阅读说明：本技术 包含番茄红素的性别特异性合成营养组合物以及包含它们的营养体系 (Gender specific synthetic nutritional compositions comprising lycopene and nutritional systems comprising the same ) 是由 S·塔卡尔 F·朱弗里达 F·德塔亚 C·A·德卡斯特罗 M-B·桑切斯布里奇 于 2018-12-20 设计创作，主要内容包括：本发明提供了性别特异性合成营养组合物以及包含它们的营养体系,该性别特异性合成营养组合物包含一定浓度的番茄红素,该浓度反映了在对应的泌乳阶段处存在于由对应性别的婴儿的母亲所产的人乳中的番茄红素浓度。(The present invention provides gender specific synthetic nutritional compositions comprising lycopene at a concentration reflecting the lycopene concentration present in human milk produced by the mother of an infant of the corresponding gender at the corresponding lactation stage, and nutritional systems comprising the same.)

1. A gender specific synthetic nutritional composition tailored for infants comprising lycopene at a concentration reflecting the concentration present in human milk produced for infants of the same gender and age.

2. The gender specific synthetic nutritional composition of claim 1 wherein said composition is tailored for infants selected from the group consisting of up to 4 months of age and an age of 4 months of age or greater.

3. A gender specific synthetic nutritional composition according to claim 2 wherein the concentration of lycopene is in the range of 0.1 μ g/m L to 0.95 μ g/m L if it is tailored for male infants up to 4 months of age and in the range of 0.07 μ g/m L to 0.36 μ g/m L if it is tailored for female infants up to 4 months of age, in the range of 0.06 μ g/m L to 0.39 μ g/m L if it is tailored for male infants up to 4 months of age or above and in the range of 0.09 μ g/m L to 0.27 μ g/m L if it is tailored for female infants up to 4 months of age or above.

4. The gender specific synthetic nutritional composition of claim 1, 2 or 3 wherein the gender specific synthetic nutritional composition is selected from the group consisting of: infant formula and compositions for infants intended to be added to or diluted with human milk.

5. A method of preparing a gender specific synthetic nutritional composition as defined in any one of claims 1 to 4, the method comprising: an appropriate amount of the sexually non-segregating synthetic nutritional composition is measured out and the sexually non-segregating synthetic nutritional composition is mixed with additives and/or diluents.

6. A nutrition system comprising a gender specific synthetic nutritional composition as defined in any one of claims 1 to 4.

7. The nutritional system according to claim 6, comprising one gender specific synthetic nutritional composition for male infants as defined in any one of claims 1 to 4 and one gender specific nutritional composition for female infants as defined in any one of claims 1 to 4.

8. The nutritional system of claim 7, wherein the male gender-specific synthetic nutritional composition and the female gender-specific synthetic nutritional composition are for infants of the same age, and wherein the concentration of lycopene in the gender-specific synthetic nutritional composition for male infants is higher than the concentration of lycopene in the gender-specific synthetic nutritional composition for female infants.

9. The nutritional system of claim 8, wherein the nutritional system comprises a gender-specific synthetic nutritional composition for male infants up to 4 months of age and a gender-specific synthetic nutritional composition for female infants up to 4 months of age, and wherein the gender-specific synthetic nutritional composition for male infants comprises from 0.03 μ g/m L to 0.84 μ g/m L more lycopene than the female gender-specific synthetic nutritional composition.

10. The nutritional system of claim 8, wherein the nutritional system comprises a gender-specific synthetic nutritional composition for male infants at or above 4 months of age and a gender-specific synthetic nutritional composition for female infants at or above 4 months of age, and wherein the gender-specific synthetic nutritional composition for male infants comprises from 0.01 μ g/m L to 0.3 μ g/m L more lycopene than the female gender-specific synthetic nutritional composition.

11. Use of a gender specific synthetic nutritional composition as defined in any one of claims 1 to 3 for providing an optimal amount of lycopene to an infant.

12. A gender specific synthetic nutritional composition as defined in any one of claims 1 to 3 for use in preventing or treating sub-optimal lycopene levels and/or optimizing antioxidant capacity and/or skin health in infants.

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

a. optionally preparing a gender specific synthetic nutritional composition as defined in any one of claims 1 to 4 from a gender independent synthetic nutritional composition;

b. feeding a gender specific synthetic nutritional composition as defined in any one of claims 1 to 4 to an infant.

14. A nutritional system as defined in any one of claims 5 to 10 for use in preventing or treating sub-optimal lycopene levels and/or optimizing antioxidant capacity and/or skin health in infants.

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

a. a sex-independent synthetic nutritional composition;

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

Technical Field

The present invention relates to gender specific synthetic nutritional compositions, nutritional systems comprising them, and their use to provide optimal amounts of lycopene to infants.

Background

Although breast feeding is optimal for infants, the presence of certain conditions may mean that breast feeding is contraindicated. In such cases where a sole source of nutrition is not available for the infant, alternative strategies for feeding them must be devised. Feeding an infant with a synthetic nutritional composition (e.g., an infant formula) is one such strategy.

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 stage of lactation and the sex of the infant of the mother. Because such age and gender differences in lycopene concentration of human milk have never been identified previously, these differences are not reflected in the composition of synthetic nutritional compositions available today for infants. Given that human milk is considered the gold standard for infant nutrition, there remains a need to tailor synthetic nutritional compositions for infants of a particular age and gender that better reflect these identified differences.

Disclosure of Invention

The invention is set forth in the claims. The present inventors have developed a gender specific synthetic nutritional composition for infants comprising lycopene at a concentration reflecting the concentration of lycopene present in human milk produced for infants of the same age/corresponding lactation stage and gender.

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

The gender specific synthetic nutritional compositions of the present invention may be prepared from gender-independent synthetic nutritional compositions by: the sexually neutral synthetic nutritional compositions are measured out in appropriate amounts and mixed with additives and/or diluents (e.g., lycopene and/or water).

The gender specific synthetic nutritional compositions of the present invention may be included in a nutritional system. The nutritional system may comprise a gender-specific synthetic nutritional composition for female infants and/or a gender-specific composition for male infants of the same age. The gender specific synthetic nutritional composition for male infants may comprise more lycopene than the gender specific synthetic nutritional composition for female infants of the same age. The gender specific synthetic nutritional composition may be used for infants selected from the following ages: 4 months old and 4 months old or more.

The lycopene concentration of the gender specific synthetic nutritional composition of the present invention reflects the lycopene concentration present in human milk produced for infants of the same gender and age (corresponding to the lactation stage). Since human milk is considered to be optimal for infant nutrition, the gender-specific synthetic nutritional composition and the nutritional system comprising the gender-specific synthetic nutritional composition of the present invention may provide an optimal amount of lycopene to an infant, e.g. an infant of the same gender as the gender for which the synthetic nutritional composition is intended. Gender specific synthetic nutritional compositions may be used, for example, to ensure optimal lycopene intake and levels, or to prevent sub-optimal lycopene levels, and/or to optimize antioxidant capacity and/or skin health in infants, e.g., infants up to 4 months of age and at or above 4 months of age.

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. Surprisingly, the results of this study indicate that the concentration of lycopene present in human milk may vary depending on the lactation stage and/or the sex of the infant of the mother. In particular, the study showed that the concentration of lycopene in human milk produced by mothers versus boys can be higher than the concentration of lycopene in human milk produced by mothers versus girls at the same lactation stage. The details of the study, analytical techniques and results are given in example 1.

Based on the findings of this study, the inventors have designed a gender specific synthetic nutritional composition comprising lycopene at a concentration reflecting the lycopene concentration present in human milk produced by infants of the same gender at the corresponding lactation stage.

The term "gender-specific synthetic nutritional composition" as used herein refers to any synthetic nutritional composition for infants, particularly for meeting the nutritional needs of female or male infants. Non-limiting examples of gender-specific synthetic nutritional compositions for infants from birth to 4 months 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 gender-specific synthetic nutritional compositions for infants from 4 months to 12 months include infant formulas, compositions for infants intended to be added to or diluted with human milk (e.g., human milk fortifiers), or foodstuffs intended for infants to eat alone or in combination with human milk (e.g., complementary foods).

The gender specific synthetic nutritional composition is intended for consumption by infants of the same gender as the gender specifically adapted thereto.

The sex of infants can be determined by their biological sex (e.g., by their sex chromosomes) (infants with the XX sex chromosome will be considered females and infants with the XY sex chromosome will be considered males).

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 gender-specific synthetic nutritional composition tailored for infants is provided, comprising lycopene at a concentration reflecting the concentration present in human milk produced for infants of the same gender at the corresponding lactation stage (e.g. up to 4 months, up to 2 months, 4 months and thereafter).

In one embodiment, the sex-specific synthetic nutritional composition is a male sex-specific synthetic nutritional composition for infants up to 4 months of age and comprises lycopene at a concentration selected from the group consisting of 0.1 μ g/m L to 0.95 μ g/m L, 0.16 μ g/m L to 0.62 μ g/m L, 0.2 μ g/m L to 0.28 μ g/m L.

Male sex-specific synthetic nutritional compositions may for example be used for infants up to 2 months of age and comprise lycopene at a concentration selected from 0.1 μ g/m L to 0.28 μ g/m L, 0.16 μ g/m L to 0.24 μ g/m L, 0.19 μ g/m L to 0.21 μ g/m L.

Male sex-specific synthetic nutritional compositions may for example be used for infants over 2 months of age (e.g. 2 to 4 months of age) and may comprise lycopene at a concentration selected from 0.09 μ g/m L to 0.96 μ g/m L, 0.18 μ g/m L to 0.62 μ g/m L, 0.27 μ g/m L to 0.45 μ g/m L.

In one embodiment, the gender specific synthetic nutritional composition is a female gender specific synthetic nutritional composition for infants up to 4 months of age and comprising lycopene at a concentration selected from the group consisting of 0.07 μ g/m L to 0.36 μ g/m L, 0.13 μ g/m L to 0.27 μ g/m L, 0.14 μ g/m L to 0.22 μ g/m L.

Female gender specific synthetic nutritional compositions may for example be used for infants up to 2 months of age and comprise lycopene at a concentration selected from 0.07 μ g/m L to 0.21 μ g/m L, 0.12 μ g/m L to 0.18 μ g/m L, and 0.14 μ g/m L to 0.15 μ g/m L.

Female sex-specific synthetic nutritional compositions may for example be used for infants over 2 months of age (e.g. 2 to 4 months of age) and may comprise lycopene at a concentration selected from 0.11 μ g/m L to 0.36 μ g/m L, 0.15 μ g/m L to 0.27 μ g/m L and 0.21 μ g/m L to 0.22 μ g/m L.

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

In one embodiment, the sex-specific synthetic nutritional composition is a male sex-specific synthetic nutritional composition for infants at 4 months of age and older and comprises lycopene at a concentration selected from the group consisting of 0.06 μ g/m L to 0.39 μ g/m L, 0.1 μ g/m L to 0.22 μ g/m L, and 0.15 μ g/m L to 0.18 μ g/m L.

In one embodiment, the gender specific synthetic nutritional composition is a female gender specific synthetic nutritional composition for infants 4 months of age and older and comprises lycopene at a concentration selected from the group consisting of 0.09 μ g/m L to 0.27 μ g/m L, 0.1 μ g/m L to 0.2 μ g/m L, 0.12 μ g/m L to 0.16 μ g/m L.

Non-limiting examples of ages of 4 months and above 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.

The lycopene concentration of the gender-specific synthetic nutritional composition as defined herein is expressed in μ g/m L this may refer to the lycopene concentration of the reconstituted gender-specific synthetic nutritional composition.

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 gender specific synthetic nutritional composition is intended may be included within the gender specific synthetic nutritional compositions of the present invention. Lycopene may for example be added as free lycopene and/or an ester of lycopene (e.g. as 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.

The gender specific synthetic nutritional compositions of the present invention may also comprise any other ingredient or excipient known for the type of gender specific synthetic nutritional composition (e.g., infant formula) under consideration.

Non-limiting examples of such ingredients include: proteins, amino acids, carbohydrates, oligosaccharides, lipids, prebiotics or probiotics, essential fatty acids, nucleotides, nucleosides, 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 gender-specific synthetic nutritional compositions of the present invention may also include gangliosides (monosialoganglioside 3(GM3) and disialoganglioside 3(GD3)), phospholipids (such as sphingomyelin, phosphatidylcholines, phosphatidylethanolamines, phosphatidylinositols, phosphatidylserines), and combinations thereof.

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) angelw.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 Acobacterium), lactococcus (L Acococcus), Enterococcus (Enterococcus), Streptococcus (Streptococcus), Kluyveromyces (Kluyveromyces), Saccharomyces (Saccharomyces), Candida (Candida), in particular Bifidobacterium longum (Bifidobacterium longum), Bifidobacterium (Bifidobacterium lacticum), Bifidobacterium animalis (Bifidobacterium animalis), Bifidobacterium breve (Bifidobacterium breve), Bifidobacterium infantis (Bifidobacterium longum), Bifidobacterium adoxoides (Bifidobacterium adoxoides), Lactobacillus acidophilus (L0 Bifidobacterium acidophilus), Lactobacillus casei (Lactobacillus L, Lactobacillus plantarum), Lactobacillus brevis (Lactobacillus plantarum) Lactobacillus plantarum (NCC 378), Lactobacillus plantarum (Lactobacillus plantarum), Lactobacillus paracasei (Lactobacillus plantarum), Lactobacillus paracasei (Lactobacillus paracasei) (NCbacillus brevis 378), Lactobacillus plantarum (Lactobacillus plantarum), Lactobacillus brevis (Lactobacillus plantarum) and Lactobacillus plantarum (Lactobacillus brevis CGMCC 468), Lactobacillus plantarum (Lactobacillus plantarum), Lactobacillus paracasei) (NCbacillus brevis (NCsanctici-368), Lactobacillus paracasei (Lactobacillus paracasei) (NCsanobacter (NCsane), Lactobacillus plantarum (NCsanobacter 5435, Lactobacillus plantarum), Lactobacillus plantarum (NCsanobacter 3, Lactobacillus plantarum), Lactobacillus paracasei) (NCsanobacter 3, Lactobacillus plantarum), Lactobacillus paracasei) (NCsanctium 3, Lactobacillus paracasei) (NCsane), Lactobacillus paracasei) (NCsanobacter lactis 3, Lactobacillus paracasei) (NCsane), Lactobacillus paracasei) (NCsanobacter alumina strain (NCsanobacter lactobacillus acidophilus (NCsane), Lactobacillus paracasei) (NCsanobacter lactis 3-368, Lactobacillus paracasei) (NCsanobacter lactis (NCsane), Lactobacillus paracasei (NCsane), Lactobacillus paracasei) (NCsane), Lactobacillus paracasei (NCsanobacter lactis (NCsane), Lactobacillus paracasei) (NCsanobacter (NCsane), Lactobacillus paracasei) (NCsanotii) (NCsane), Lactobacillus paracasei) (NCsanctium), Lactobacillus paracase.

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 E, vitamin B1, vitamin B2, vitamin B6, vitamin B12, 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 the synthetic nutritional compositions that may be used in the gender-specific synthetic nutritional compositions of the present invention are set forth in the guidelines promulgated by the Codex Alimentarius for the type of synthetic nutritional composition involved, e.g., infant formula, human milk fortifier, follow-up formula, or a foodstuff intended for consumption by an infant, e.g., a supplemental food.

The gender-specific synthetic nutritional compositions of the present invention may be prepared by well-known methods in the art for preparing the type of gender-specific synthetic nutritional compositions involved (e.g., infant formulas, follow-up formulas, compositions for infants intended to be added to or diluted with human milk (e.g., human milk fortifiers), or foodstuffs intended for infants to eat alone or in combination with human milk (e.g., complementary foods)).

An exemplary method for preparing gender-specific powdered infant formula is as follows. The protein source, carbohydrate source and fat source may be blended together in the appropriate proportions. An emulsifier may be added to the blend. 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 to a suitable drying apparatus (such as a spray dryer or freeze dryer) and converted to a powder. The powder should have a moisture content of less than about 3% by weight.

If it is desired that the probiotic(s) may be added, they 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 gender specific powdered infant formulas by dry blending.

The gender specific synthetic nutritional compositions of the present invention may also be prepared from gender-independent synthetic nutritional compositions by a method comprising: an appropriate amount of said sex-independent synthetic nutritional composition is measured out and mixed with additives and/or diluents (e.g. lycopene and/or water) in order to obtain a sex-specific synthetic nutritional composition according to the invention. The supplement may be a gender specific supplement.

The supplement may be a gender-specific supplement comprising lycopene in a specific concentration such that when mixed with a gender-specific synthetic nutritional composition and optionally a diluent, the resulting mixture is a gender-specific synthetic nutritional composition according to the present invention.

Sex-independent synthetic nutritional compositions may be prepared by methods well known in the art for the type of composition involved (e.g., as listed above for infant formula).

The term "sex-independent" as used herein is synonymous with both male and female.

One or more of the gender-specific synthetic nutritional compositions of the present invention may be included in a 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, for example a collection of infant formulas sold under the same brand and tailored/tailored to the nutritional needs of infants of different ages and/or gender and/or different delivery modalities (e.g. caesarean section). 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 yet another aspect of the invention, a nutritional system comprising a gender-specific synthetic nutritional composition of the present invention is provided.

In one embodiment, the nutritional system comprises a gender-specific synthetic nutritional composition for a male infant and a gender-specific synthetic nutritional composition for a female infant, wherein said male gender-specific synthetic nutritional composition and said female gender-specific synthetic nutritional composition are for infants of the same age, and wherein the concentration of lycopene in said gender-specific synthetic nutritional composition for a male infant is higher than the concentration of lycopene in said gender-specific synthetic nutritional composition for a female infant.

The concentration of lycopene in the male sex synthetic nutritional composition may be higher by any amount.

In one embodiment, the nutritional system comprises a gender-specific synthetic nutritional composition for a male infant up to 4 months of age and a gender-specific synthetic nutritional composition for a female infant up to 4 months of age, wherein the concentration of lycopene in said male gender-specific synthetic nutritional composition is higher than the concentration of lycopene in said female gender-specific synthetic nutritional composition.

The male sex-specific synthetic nutritional composition may comprise more lycopene than the female sex-specific synthetic nutritional composition, e.g., 0.03 μ g/m L to 0.84 μ g/m L, 0.05 μ g/m L to 0.22 μ g/m L, 0.06 μ g/m L to 0.2 μ g/m L.

The sex-specific synthetic nutritional composition may for example be for infants up to 2 months of age and the male sex-specific synthetic nutritional composition may comprise 0.03 μ g/m L to 0.2 μ g/m L, 0.05 μ g/m L to 0.07 μ g/m L more lycopene than the female sex-specific synthetic nutritional composition.

The sex-specific synthetic nutritional composition may for example be for infants over 2 months of age (e.g. 2 to 4 months of age), and the male sex-specific synthetic nutritional composition may comprise 0.05 μ g/m L to 0.84 μ g/m L, 0.05 μ g/m L to 0.24 μ g/m L more lycopene than the female sex-specific synthetic nutritional composition.

In another specific embodiment, the nutritional system comprises a gender-specific synthetic nutritional composition for male infants over 4 months of age and a gender-specific synthetic nutritional composition for female infants over 4 months of age, wherein the concentration of lycopene in said male gender-specific synthetic nutritional composition is higher than the concentration of lycopene in said female gender-specific synthetic nutritional composition.

The concentration of lycopene in the female gender synthetic nutritional composition may be higher by any amount.

The male sex-specific synthetic nutritional composition may comprise more lycopene than the female sex-specific synthetic nutritional composition, e.g., 0.01 μ g/m L to 0.3 μ g/m L, 0.04 μ g/m L to 0.12 μ g/m L, and 0.01 μ g/m L to 0.032 μ g/m L.

The nutritional system of the present invention may further comprise a nutritional composition for children over 12 months of age.

The gender specific synthetic nutritional composition according to the present invention is particularly suitable for a process for preparing a single serving of infant formula using capsules, each containing a unit dose of a synthetic nutritional composition in concentrated form (e.g. a gender specific synthetic nutritional composition), and the interior of the capsule is equipped with an opening means for discharging the reconstituted synthetic nutritional composition directly from the capsule into a receiving container, such as a feeding bottle. Such a process is described in WO 2006/077259.

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

Capsules may contain the synthetic nutritional compositions (gender specific and non-gender specific) in powder form or in concentrated liquid form, in both cases the synthetic nutritional compositions may be reconstituted with an appropriate amount of water. The composition and amount of infant formula in the capsules may vary depending on the gender and/or age of the infant. If desired, capsules of different sizes may be provided to prepare infant formulas for infants of different gender and/or age.

When referring to infant nutrition, because human milk is the gold standard and because the lycopene concentration of the gender specific synthetic nutritional composition of the present invention better reflects the lycopene concentration present in human milk at the corresponding lactation stage of the mother of an infant of the corresponding gender, they and the nutritional system comprising them can be used to provide an optimal amount of lycopene to an infant, 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 in infants, e.g. infants up to 4 months of age or infants at 4 months of age and above.

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, a gender specific synthetic nutritional composition of the invention is provided for use in preventing and/or treating sub-optimal lycopene levels, for example in infants, such as infants up to 4 months of age, or 4 months of age or older.

The gender specific synthetic nutritional compositions of the present invention may provide optimal amounts of lycopene to infants, in particular to infants up to 4 months of age, or 4 months of age or above.

The nutrition system may for example provide an optimal amount of lycopene to an infant, in particular to an infant of 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 gender-specific synthetic nutritional composition of the present invention from a gender-independent synthetic nutritional composition;

b) feeding an infant with a gender specific synthetic nutritional composition according to the present invention, in particular to an infant of the corresponding gender and age, more in particular to an infant up to 4 months of age, or 4 months of age or more.

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. Gender specific synthetic nutritional compositions may be prepared from synthetic nutritional compositions that are not gender specific. 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 to an infant up to 4 months of age, or 4 months of age or above, the kit comprising:

a) a sex-independent synthetic nutritional composition;

b) a label indicating the dosage requirements of the infant in order to obtain a gender specific nutritional composition according to the present invention.

The dosage requirements may relate to the amount of the gender-independent synthetic nutritional composition used and/or the frequency of consumption (e.g., 4 times per day).

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.