US20160309768A1 - Synthetic milk compositions for optimal growth and development and prevention of obesity in male and female infant and children - Google Patents

Synthetic milk compositions for optimal growth and development and prevention of obesity in male and female infant and children Download PDF

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US20160309768A1
US20160309768A1 US15/104,027 US201415104027A US2016309768A1 US 20160309768 A1 US20160309768 A1 US 20160309768A1 US 201415104027 A US201415104027 A US 201415104027A US 2016309768 A1 US2016309768 A1 US 2016309768A1
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composition
infant
kcal
infants
energy
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Carlos Antonio De Castro
Frederic Destaillats
Francesca Giuffrida
Sagar THAKKAR
Rajat Mukherjee
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Societe des Produits Nestle SA
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Nestec SA
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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A23L33/12—Fatty acids or derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/30—Dietetic or nutritional methods, e.g. for losing weight
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/332—Promoters of weight control and weight loss

Definitions

  • the invention concerns synthetic nutritional compositions for infants and young children up to the age of thirty-six months, particularly infant formulae and growing-up milks.
  • the compositions vary according to sex of the infant or young child.
  • human breast milk represents the uncontested gold standard in terms of infant nutrition.
  • breastfeeding is inadequate or unsuccessful for medical reasons or because of mother choice not to breastfeed.
  • Infant formulae have been developed for these situations.
  • Infant formulae, follow-up formulae and grown-up milks which may be aimed at different age groups of 0 to 6 months, 6 months to 1 year and 1 year to 3 years respectively, are known. These infant formulae, follow-up formulae and growing-up milks aim to meet the requirements of infants and young children at the different ages.
  • An age-tailored nutrition system for infants is described in WO 2009/068549, wherein a protein nature and content are adapted to specific age groups.
  • the recommended World Health Organization (WHO) and Codex Alimentarius Commission guidelines for infant formulae and follow-up formulae state that the infant formulae and follow-up formulae shall not provide less than 60 kcal/100 mL and not more than 85 kcal/100 mL.
  • breast milk may contribute to the protective effects of breastfeeding against obesity in infants later in life [Ian M. P., et al. (2009) Opportunities for the Primary Prevention of Obesity during Infancy, Adv Pediatr. 56:107-133; Tounian P., (2011) Programming towards Childhood Obesity, Ann. Nutr. Metab. 58:30-41].
  • infant formulae and/or follow-up formulae dosage and caloric density do not take into consideration the complementary food eaten by infants and young children when overfeeding the infants and young children.
  • starter formulas that target all children of 0-6 months do not distinguish the nutritional needs of infants aged 0-3 months from those aged 3 to 6 months old. It is known that breast milk composition changes considerably from the first to second and third month of lactation for example.
  • infant formulae and/or follow-up formulae do not take into consideration the sex of the child.
  • Powe and associates [Powe C. E. et al. (2010); Infant sex predicts breast milk energy content, American journal of human biology, 22:50-54] have recently reported differences in energy content based on the gender of the new born infant. Milk secreted from the mothers of male infant was reported to be 25% greater in energy content when compared with the milk of mothers of female infants. This recent data is not surprising given that girls and boys have different physiological needs based upon the World Health Organization standard growth curves for boys and girls. Thus, the tendency to overfeed infants and young children is even more accentuated for girls, because the composition of current infant formulae and/or follow-up formulae of known infant formulae is the same for boys and girls.
  • This diet should take into account the gender of the infant or young child. It should also take into account the age of the child, specifically in months, for example 0-3, 3-6, 6-12 months etc. The diet should promote health benefits in the long term to the infants and young children.
  • the inventors have analyzed the milk from mothers to boys and from mothers to girls, at 30, 60 and 120 days post-partum in a longitudinal clinical study. Based on their results, they have designed synthetic nutritional formulas that have distinct amounts of certain nutrients for boys and for girls.
  • the compositions of the present invention have been designed to ensure balanced growth and to prevent obesity in infancy and later in life.
  • the present invention concerns synthetic nutritional formulations for infants and young children, meaning in the context of the invention, up to the age of 36 months.
  • the compositions are especially adapted to the gender and the age of the child.
  • the invention further relates to administration of these compositions for promoting balanced growth and preventing obesity.
  • the first aspect of the invention concerns a synthetic nutritional composition especially adapted to the nutritional needs of a male infant or child.
  • the composition comprises:
  • composition may also comprise:
  • composition may also comprise one or a mixture of phopholipids e.-g.:
  • composition additionally comprises:
  • composition is especially adapted to the nutritional needs of a male infant less than 3 months old.
  • This composition comprises:
  • composition is especially adapted to the nutritional needs a male infant or child older than 3 months old and younger than 36 months.
  • This composition comprises:
  • a synthetic nutritional composition especially adapted to the nutritional needs of a female infant or young child comprising:
  • the synthetic nutritional composition also comprises:
  • the synthetic nutritional composition also comprises any one or a mixture of phospholipids e.-g.:
  • the synthetic nutritional composition also comprises:
  • composition is especially adapted to the nutritional needs of a female infant younger than 3 months old.
  • This composition comprises:
  • composition for females is especially adapted to the nutritional needs of a female infant or child older than 3 months old and younger than 36 months.
  • This composition is according to the second aspect of the invention, and comprises:
  • a set of two distinct synthetic nutritional compositions wherein the first composition is especially adapted to the nutritional needs of a male infant or child, as described according to the first aspect of the invention.
  • the second composition as described according to the first aspect of the invention is especially adapted to the nutritional needs of a female infant or child.
  • the compositions of the invention are designed to ensure balanced growth and prevent obesity in male and female infants or young children during infancy, childhood and later in life.
  • the synthetic nutritional composition of the invention may be an infant formula in the form of a powder, liquid or concentrated liquid, or is a human milk fortifier.
  • FIGS. 1-3 show the results of the analysis of nutrients in the breast milk of 50 mothers in trial detailed in Example 1. Samples were taken at 30, 60 and 120 days post-partum. Quantities were measured in mg/100 ml. The measurements of milk of mothers to boys are shown with a dashed line, while the solid line shows the measurements of milk of mothers to girls.
  • the P[gender] value relates to the differences in milk with respect to the sex of the baby.
  • the P[age] values are differences in gender with respect to time; P[age] is a P value considering a linear model and P[age 2 ] using a quadratic model.
  • FIG. 1A shows energy density
  • FIG. 1B lipids
  • FIG. 1C linoleic acid
  • FIG. 3A shows phosphatidylcholine
  • FIG. 3B shows phosphatidylethanolamine
  • FIG. 3C shows phosphatidylinositol
  • FIG. 3D shows total phospholipids.
  • infants according to the Commission Directive 2006/141/EC of 22 Dec. 2006 on infant formulae and follow-on formulae, article 1.2 (a), the term “infants” means children under the age of 12 months.
  • Young Children (including young boys and young girls): according to the Commission Directives 2006/141/EC of 22 Dec. 2006 and/or 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae, article 1.2 (b), the term “young children” means children aged between one and three years.
  • infant formulae according to the Commission Directives 2006/141/EC of 22 Dec. 2006 and/or 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae, article 1.2 (c), the term “infant formulae” means foodstuffs intended for particular nutritional use by infants during the first four to six months of life and satisfying by themselves the nutritional requirements of this category of persons. It has to be understood that infants can be fed solely with infant formulas, or that the infant formula can be used by the carer as a complement of human milk. It is synonymous to the widely used expression “starter formula”.
  • follow-on formulae according to the Commission Directives 2006/141/EC of 22 Dec. 2006 and/or 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae, article 1.2 (d), the term “follow-on formulae” means foodstuffs intended for particular nutritional use by infants aged over four months and constituting the principal liquid element in a progressively diversified diet of this category of persons.
  • Growing-up milk milk-based nutritional composition especially adapted to a child of between one year and three years old.
  • Human Milk fortifier Nutritional composition for infants or young children intended to be added to or diluted with human milk.
  • hypoallergenic composition means a composition which is unlikely to cause allergic reactions.
  • sialylated oligosaccharide means an oligosaccharide having a sialic acid residue.
  • fucose residue means an oligosaccharide having a fucose residue.
  • prebiotic means non-digestible carbohydrates that beneficially affect the host by selectively stimulating the growth and/or the activity of healthy bacteria such as bifidobacteria in the colon of humans [Gibson G R, Roberfroid M B. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics . J Nutr. 1995; 125:1401-12].
  • probiotic means microbial cell preparations or components of microbial cells with a beneficial effect on the health or well-being of the host [Salminen S, Ouwehand A. Benno Y. et al. “ Probiotics: how should they be defined ” Trends Food Sci. Technol. 1999:10 107-10].
  • An “allergy” is an allergy which has been detected by a medical doctor and which can be treated occasionally or in a more durable manner.
  • a “food allergy” is an allergy with respect to a nutritional composition.
  • the present inventors have carried out a major study on breast milk composition. This study involved both developing advanced analytical technologies to analyze milk samples and performing a longitudinal clinical trial with human milk sampling at 30, 60 and 120 days post-partum (see Example 1).
  • the milk samples were quantitatively analyzed for macronutrients, fatty acids and phospholipids.
  • the inventors have surprisingly found very significant differences, between milk of mothers of male infants compared to that of female infants, not only in energy (differences are greater than previously reported), but also in the quantities of lipids, total polyunsaturated acids (PUFAs) and phospholipids.
  • PUFAs total polyunsaturated acids
  • results of this trial indicated surprisingly significant differences in the levels of linoleic acid (LA), phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol, phosphatidylserine and total phospholipids for boys and girls (see Table 2 and FIGS. 1-3 ). In some cases, this difference between male and female destined milk varied over time (between 0-120 days).
  • LA linoleic acid
  • phosphatidylcholine phosphatidylethanolamine
  • phosphatidylinositol phosphatidylserine
  • total phospholipids for boys and girls
  • compositions that are especially adapted to meet the nutritional needs of male and female infant and young children.
  • no gender specific formulations for infants or young children are known.
  • compositions According to the Invention:
  • compositions of the invention are designed to meet the nutritional needs of male and female infants and young children.
  • the compositions ensure balanced growth and prevent obesity in male and female infants or young children and later in life.
  • the synthetic nutritional compositions of the invention are designed for consumption by children from birth to three years old. They are specifically designed to be gender specific. In certain embodiments, they are also age specific, being designed for infants younger than three months old, or older than three months, but less than 36 months.
  • the synthetic nutritional compositions of the invention may be an infant formula in the form of a powder, liquid or concentrated liquid.
  • the infant formula may be based on a cow's milk, goat's milk or buffalo milk.
  • the infant formula may be a starter formula for infants that are less than 6 months old or a follow-on formula for infants that are more than 6 months old.
  • the composition of the invention may be a growing up milk, or a human milk fortifier.
  • the composition may be cow's milk whey based infant formula.
  • the formula may also be a hypoallergenic (HA) formula in which the cow milk proteins are (partially or extensively) hydrolysed.
  • the formula may also be based on soy milk or a non-allergenic formula, for example one based on free amino acids.
  • the nutritional compositions of the invention contain specific quantities of lipids, essential fatty acids, specifically linoleic acid (LA), and polyunsaturated fatty acids (PUFAs).
  • the specific quantities of these nutrients are gender specific.
  • Quantities of phospholipids including phosphatidylcholine, phosphatidylethanolamine, phosphatidylinositol and phosphatidylserine also vary for male and female destined compositions.
  • the total number of phospholipids also varies. All of the latter components—essential fatty acids, sphingomyelin and phospholipids, are known to be important for balanced growth.
  • the quantities of all the nutrients expressed herein as mg/100 ml or g/100 ml reflect the amounts of nutrients present in the final liquid product, to be consumed by the infant or young child.
  • the composition may be a powdered infant formula that is diluted with water to give a final liquid product.
  • the composition according to the invention may also be a concentrated liquid that is diluted with water to achieve the final liquid product.
  • the composition of the invention may be a liquid product that is directly consumed by the infant or child as is.
  • the composition according to the invention may be a human milk fortifier that is added to or diluted with human milk. In this case, the concentration of the nutrients already present in the human milk (to which the human milk fortifier is added) are to be taken as the average values for lactating mothers that are known or predicted from published clinical data.
  • the first aspect of the invention concerns a synthetic nutritional composition especially adapted to the nutritional needs of a male infant or child.
  • the composition comprises:
  • composition may also comprise:
  • composition may also comprise one or a mixture of phopholipids e.-g.:
  • composition additionally comprises:
  • composition is especially adapted to the nutritional needs of a male infant less than 3 months old.
  • This composition comprises:
  • composition is especially adapted to the nutritional needs a male infant or child older than 3 months old and younger than 36 months.
  • This composition comprises:
  • a synthetic nutritional composition especially adapted to the nutritional needs of a female infant or young girl comprising:
  • the synthetic nutritional composition also comprises any one or a mixture of phospholipids e.-g.:
  • the synthetic nutritional composition also comprises:
  • composition is especially adapted to the nutritional needs of a female infant younger than 3 months old.
  • This composition comprises:
  • composition for females is especially adapted to the nutritional needs of a female infant or child older than 3 months old and younger than 36 months.
  • This composition is according to the second aspect of the invention, and comprises:
  • a set of two distinct synthetic nutritional compositions comprising a first composition and second composition.
  • the first composition is any of the compositions described above that are especially adapted to the nutritional needs of a male infant or child.
  • the second composition is any of the compositions described above that is especially adapted to the nutritional needs of a female infant or child.
  • the first and second compositions are conditioned separately.
  • the first and second compositions in the set are commercialized under the same marketing concept umbrella.
  • the set of the invention can preferably be commercialized under the same marketing concept (for example gender segmentation and/or specific adaptation of nutritional compositions for male and female infants or children).
  • the first and second compositions are distinct in that they differ by at least 10% in the quantity of at least one of the common components in the two compositions chosen among a. to h.
  • the first and second compositions may be then conditioned separately, or group together in another outer container, or packaging.
  • the packaging may be for example simply a layer or plastic film, a bag, box, piece of foil, or other means to keep the first and second compositions grouped together.
  • the set may comprise additional third, fourth and fifth etc. compositions that are especially adapted to meet the nutritional needs of infants or young children that are for example, 3-6 months old 6-9 months old or 9-12 months old.
  • the set may also contain additional compositions that target in the same way children older than one year up to three years old.
  • compositions of the invention may also be present in the compositions of the invention.
  • the nutritional compositions of the invention may contain other ingredients which may act to enforce the technical effect of the components a.-k.
  • the prebiotics that may be used in accordance with the present invention are not particularly limited and include all food substances that promote the growth of probiotics or health beneficial micro-organisms in the intestines.
  • they may be selected from the group consisting of oligosaccharides, optionally containing fructose, galactose, mannose; dietary fibers, in particular soluble fibers, soy fibers; inulin; or mixtures thereof.
  • Preferred prebiotics are fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), isomalto-oligosaccharides (IMO), xylo-oligosaccharides (XOS), arabino-xylo oligosaccharides (AXOS), mannan-oligosaccharides (MOS), oligosaccharides of soy, glycosylsucrose (GS), lactosucrose (LS), lactulose (LA), palatinose-oligosaccharides (PAO), malto-oligosaccharides, gums and/or hydrolysates thereof, pectins and/or hydrolysates thereof.
  • FOS fructo-oligosaccharides
  • GOS galacto-oligosaccharides
  • IMO isomalto-oligosaccharides
  • XOS xylo-oligosaccharides
  • AXOS arabino-xy
  • the human milk oligosaccharides for example sialylated oligosaccharides, described in WO 2012/069416 published on May 31, 2012 may be included in the composition according to the invention.
  • the latter oligosaccharides may act in synergy with the essential fatty acids and phospholipids of the invention to promote the healthy establishment of cognitive function in the young developing infant or young child.
  • Probiotic may be added to the composition. All probiotic micro-organisms may be added additionally.
  • the probiotic may be selected for this purpose from the group consisting of Bifidobacterium, Lactobacillus, Lactococcus, Enterococcus, Streptococcus, Kluyveromyces, Saccharoymces, Candida , in particular selected from the group consisting of Bifidobacterium longum, Bifidobacterium lactis, Bifidobacterium animalis, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium adolescentis, Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus paracasei, Lactobacillus salivarius, Lactobacillus lactis, Lactobacillus rhamnosus, Lactobacillus johnsonii, Lactobacillus plantarum, Lactobacillus salivarius, Lactococcus lac
  • the synthetic nutritional compositions of the invention comprise probiotics active or inactivated, dead or alive, preferably in sufficient dose to be effective (e.g between 10 6 to 10 11 or between 10 7 and 10 9 cfu/g of composition).
  • the composition of the invention for male infant comprises a probiotic having a specific effect for male infant and is different from the probiotic comprised in the composition of the invention for female infant.
  • such probiotics comprise Bifidobacterium lactis or Lactobacillus rhamnosus GG for male and B. Longum for female (or possibly vice-versa).
  • probiotics comprise Bifidobacterium Lactis for male and Lactobacillus Rhamnosus for female (or possibly vice-versa).
  • the choice of probiotics is specifically adapted for the particular needs of male and female infants, in particular for the optimum growth and/or prevention of obesity later in life.
  • Vitamins, minerals and other micronutrients suitable for administration to children under the age of three may be added to the compositions of the invention.
  • compositions of the Invention Promote the Balanced Development and Prevent Obesity Later in Life:
  • compositions according to the invention are especially adapted to promote the balanced growth and prevent obesity in infants and young children.
  • the indicators of normative growth are defined by World Health Organization (WHO) [Acta P ⁇ diatrica, 2006; Suppl 450: 76-85]. These indicators are: length/height-for-age, weight-for-age weight-for-length, weight-for-height, body mass, index-for-age (BMI-for-age), head circumference-for-age, arm circumference-for-age, subscapular skinfold-for-age, triceps skinfold-for-age, motor development milestones, weight velocity, length velocity and head circumference velocity. Furthermore, each indicator is available independently for male and female gender of the infant. The value of any particular indicator of an infant between 3rd and 97th percentile at a corresponding time point is considered normal and/or optimal.
  • Lipids in human milk provide to the infant the calories needed for growth as well as essential fatty acids and phospholipids such as phosphatidylcholine, phosphatidyethanolamine, phosphatidylserine, phosphatidylinositol and spingomelin [Jensen R G., (1999), Lipids in Human Milk, Lipids 34, 1243-1271].
  • the essential fatty acids include alpha-linolenic acid (ALA), an omega-3 fatty acid, and linoleic acid (LA), an omega-6 fatty acid. ALA and LA cannot be synthesized by humans and thus must be obtained from the diet.
  • PC Phosphatidylcholine
  • choline are critically important nutrients for the normal development of the infant [Zeisel, S. H. (1998) Choline and Phosphatidylcholine are important components of an infant's diet, in Lipids in Infant Nutrition, AOCS Press, Champaign, Ill.].
  • Phosphatidylcholine is the prevalent phospholipid found in cell membranes and is an important methyl donor and is involved in cholesterol homeostasis. Metabolism of PC, sphingomyelin and phosphatidylethanolamine (PE) are related, and therefore, PE is an important nutrient to support infant growth and development.
  • dietary phospholipids such as PC, PE and phosphatidylinositol are converted into lyphosphospholipids in the gastrointestinal tract by the action of the phospholipase A2 [Chanussot F., Lécithine, metabolism et nutrition, Lavoisier (2008)].
  • compositions according to the invention that are especially adapted to meet the nutritional needs of male infants and young children promote balanced growth in these male infants and young children and prevent obesity these children later in life.
  • compositions according to the invention that are especially adapted to meet the nutritional needs of female infants and young children promote balanced growth in these female infants and young children and prevent obesity these children later in life.
  • the synthetic nutritional composition of the invention is an infant formula (or a follow-on formula or a growing up milk or a human milk fortifier), for infant of less than 36 months, less than 24 months, less than 12 months, less than 6 months or preferably of 3 months or less. It is generally known, or at least hypothesized, that early nutritional interventions can be more effective (in comparison to intervention at later stages in life) in programming the metabolic pathways of the infants to induce optimal balanced growth and thus prevent obesity during infancy and later in life
  • the synthetic nutritional composition of the invention is an infant formula intended and/or especially designed for preterm infants and/or caesarean-born infants. It is generally known, or at least hypothesized, that these subject groups are more prone to suffer from unbalanced growth (and, thus, from being obese later in life) due to the immaturity of their metabolic pathways and physiological conditions at birth. Early adaptation and control of the diet is therefore of the highest importance.
  • the synthetic nutritional composition of the invention is an infant formula (or a follow-on formula or a growing up milk or a human milk fortifier), for infants born from mothers or parents having a history of obesity or overweight. It is generally known, or at least hypothesized, that these subjects groups are more prone to suffer from unbalanced growth (and, thus, from being obese later in life), due, for example, to genetic or epi-genetic predispositions. It is, therefore, critical to address such issues as early as possible during infancy by a specifically adapted diet.
  • the present inventors designed a longitudinal clinical trial with 50 lactating mothers with milk sampling at 30 (visit 1), 60 (visit 2) and 120 (visit 3) days post-partum.
  • the milk samples were quantitatively analyzed for energy and total solids.
  • the MIR analyses were performed with the Human Milk Analyzer (HMA, Miris, Sweden).
  • the HMA is based on a semisolid MIR transmission spectroscopy, designed specifically for determination of the macronutrient composition of human milk.
  • the use of the machine was according to manufacturer's instructions. Briefly 1 mL of previously warmed sample (up to 40° C. in water bath) was sonicated for 1 min before manual injection to the milk inlet. The analysis was conducted within next minute before the milk was retrieved and the inlet washed with de-ionized water. The cell was also washed with supplied detergent every 5 sample injections. Also every 10 samples an in-house control as well as calibrating standard provided by Miris were ran for quality control purposes.
  • Fatty acid methyl esters were prepared using HCl/Methanol (3N) as a catalyst.
  • the methylation procedure was as follows: In a 15 mL test tube equipped with Teflon-lined screw caps, 250 ⁇ L of human milk was added followed by 300 ⁇ L of internal standard FAME 11:0 and 300 ⁇ L of internal standard TAG 13:0, 2 mL of methanol, 2 mL of methanol/HCL (3N) and 1 mL of n-hexane. Test tubes were firmly capped, shaken vigorously and heated at 100° C. for 60 min, with occasional additional shaking. Care was taken to fit the cap tightly with cap liner to avoid leaks when tubes are heated at 100° C.
  • a 7890A gas-chromatograph with a 7693 autosampler with preparative station module (Agilent Technologies, Palo Alto, Calif.) equipped with a fused-silica CP-Sil 88 capillary column (100% cyanopropylpolysiloxane; 100 m, 0.25 mm id, 0.25 ⁇ m film thickness; Agilent, Palo Alto, Calif.) was used with a split injector (1:25 ratio) heated at 250° C. and a flame-ionization detector operated at 300° C.
  • the oven temperature programming used was 60° C. isothermal for 5 min, increased to 165° C. at 15° C./min, isothermal for 1 min at this temperature, and then increased to 195° C.
  • Phospholipid families were separated by normal-phase high-performance liquid chromatography using 2 Nucleosil 50-5, 250 ⁇ 3 mm, 5 ⁇ (Macherey-Nagel, Easton, USA) equipped with pre-column Nucleosil 50-5, 8 ⁇ 3 mm, 5 ⁇ (Macherey-Nagel, Easton, USA).
  • the chromatography system consisted of an Agilent 1200 module (Agilent Technologies, Basel, Switzerland) and an in-line PL-ELS 1000 evaporative light scattering detector (Polymer Laboratories, Shropshire England). All chromatography was performed at 55° C.
  • Gangliosides were separated by LC using an Aquity BEH C18 column (1.7 ⁇ m; 150 ⁇ 2.1 mm i.d.; Waters).
  • the chromatography system consisted of Infinity 1290 modules (Agilent Technologies, Basel, Switzerland) coupled to triple quadrupole mass spectrometer (Applied biosystems/MSD Sciex, 5500 Ontario, Canada). All chromatography was performed at 50° C.
  • Solvent A composed of water/methanol/ammonium acetate (1 mM) (90/10/0.1 v/v/v) and solvent B of methanol/ammonium acetate (1 mM) (100/0.1 v/v).
  • Disialogangliosides 3 (GD3) and monosialogangliosides 3 (GM3), were monitored by transitions of the precursor ions to the m/z 290 product ion listed in the Table 1.
  • the ion m/z 290 corresponds to Neu5Ac fragments obtained from B type of cleavage according to (13). Data were collected and processed using Multiquant software 2.1 (Applied Biosystems, Sciex, Ontario, Canada). Quantification was performed by calibration curve.
  • Stock solutions of GD3 and GM3 were prepared in methanol 70% (1 mg/mL) and further dilutions to volume with methanol 70% were performed to give 6 concentration levels covering a range from 7.5 to 22.5 ⁇ g/mL.
  • Total area of GD3 and GM3 was calculated as the sums of peak areas of the transitions of the precursor ions to the m/z 290 product ion.
  • Data collection points are 1, 2 and 4 months after infants' birth.
  • Table 2 shows the Min, Mean, SD and Max for each unit of measurement
  • Statistical models fitted to the raw data are shown in FIGS. 1-3 . Longitudinal analysis was carried out using linear mixed models. The figures also show the sequential effect of each of the terms age, age 2 , gender and age-gender interactions in this particular order in terms of the P-value for the corresponding F-test.
  • the P[age] is a P value considering a linear model and P[age 2 ] corresponds to a quadratic one.
  • the appropriate model is chosen according to whether the trajectory is linear (P[age]) or curved (P[age 2 ]).
  • Random effects are subject specific terms to model the underlying correlation between repeat measures.
  • the protein source is a conventional mix of whey protein and casein.
  • the protein source is a conventional mix of whey protein and casein.
  • the protein source is a conventional mix of whey protein and casein.
  • the protein source is a conventional mix of whey protein and casein.

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