AU2011100139A4 - Infant formula: Whey-Casein Ratio - Google Patents

Description

AUSTRALIA Patents Act 1990 COMPLETE SPECIFICATION Innovation Patent Applicant(s): ABBOTT LABORATORIES Invention Title: INFANT FORMULA: Whey-Casein Ratio The following statement is a full description of this invention, including the best method for performing it known to us: -2 INFANT FORMULA: WHEY-CASEIN RATIO FIELD 5 The present invention relates to infant formula. In particular, the present invention relates to infant formula with specific nutrient levels and compositional ingredients. BACKGROUND 10 Infant formula are intended to serve as a substitute for breast milk in infants who cannot be fed at the breast or for whom breast milk is not available. The composition of infant formula should serve to meet the particular nutritional requirements and to promote normal growth and development of the infants for whom they are intended. 15 Typically infant formulas contain purified cow's milk whey and casein as a protein source, a blend of vegetable oils as a fat source, lactose as a carbohydrate source, a vitamin mineral mix, and other ingredients depending on the manufacturer. In addition, there are infant formulas using soybean as a protein source in place of cow's milk and formulas using hydrolysed protein reduced into its component amino acids for infants who are 20 allergic to other proteins. An upswing in breastfeeding has been accompanied by a deferment in the average age of introduction of other foods (such as cow's milk), resulting in increased use of both breastfeeding and infant formula between the ages of 3-12 months. 25 Data on the composition of human milk of healthy, well-nourished women can provide some guidance for the composition of infant formulae, but gross compositional similarity is not an adequate determinant or indicator of the safety and nutritional adequacy of infant formulae. Human milk composition shows remarkable variation. Moreover, there are considerable differences in the bioavailability and metabolic effects of similar 30 contents of many specific nutrients in human milk and formula, respectively. Therefore, the adequacy of infant formula composition should be determined by a comparison of its effects on physiological (e.g. growth patterns), biochemical (e.g. plasma markers) and functional (e.g. immune responses) outcomes in infants fed formulae with those found in populations of healthy, exclusively breast-fed infants. 35 Infant formula should only contain components in such amounts that serve a nutritional purpose or provide another benefit. The composition of the diet of infants has a major impact on short and long term child health and development. 40 Consequently, while there are a plethora of infant formula on the market many of these formulae are not sufficient balanced to provide nutritional requirements without overloading the infants system. Therefore, there is a continued need to develop infant formula with a balance of nutrients that provides a close approximation to human breast milk. 45 -3 SUMMARY In a first aspect, the present invention provides an infant formula comprising (i) 1 g/100 kcal to 10 g/1 00 kcal protein; 5 (ii) 4 g/100 kcal to 9 g/100 kcal lipids; (iii) 8 g/1 00 kcal to 15 g/1 00 kcal carbohydrates; (iv) 200 mg/100 kcal to 10,000 mg/100 kcal minerals and trace elements; and (v) whey to casein ratio of 1:10 to 10:1. 10 Preferably, the infant formula of the present invention provides energy between 55 kcal/100ml and 75 kcal/100ml. The infant formula can comprise cows' milk protein, hydrolysed cows' milk protein soy protein isolates or combinations thereof. However, the total protein content should not 15 exceed 10 g/100 kcal protein. Total lipids for the infant formula should be between 4 g/1 00 kcal to 9 g/1 00 kcal. In some embodiments, the lipids include linoleic acid, a-linolenic acid, lauric and myristic acids, trans fatty acids and erucic acid. 20 The total carbohydrates in the infant formula of the present invention are between 8 g/100 kcal to 15 g/100 kcal. The carbohydrates that may be used in the formula can vary widely. Examples of carbohydrates suitable for infants include hydrolyzed corn starch, maltodextrin, glucose polymers, sucrose, corn syrup, corn syrup solids, rice derived 25 carbohydrate, glucose, fructose, lactose, high fructose corn syrup and indigestible oligosaccharides such as fructooligosaccharides (FOS). Any single carbohydrate listed above, or any combination thereof, as appropriate, may be utilized. It will be appreciated by those skilled in the art that the infant formula may contain a 30 mixture of vitamins. In some embodiments, the infant formula of the present invention comprise one or more of vitamins selected from the group consisting of Vitamin A, Vitamin D 3 , Vitamin E, Vitamin K, Thiamin, Riboflavin, Niacin, Vitamin B6, Vitamin B 12 , Pantothetic acid, Folic acid, Vitamin C and Biotin or combination thereof. 35 The total vitamin content should not exceed 5,000 pg/1 00 kcal vitamins; however, the total vitamin content can be made up of various combinations of vitamins. Indicative concentration ranges of vitamins include Vitamin A - 60 pg to 180 pg/i 00 kcal; Vitamin

D

3 1 pg to 3 pg/1 00 kcal, Vitamin E 0.5 g to 5 pg/1 00 kcal, Vitamin K 4 pg to 25 pg/1 00 kcal, Thiamin 60 pg to 300 pg/I 00 kcal, Riboflavin 80 pg to 400 pg/1 00 kcal, Niacin 300 40 pg to 1500 pg/1 00 kcal, Vitamin B 45 pg to 175 pg/1 00 kcal, Vitamin B 12 0.1 pg to 0.5 pg/1 00 kcal, Pantothetic acid 400 pg to 2000 pg/1 00 kcal, Folic acid 10 pg to 50 pg/1 00 kcal, Vitamin C 8 pg to 30 pg/100 kcal and Biotin 1.5 pg to 7.5 pg/100 kcal. Minerals and trace elements are typically included especially calcium, iron phosphorus, 45 magnesium, sodium, chloride and the like. In some embodiments, the minerals and trace elements are selected from the group consisting of iron, calcium, phosphorus, -4 magnesium, sodium, chloride, potassium, manganese, fluoride, iodine, selenium, copper, zinc or combinations thereof. Obviously, the amount of mineral or trace element will vary depending upon the nature of 5 the mineral or trace element of the source used. Indicative concentration ranges of minerals and trace elements include iron 0.3 mg to 4 mg/1 00 kcal; calcium 50 mg to 140 mg/1 00 kcal, phosphorus 25 mg to 100 mg/1 00 kcal, magnesium 5 mg to 15 mg/100 kcal, sodium 20 mg to 60 mg/1 00 kcal, chloride 50 mg to 160 mg/1 00 kcal, potassium 60 mg to 160 mg/100 kcal, manganese 1 pg to 50 g/100 kcal, fluoride 0 pg to 60 pg/100 10 kcal, iodine 10 pg to 50 pg/100 kcal, selenium 1 pg to 9 pg/100 kcal, copper 35 pg to 80 tg/100 kcal and zinc 0.5 mg to 1.5 mg/1 00 kcal. Persons skilled in the art will appreciate that the infant formula of the present invention can further comprise other substances such as choline, myo-inositol, L-carnitine, taurine, 15 nucleotides, phospholipids and the like. In some embodiments, the infant formula of the present invention further comprises 7 mg/100 kcal and 50 mg/100 kcal choline, 4 mg to 40 mg/100 kcal myo-inositol or 1.2 mg/100 kcal and 5 mg/100 kcal L-carnitine and combinations thereof. 20 DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION Before describing the preferred embodiments of the invention the following definitions are provided: 25 "Subject" means any mammal, preferably a human. "Infant" as used herein, refers generally to children less than about 2 years of age, most typically less than about 1 year of age, and the term "infant formula" as used herein 30 refers to the compositions of the present invention and is meant to limit the use thereof to such infants to meet their sole, primary, or supplemental nutritional needs. In the United States, the content of an infant formula is dictated by the federal regulations set forth at 21 C.F.R. Sections 100, 106, and 107. These regulations define macronutrient, vitamin, mineral, and other ingredient levels in an effort to stimulate the nutritional and other 35 properties of human breast milk. All percentages, parts and ratios as used herein are by weight of the total composition, unless otherwise specified. All such weights as they pertain to listed ingredients are based on the active level and, therefore, do not include solvents or by-products that may 40 be included in commercially available materials, unless otherwise specified Any reference to a numerical range in this application should be construed as an express disclosure of every number specifically contained within that range and of every subset of numbers contained within that range. Further, this range should be construed as 45 providing support for a claim directed to any number, or subset of numbers in that range. 7M47111 1 I(GHMaffersi -5 For example, a disclosure of 1 tol0 should be construed as supporting a range of 2 to 8, 3 to 7, 5 to 6, 1 to 9, 3.6 to 4.6, 3.5 to 9.9, 1.1 to 9.9, etc. All references to singular characteristics or limitations of the present invention shall 5 include the corresponding plural characteristic or limitation, and vice versa, unless otherwise specified or clearly implied to the contrary by the context in which the reference is made. All combinations of method or process steps as used herein can be performed in any 10 order, unless otherwise specified or clearly implied to the contrary by the context in which the referenced combination is made. The infant formulas of the present invention, including the many embodiments described herein, can comprise, consist of, or consist essentially of the essential elements and 15 limitations of the invention described herein, as well as any additional or optional ingredients, components, or limitations described herein or otherwise useful in infant nutritional formula applications. 1. COMPOSITIONAL INGREDIENTS 20 The energy density of infant formulae of the present invention is in the range of 55-75 kcal/1 00 ml, which is appropriate to support physiological rates of weight gain in healthy infants. This range of energy density is provided by the combination of specific ingredients as described herein. 25 Proteins Infant formula of the present invention will contain 1 g to 10 g per 100 kcal protein. Protein sources include cows' milk protein, hydrolyzed cows' milk protein, soy proteins or 30 combinations thereof. Commercial protein sources are readily available and known to one practicing in the art. For example, caseinates, whey, hydrolyzed caseinates, hydrolyzed whey and milk proteins are available from New Zealand Milk Products of Santa Rosa, Calif. Soy and hydrolyzed soy proteins are available from Protein Technologies International of Saint Louis, Mo. Pea protein is available from Feinkost 35 Ingredients Company of Lodi, Ohio. Rice protein is available from California Natural Products of Lathrop, Calif. Sesame seed protein is available from Dipasa USA, Inc., of Brownsville, Tex. Corn protein is available from EnerGenetics Inc. of Keokuk, Iowa. Additionally, mineral enriched proteins are available from New Zealand Milk Products of Santa Rosa, Calif. and Protein Technologies International of Saint Louis, Mo. 40 In some preferred embodiments, the whey to casein ration will be 1:10 to 10:1 g/g. It is appreciated by those skilled in the art that human breast milk is whey-dominant in the earlier stages of expression, with the ratio of whey to casein changing over the stages of lactation. 45 2&4711 1 (MHMntinf -6 Whey-dominant formulas are primarily based on whey protein in milk. Whey-dominant formulas have the bonus of being easier for infants under four months to digest than casein-dominant formulas. 5 Casein-dominant formulas use, largely, curd from dairy milk. While often less expensive, casein-dominant formulas are generally better suited to older infants due to the difficulty younger babies have in digesting casein. Lipids 10 Infants require lipids for optimal growth and development. Lipids provide energy, promote the absorption of fat-soluble vitamins, and provide the essential fatty acids that are required for normal growth and development. Any lipid that is suitable for consumption by a human infant may be utilized in the present invention. Non-exclusive examples of lipids 15 include coconut oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil (medium chain triglycerides), sunflower oil, high oleic sunflower oil, structured triglycerides, palm and palm kernel oils, palm olein, canola oil, marine oils, cottonseed oils, and combinations thereof. 20 Total lipids for the infant formula should be between 4 g/1 00 kcal to 9 g/1 00 kcal, which represents about 40-60% of the energy content and is comparable to human breast milk. In some embodiments, the lipids include linoleic acid, a-linolenic acid, lauric and myristic acids, trans fatty acids and erucic acid. 25 Other suitable lipids or related materials suitable for use in the infant formulas include those that provide specific fatty acids, including arachidonic acid, docosahexaenoic acid, or mixtures thereof. These materials are known to provide beneficial effects in infants such as enhanced brain and vision development, descriptions of which are set forth in 30 U.S. Pat. No. 5,492,938 (Kyle et al.), which descriptions are incorporated herein by reference. Non-limiting examples of suitable sources of arachidonic acid and docosahexaenoic acid include marine oil, egg-derived oils, fungal oil, algal oil, and combinations thereof. 35 Carbohydrates Carbohydrates are an essential source of energy for the infant. Taking into account the glucose needs of the human brain, the recommended minimum total carbohydrate content is 8.0 g/100 kcal. A maximum carbohydrate content of 15.0 g/1 00 kcal being 40 equivalent to about 60% of energy content. The carbohydrates that may be used in the formula can vary widely. Examples of carbohydrates suitable for infants include hydrolyzed corn starch, maltodextrin, glucose polymers, sucrose, corn syrup, corn syrup solids, rice derived carbohydrate, glucose, 45 fructose, lactose, high fructose corn syrup and indigestible oligosaccharides such as 2544711 1 (GHMatters) -7 fructooligosaccharides (FOS). Any single carbohydrate listed above, or any combination thereof, as appropriate, may be utilized. Commercial sources for the carbohydrates listed above are readily available and known 5 to one practicing the art. For example, corn syrup solids are available from Cerestar USA, Inc in Hammond, Ind. Glucose and rice based syrups are available from California Natural Products in Lathrop, Calif. Various corn syrups and high fructose corn syrups are available from Cargil in Minneapolis, Minn. Fructose is available from A. E. Staley in Decatur, Ill. Maltodextrin, glucose polymers, hydrolyzed corn starch are available from 10 Cerestar USA, Inc., in Hammond, Ind. Sucrose is available from Domino Sugar Corp. in New York, N.Y. Lactose is available from Foremost in Baraboo, Wis. and indigestible oligosaccharides, such as FOS, are available from Golden Technologies Company of Golden, Colo. 15 Lactose The dominant digestible carbohydrate in human milk is lactose, which provides about 40% of the energy value. Lactose is considered to provide beneficial effects for gut physiology, including prebiotic effects, softening of stools, and enhancement of water, 20 sodium and calcium absorption. Lactose is typically the predominant carbohydrate in infant formula (like human formula). However, some infants are lactose intolerant. If desired, the carbohydrate source may be lactose free, or have reduced lactose content. Any carbohydrate that is considered 25 suitable for consumption by human infants may be utilized to replace the lactose (i.e., a gram per gram replacement). Examples of suitable carbohydrates include hydrolyzed or intact, naturally and/or chemically modified starches sourced from corn, tapioca, rice or potato, in waxy or non-waxy forms. Other examples of low lactose carbohydrates include hydrolyzed cornstarch, maltodextrin, glucose polymers, sucrose, corn syrup, corn syrup 30 solids, glucose, fructose, high fructose corn syrup and indigestible oligosaccharides, such as fructooligosaccharides (FOS). Any single carbohydrate listed above, or any combination thereof, as appropriate may be utilized. Other suitable carbohydrates will be readily apparent to those skilled in the art. 35 Vitamins The infant formula of the present invention comprises one or more of vitamins selected from the group consisting of Vitamin A, Vitamin D 3 , Vitamin E, Vitamin K, Thiamin, Riboflavin, Niacin, Vitamin B 6 , Vitamin B1 2 , Pantothetic acid, Folic acid, Vitamin C and 40 Biotin or combination thereof. The total vitamin content can be made up of various combinations of vitamins. Indicative concentration ranges of vitamins include Vitamin A - 60 pg to 180 pg/100 kcal; Vitamin

D

3 1 ptg to 3 lig/100 kcal, Vitamin E 0.5 pag to 5 pg/100 kcal, Vitamin K 4 lag to 25 gg/100 45 kcal, Thiamin 60 gg to 300 pg/100 kcal, Riboflavin 80 pg to 400 jtg/100 kcal, Niacin 300 Ag to 1500 pg/100 kcal, Vitamin Br45 pg to 175 pg/100 kcal, Vitamin B12 0.1 pg to 0.5 -8 Lg/100 kcal, Pantothetic acid 400 pg to 2000 pg/i 00 kcal, Folic acid 10 pg to 50 pg/1 00 kcal, Vitamin C 8 pg to 30 pg/1 00 kcal and Biotin 1.5 pg to 7.5 pg/i 00 kcal. Minerals and trace elements are typically included especially calcium, iron phosphorus, 5 magnesium, sodium, chloride and the like. In some embodiments, the minerals and trace elements are selected from the group consisting of iron, calcium, phosphorus, magnesium, sodium, chloride, potassium, manganese, fluoride, iodine, selenium, copper, zinc or combinations thereof. 10 Obviously, the amount of mineral or trace element will vary depending upon the nature of the mineral or trace element of the source used. Indicative concentration ranges of minerals and trace elements include iron 0.3 mg to 4 mg/100 kcal; calcium 50 mg to 140 mg/1 00 kcal, phosphorus 25 mg to 100 mg/1 00 kcal, magnesium 5 mg to 15 mg/1 00 kcal, sodium 20 mg to 60 mg/1 00 kcal, chloride 50 mg to 160 mg/1 00 kcal, potassium 60 15 mg to 160 mg/100 kcal, manganese 1 pg to 50 pg/100 kcal, fluoride 0 pg to 60 pg/100 kcal, iodine 10 pg to 50 pg/100 kcal, selenium 1 pg to 9 pg/100 kcal, copper 35 pg to 80 pg/1 00 kcal and zinc 0.5 mg to 1.5 mg/1 00 kcal. Iron 20 The infant formula of the present invention may provide a minimal iron content of 4 mg/L (about 0.6 mg/1 00 kcal). The infant formulas of this invention may optionally contain a stabilizer. Suitable 25 stabilizers for use in infant nutritionals are well known to those skilled in the art. Suitable stabilizers include, but are not limited to, gum arabic, guar gum, gellan gum, locust bean gum, pectin, low methoxyl pectin, gelatin, microcrystalline cellulose, CMC (sodium carboxymethylcellulose), carrageenans, and mixtures thereof. The amount of stabilizers utilized will vary depending upon the stabilizer(s) selected, the other ingredients present, 30 and the stability and viscosity of the formula that is sought. Appropriate amounts can be determined by those of skill in the art based on the particular characteristics (e.g., viscosity, shelf life, acceptable sedimentation rates, etc.) being sought in the formula. The infant formula of the present invention further comprises free amino acids. Non 35 limiting free amino acids suitable for use include L-alanine, L-arginine, L-asparagine, L aspartic acid, L-cystine, L-glutamic acid, L-glutamine, glycine, L-histidine, L-isoleucine, L leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, L-taurine, L threonine, L-tryptophan, L-tyrosine, L-valine, and combinations thereof. 40 In some embodiments, the amino acids used in the infant formula are as follows: Amino acid g/100 g protein mg/1 00 kcal Cystine 2.1 38 Histidine 2.3 41 45 Isoleucine 5.1 92 Leucine 9.4 169 -9 Lysine 6.3 114 Methionine 1.4 24 Phenylalanine 4.5 81 Threonine 4.3 77 5 Tryptophan 1.8 33 Tyrosine 4.2 75 Valine 4.9 99 Optional Ingredients 10 The infant formulas of the present invention may further comprise other optional ingredients, either active or inactive, and includes those materials that may modify the physical, chemical, aesthetic or processing characteristics of the formulas or serve as pharmaceutical or additional nutritional components when used in the targeted 15 population. Many such optional ingredients are known for use in food and nutritional products, including infant formulas, and may also be used in the infant formulas of the present invention, provided that such optional materials are compatible with the essential components described herein, are safe and effective for their intended use, and do not otherwise unduly impair product performance. Non-limiting examples of such optional 20 ingredients include preservatives, anti-oxidants, emulsifying agents, pharmaceuticals, buffers, colorants, flavors, nucleotides and nucleosides, thickening agents, stabilizers, and other excipients or processing aids. II. METHOD OF MAKING 25 Methods for producing the infant formulas of the present invention are well known to those skilled in the art. The reader's attention is directed to U.S. Pat. No. 6,099,871 which discloses one method for producing such powders. U.S. Patent Application Ser. No. 60/306,304, filed Jul. 18, 2001, the contents of which are hereby incorporated by 30 reference exemplifies the production of such powders. As a general over view, powdered formula is prepared by the formation of a slurry from one or more solutions that contain water and one or more of the following: carbohydrates, proteins, lipids, stabilizers, vitamins and minerals. This slurry is 35 emulsified, homogenized and cooled. The slurry will then be heated and dried to obtain a powder. The powder resulting from drying may be dry blended or agglomerated with further ingredients, if desired. Ill. METHOD OF USE 40 The present invention is also directed to a method of providing infants with a satisfactory intake of nutrition. In the context of the methods of the present invention, the nutrition provided the infants can be used to meet their sole, primary, or supplemental nutritional needs. For powder embodiments, each method also includes the step of reconstituting 45 the powder with an aqueous vehicle, most typically water or human milk, to form the desired caloric density, which is then orally or enterally fed to the infant to provide the 254A711 1 (OHMrttersi - 10 desired nutrition. The powder is reconstituted with a quantity of water, or other suitable fluid such as human milk, to produce a volume suitable for about one feeding. Generally, from about 8 g to about 9 g of the nutritional powder are reconstituted with about 55 ml to about 65 ml of water to produce the desired nutrient density. 5 Reference now will be made in detail to the embodiments of the invention, one or more examples of which are set forth below. Each example is provided by way of explanation of the invention, not limitation of the invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the present invention 10 without departing from the scope or spirit of the invention. For instance, features illustrated or described as part of one embodiment can be used on another embodiment to yield a still further embodiment. Thus, it is intended that the present invention cover such modifications and variations as 15 come within the scope of the appended claims and their equivalents. Other objects, features and aspects of the present invention are disclosed in or are obvious from the following detailed description. It is to be understood by one of ordinary skill in the art that the present discussion is a description of exemplary embodiments only, and is not intended as limiting the broader aspects of the present invention. 20 EXAMPLE 1 Infant formula prepared ready for consumption in accordance with the present invention shall contain per 100 ml not less than 55 kcal (225 kJ) and not more than 75 kcal (305 25 kJ) of energy, and it shall contain per 100 kcal the ingredients, with minimum and maximum levels where applicable, as listed in Table 1. IUA741 t W .. m - 11 TABLE 1 - Compositional Requirement of Infant Formula Component Unit Minimum Maximum Energy kcal/1 00 ml 55 75 Proteins Cows' milk protein g/100 kcal 1 3.5 Soy protein isolates g/100 kcal 2 3.2 Hydrolyzed cows' milk protein g1100 kcal 1.5T 3.2 Lipids Total fat g/100 kcal 4 6.5 Linoleic acid g/100 kcal 0.2 1.5 a-linolenic acid mg/100 kcal 40 100 Ratio linoleic/a-linolenic acids 5:1 15:1 Lauric + myristic acids % of fat 5 20 Trans fatty acids % of fat 0.5 3 Erucic acid % of fat 0 1 Carbohydrates Total carbohydrates g/1 00 kcal 8.0 15.0 Vitamins Vitamin A pg RE/100 kcal 55 200 Vitamin D pg/100 kcal 1 2.5 Vitamin E mg a-TE/100 kcal 0.5 5 Vitamin K pg/100 kcal 4 25 Thiamin pg/100 kcal 60 300 Riboflavin Vg/1 00 kcal 80 400 Niacin pg/100 kcal 300 1500 Vitamin B 6 pg/100 kcal 35 175 Vitamin 812 pg/i 00 kcal 0.1 0.5 Pantothenic acid pg/i 00 kcal 400 2000 Folic acid pg/1 00 kcal 10 50 Vitamin C mg/100 kcal 8 30 Biotin mg/1 00 kcal 1.5 7.5 Minerals and trace elements pg/100 kcal Iron (based on cows' milk protein and protein hydrolysate) 0.3 1.3 Iron (based on soy protein isolate) mg/100 kcal 0.45 2.0 Calcium mg/100 kcal 50 140 Phosphorus (based on cows' milk protein and protein hydrolysate) mg/1 00 kcal 25 90 Phosphorus (formula based on soy protein isolate) mg/i 00 kcal 30 100 Ratio calcium/phosphorus mg/mgokcal 1:1 2:1 Magnesium mg/mg 5 15 Sodium mg/100 kcal 20 60 Chloride mg/100 kcal 50 160 Potassium mg/100 kcal 60 160 Manganese mg/100 kcal 1 50 Fluoride mg/100 kcal NS 60 Iodine mg/100 kcal 10 50 Selenium mg/100 kcal 1 9 Copper mg/100 kcal 35 80 Zinc mg/100 kcal 0.5 1.5 Other substances mg/100 kcal Choline 7 50 Myo-inositol mg/100 kcal 4 40 L-carnitine mg/100kcal 1.2 NS mg/100 kcal 1 1

Claims (5)

1. An infant formula comprising (i) 1 g/100 kcal to 10 g/100 kcal protein; 5 (ii) 4 g/100 kcal to 9 g/100 kcal lipids; (iii) 8 g/1 00 kcal to 15 g/1 00 kcal carbohydrates; (iv) 200 mg/1 00 kcal to 10,000 mg/1 00 kcal minerals and trace elements; and (v) whey to casein ratio of 1:10 to 10:1. 10

2. The infant formula of claim 1, wherein the formula provides energy between 55 kcal/100ml and 75 kcal/100ml.

3. The infant formula of claim 1 or claim 2, wherein the vitamins comprise one or more of Vitamin A, Vitamin D 3 , Vitamin E, Vitamin K, Thiamin, Riboflavin, Niacin, VitaminB 6 , Vitamin B 1 2 , 15 Pantothenic acid, Folic acid, Vitamin C and Biotin or combination thereof.

4. The infant formula of any one of claims 1 to 3, wherein the minerals and trace elements comprise between 0.3 and 4 mg/100 kcal iron. 20

5. The infant formula of any one of claims 1 to 4, wherein the formula further comprises one or more of choline, myo-inositol, L-camitine, taurine, nucleotides, and phospholipids. 9litA711 1 /CMHattlrs\