tetraose a
|
Sialyllacto-N-
36.89919403
147.2063842
6.388328416
492.4752761
|
Tetraose a
|
|
TABLE XXIV
|
|
param
unit
DELITYP
visit
N
mean
Sd
median
|
|
Sialyllacto-N-
mg/L
UNIQUE
V1
170
79.18246062
42.28283
68.72569099
|
Tetraose b
|
Sialyllacto-N-
mg/L
UNIQUE
V2
214
78.58361782
42.06355
70.1670586
|
Tetraose b
|
Sialyllacto-N-
mg/L
UNIQUE
V3
189
75.84894256
38.80082
67.84839427
|
Tetraose b
|
Sialyllacto-N-
mg/L
UNIQUE
V4
170
64.81255413
32.93704
58.95748683
|
Tetraose b
|
Sialyllacto-N-
mg/L
UNIQUE
V5
162
57.12345702
30.98851
50.59947014
|
Tetraose b
|
Sialyllacto-N-
mg/L
UNIQUE
V6
155
52.23655174
29.0665
44.63595583
|
Tetraose b
|
Sialyllacto-N-
mg/L
WITH
V1
64
79.88850896
33.7112
72.77711539
|
Tetraose b
SIBLINGS
|
Sialyllacto-N-
mg/L
WITH
V2
75
82.99519595
33.57784
73.74143426
|
Tetraose b
SIBLINGS
|
Sialyllacto-N-
mg/L
WITH
V3
71
81.41914544
34.10483
78.12830055
|
Tetraose b
SIBLINGS
|
Sialyllacto-N-
mg/L
WITH
V4
67
63.55755653
31.84949
55.58607088
|
Tetraose b
SIBLINGS
|
Sialyllacto-N-
mg/L
WITH
V5
66
55.35928595
31.36357
46.55150531
|
Tetraose b
SIBLINGS
|
Sialyllacto-N-
mg/L
WITH
V6
63
45.79773144
24.27547
37.24666837
|
Tetraose b
SIBLINGS
|
|
param
q1.25%
q3.75%
min
max
|
|
Sialyllacto-N-
53.1564539
90.75480198
14.91737174
275.7441984
|
Tetraose b
|
Sialyllacto-N-
48.80673735
96.07204811
19.62994206
323.091464
|
Tetraose b
|
Sialyllacto-N-
47.47623501
95.76248549
18.2993516
230.1699462
|
Tetraose b
|
Sialyllacto-N-
42.03248619
77.48231245
17.91900028
203.3889653
|
Tetraose b
|
Sialyllacto-N-
34.20021019
69.2258118
15.77729891
176.0331169
|
Tetraose b
|
Sialyllacto-N-
31.10428435
63.33068783
14.36759859
161.4190188
|
Tetraose b
|
Sialyllacto-N-
59.09832119
95.39076549
36.70322691
190.496288
|
Tetraose b
|
Sialyllacto-N-
63.00766627
99.34148018
16.07949427
176.9251632
|
Tetraose b
|
Sialyllacto-N-
58.42526875
97.31339889
16.14913449
192.4038113
|
Tetraose b
|
Sialyllacto-N-
40.10314569
78.74882648
17.09181849
177.5190818
|
Tetraose b
|
Sialyllacto-N-
31.64970623
67.96184529
17.88112005
159.9283979
|
Tetraose b
|
Sialyllacto-N-
28.09090242
56.62478649
17.40002881
118.0078565
|
Tetraose b
|
|
Example 2
Table XXV sets out a human milk fortifier composition for in accordance with the invention. Said human milk fortifier may be for use to supplement the breast milk produced for an infant of up to 1 month of age by a primiparous mother.
TABLE XV
|
|
Nutrient
Per 100 kcal
|
|
|
Energy (kcal)
100
|
Lipid (g)
9.76
|
DHA (mg)
37.26
|
Linoleic acid (mg)
1124.76
|
α-linolenic acid (mg)
107.1
|
ARA (mg)
47.68
|
ARA/DHA ratio
1.28
|
Linoleic/α-linolenic ratio
10.5
|
EPA (mg)
4.06
|
EPA/DHA ratio
0.11
|
MCT (g)
1.4
|
Protein (g)
0.7
|
Carbohydrate (g)
2.3
|
Minerals and electrolytes
|
Na (mg)
71.25
|
K (mg)
113.62
|
Cl (mg)
100.12
|
Ca (mg)
116.41
|
P (mg)
69.27
|
Mg (mg)
8.50
|
Mn (μg)
7.40
|
Fe (mg)
2.11
|
Cu (mg)
0.10
|
Zn (mg)
1.48
|
I (μg)
33.76
|
Se (μg)
6.75
|
F (μg)
1.40
|
Cr (μg)
0.88
|
Mo (μg)
0.93
|
Vitamins and trace elements
|
Vitamin A (μg)
518.04
|
Vitamin D (μg)
4.61
|
Vitamin E (mg)
4.3
|
Vitamin K (μg)
8.3
|
Vitamin C (mg)
24.4
|
Vitamin B1 (mg)
0.159
|
Vitamin B2 (mg)
0.227
|
Niacin (mg)
1.99
|
Vitamin B6 (mg)
0.16
|
Folic acid (μg)
50.17
|
Vitamin B12 (μg)
0.26
|
Pantothenic acid (mg)
1.08
|
Biotin (μg)
4.70
|
Choline (mg)
10.01
|
Inositol (mg)
5.59
|
Taurine (mg)
6.98
|
Carnitine (mg)
4.89
|
3-Fucosyllactose (mg)
13.5
|
Lacto-N-Fucosylpentaose II
15
|
(mg)
|
|
The composition according to the present invention may be formulated with many variations without departing from the scope of the invention as defined in the claims.
Example 3
Table XVI sets out an HMO human milk fortifier composition in accordance with the invention. Said human milk fortifier may be for use to supplement the breast milk produced for an infant of up to 1 month of age by a primiparous mother.
TABLE XVI
|
|
HMO
mg/L
|
|
|
3-Fucosyllactose
90
|
Lacto-N-Fucosylpentaose II
100
|
2′-Fucosyllactose
100
|
Lactose
??
|
|
Example 4
Table XVII sets out a human milk fortifier composition for in accordance with the invention. Said human milk fortifier may be for use to supplement the breast milk produced for an infant of up to 1 month of age by a multiparous mother. Said human milk fortifier composition may be comprised in a nutritional system with the human milk fortifier composition set out in example 2 wherein said composition of example 2 is specifally tailored for use to supplement the breast milk produced for an infant of up to 1 month of age by a primiparous mother.
TABLE XVII
|
|
Nutrient
Per 100 kcal
|
|
|
Energy (kcal)
100
|
Lipid (g)
9.76
|
DHA (mg)
37.26
|
Linoleic acid (mg)
1124.76
|
α-linolenic acid (mg)
107.1
|
ARA (mg)
47.68
|
ARA/DHA ratio
1.28
|
Linoleic/α-linolenic ratio
10.5
|
EPA (mg)
4.06
|
EPA/DHA ratio
0.11
|
MCT (g)
1.4
|
Protein (g)
0.7
|
Carbohydrate (g)
2.3
|
Minerals and electrolytes
|
Na (mg)
71.25
|
K (mg)
113.62
|
Cl (mg)
100.12
|
Ca (mg)
116.41
|
P (mg)
69.27
|
Mg (mg)
8.50
|
Mn (μg)
7.40
|
Fe (mg)
2.11
|
Cu (mg)
0.10
|
Zn (mg)
1.48
|
I (μg)
33.76
|
Se (μg)
6.75
|
F (μg)
1.40
|
Cr (μg)
0.88
|
Mo (μg)
0.93
|
Vitamins and trace elements
|
Vitamin A (μg)
518.04
|
Vitamin D (μg)
4.61
|
Vitamin E (mg)
4.3
|
Vitamin K (μg)
8.3
|
Vitamin C (mg)
24.4
|
Vitamin B1 (mg)
0.159
|
Vitamin B2 (mg)
0.227
|
Niacin (mg)
1.99
|
Vitamin B6 (mg)
0.16
|
Folic acid (μg)
50.17
|
Vitamin B12 (μg)
0.26
|
Pantothenic acid (mg)
1.08
|
Biotin (μg)
4.70
|
Choline (mg)
10.01
|
Inositol (mg)
5.59
|
Taurine (mg)
6.98
|
Carnitine (mg)
4.89
|
|
The composition according to the present invention may be formulated with many variations without departing from the scope of the invention as defined in the claims.