阅读说明：本技术 为特定年龄婴儿定制的合成营养组合物以及包含它们的营养体系 (Synthetic nutritional compositions tailored for infants of specific ages and nutritional systems comprising them ) 是由 S·塔卡尔 C·A·德卡斯特罗 F·德塔亚 F·朱弗里达 于 2018-12-20 设计创作，主要内容包括：本发明提供了为特定年龄婴儿定制的合成营养组合物以及包含它们的营养体系,所述合成营养组合物包含一定浓度的番茄红素,该浓度反映了存在于为相同年龄婴儿所产的人乳中的番茄红素浓度。(The present invention provides synthetic nutritional compositions tailored for infants of a particular age comprising lycopene at a concentration reflecting the concentration of lycopene present in human milk produced for infants of the same age, and nutritional systems comprising the same.)

1. A synthetic nutritional composition tailored for an infant of a specific age, said synthetic nutritional composition comprising lycopene at a concentration reflecting the lycopene concentration present in human milk produced for an infant of the same age.

2. The synthetic nutritional composition of claim 1, wherein the synthetic nutritional composition is tailored for an infant of a particular age selected from the group consisting of up to 4 months of age and over 4 months of age.

3. The synthetic nutritional composition of claim 2, wherein the lycopene concentration is from 0.07 μ g/m L to 0.96 μ g/m L if the synthetic nutritional composition is tailored for infants up to 4 months of age, and from 0.06 μ g/m L to 0.39 μ g/m L if the synthetic nutritional composition is tailored for infants over 4 months of age.

4. A synthetic nutritional composition tailored for an infant of a specific age according to any one of claims 1 to 3 selected from the group consisting of: infant formula and compositions for infants intended to be added to or diluted with human milk fortifiers.

5. A method of preparing a synthetic nutritional composition tailored for an infant of a specific age as defined in any one of claims 1 to 4, the method comprising: an appropriate amount of a specific synthetic nutritional composition, regardless of age, is measured and mixed with additives and/or diluents.

6. A nutrition system comprising a synthetic nutritional composition tailored for an infant of a specific age as defined in any one of claims 1 to 4.

7. The nutritional system according to claim 6, comprising a synthetic nutritional composition tailored for an infant with up to 4 months of age as defined in claim 3, and a synthetic nutritional composition tailored for an infant with more than 4 months of age as defined in claim 3, wherein the lycopene concentration in the synthetic nutritional composition tailored for an infant with up to 4 months of age is higher than the lycopene concentration of the synthetic nutritional composition tailored for an infant with more than 4 months of age.

8. The nutritional system of claim 7 wherein the synthetic nutritional composition tailored for an infant at maximum 4 months of age comprises from 0.005 μ g/m L to 0.95 μ g/m L more lycopene than the synthetic nutritional composition tailored for an infant at more than 4 months of age.

9. Use of a synthetic nutritional composition tailored for an infant of a specific age as defined in any one of claims 1 to 4 to provide an optimal amount of lycopene to an infant.

10. A synthetic nutritional composition tailored for an infant of a specific age according to any one of claims 1 to 4 for use in preventing sub-optimal lycopene levels in an infant.

11. A synthetic nutritional composition tailored for an infant of a specific age as defined in any one of claims 1 to 4 for optimizing antioxidant capacity and skin health.

12. A method for providing an optimal amount of lycopene to an infant, said method comprising:

a. optionally preparing a synthetic nutritional composition tailored for an infant of a specific age as defined in any one of claims 1 to 4 with a specific synthetic nutritional composition of no-age;

b. feeding an infant, in particular an infant of a tailored age for said synthetic nutritional composition, as defined in any one of claims 1 to 4, with a synthetic nutritional composition tailored for an infant of a specific age.

13. A nutritional system as defined in any one of claims 6 to 8 for use in the prevention or treatment of sub-optimal lycopene levels and/or to optimize antioxidant capacity and/or skin health in infants.

14. A kit for providing an optimal amount of lycopene to an infant, said kit comprising:

a. age-independent specific synthetic nutritional compositions

b. Label indicating the dosage requirements of an infant in order to obtain a synthetic nutritional composition tailored for an infant of a specific age as defined in any one of claims 1 to 4.

Technical Field

The present invention relates to synthetic nutritional compositions tailored for infants of a specific age, to nutritional systems comprising them, and to their use to provide an optimal amount of lycopene to an infant.

Background

Although breast feeding is optimal for infants, the presence of certain conditions may mean that breast feeding is contraindicated. In cases where such a unique source of nutrition is not available to the infant, alternative strategies need to be employed to feed them. One alternative strategy is to feed the infant with a synthetic nutritional composition (e.g. an infant formula).

The composition of the aforementioned synthetic nutritional compositions (e.g. infant formula) is intended to replicate the composition of human milk (hereinafter HM). However, replicating human milk is not a trivial task. Not only does human milk contain multiple components, its composition is extremely dynamic, and these dynamics have largely not been explored and characterized.

The present inventors have now surprisingly found that the concentration of lycopene in human milk may vary depending on the lactation stage. Since such differences in lycopene concentration of human milk have never been identified before, these differences are not reflected in the composition of synthetic nutritional compositions available today for infants. Given that human milk meets the gold standard associated with infant nutrition, there remains a need for synthetic nutritional compositions that better reflect these identified differences and are tailored for infants of a particular age.

Disclosure of Invention

The invention is set forth in the claims. The present inventors have developed a synthetic nutritional composition tailored for infants of a particular age comprising lycopene at a concentration reflecting the concentration of lycopene present in human milk produced for infants of the same age (e.g. at the same lactation stage).

The synthetic nutritional composition may be, for example, an infant formula or a composition for infants intended to be added to or diluted with human milk.

A synthetic nutritional composition tailored for an infant of a particular age may be included in the nutritional system. The lycopene concentration of the synthetic nutritional composition tailored for infants of a particular age may vary. The lycopene concentration in a synthetic nutritional composition tailored for infants up to 4 months of age may be higher compared to a synthetic nutritional composition tailored for infants over 4 months of age. In addition, the lycopene concentration in a synthetic nutritional composition tailored for infants over 2 months of age (e.g. 2 months of age to up to 4 months of age) may be higher compared to a synthetic nutritional composition tailored for infants over 2 months of age.

The lycopene concentration of the synthetic nutritional composition of the present invention more accurately reflects the lycopene concentration present in human milk produced by infants of the same age (i.e. at the same lactation stage). In view of this, and because human milk is considered to be optimal for infant nutrition, they can provide an optimal amount of lycopene to the infant and can be used to ensure optimal lycopene levels in the infant and thereby optimize antioxidant capacity and skin health.

The synthetic nutritional composition of the present invention may be prepared from an age-independent synthetic nutritional composition by: an appropriate amount of the non-age-tailored synthetic nutritional composition is measured and mixed with additives and/or diluents (e.g., lycopene and/or water).

Detailed Description

The present inventors carried out a longitudinal study evaluating the nutritional composition of human milk collected from mothers at different lactation stages, 30 days (1 month), 60 days (2 months) and 120 days (4 months) post partum. The present inventors have surprisingly found that the results indicate that the concentration of lycopene present in human milk may vary depending on the lactation stage. In particular, the present inventors found that the results indicate that the concentration of lycopene in human milk may differ between human milk produced up to 4 months postpartum and human milk produced 4 months postpartum. More specifically, the present inventors found that the results of the study indicate that the concentration of lycopene in human milk produced up to 4 months after birth may be higher compared to the concentration of lycopene in human milk produced up to 4 months after birth. The study also showed that the concentration of lycopene in human milk produced up to 2 months post partum may be higher compared to the concentration of lycopene in human milk produced 2 months post partum (e.g. 2 to 4 months post partum).

Based on the findings of the studies, the present inventors have designed a synthetic nutritional composition tailored for infants of a specific age, wherein the lycopene concentration reflects the lycopene concentration present in human milk produced for infants of the same age (corresponding to the lactation stage).

The term "synthetic nutritional composition tailored for an infant of a specific age" as used herein refers to any synthetic nutritional composition intended to be consumed by an infant of a specific age and specifically adapted to the nutritional needs of an infant of said specific age.

Non-limiting examples of synthetic nutritional compositions tailored for infants up to 4 months of age include: infant formulas and compositions for infants intended to be added to or diluted with human milk (e.g. human milk fortifiers).

Non-limiting examples of synthetic nutritional compositions tailored for infants over 4 months of age include infant formulas, compositions for infants intended to be added to or diluted with human milk (e.g., human milk fortifiers), or foodstuffs intended to be consumed by infants either alone or in combination with human milk (e.g., complementary foods).

The term "infant" as used herein, refers to a human infant not older than 12 months of age.

In one aspect of the invention, a synthetic nutritional composition tailored for an infant of a specific age selected from the group consisting of over 4 months of age and up to 4 months of age is provided, wherein the lycopene concentration in the age-tailored synthetic nutritional composition mimics the lycopene concentration present in human milk produced for an infant of the same age.

Non-limiting examples of ages over 4 months include: 4. 5, 6, 7, 8, 9, 10, 11 and 12 months of age, 4 to 6 months of maximum age, 6 to 9 months of age, 6 to 12 months of age.

Non-limiting examples of ages of up to 4 months include: 2 weeks at maximum, 1 month at maximum, 2 weeks to 1 month at maximum, 2 months at maximum, 1 month to 2 months at maximum, and more than 2 months at maximum.

Non-limiting examples of maximum 2 months of age include: 2 weeks at maximum, 1 month at maximum, 2 weeks to 1 month at maximum, 2 months at maximum, 1 month to 2 months at maximum.

Non-limiting examples of ages over 2 months include: 2 months to several months, 2 months to 3 months at maximum, 3 months to 4 months at maximum, 3 months, 2 months; 4. 5, 6, 7, 8, 9, 10, 11 and 12 months of age, 4 to 6 months of maximum age, 6 to 9 months of age, 6 to 12 months of age.

Non-limiting examples of ages from 2 months to up to 4 months include: 2 months to 3 months at maximum, 3 months to 4 months at maximum, 3 months, 2 months.

In one embodiment, the synthetic nutritional composition is tailored for infants up to 4 months of age and comprises a lycopene concentration selected from 0.07 μ g/m L to 0.96 μ g/m L, 0.13 μ g/m L to 0.3 μ g/m L, 0.17 μ g/m L to 0.29 μ g/m L3 for example, the synthetic nutritional composition is tailored for infants up to 2 months of age and comprises a lycopene concentration selected from 0.07 μ g/m L to 0.27 μ g/m L, 0.13 μ g/m L6 to 0.21 μ g/m L, 0.17 μ g/m L to 0.19 μ g/m L, or for example, the synthetic nutritional composition is tailored for infants over 2 months of age (e.g. 2 months to 4 months of age) and comprises a lycopene concentration selected from 0.09 g/m 6326 to 0.3 μ g/m 3929 μm3 to 0.3 μm L6 μ g/m 3, 0.1 μ g/m 3 to 0.3 μm 3619 μm.

In another embodiment, the synthetic nutritional composition is tailored for infants over 4 months of age and comprises a lycopene concentration selected from 0.06 μ g/m L to 0.39 μ g/m L, 0.11 μ g/m L to 0.21 μ g/m L, 0.12 μ g/m L to 0.18 μ g/m L.

The lycopene concentration of a synthetic nutritional composition tailored for an infant of a particular age as defined herein is expressed in μ g/m L this may refer to the lycopene concentration of a reconstituted synthetic nutritional composition tailored for an infant of a particular age.

The lycopene concentration of a synthetic nutritional composition tailored for an infant of a particular age as defined herein is expressed in μ g/m L this may refer to the lycopene concentration of a reconstituted synthetic nutritional composition tailored for an infant of a particular age.

The lycopene concentration of the composition can be measured by methods well known in the art, in particular, the lycopene concentration can be measured by extraction of lipid and lipophilic molecules by organic solvents.

Any form of lycopene suitable for administration to the infant for which the synthetic nutritional composition is intended may be included in the synthetic nutritional compositions of the present invention. Lycopene may for example be added as free lycopene and/or an ester of lycopene (e.g. one or more fatty acid esters of lycopene).

Lycopene, used in any form (e.g. free lycopene or an ester of lycopene) may be derived from natural sources, in particular it may be derived from animal or plant or algal sources.

Synthetic nutritional compositions tailored for infants of a particular age may also include any other ingredient or excipient known to be employed in such synthetic nutritional compositions in question (e.g., infant formula).

Non-limiting examples of such ingredients include: proteins, amino acids, carbohydrates, oligosaccharides, lipids, prebiotics or probiotics, essential fatty acids, nucleotides, nucleosides, other vitamins, minerals, and other micronutrients.

Non-limiting examples of proteins include casein, α -lactalbumin, whey, soy protein, rice protein, corn protein, oat protein, barley protein, wheat protein, rye protein, pea protein, egg protein, sunflower protein, potato protein, fish protein, meat protein, lactoferrin, serum albumin, immunoglobulins, 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, tryptophan, asparagine, aspartic acid, and combinations thereof.

Non-limiting examples of carbohydrates include lactose, sucrose (saccharose), maltodextrin, 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, milk fat, and combinations thereof.

Non-limiting examples of essential fatty acids include linoleic acid (L a), α -linolenic acid (a L a), and polyunsaturated fatty acids (PUFAs). the nutritional compositions of the present invention may also comprise gangliosides (monosialoganglioside 3(GM3) and disialoganglioside 3(GD3)), phospholipids (such as sphingomyelin, phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol, phosphatidylserine), and combinations of these.

Non-limiting examples of prebiotics include oligosaccharides optionally containing fructose, galactose, mannose, dietary fiber, particularly soluble fiber, soy fiber, inulin, and combinations thereof preferred prebiotics are Fructooligosaccharides (FOS), Galactooligosaccharides (GOS), Isomaltooligosaccharides (IMO), Xylooligosaccharides (XOS), Arabinoxylanoligosaccharides (AXOS), oligomannose (MOS), soy oligosaccharides, Glucosylsucrose (GS), lactosucrose (L S), lactulose (L a), palatinose oligosaccharides (PAO), maltooligosaccharides, gums and/or hydrolysates thereof, pectins and/or hydrolysates thereof, and combinations of the foregoing.

Further examples of oligosaccharides are described in Wrodnigg, t.m.; stutz, A.E, (1999) Angew. chem. int. Ed.38: 827-828 and WO 2012/069416 (incorporated herein by reference).

Non-limiting examples of probiotic bacteria include Bifidobacterium (Bifidobacterium), Lactobacillus (L Acobacter), lactococcus (L Acococcus), Enterococcus (Enterococcus), Streptococcus (Streptococcus), Kluyveromyces (Kluyveromyces), Saccharomyces (Saccharomyces), Candida (Candida), in particular selected from Bifidobacterium longum (Bifidobacterium longum), Bifidobacterium lactis (Bifidobacterium lactis), Bifidobacterium animalis (Bifidobacterium animalis), Bifidobacterium breve (Bifidobacterium breve), Bifidobacterium infantis (Bifidobacterium infantis), Bifidobacterium adopitis (Bifidobacterium adopitis), Lactobacillus (Bifidobacterium lactis), Lactobacillus acidophilus (Lactobacillus acidophilus), Lactobacillus casei (Lactobacillus brevis), Lactobacillus casei (Lactobacillus plantarum L), Lactobacillus adolescentis (Bifidobacterium adopiticus) (Lactobacillus plantarum), Lactobacillus paracasei (Lactobacillus paracasei), Lactobacillus paracasei (Lactobacillus paracasei) (NCbacillus brevis 378), Lactobacillus paracasei (Lactobacillus paracasei), Lactobacillus paracasei) (NCsanobacter (Lactobacillus plantarum), Lactobacillus paracasei) (NCsanobacter sp.4868), Lactobacillus paracasei (Lactobacillus paracasei) (NCsane), Lactobacillus paracasei) (NCsanobacter 5468), Lactobacillus paracasei) (NCsanum (NCsane), Lactobacillus paracasei) (NCsane), Lactobacillus paracasei (NCsanobacter 4868), Lactobacillus paracasei (NCsane), Lactobacillus paracasei (NCsanobacter (NCsane), Lactobacillus paracasei) (NCsanobacter sanobacter 4868), Lactobacillus paracasei (NCsanobacter sanum sanctii), Lactobacillus sanum sanctii) (NCsanum sanum), Lactobacillus sanum), Lactobacillus sanum), Lactobacillus sanum), Lactobacillus sanum san.

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 other vitamins and minerals include 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, phosphorus, iodine, iron, magnesium, copper, zinc, manganese, chlorine, potassium, sodium, selenium, chromium, molybdenum, taurine, L-carnitine, and combinations thereof.

Other suitable and desirable ingredients of synthetic nutritional compositions that can be used in synthetic nutritional compositions tailored for infants of a particular age are described in guidelines issued by the Codex Alimentarius for the type of synthetic nutritional composition involved, e.g., infant formula, human milk fortifier, follow-up formula, or food for consumption by infants (e.g., complementary food).

Synthetic nutritional compositions tailored for infants of a particular age can be prepared by well-known methods in the art for preparing synthetic nutritional compositions of the type in question (e.g., infant formulas, follow-up infant formulas, infant compositions for addition to or dilution with human milk (e.g., human milk fortifiers), foods for consumption by infants alone or in combination with human milk (e.g., complementary foods)).

An exemplary method for preparing an age-tailored powdered infant formula is as follows. The protein source, carbohydrate source and fat source may be mixed in the appropriate proportions. An emulsifier may be added to the mixture. Vitamins, minerals and lycopene may be added at this point (e.g., in a vitamin premix containing lycopene), but are usually added later to avoid thermal degradation. Any lipophilic vitamins, emulsifiers, etc. may be first dissolved in the fat source prior to blending. Water (preferably water subjected to reverse osmosis) may then be mixed in to form a liquid mixture.

The liquid mixture may then be subjected to a heat treatment to reduce bacterial load. For example, the liquid mixture may be rapidly heated to a temperature in the range of about 80 ℃ to about 110 ℃ for about 5 seconds to about 5 minutes. This can be done by steam injection or by a heat exchanger, for example a plate heat exchanger.

The liquid mixture may then be cooled, for example, by chilling, to about 60 ℃ to about 85 ℃. The liquid mixture may then be homogenized; for example, in two stages: the first stage is conducted at about 7MPa to about 40MPa, and the second stage is conducted at about 2MPa to about 14 MPa. The homogenized mixture may then be further cooled in order to add any heat sensitive components, such as vitamins and minerals. The pH and solids content of the homogenized mixture is conveniently standardized at this point.

The homogenized mixture may be transferred into a suitable drying apparatus, such as a spray dryer or freeze dryer, to convert it into a powder. The powder should have a moisture content of less than about 3% by weight.

If it is desired that one or more probiotics may be added, the probiotics may be cultured according to any suitable method and then made, for example by freeze drying or spray drying, for addition to the infant formula. Alternatively, bacterial preparations that have been made into a suitable form can be purchased from professional suppliers such as the danish Hansen group company (Christian Hansen) and japan serin dairy co. Such bacterial preparations may be added to age-tailored powdered infant formulas by dry blending.

Synthetic nutritional compositions tailored for infants of a particular age can also be prepared with synthetic nutritional compositions not tailored for age by a process comprising the following steps; an appropriate amount of the non-age-tailored synthetic nutritional composition is measured and then mixed with additives and/or diluents (e.g. water) to obtain a synthetic nutritional composition tailored for an infant of a specific age according to the invention.

The supplement may be an age-tailored supplement comprising lycopene in a specific concentration such that when it is mixed with a specific synthetic nutritional composition of no age and optionally a diluent, the resulting mixture is a synthetic nutritional composition tailored for an infant of a specific age according to the invention.

Specific synthetic nutritional compositions of no age can be prepared by methods well known in the art for such compositions in question (e.g., as listed above for infant formulas).

One or more synthetic nutritional compositions tailored for an infant of a particular age may be included in the nutritional system.

The term "nutrition system" as used herein refers to a collection of more than one synthetic nutritional composition advertised or sold as part of the same product line, e.g., a collection of infant formulas sold under the same brand adapted to meet the nutritional needs of infants of different ages and/or gender and/or different modes of delivery (e.g., caesarean delivery). The various synthetic nutritional compositions that make up the nutritional system may be packaged separately, for example, in capsules or boxes. The packages may be sold separately, may be sold in combination (e.g., wrapped in plastic film or combined in a box), or may be sold in a combination of the two. The nutrition system may further comprise a synthetic nutritional composition suitable for children over 12 months of age.

In a further aspect of the invention, there is provided a nutritional system comprising a synthetic nutritional composition according to the invention tailored for an infant of a specific age.

In one embodiment, the nutritional system comprises a synthetic nutritional composition tailored for an infant up to 4 months of age and a synthetic nutritional composition tailored for an infant over 4 months of age, wherein the lycopene concentration of said synthetic nutritional composition tailored for an infant up to 4 months of age is higher compared to said synthetic nutritional composition tailored for an infant over 4 months of age.

The lycopene concentration of a synthetic nutritional composition tailored for infants up to 4 months of age may be higher by any amount.

In one embodiment, a synthetic nutritional composition tailored for an infant of up to 4 months of age comprises 0.005 μ g/m L to 0.95 μ g/m L, 0.06 μ g/m L to 0.2 μ g/m L, 0.01 μ g/m L to 0.12 μ g/m L, 0.006 μ g/m L to 0.06 μ g/m L more lycopene than a synthetic nutritional composition tailored for an infant of over 4 months of age.

Non-limiting examples of ages of 2 months maximum include: a maximum of 2 weeks, a maximum of 1 month, 1 month to a maximum of 2 months, 3 months, 2 to 4 months, 3 to 4 months.

Non-limiting examples of ages over 4 months include: 4. 5, 6, 7, 8, 9, 10, 11, and 12 months of age, 4 to 6 months of age, 4 to 12 months of age, 6 to 9 months of age, and 9 to 12 months of age.

In one embodiment, the nutritional system comprises a synthetic nutritional composition tailored for an infant with an age of 2 months maximum and a synthetic nutritional composition tailored for an infant with an age of more than 2 months (e.g. 2 to 4 months), wherein the lycopene concentration of said synthetic nutritional composition tailored for an infant with an age of 2 months maximum is higher compared to said synthetic nutritional composition tailored for an infant with an age of 2 months maximum.

The lycopene concentration of a synthetic nutritional composition tailored for infants up to 2 months of age may be higher by any amount.

In one embodiment, the synthetic nutritional composition tailored for an infant of up to 2 months of age comprises 0.01 μ g/m L to 0.9 μ g/m L, 0.03 μ g/m L to 0.7 μ g/m L, or 0.03 μ g/m L to 0.12 μ g/m L, 0.007 μ g/m L to 0.06 μ g/m L more lycopene than synthetic nutritional composition tailored for an infant of over 2 months of age.

The synthetic nutritional composition tailored for an infant of a specific age according to the invention is particularly suitable for a process for preparing an individual portion of infant formula using capsules, wherein each capsule contains a unit dose of the synthetic nutritional composition, e.g. an age-tailored synthetic nutritional composition in concentrated form, each capsule being equipped with opening means inside for discharging the reconstituted synthetic nutritional composition directly from the capsule into a receiving container, such as a feeding bottle. This method is described in W02006/077259.

Different synthetic nutritional compositions, including those tailored for an infant of a particular age, may be packaged as individual capsules and provided to the consumer in a multi-pack containing a sufficient number of capsules to meet the eating needs of an infant of a particular age or age range, e.g., a week. Suitable capsule configurations are disclosed in WO 2003/059778.

The capsules may contain a synthetic nutritional composition tailored for an infant of a particular age in powder form or in concentrated liquid form, in both cases the synthetic nutritional composition may be reconstituted with an appropriate amount of water. The amount of synthetic nutritional composition and/or synthetic nutritional composition (e.g., infant formula in a capsule) that is customized for an infant of a particular age may vary with the age of the infant. If necessary, capsules of different sizes may be provided to prepare infant formulas for infants of different ages.

When referring to infant nutrition, because human milk is the gold standard and because the lycopene concentration of the synthetic nutritional compositions of the present invention better reflects the lycopene concentration present in human milk at the corresponding lactation stage, they and the nutritional systems comprising them can be used to provide optimal amounts of lycopene in infants and to ensure optimal lycopene levels or to prevent or treat sub-optimal lycopene levels and/or to optimize antioxidant capacity and/or skin health.

Lycopene has a number of health benefits including its antioxidant capacity, the benefit of protecting skin from photodamage.

In a further aspect of the invention, there is provided a specific synthetic nutritional composition of the invention for use in the prevention and/or treatment of sub-optimal lycopene levels, e.g. in infants, e.g. at maximum 4 months of age, or 4 months of age or older.

The synthetic nutritional composition of the present invention may provide an optimal amount of lycopene to the infant. Specifically to infants up to 4 months of age or to infants over 4 months of age.

The nutrition system may provide an optimal amount of lycopene to infants up to 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1 month of age and/or up to 2 weeks of age.

In another aspect of the present invention there is provided a method for providing an optimal amount of lycopene and/or preventing or treating sub-optimal lycopene levels and/or optimizing antioxidant capacity and or skin health in an infant, the method comprising:

a) optionally preparing a synthetic nutritional composition tailored for an infant of a specific age according to the invention with a synthetic nutritional composition not tailored for age;

b) feeding an infant with a synthetic nutritional composition according to the invention tailored for an infant of a specific age, in particular to an infant of the age for which the synthetic nutritional composition is tailored, more in particular to an infant of up to 4 months of age or to an infant of more than 4 months of age.

In a further aspect of the invention there is provided the use of a composition of the invention in the manufacture of a composition to provide an optimal amount of lycopene and/or to prevent or treat sub-optimal lycopene levels, and/or to optimise antioxidant capacity and or skin health in an infant, for example an infant up to 4 months of age, or 4 months of age or above.

As described herein, a synthetic nutritional composition tailored for an infant of a particular age according to the invention may be prepared with a synthetic nutritional composition that is not tailored for age. Thus, in a further aspect of the present invention, there is provided a kit for providing an optimal amount of lycopene to an infant (in particular a small infant), said kit comprising:

a) age-independent customized synthetic nutritional composition

b) A label indicating the dosage requirements of said non-age tailored synthetic nutritional composition in order to obtain a synthetic nutritional composition tailored for an infant of a specific age according to the invention.

Dosage requirements may relate to the amount of non-age-tailored synthetic nutritional composition employed and/or the frequency of consumption (e.g., 4 times per day).

The kit and method may provide an optimal amount of lycopene to infants, in particular infants up to 4 months of age or infants over 4 months of age.

It will be understood that all features of the invention disclosed herein may be freely combined, and that variations and modifications may be made to these features without departing from the scope of the invention as defined in the claims. Additionally, if there are known equivalents to specific features, then such equivalents are incorporated into the specification as if explicitly set forth herein.

The following are a series of non-limiting examples that serve to illustrate the invention.

Longitudinal clinical trial：

The present inventors designed a longitudinal clinical trial involving 50 nursing mothers, taking milk samples at 30 days postpartum (visit 1), 60 days postpartum (visit 2) and 120 days postpartum (visit 3), respectively. The milk samples were analyzed quantitatively for lycopene.

Human milk collectionThe term infant volunteer mother is apparently healthy and non-smoker (n 50; 31.1 ± 3.1 years), a sample of breast milk (about 30m L) is provided, the sample is collected using a breast pump to squeeze one breast well while nursing the infant with the other breastAvoid lipid content changes during lactation.an approximately 30m L aliquot was isolated and placed in conical polypropylene tubes for this study, leaving milk to feed the infant.samples collected for study were stored at-80 ℃ until analysis.data collection points were 30 days (1 month), 60 days (2 months) and 120 days (4 months) postpartum.

Measurement of lycopene concentration in the sample:

the lycopene concentration of each sample was measured via a method employing the following 3 steps: by passing

Step 1: liquid-liquid extraction:

the following were added to a 1M1 human milk sample:

79 g/L of 5. mu. L EtOH/BHT,

10 μ L deferoxamine mesylate,

4m L MeOH and

1m L30% w, w KOH.

The composition was mixed vigorously using a vortex for 30 seconds and then placed in a 37 ℃ water bath for 30 minutes for saponification after saponification, the composition was cooled down on ice after cooling, 5m L hexane/BHT (4.1.3) was added to it and the composition was mixed using a vortex for 20 seconds the composition was centrifuged at 2500 rpm for 10 minutes at 4 ℃ the organic phase was collected in a 15m L pyrex tube the above process was repeated two more times with human milk taken from the same sample all the organic phases collected from the same sample were combined (with the previous organic phase).

Step 2: evaporation and resuspension

The organic phase was placed under a stream of nitrogen until completely dried then the sediment was redissolved in 70 μ L dioxane/ethanol and mixed with vortex for 15 seconds 70 μ L acetonitrile was added to the composition and the composition was mixed with vortex for 15 seconds.

If a precipitate formed, the composition was centrifuged at 2500 rpm for 10 minutes at room temperature and the full volume of the tube containing the resuspended composition was transferred to UP L C.

And step 3: chromatography and UV detection

ACQUITY UP L C system with fluorescence detector and UV detector.

ACQUITY UP L C HSS T3 column,1.8μm，2.1mm Waters X150mm，176001133。

mobile phase a ammonium acetate 0.05M (3.85 g ammonium acetate dissolved in 1000M L water in a 1L vial).

Mobile phase B ACN/ether/MeOH (weight 588.75g acetonitrile, 71.34g diethyl ether and 118.77g methanol in a 1L vial).

The following conditions were used for chromatography:

the results of the analysis of human milk for lycopene concentration are shown in table I.

TABLE I

Statistical analysis：

Then the following linear mixture model was used for statistical analysis of the compositional analysis results:

lycopene + B0+ B1 at point + B2 gender + B3 at point + gender +

Wherein the time point, gender and their interaction are considered as a fixed effect of the model and the interaction between the time point and gender is taken into account. The prefixes B0, B1, B2 and B3 refer to the regression coefficients corresponding to the different fixed variables, which quantify the effect of these variables on the lycopene level.

Refers to the stochastic effect of the model controlling fluctuations within the individual.

The results of the statistical analysis (statistical inferences) are shown in table II. The time period difference and the corresponding P value are shown.

TABLE II