Agents, compositions, and methods for supporting motor development

Abstract

The present invention relates to one or more human milk oligosaccharides (HMOs) for use in supporting motor development in a subject, wherein the one or more HMOs comprise or consist of 3' sialyllactose (3'-SL), lacto-N-hexaose (LNH), and / or disialyllacto-N-tetraose (DSLNT).

Description

[Technical Field]

[0001] The present invention relates to agents, compositions and methods for supporting motor development. [Background technology]

[0002] Infancy is a critical period during which the brain undergoes significant maturation that is associated with specific behavioral and cognitive outcomes. Effective motor skill development is a key aspect of child development (see, for example, Adolph KE, Hoch JE, 2020. Nestle Nutr Inst Workshop Se. 95, pp. 136-144).

[0003] Evidence linking breastfeeding to early motor development is mixed, with some studies showing improved motor development in breastfed infants and toddlers, while others show no association or no improvement, particularly in gross motor development. The relationship between breastfeeding and motor skill acquisition is difficult to clarify due to common research issues, such as incomplete control of confounding variables, retrospective exposure assessment, differences in motor skill assessment across studies, and the assessment of some motor skills too early (see Michels, KA, et al., 2017. The American Journal of Clinical Nutrition, 106(6), pp.1456-1462).

[0004] Thus, there is a need for new nutritional interventions to promote motor development, for example, in infants, toddlers, or younger children. A need exists for providing such benefits in a manner that does not induce side effects and / or is easy to provide and acceptable to parents or health care professionals. There is also a need for providing such benefits in a manner that keeps the costs associated with such provision reasonable and affordable for most people. Summary of the Invention

[0005] The present inventors have surprisingly found that specific human milk oligosaccharides (HMOs) are associated with positive motor skills in breastfed infants. The HMOs identified by the inventors have not previously been reported to be associated with motor skills.

[0006] In one aspect, the invention provides one or more human milk oligosaccharides (HMO) for use in supporting motor development in a subject, the one or more HMOs comprising or consisting of 3' sialyllactose (3'-SL), lacto-N-hexaose (LNH), and / or disyallacto-N-tetraose (DSLNT).

[0007] In another aspect, the present invention provides the use of one or more human milk oligosaccharides (HMOs) for supporting motor development in a subject, wherein the one or more HMOs comprise or consist of 3' sialyllactose (3'-SL), lacto-N-hexaose (LNH), and / or disialyllacto-N-tetraose (DSLNT).

[0008] In another aspect, the present invention provides a method for supporting motor development in a subject, comprising administering to the subject one or more human milk oligosaccharides (HMOs), wherein the one or more HMOs comprise or consist of 3' sialyllactose (3'-SL), lacto-N-hexaose (LNH), and / or disialyllacto-N-tetraose (DSLNT).

[0009] Any suitable HMO described herein may be used. In some embodiments, one or more HMOs comprise or consist of 3'-SL. In some embodiments, one or more HMOs comprise or consist of LNH. In some embodiments, one or more HMOs comprise or consist of DSLNT.

[0010] The one or more HMOs may be administered by any suitable means and in any suitable amount. Preferably, the one or more HMOs are administered orally. Preferably, the one or more HMOs are administered separately, simultaneously, or sequentially. In a preferred embodiment, the one or more HMOs are administered simultaneously. Preferably, the one or more HMOs are administered to the subject in a total amount of about 0.05 g / day to about 5 g / day. Preferably, 3'-SL is administered to the subject in an amount of about 0.05 g / day to about 5 g / day. Preferably, LNH is administered to the subject in an amount of about 0.05 g / day to about 5 g / day. Preferably, DSLNT is administered to the subject in an amount of about 0.1 g / day to about 5 g / day.

[0011] The one or more HMOs may be provided in any suitable form. Preferably, the one or more HMOs are in the form of a nutritional composition. In some embodiments, the nutritional composition is an infant formula, a follow-on formula, or a growing-up milk. In a preferred embodiment, the nutritional composition is an infant formula. Preferably, the starter infant formula, the follow-on formula, and the growing-up milk each have a content of about 60 kcal / 100 mL to about 80 kcal / 100 mL and contain protein in an amount of about 1.5 g / 100 kcal to about 2.5 g / 100 kcal, carbohydrates in an amount of about 8 g / 100 kcal to about 15 g / 100 kcal, and lipids in an amount of about 3 g / 100 kcal to about 8 g / 100 kcal.

[0012] The nutritional composition may contain one or more HMOs in any suitable amount. Preferably, the nutritional composition contains one or more HMOs in a total amount of about 0.05 g / L to about 5 g / L. Preferably, the nutritional composition contains 3'-SL in an amount of about 0.05 g / L to about 1.0 g / L. Preferably, the nutritional composition contains LNH in an amount of about 0.05 g / L to about 1.0 g / L. Preferably, the nutritional composition contains DSLNT in an amount of about 0.1 g / L to about 2.0 g / L.

[0013] The subject may be any suitable subject. The subject may be a human subject. In some embodiments, the subject is an infant, toddler, or young child. In preferred embodiments, the subject is an infant. In some embodiments, the subject is about 12 months of age or younger. In some embodiments, the subject is about 11 months of age or younger, about 10 months of age or younger, about 9 months of age or younger, about 8 months of age or younger, about 7 months of age or younger, or about 6 months of age or younger.

[0014] One or more HMOs can promote the development of fine motor skills and / or gross motor skills of a subject. One or more HMOs can improve the motor skills of a subject. One or more HMOs can improve the ability of a subject to control and coordinate muscles to perform desired movements. The motor skills of a subject can be measured using the Bayley scale, for example, Bayley-III. [Brief explanation of the drawings]

[0015] [Figure 1] Association between 3'-SL in breast milk at 3 months and infants' fine motor scores at 12 months. A regression modeling approach was used to determine the association between 3'-SL in breast milk collected at 2 and 3 months and fine motor scores measured using the Bayley-III scale at 12 months. p=0.0256. [Figure 2] Association between LNH in breast milk at 3 months and infants' overall motor score at 6 months. A regression model approach was used to assess the association between LNH in breast milk collected at 3 months and infants' overall motor score measured using the Bayley-III scale at 6 months. p=0.0116. [Figure 3] Association between DSLNT in breast milk at 2 months and infants' overall motor score at 6 months A regression model approach was used to assess the association between DSLNT in breast milk collected at 2 months and infants' overall motor score measured using the Bayley-III scale at 6 months. p=0.027. DETAILED DESCRIPTION OF THE INVENTION

[0016] Various preferred features and embodiments of the present invention will now be described by way of non-limiting example, it being understood that those skilled in the art can combine all features of the invention disclosed herein without departing from the scope of the invention as disclosed.

[0017] Any reference herein to a prior art document should not be taken as an acknowledgement that such prior art is well known or forms part of the common general understanding in the art. All publications mentioned herein are incorporated herein by reference.

[0018] As used herein, the words "comprises," "comprising," and similar words should not be construed in an exclusive or exhaustive sense. In other words, they mean "including, but not limited to." The terms "comprises," "comprising," and the like also include the term "consisting of."

[0019] The practice of the present invention will employ conventional techniques that are within the capabilities of those skilled in the art, unless otherwise indicated. Such techniques are explained in the literature. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0020] Numerical ranges are inclusive of the numbers defining the range, and all percentages disclosed herein are on a weight / weight basis unless otherwise specified. As used herein, the term "about" means approximately, in the region of, roughly, or in the vicinity of. When the term "about" is used in conjunction with a numerical value or range, that value or range modifies that value or range by extending the upper and lower boundaries of the stated numerical value(s). In general, the terms "about" and "approximately" are used herein to adjust numerical value(s) above and below the stated value(s) by 10%.

[0021] Human milk oligosaccharides (HMO) The present invention relates to the use of one or more human milk oligosaccharides (HMOs) to promote motor development and / or improve motor skills. In some embodiments, one or more HMOs are used in a therapeutic method.

[0022] The one or more HMOs may be administered by any suitable route and in any suitable form. Preferably, the one or more HMOs are administered orally and / or enterally. In a preferred embodiment, the one or more HMOs are administered orally. The one or more HMOs may be administered separately, simultaneously, or sequentially. In a preferred embodiment, the one or more HMOs are administered simultaneously.

[0023] Many types of HMOs exist in human milk, and they are typically based on combinations of glucose, galactose, sialic acid (N-acetylneuraminic acid), fucose, and / or N-acetylglucosamine, with numerous and diverse linkages between them. Almost all HMOs have a lactose moiety at the reducing end, and sialic acid and / or fucose (if present) occupy the terminal positions of the non-reducing end. HMOs can be acidic (e.g., charged sialic acid-containing oligosaccharides) or neutral (e.g., fucosyl oligosaccharides). See, e.g., Chen, X., 2015. Advances in carbohydrate chemistry and biochemistry, 72, pp. 113-190.

[0024] HMOs present in human milk include lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), 2'-fucosyllactose (2'FL), 3-fucosyllactose (3FL), lactodifucotetraose (LDFT), lacto-N-difucohexaose I (LNDFHI), lacto-N-fucopentaose I (LNFP-I), lacto-N-fucopentaose II (LNFP-II), lacto-N-fucopentaose III (LNFP-III), trifucosyllacto-N-hexaose (TF-LNH), 3'-sialyllactose (3'SL), 6'-sialyllactose (6'SL), disialyllacto-N-tetraose (DSLNT), and sialyllacto-N-neotetraose c (LST). c) and fucosyldisialyllacto-N-hexaose I (FDS-LNH-I). See, for example, Soyyilmaz, B., et al., 2021. Nutrients, 13(8), p. 2737.

[0025] In some embodiments, one or more HMOs comprise or consist of 3' sialyllactose (3'-SL), lacto-N-hexaose (LNH), and / or disialyllacto-N-tetraose (DSLNT). In some embodiments, one or more HMOs comprise or consist of 3' sialyllactose (3'-SL), lacto-N-hexaose (LNH), or disialyllacto-N-tetraose (DSLNT).

[0026] A subject can be administered any suitable amount of one or more HMOs in any suitable form and via any suitable route of administration (e.g., in any form and via any route described herein). Suitable doses of HMOs are described, for example, in EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), 2022. EFSA Journal, 20(12), p. e07645.

[0027] Preferably, the one or more HMOs are administered to the subject in a total amount of at least about 0.05 g / day, at least about 0.1 g / day, at least about 0.2 g / day, at least about 0.3 g / day, at least about 0.4 g / day, or at least about 0.5 g / day. Preferably, the one or more HMOs are administered to the subject in an amount of about 5 g / day or less, about 4 g / day or less, about 3 g / day or less, about 2 g / day or less, or about 1 g / day or less. Preferably, the one or more HMOs are administered to the subject in an amount of about 0.05 g / day to about 5 g / day, about 0.1 g / day to about 2 g / day, or about 0.1 g / day to about 1 g / day.

[0028] HMOs can be obtained by any suitable method. Suitable methods for synthesizing HMOs are well known to those skilled in the art. For example, processes have been developed for producing oligosaccharides by microbial fermentation, enzymatic processes, chemical synthesis, or a combination of these techniques (see, for example, Zeuner et al., 2019. Molecules, 24(11), p.2033).

[0029] 3'sialyllactose (3'-SL) In some embodiments, one or more HMOs comprise or consist of 3' sialyllactose (3'-SL). In some embodiments, one or more HMOs consist of 3'-SL. In some embodiments, one or more HMOs are 3'-SL.

[0030] 3'sialyllactose (3'-SL) is an abundant sialylated HMO in human milk that can have the structure: [ka] During the ceremony, [ka] is N-acetylneuraminic acid, [ka] is galactose, [ka] is glucose.

[0031] Preferably, 3'-SL is administered to a subject in an amount of at least about 0.05 g / day, at least about 0.1 g / day, or at least about 0.2 g / day. Preferably, 3'-SL is administered to a subject in an amount of about 5 g / day or less, about 1 g / day or less, or about 0.5 g / day or less. Preferably, 3'-SL is administered to a subject in an amount of about 0.05 g / day to about 5 g / day, about 0.05 g / day to about 1 g / day, or about 0.05 g / day to about 0.5 g / day.

[0032] Lacto-N-hexaose (LNH) In some embodiments, one or more HMOs comprise or consist of lacto-N-hexaose (LNH). In some embodiments, one or more HMOs consist of LNH. In some embodiments, one or more HMOs are LNH.

[0033] Lacto-N-hexaose (LNH) is a non-fucosylated, non-sialylated Galβ1-3GlcNAc core (human milk oligosaccharide) that may have the following structure: [ka] During the ceremony, [ka] is galactose, [ka] is N-acetylglucosamine, [ka] is glucose.

[0034] Preferably, LNH is administered to a subject in an amount of at least about 0.05 g / day, at least about 0.1 g / day, or at least about 0.2 g / day. Preferably, LNH is administered to a subject in an amount of about 5 g / day or less, about 1 g / day or less, or about 0.5 g / day or less. Preferably, LNH is administered to a subject in an amount of about 0.05 g / day to about 5 g / day, about 0.05 g / day to about 1 g / day, or about 0.05 g / day to about 0.5 g / day.

[0035] Disialyl lacto-N-tetraose (DSLNT) In some embodiments, one or more HMOs comprise or consist of disialyllacto-N-tetraose (DSLNT). In some embodiments, one or more HMOs consist of DSLNT. In some embodiments, one or more HMOs are DSLNT.

[0036] Disialyllacto-N-tetraose (DSLNT) is a disialylated Galβ1-3GlcNAc core human milk oligosaccharide that can have the structure: [ka] During the ceremony, [ka] is N-acetylneuraminic acid, [ka] is galactose, [ka] is N-acetylglucosamine, [ka] is glucose.

[0037] Preferably, DSLNT is administered to a subject in an amount of at least about 0.1 g / day, at least about 0.15 g / day, or at least about 0.2 g / day. Preferably, DSLNT is administered to a subject in an amount of about 5 g / day or less, about 1 g / day or less, or about 0.5 g / day or less. Preferably, DSLNT is administered to a subject in an amount of about 0.1 g / day to about 5 g / day, about 0.1 g / day to about 1 g / day, or about 0.1 g / day to about 0.5 g / day.

[0038] Nutritional Composition Suitably, the one or more HMOs are in the form of a composition, which may contain the one or more HMOs in any effective amount.

[0039] In one aspect, the invention provides a composition (e.g., a nutritional composition, such as an infant formula, follow-on formula, or growing-up milk) comprising one or more human milk oligosaccharides (HMOs) for use in supporting motor development and / or improving motor skills.

[0040] In another aspect, the present invention provides the use of one or more human milk oligosaccharides (HMOs) for the manufacture of a composition (e.g., a nutritional composition, such as an infant formula, follow-on formula, or growing-up milk) for supporting motor development and / or improving motor skills.

[0041] In another aspect, the present invention provides a method for supporting motor development and / or improving motor skills, the method comprising administering a composition (e.g., a nutritional composition, such as an infant formula, follow-on formula, or growing-up milk) comprising one or more human milk oligosaccharides (HMOs).

[0042] The composition may be any type of composition that can incorporate one or more HMOs, such as a composition in the form of a food or beverage product, a dietary supplement, or a pharmaceutical composition. The composition may be in the form of a solid (e.g., powder), liquid, or semi-liquid. The one or more HMOs may be in the form of a food composition, a beverage, a nutritional formula, a dietary supplement, a nutraceutical, or a pharmaceutical composition.

[0043] Food and beverage products include all products intended for oral consumption by humans for the purpose of providing nutrition and / or pleasure. For example, the composition may be a food or beverage product, such as a product for infants, toddlers, and / or young children. Examples of food and beverage products include dairy products, such as milk products or yogurt, soups, sauces, sweet and savory snacks, powdered drinks, and cereal products.

[0044] In some embodiments, the one or more HMOs are in the form of a nutritional composition, a medical food product for clinical nutrition, or a supplement.

[0045] In some embodiments, one or more HMOs are in the form of a nutritional composition. As used herein, "nutritional composition" can refer to a composition that provides nutrition to a subject. This nutritional composition is usually administered orally or intravenously and typically includes a lipid or fat source and a protein source.

[0046] The nutritional composition may be a synthetic nutritional composition. As used herein, "synthetic nutritional composition" may mean a nutritional composition obtained by chemical and / or biological means, which may be substantially chemically identical to a naturally occurring composition.

[0047] In some embodiments, the one or more HMOs are in the form of a medical food product for clinical nutrition. As used herein, "medical food product for clinical nutrition," also known as a "food for special medical purposes (FSMP)," refers to a specialized food designed to help meet the nutritional or dietary needs of subjects living with a disease, disorder, or medical condition that makes it impossible, temporarily or permanently, to achieve adequate nutritional intake from normal foods or through modification of a normal diet.

[0048] In some embodiments, the one or more HMOs are in the form of an infant formula, a follow-on formula, or a growing-up milk.

[0049] In some embodiments, the one or more HMOs are in the form of an infant formula. As used herein, the term "infant formula" refers to a food product intended for specific nutritional supplementation of infants during the first month of life, which by itself meets the nutritional requirements of infants falling within this category (e.g., Article 2(c) of the European Commission Directive 91 / 321 / EEC 2006 / 141 / EC of 22 December 2006, relating to infant formulas and follow-on formulas). The term also refers to nutritional compositions intended for infants, as defined in Codex Alimentarius (Codex STAN72-1981), and special infant foods (including foods for special medical purposes). The infant formula may be a preterm infant formula, a human milk fortifier, a starter infant formula, a follow-on formula, a baby food formula, or an infant cereal formula.

[0050] In some embodiments, the one or more HMOs are in the form of a starter infant formula. Typically, a "starter infant formula" is intended to be a breast milk substitute for an infant from the newborn stage onwards.

[0051] In some embodiments, the one or more HMOs are in the form of a follow-on formula. A "follow-up formula" or "follow-on formula" may be given from month 6 onwards. This formula may constitute the primary liquid component of an increasingly diverse diet for individuals in this category.

[0052] In some embodiments, the one or more HMOs are in the form of a preterm formula. As used herein, the term "preterm formula" refers to an infant formula intended for preterm infants.

[0053] In some embodiments, the one or more HMOs are in the form of a milk fortifier. As used herein, the term "milk fortifier" refers to a liquid or solid nutritional composition suitable for mixing with breast milk (or human milk, in the case of human milk fortifiers) or infant formula. Fortifiers are used to increase the calories, protein, minerals, and vitamins in breast milk given to preterm or low birth weight infants. The term "breast milk" should be understood as mother's milk or mother's colostrum, or donor's milk or the colostrum of donor's milk.

[0054] In some embodiments, the one or more HMOs are in the form of a baby food formula. As used herein, the term "baby food formula" refers to a food product intended for specific nutritional use by infants or children, e.g., young children, during the first year of life.

[0055] In some embodiments, the one or more HMOs are in the form of growing-up milk. As used herein, the term "growing-up milk" (or GUM) refers to a milk formula product fed from age 1 onwards. GUMs are generally dairy-based drinks adapted to the specific nutritional needs of young children (e.g., children from about 1 to about 3 years of age). Growing-up milk is also known as "young child formula" or "infant milk".

[0056] In some embodiments, the one or more HMOs are in the form of an infant cereal composition. As used herein, the term "infant cereal composition" refers to a food product intended for specific nutritional use by an infant or child, e.g., a young child, during the first year of life.

[0057] In some embodiments, the one or more HMOs are in the form of a milk formula. As used herein, the term "milk formula" may refer to, for example, a food product intended for childhood nutrition, which may provide a sole or supplemental source of nutrition for, for example, children aged about 3 years or older. In some embodiments, the milk formula is GrowMilk.

[0058] In some embodiments, the composition is in powder form and is reconstituted with an aqueous medium (e.g., water) prior to administration, while in other embodiments, the composition is in liquid form ready for administration (e.g., a ready-to-feed formula).

[0059] In another embodiment, one or more HMOs are in the form of a supplement. As used herein, "supplement" or "dietary supplement" can be used to supplement a subject's nutrition (and is typically used as such, but dietary supplements can also be added to any type of composition intended for ingestion by a subject). When the composition is a supplement, such a composition can be provided in the form of a unit dose. Supplements typically exist in the form of liquids, gels, powders, or tablets or capsules. Powder supplements typically include supplements that are to be dissolved in water or milk, or sprinkled on food or beverages. Such supplements are intended to provide additional nutritional and / or health benefits to the subject who takes the supplement. Supplements can be used to provide nutritional and / or health benefits to humans and animals.

[0060] In another embodiment, the one or more HMOs are in the form of a fortifier. The fortifier may be an infant formula fortifier or a growing-up milk fortifier.

[0061] In another embodiment, the one or more HMOs are in the form of a pharmaceutical product, such as a drop, syrup, powder, tablet, or capsule product intended to treat or prevent an adverse medical condition in a subject in need thereof.

[0062] Human milk oligosaccharides (HMO) The one or more HMOs can be present in the composition in any suitable amount.

[0063] For example, in infant formula, follow-on formula, or growing-up milk, a skilled artisan may base the amount of HMO on the amount present in human breast milk produced for an infant or child of the same age, particularly produced by a nutritionally replete mother (see, e.g., Soyyilmaz, B., et al., 2021. Nutrients, 13(8), p. 2737). Such amounts may be within the following ranges in human breast milk: 3'-SL: about 0.05 g / L to about 0.5 g / L; LNH: about 0.05 g / L to about 0.5 g / L; and DSLNT: about 0.05 g / L to about 1.0 g / L. However, the amounts may fall outside these ranges depending, for example, on the bioavailability of the HMO from infant formula compared to human breast milk.

[0064] Preferably, the nutritional composition (e.g., infant formula, follow-on formula, or growing-up milk) comprises one or more HMOs in a total amount of at least about 0.05 g / L, at least about 0.075 g / L, or at least about 0.1 g / L. Preferably, the nutritional composition (e.g., infant formula, follow-on formula, or growing-up milk) comprises one or more HMOs in a total amount of no more than about 10.0 g / L, no more than about 5.0 g / L, or no more than about 2.5 g / L. Preferably, the nutritional composition (e.g., infant formula, follow-on formula, or growing-up milk) comprises one or more HMOs in a total amount of from about 0.05 g / L to about 10.0 g / L, from about 0.05 g / L to about 5.0 g / L, from about 0.075 g / L to about 5.0 g / L, or from about 0.1 g / L to about 2.5 g / L. If the nutritional composition is in powder form, these amounts may be after reconstitution with a liquid according to the instructions provided.

[0065] Preferably, the nutritional composition (e.g., infant formula, follow-on formula, or growing-up milk) comprises one or more HMOs in a total amount of at least about 0.05%, at least about 0.1%, or at least about 0.2% by weight on a dry weight basis. Preferably, the nutritional composition (e.g., infant formula, follow-on formula, or growing-up milk) comprises one or more HMOs in a total amount of no more than about 5%, no more than about 2%, or no more than about 1% by weight on a dry weight basis. Preferably, the nutritional composition (e.g., infant formula, follow-on formula, or growing-up milk) comprises one or more HMOs in a total amount of about 0.05% to about 5%, about 0.1% to about 2%, or about 0.1% to about 1% by weight on a dry weight basis.

[0066] Preferably, the nutritional composition (e.g., infant formula, follow-on formula, or growing-up milk) comprises 3'-SL in an amount of at least about 0.01 g / L, at least about 0.02 g / L, or at least about 0.05 g / L. Preferably, the nutritional composition comprises 3'-SL in an amount of about 1.0 g / L or less, about 0.8 g / L or less, or about 0.5 g / L or less. Preferably, the nutritional composition (e.g., infant formula, follow-on formula, or growing-up milk) comprises 3'-SL in an amount of about 0.01 g / L to about 1.0 g / L, about 0.02 g / L to about 0.8 g / L, or about 0.05 g / L to about 0.5 g / L. If the nutritional composition is in powder form, these amounts may be after reconstitution with a liquid according to the instructions provided.

[0067] Preferably, the nutritional composition (e.g., infant formula, follow-on formula, or growing-up milk) comprises LNH in an amount of at least about 0.01 g / L, at least about 0.02 g / L, or at least about 0.05 g / L. Preferably, the nutritional composition comprises LNH in an amount of about 1.0 g / L or less, about 0.8 g / L or less, or about 0.5 g / L or less. Preferably, the nutritional composition (e.g., infant formula, follow-on formula, or growing-up milk) comprises LNH in an amount of about 0.01 g / L to about 1.0 g / L, about 0.02 g / L to about 0.8 g / L, or about 0.05 g / L to about 0.5 g / L. If the nutritional composition is in powder form, these amounts may be after reconstitution with a liquid according to the instructions provided.

[0068] Preferably, the nutritional composition (e.g., infant formula, follow-on formula, or growing-up milk) comprises DSLNT in an amount of at least about 0.01 g / L, at least about 0.02 g / L, at least about 0.05 g / L, or at least about 0.1 g / L. Preferably, the nutritional composition comprises DSLNT in an amount of about 2.0 g / L or less, about 1.5 g / L or less, or about 1.0 g / L or less. Preferably, the nutritional composition (e.g., infant formula, follow-on formula, or growing-up milk) comprises DSLNT in an amount of about 0.02 g / L to about 2.0 g / L, about 0.05 g / L to about 1.5 g / L, or about 0.1 g / L to about 1.0 g / L. If the nutritional composition is in powder form, these amounts may be after reconstitution with a liquid according to the instructions provided.

[0069] Other ingredients The nutritional compositions of the present invention (e.g., infant formula, follow-on formula, or growing-up milk) may contain a protein source, a carbohydrate source, and a lipid source. However, in some embodiments, particularly when the nutritional composition of the present invention is a supplement or fortifier, only lipid (or a lipid source) may be present.

[0070] Nutritional compositions of the present invention (e.g., infant formula, follow-on formula, or growing-up milk) may have a calorie content of about 50 kcal / 100 mL to about 90 kcal / 100 mL, about 55 kcal / 100 mL to about 85 kcal / 100 mL, about 60 kcal / 100 mL to about 80 kcal / 100 mL, about 65 kcal / 100 mL to about 75 kcal / 100 mL, or about 65 kcal / 100 mL to about 70 kcal / 100 mL. If the nutritional composition is in powder form, these amounts may be after reconstitution with a liquid according to the instructions provided.

[0071] The nutritional compositions of the present invention (e.g., infant formula, follow-on formula, or growing-up milk) may have, on a dry weight basis, about 100 kcal / 100g to about 1000 kcal / 100g, about 200 kcal / 100g to about 800 kcal / 100g, or about 400 kcal / 100g to about 600 kcal / 100g.

[0072] protein Nutritional compositions (e.g., infant formula, follow-on formula, or growing-up milk) according to the present invention may contain a protein source, which may be in an amount of about 1 g to about 4 g / 100 kcal, about 1.5 g to about 3 g / 100 kcal, or about 1.5 g to about 2.5 g / 100 kcal.

[0073] For example, protein sources based on whey, casein, and mixtures thereof can be used, as well as vegetable protein sources, such as soybean-based protein sources. With regard to whey protein, the protein source may be based on acid whey, sweet whey, or a mixture thereof, and may contain α-lactalbumin and β-lactoglobulin in any desired proportion. In some embodiments, the primary protein source is whey (i.e., more than 50%, e.g., more than 60% or more than 70% of the protein is derived from whey protein). The protein may be a native protein, a hydrolyzed protein, or a mixture of native and hydrolyzed proteins. The term "intact" means that the majority of the protein is in an intact state, i.e., the molecular structure is unchanged, e.g., at least 80% of the protein is unchanged, e.g., at least 85% of the protein is unchanged, preferably at least 90% of the protein is unchanged, and even more preferably, at least 95% of the protein is unchanged, e.g., at least 98% of the protein is unchanged. In certain embodiments, the protein is completely unchanged.

[0074] The term "hydrolyzed" in the context of the present invention means that a protein has been hydrolyzed or broken down into its constituent amino acids.

[0075] Protein can be either completely hydrolyzed or partially hydrolyzed.When hydrolyzed protein is required, the hydrolysis process can be carried out as desired as known in the art.For example, whey protein hydrolysate can be prepared by enzymatically hydrolyzing whey fraction in one or more steps.It has been found that if the whey fraction used as starting material is substantially lactose-free, the lysine blackage that the protein undergoes during the hydrolysis process is significantly reduced.This can reduce the degree of lysine blackening from about 15% by weight of total lysine to less than about 10% by weight, for example, about 7% by weight of lysine, which significantly improves the nutritional value of the protein source.

[0076] In a particular embodiment, the protein of the composition is hydrolyzed, fully hydrolyzed, or partially hydrolyzed. The degree of hydrolysis (DH) of the protein may be between 2 and 20, or between 8 and 40, or between 20 and 60, or between 20 and 80, or greater than 10, greater than 20, greater than 40, greater than 60, greater than 80, or greater than 90.

[0077] At least 70%, 80%, 85%, 90%, 95%, or 97% of the protein may be hydrolyzed, hi certain embodiments, 100% of the protein is hydrolyzed.

[0078] In one particular embodiment, the protein of the composition is a vegetable protein.

[0079] carbohydrates Nutritional compositions (e.g., infant formula, follow-on formula, or growing-up milk) according to the present invention may contain a carbohydrate source, which may be in an amount of about 5 g to about 20 g / 100 kcal, about 10 g to about 15 g / 100 kcal, or about 8 g to about 15 g / 100 kcal.

[0080] Although any carbohydrate source commonly found in nutritional compositions may be used, such as lactose, sucrose, saccharose, maltodextrin, starch, and mixtures thereof, one preferred carbohydrate source is lactose.

[0081] lipids Nutritional compositions (e.g., infant formula, follow-on formula, or growing-up milk) according to the present invention may contain lipids and essential fatty acids. The lipids may be in an amount of about 1 g to about 10 g / 100 kcal, about 2 g to about 8 g / 100 kcal, or about 3 g to about 8 g / 100 kcal.

[0082] 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. The composition may be particularly beneficial if it contains fat in an amount of about 25 to about 30 g / 100 g of dry weight of the composition. Non-limiting examples of essential fatty acids include linoleic acid (LA) and alpha-linolenic acid (ALA). The compositions of the present invention may further contain gangliosides, monosialoganglioside-3 (GM3) and disialoganglioside-3 (GD3), and combinations thereof.

[0083] others The nutritional compositions of the present invention (e.g., infant formula, follow-on formula, or growing-up milk) may also contain nutritionally relevant amounts of all vitamins and minerals considered essential for a daily diet. Minimum required amounts have been established for certain vitamins and minerals. Examples of minerals, vitamins, and other nutrients optionally present in the compositions of the present invention include vitamin A, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B12, vitamin E, vitamin K1, vitamin K2, 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, and L-carnitine. Minerals are usually added in salt form. The presence and amount of specific minerals and other vitamins will vary depending on the target population.

[0084] If desired, the nutritional compositions of the present invention (e.g., infant formula, follow-on formula, or growing-up milk) may contain emulsifiers and stabilizers, such as soy, lecithin, citrate esters of mono- and diglycerides, and the like.

[0085] Preparation of the Composition The composition according to the present invention can be prepared by any known or other suitable method. For example, a nutritional composition (e.g., infant formula, follow-on formula, or growing-up milk) can be prepared by blending a protein source, a carbohydrate source, and a fat source together in appropriate proportions. If used, an emulsifier can be included at this point. Vitamins and minerals can be added at this point, but can also be added later, usually to avoid thermal degradation. Water, preferably reverse osmosis treated water or deionized water, can then be added and mixed to form a liquid mixture. The temperature of the mixture is preferably room temperature, but can also be higher. The liquid mixture can then be heat-treated to reduce bacterial content. The mixture can then be homogenized.

[0086] If it is desired to produce a powdered composition, the homogenized mixture is dried in suitable drying equipment, such as a spray dryer or freeze dryer, to form a powder.

[0087] The processes used in formula manufacturing are based on the concept that products must be nutritionally adequate and microbiologically safe for consumption. Therefore, steps that eliminate or limit microbial growth are central to the manufacturing process. While the processing techniques for each specific formula are proprietary to the manufacturer, they generally involve preserving an oil-in-water (o / w) emulsion by dehydration in the case of powdered products, or sterilization in the case of ready-to-feed or concentrated liquid products. Powdered formulas can be produced using a variety of processes, such as dry-blending dehydrated ingredients to form a homogeneous formula, or hydrating and wet-blending a mixture of macroingredients, such as fat, protein, and carbohydrate ingredients, followed by evaporation and spray-drying the resulting mixture. A combination of the two processes may also be used, where a base powder is first produced by wet-blending and spray-drying all or some of the macroingredients, followed by dry-blending the remaining ingredients, including carbohydrates, minerals, vitamins, and other micronutrients, to create the final formula. Liquid formulas are available in ready-to-feed form or as concentrates that must usually be diluted 1:1 with water. The manufacturing processes used for these products are similar to those used to make recombined milk.

[0088] If it is desired to produce a liquid formula, the homogenized mixture may be filled, preferably aseptically, into a suitable container. However, liquid compositions may also be retorted in the container, and suitable equipment for this type of filling and retorting is commercially available.

[0089] How to support motor development One or more HMOs may be used to promote motor development.

[0090] The terms "support," "promote," "enhance," or "improve" may be used interchangeably in the context of the present invention and should be understood to include supporting or assisting the normal development or growth of an individual.

[0091] As used herein, " motor development " can refer to the subject's development of motor skills. Suitable methods and parameters for measuring motor development will be known to those skilled in the art (see, for example, Malina, RM, 2004. International journal of sport and health science, 2, pp.50-66). Developmental milestones in motor development are described, for example, in Gerber, RJ, et al., 2010 Pediatrics, 31(7), pp.267-277.

[0092] As used herein, "motor skills" may refer to the ability to control and coordinate muscles to perform desired movements. Motor skills may include fine motor skills and gross motor skills. Fine motor skills require the use of smaller muscle groups (e.g., those in the wrists, hands, fingers, feet, and toes) to perform smaller movements. Gross motor skills require the use of larger muscle groups in the legs, torso, and arms to perform tasks such as walking, balancing, and crawling. In some embodiments, one or more HMOs (e.g., 3'SL) promote the development of fine motor skills. In some embodiments, one or more HMOs promote the development of gross motor skills. In some embodiments, one or more HMOs (e.g., LNH and / or DSLNT) promote the development of fine motor skills and gross motor skills (i.e., gross motor skills).

[0093] In some embodiments, the subject's motor skills are measured by the Bayley Scales of Infant and Toddler Development. The Bayley Scales of Infant and Toddler Development are a standard set of measures primarily used to assess the development of infants and toddlers aged 1-42 months. In some embodiments, the subject's motor skills are measured by the Bayley III. The Bayley III has three main subtests, including motor scales that assess gross and fine motor skills, such as grasping, sitting, stacking blocks, and climbing stairs (see, e.g., Bayley, N., 2006. Bayley scales of infant and toddler development).

[0094] As used herein, "supporting motor development" can refer to supporting normal motor development during infancy, childhood, and adolescence, for example. Supporting motor development can result in normal motor skills.

[0095] In one aspect, the invention provides one or more HMOs for use in supporting motor development in a subject. In another aspect, the invention provides the use of one or more HMOs for supporting motor development in a subject. In another aspect, the invention provides a method of supporting motor development in a subject, the method comprising administering to the subject an effective amount of one or more HMOs.

[0096] In one aspect, the present invention provides a 3'-SL for use in supporting motor development (e.g., fine motor skill development) in a subject. In another aspect, the present invention provides a use of a 3'-SL for supporting motor development (e.g., fine motor skill development) in a subject. In another aspect, the present invention provides a method for supporting motor development (e.g., fine motor skill development) in a subject, the method comprising administering an effective amount of a 3'-SL to the subject.

[0097] In one aspect, the invention provides an LNH for use in supporting motor development (e.g., the development of fine motor skills and / or gross motor skills) in a subject. In another aspect, the invention provides the use of an LNH for supporting motor development (e.g., the development of fine motor skills and / or gross motor skills) in a subject. In another aspect, the invention provides a method for supporting motor development (e.g., the development of fine motor skills and / or gross motor skills) in a subject, the method comprising administering to the subject an effective amount of an LNH.

[0098] In one aspect, the invention provides a DSLNT for use in supporting motor development (e.g., the development of fine motor skills and / or gross motor skills) in a subject. In another aspect, the invention provides a use of a DSLNT for supporting motor development (e.g., the development of fine motor skills and / or gross motor skills) in a subject. In another aspect, the invention provides a method for supporting motor development (e.g., the development of fine motor skills and / or gross motor skills) in a subject, the method comprising administering to the subject an effective amount of a DSLNT. How to improve motor skills One or more HMOs may be used to improve motor skills (eg, fine motor skills and / or gross motor skills).

[0099] One or more HMOs according to the present invention may improve motor skills in subjects aged 6, 9, 12, 18, 24, or 36 months. One or more HMOs according to the present invention may improve motor skills in subjects aged 6 to 36 months. One or more HMOs according to the present invention (e.g., 3'SL) may improve motor skills in subjects aged 6 months. One or more HMOs according to the present invention (e.g., LNH and / or DSLNT) may improve motor skills in subjects aged 12 months.

[0100] Developmental milestones in motor development are described, for example, in Gerber, RJ, et al., 2010 Pediatrics, 31(7), pp.267-277. The motor skills of a 6-month-old subject may include one or more of: pivoting while prone, crawling while prone. The motor skills of a 12-month-old subject may include one or more of: picking up a second object while holding a first object, holding a crayon, scribbling after demonstration, and pinching with fingertips.

[0101] One or more HMOs according to the present invention may improve fine motor skills in subjects aged 6, 9, 12, 18, 24, or 36 months. One or more HMOs according to the present invention may improve fine motor skills in subjects aged 6-36 months. One or more HMOs according to the present invention (e.g., 3'SL) may improve fine motor skills in subjects aged 6 months. One or more HMOs according to the present invention (e.g., LNH and / or DSLNT) may improve fine motor skills in subjects aged 12 months.

[0102] One or more HMOs according to the present invention may improve gross motor skills in subjects aged 6, 9, 12, 18, 24, or 36 months. One or more HMOs according to the present invention may improve gross motor skills in subjects aged 6-36 months. One or more HMOs according to the present invention (e.g., LNH and / or DSLNT) may improve gross motor skills in subjects aged 12 months.

[0103] In one aspect, the present invention provides one or more HMOs for use in improving motor skills in a subject. In another aspect, the present invention provides the use of one or more HMOs for improving motor skills in a subject. In another aspect, the present invention provides a method for improving motor skills in a subject, the method comprising administering to the subject an effective amount of one or more HMOs.

[0104] In one aspect, the present invention provides a 3'-SL for use in improving motor skills (e.g., fine motor skills) in a subject. In another aspect, the present invention provides a use of a 3'-SL for improving motor skills (e.g., fine motor skills) in a subject. In another aspect, the present invention provides a method for improving motor skills (e.g., fine motor skills) in a subject, comprising administering an effective amount of a 3'-SL to the subject.

[0105] In one aspect, the invention provides an LNH for use in improving motor skills (e.g., fine motor skills and / or gross motor skills) in a subject. In another aspect, the invention provides a use of an LNH for improving motor skills (e.g., fine motor skills and / or gross motor skills) in a subject. In another aspect, the invention provides a method for improving motor skills (e.g., fine motor skills and / or gross motor skills) in a subject, the method comprising administering an effective amount of an LNH to the subject.

[0106] In one aspect, the present invention provides DSLNT for use in improving a motor skill (e.g., fine motor skills and / or gross motor skills) in a subject. In another aspect, the present invention provides a use of DSLNT for improving a motor skill (e.g., fine motor skills and / or gross motor skills) in a subject. In another aspect, the present invention provides a method for improving a motor skill (e.g., fine motor skills and / or gross motor skills) in a subject, the method comprising administering an effective amount of DSLNT to the subject.

[0107] subject The subject may be any suitable subject. Preferably, the subject may be a human.

[0108] In preferred embodiments, the subject is an infant, toddler, or young child. The term "infant" can refer to a subject between about 0 and about 1 year of age. The term "toddler" can refer to a subject between about 1 and about 3 years of age. The term "young child" can refer to a subject between about 3 and about 10 years of age, between about 3 and about 9 years of age, between about 3 and about 8 years of age, between about 3 and about 7 years of age, between about 3 and about 6 years of age, or between about 3 and about 5 years of age.

[0109] In preferred embodiments, the subject is an infant. In some embodiments, the subject is a newborn. In some embodiments, the subject is a preterm infant.

[0110] In some embodiments, the subject is about 5 years old or younger, about 4 years old or younger, about 3 years old or younger, about 2 years old or younger, or about 1 year old or younger. In some embodiments, the subject is about 12 months old or younger, about 11 months old or younger, about 10 months old or younger, about 9 months old or younger, about 8 months old or younger, about 7 months old or younger, or about 6 months old or younger. In some embodiments, the subject is about 9 months old or younger.

[0111] In some embodiments, the one or more HMOs are administered to the subject during the first, third, sixth, nineth, twelve, eighteen, fourteen, or thirty-sixth months of life. For example, the one or more HMOs are administered to the subject starting at birth and continuing through twelve, eighteen, twenty-four, or thirty-six months of age.

[0112] The subject may be at risk of poor motor development. The main risks for poor child development include intrauterine growth retardation, growth stunting, iodine deficiency, iron deficiency anemia, malaria, lead exposure, HIV, maternal depression, and lack of cognitive stimulation. In addition, maternal education and breastfeeding have been identified as protective factors (Walker, SP, et al., 2011. The Lancet, 378 (9799), pp. 1325-1338). In some embodiments, the subject has and / or suffers from intrauterine growth retardation, growth stunting, iodine deficiency, iron deficiency anemia, malaria, lead exposure, HIV, perinatal depression, maternal depression, and / or lack of cognitive stimulation. The subject may be at risk of poor motor skills.

[0113] The subject may have had and / or have insufficient motor development. Any suitable screening tool can be used (see, for example, Johnson, S. and Marlow, N., 2006. Early human development, 82(3), pp.173-183). The subject may have had and / or have insufficient motor skills. This can be measured by any method known in the art, for example, using the Bayley scale, for example, Bayley-III. [Example]

[0114] The present invention is further described with reference to the following examples, it being understood that the invention as claimed is in no way intended to be limited by these examples.

[0115] Example 1 - Relationship between athletic performance and human milk oligosaccharide (HMO) concentrations in breast milk We investigated the association between motor skills and milk concentrations of specific human milk oligosaccharides (HMOs) in 6- and 12-month-old infants.

[0116] HMO concentrations in breast milk were measured in a cohort of 60 infants at 2 and 3 months of age. Infant motor skills were assessed using the Bayley-III Scale (Bayley N., 2006. Bayley Scales of Infant and Toddler Development, Third Edition. San Antonio, TX: Psychorp), including subscores for fine and gross motor skills. A regression modeling approach was used, with covariates including maternal net income, maternal socioeconomic background / education, weight, gestational age, and infant sex (covariates were imputed and missing values ​​were replaced with the population mean).

[0117] Specific HMOs (3'-SL, LNH, and DSLNT) are associated with positive motor skills in 6- and 12-month-old infants (see Table 1 below and Figures 1-3).

[0118] [Table 1]

[0119] Our findings surprisingly show an association between specific HMOs and positive motor skills in infants at 6 and 12 months of age. We surprisingly show that 3'-SL in breast milk at 2 and 3 months of age is associated with positive fine motor skills at 12 months of age, and that LNH in breast milk at 3 months of age and DSLNT in breast milk at 2 months of age are independently associated with overall motor scores at 6 months of age.

[0120] Improvement of motor skills is particularly beneficial in 6-month-old subjects, as this is a critical age for important milestones in gross motor skills, including pivoting while prone, crawling while prone, and picking up a second object while holding one (see, e.g., Scharf RJ, Scharf GJ, Stroustrup A., 2016. Pediatr Rev. 37(1), pp. 25-37). 12 months is also a critical age for important milestones in fine motor skills, such as holding a crayon, scribbling after demonstration, and pinching with the fingertips.

[0121] Embodiment Various preferred features and embodiments of the present invention will now be described with reference to the following numbered paragraphs.

[0122] 1. One or more human milk oligosaccharides (HMO) for use in supporting motor development in a subject, the one or more HMO comprising or consisting of 3' sialyllactose (3'-SL), lacto-N-hexaose (LNH), and / or disialyllacto-N-tetraose (DSLNT).

[0123] 2. Use of one or more human milk oligosaccharides (HMOs) to support motor development in a subject, wherein the one or more HMOs comprise or consist of 3' sialyllactose (3'-SL), lacto-N-hexaose (LNH), and / or disialyllacto-N-tetraose (DSLNT).

[0124] 3. A method for supporting motor development in a subject, comprising administering to the subject an effective amount of one or more human milk oligosaccharides (HMO), wherein the one or more HMOs comprise or consist of 3' sialyllactose (3'-SL), lacto-N-hexaose (LNH), and / or disialyllacto-N-tetraose (DSLNT).

[0125] 4. One or more HMOs for use according to paragraph 1, the use according to paragraph 2 or the method according to paragraph 3, wherein said one or more HMOs comprise or consist of a 3'-SL.

[0126] 5. One or more HMOs for use according to paragraph 1 or 4, the use according to paragraph 2 or 4 or the method according to paragraph 3 or 4, wherein said one or more HMOs comprise or consist of LNH.

[0127] 6. One or more HMOs for the use according to any one of paragraphs 1 or 4-5, the use according to any one of paragraphs 2 or 4-5, or the method according to any one of paragraphs 3 or 4-5, wherein said one or more HMOs comprise or consist of DSLNT.

[0128] 7. One or more HMOs for use according to any one of paragraphs 1 or 4 to 6, the use according to any one of paragraphs 2 or 4 to 6, or the method according to any one of paragraphs 3 or 4 to 6, wherein the one or more HMOs are administered by oral administration.

[0129] 8. One or more HMOs for the use according to any one of paragraphs 1 or 4 to 7, the use according to any one of paragraphs 2 or 4 to 7 or the method according to any one of paragraphs 3 or 4 to 7, wherein said one or more HMOs are administered separately, simultaneously or sequentially, preferably said one or more HMOs are administered simultaneously.

[0130] 9. The one or more HMOs for use according to any one of paragraphs 1 or 4 to 8, the use according to any one of paragraphs 2 or 4 to 8, or the method according to any one of paragraphs 3 or 4 to 8, wherein the one or more HMOs are administered to the subject in a total amount of from about 0.05 g / day to about 5 g / day.

[0131] 10. One or more HMOs for the use of any one of paragraphs 1 or 4 to 9, the use of any one of paragraphs 2 or 4 to 9, or the method of any one of paragraphs 3 or 4 to 9, wherein 3'-SL is administered to the subject in an amount of about 0.05 g / day to about 5 g / day.

[0132] 11. One or more HMOs for use according to any one of paragraphs 1 or 4 to 10, the use according to any one of paragraphs 2 or 4 to 10, or the method according to any one of paragraphs 3 or 4 to 10, wherein LNH is administered to the subject in an amount of from about 0.05 g / day to about 5 g / day.

[0133] 12. One or more HMOs for the use of any one of paragraphs 1 or 4 to 11, the use of any one of paragraphs 2 or 4 to 11, or the method of any one of paragraphs 3 or 4 to 11, wherein DSLNT is administered to the subject in an amount of from about 0.1 g / day to about 5 g / day.

[0134] 13. One or more HMOs for the use according to any one of paragraphs 1 or 4 to 12, the use according to any one of paragraphs 2 or 4 to 12, or the method according to any one of paragraphs 3 or 4 to 12, wherein the one or more HMOs are in the form of a nutritional composition.

[0135] 14. One or more HMOs for use according to paragraph 13, the use according to paragraph 13 or the method according to paragraph 13, wherein the nutritional composition is an infant formula, a follow-on formula or a growing-up milk, preferably wherein the nutritional composition is an infant formula.

[0136] 15. One or more HMOs for the use according to paragraph 13 or 14, the use according to paragraph 13 or 14, or the method according to paragraph 13 or 14, wherein the nutritional composition comprises the one or more HMOs in a total amount of from about 0.05 g / L to about 5 g / L.

[0137] 16. One or more HMOs for the use of any one of paragraphs 12 to 15, the use of any one of paragraphs 12 to 15, or the method of any one of paragraphs 12 to 15, wherein the nutritional composition comprises 3'-SL in an amount of from about 0.05 g / L to about 1.0 g / L.

[0138] 17. The one or more HMOs for use according to any one of paragraphs 12 to 16, the use according to any one of paragraphs 12 to 16, or the method according to any one of paragraphs 12 to 16, wherein the nutritional composition comprises LNH in an amount of from about 0.05 g / L to about 1.0 g / L.

[0139] 18. The one or more HMOs for use according to any one of paragraphs 12 to 17, the use according to any one of paragraphs 12 to 17, or the method according to any one of paragraphs 12 to 17, wherein the nutritional composition comprises DSLNT in an amount of from about 0.1 g / L to about 2.0 g / L.

[0140] 19. One or more HMOs for the use according to any one of paragraphs 1 or 4 to 18, the use according to any one of paragraphs 2 or 4 to 18, or the method according to any one of paragraphs 3 or 4 to 18, wherein the subject is a human subject.

[0141] 20. One or more HMOs for use according to any one of paragraphs 1 or 4 to 19, the use according to any one of paragraphs 2 or 4 to 19, or the method according to any one of paragraphs 3 or 4 to 19, wherein the subject is an infant, toddler or young child.

[0142] 21. One or more HMOs for use according to any one of paragraphs 1 or 4 to 20, the use according to any one of paragraphs 2 or 4 to 20, or the method according to any one of paragraphs 3 or 4 to 20, wherein the subject is an infant.

[0143] 22. One or more HMOs for use according to any one of paragraphs 1 or 4 to 21, the use according to any one of paragraphs 2 or 4 to 21, or the method according to any one of paragraphs 3 or 4 to 21, wherein the subject is about 12 months of age or less.

[0144] 23. One or more HMOs for use according to any one of paragraphs 1 or 4 to 22, the use according to any one of paragraphs 2 or 4 to 22, or the method according to any one of paragraphs 3 or 4 to 22, wherein the subject is about 11 months or less, about 10 months or less, about 9 months or less, about 8 months or less, about 7 months or less, or about 6 months or less in age.

[0145] 24. One or more HMOs for use according to any one of paragraphs 1 or 4 to 23, the use according to any one of paragraphs 1 or 4 to 23, or the method according to any one of paragraphs 1 or 4 to 23, wherein the one or more HMOs promote the development of fine motor skills and / or gross motor skills in the subject.

[0146] 25. One or more HMOs for use according to any one of paragraphs 1 or 4 to 24, the use according to any one of paragraphs 2 or 4 to 24, or the method according to any one of paragraphs 3 or 4 to 24, wherein the one or more HMOs improve the motor skills of the subject.

[0147] 26. One or more HMOs for use according to any one of paragraphs 1 or 4 to 25, the use according to any one of paragraphs 2 or 4 to 25, or the method according to any one of paragraphs 3 or 4 to 25, wherein the one or more HMOs improve the subject's ability to control and coordinate their muscles to perform a desired movement.

[0148] 27. One or more HMOs for use according to any one of paragraphs 1 or 4 to 26, the use according to any one of paragraphs 2 or 4 to 26, or the method according to any one of paragraphs 3 or 4 to 26, wherein the motor skills of the subject are measured using the Bayley scale, for example the Bayley-III.

[0149] Although the present invention has been described by example, it should be understood that variations and modifications can be made without departing from the scope of the invention as defined in the claims. Furthermore, where known equivalents exist for specific features, such equivalents are incorporated as if specifically referred to herein.

Claims

1. 1. One or more human milk oligosaccharides (HMOs) for use in supporting motor development in a subject, the one or more HMOs comprising or consisting of 3' sialyllactose (3'-SL), lacto-N-hexaose (LNH), and / or disialyllacto-N-tetraose (DSLNT).

2. 2. The one or more HMOs for use according to claim 1, wherein said one or more HMOs comprise or consist of a 3'-SL.

3. 3. The one or more HMOs for use according to claim 1 or 2, wherein said one or more HMOs comprise or consist of LNH.

4. 4. One or more HMOs for use according to any one of claims 1 to 3, wherein said one or more HMOs comprise or consist of DSLNTs.

5. The one or more HMOs for use according to any one of claims 1 to 4, wherein said one or more HMOs are administered by oral administration.

6. 6. One or more HMOs for use according to any one of claims 1 to 5, wherein said one or more HMOs are administered separately, simultaneously or sequentially, preferably said one or more HMOs are administered simultaneously.

7. 7. The one or more HMOs for use according to any one of claims 1 to 6, wherein said one or more HMOs are administered to said subject in a total amount of from about 0.05 g / day to about 5 g / day.

8. The one or more HMOs for use according to any one of claims 1 to 7, wherein said one or more HMOs are in the form of a nutritional composition.

9. 9. One or more HMOs for use according to claim 8, wherein said nutritional composition is an infant formula, a follow-on formula or a growing-up milk, preferably said nutritional composition is an infant formula.

10. 10. The one or more HMOs for use according to claim 8 or 9, wherein said nutritional composition comprises said one or more HMOs in a total amount of from about 0.05 g / L to about 5 g / L.

11. The one or more HMOs for use according to any one of claims 1 to 10, wherein the subject is an infant, toddler or young child, preferably the subject is an infant.

12. 12. The one or more HMOs for use according to any one of claims 1 to 11, wherein the subject is about 12 months or less, about 11 months or less, about 10 months or less, about 9 months or less, about 8 months or less, about 7 months or less, or about 6 months or less in age.

13. 13. One or more HMOs for use according to any one of claims 1 to 12, wherein said one or more HMOs promote the development of fine and / or gross motor skills in said subject.

14. 14. One or more HMOs for use according to any one of claims 1 to 13, wherein said one or more HMOs improve the subject's ability to control and coordinate their muscles to perform a desired movement.

15. The one or more HMOs for use according to any one of claims 1 to 14, wherein the motor skills of the subject are measured using the Bayley scale, for example the Bayley-III.

Images