Formulas comprising optimised amino acid profiles

#This application is the National Phase of International Patent Application No. PCT/NL2014/050314, filed May 19, 2014, published on Nov. 26, 2015 as WO 2015/178761 A1. The contents of which are herein incorporated by reference in its entirety.

#The present invention relates to infant formulas and follow-on formulas containing optimised amino acid profiles, in particular optimised concentrations and/or weight ratios of phenylalanine. The formulas may contain intact proteins, hydrolysed proteins, protein fractions, free amino acids and/or a combination thereof selected based on their ability to provide the formula with an optimised amino acid profile. The present invention also relates to the administration of these formulas to infants, particularly term infants, in order to achieve balanced growth and/or development, in particular balanced growth and/or development of the brain of infants, and may also assist in preventing or reducing the risk of obesity later in life.

#Amino acids are essential building blocks of proteins in the human body. Some amino acids are classified as essential, meaning that the human body cannot synthesise the amino acid so it must be sourced from the diet. The essential amino acids for humans are valine, isoleucine, leucine, lysine, methionine, threonine, phenylalanine, histidine, and tryptophan. Cysteine and tyrosine are considered to be conditionally essential amino acids, because of their strong link to methionine and phenylalanine respectively. The remaining amino acids (alanine, arginine, asparagine, aspartic acid, glutamic acid, glutamine, glycine, proline, and serine) are non-essential amino acids and can either be synthesised or sourced from the diet.

#FIG. 1 shows an example of a graph plotted by the IAAO method for a test amino acid as described in the introduction for Example 1.

#FIG. 2 shows the rates of release of 13CO2 in the breath of 21 term infants (F13CO2) at different phenylalanine intakes as described in Example 1, and in particular Example 1a. Using a biphasic linear regression crossover model, the mean breakpoint was estimated to be 58 mg·kg−1·d−1 (P<0.01, r2=0.54).

#FIG. 3 shows the rates of release of 13CO2 in the breath of 32 term infants (F13CO2) at different threonine intakes as described in Example 1b. Using a biphasic linear regression crossover model, the mean breakpoint was estimated to be 68 mg·kg−1·d−1 (P<0.0001, r2=0.362).

#1. A formula comprising a proteinaceous composition, wherein the formula: a) comprises 2.8-4.3 g phenylalanine per 100 g protein; b) comprises 39-46 mg phenylalanine per 100 mL formula; c) provides, or is formulated to provide phenylalanine in an amount of 58-70 mg/kg body weight per day; and/or d) comprises a weight ratio of phenylalanine to the sum of isoleucine, leucine, valine, tryptophan, tyrosine, and methionine of from 1:7.237 (0.138) to 1:10.810 (0.0925). 2. The formula of embodiment 1, comprising 10-12 mg tryptophan per 100 mL formula and/or providing, or being formulated to provide tryptophan in an amount of 15-17 mg/kg body weight per day. 3. The formula of embodiment 1 or 2, comprising a weight ratio of tryptophan to the sum of isoleucine, leucine, valine, phenylalanine, tyrosine, and methionine of from 1:30.327 (0.0330) to 1:45.304 (0.0221). 4. The formula according to any one of embodiments 1-3, comprising 45-52 mg threonine per 100 mL formula, and/or providing, or being formulated to provide threonine in an amount of 68-78 mg/kg body weight per day. 5. The formula according to any one of embodiments 1-4, comprising a ratio of phenylalanine to threonine of from 1:0.959 (1.042) to 1:1.433 (0.698). 6. The formula according to any one of embodiments 1-5, being an infant formula. 7. The formula according to embodiment 6, comprising 0.9 to 1.4 g of protein per 100 mL of infant formula and/or 1.4 to 2.1 g of protein per 100 kcal of infant formula. 8. Use of a composition in the manufacture of a formula for providing nutrition to an infant, wherein the formula is a formula according to any one of embodiments 1-7. 9. Use of a composition in the manufacture of a formula for promoting, assisting or achieving balanced growth or development in an infant and/or for preventing or reducing the risk of unbalanced growth or development in an infant, wherein the formula is a formula according to any one of embodiments 1-7. 10. Use of a composition in the manufacture of a formula for promoting, assisting or achieving balanced growth or development of the brain of an infant and/or the cognitive function of an infant, wherein the formula is a formula according to any one of embodiments 1-7. 11. Use of a composition in the manufacture of a formula for promoting, assisting or achieving balanced growth or development of the body of an infant and/or the infant's body composition, wherein the formula is a formula according to any one of embodiments 1-7. 12. Use of a composition in the manufacture of a formula for preventing or reducing the risk of obesity later in life in an infant, wherein the formula is a formula according to any one of embodiments 1-7. 13. Use according to any of embodiments 8-12, wherein said infant is a term infant. 14. Method for providing nutrition to an infant; and/or for promoting, assisting or achieving balanced growth or development in an infant and/or for preventing or reducing the risk of unbalanced growth or development in an infant; and/or for preventing or reducing the risk of obesity later in life in an infant, said method comprising administering a formula according to any one of embodiments 1-7 to said infant. 15. Method of embodiment 14, for promoting, assisting or achieving balanced growth or development of the brain of the infant and/or the cognitive function of the infant. 16. Method of embodiment 14, for promoting, assisting or achieving balanced growth or development of the body of an infant and/or the infant's body composition. 17. A proteinaceous composition comprising: a) 2.8-4.3 g phenylalanine per 100 g protein; and/or b) a weight ratio of phenylalanine to the sum of isoleucine, leucine, valine, tryptophan, tyrosine, and methionine of from 1:7.237 (0.138) to 1:10.810 (0.0925). 18. The proteinaceous composition of embodiment 17, comprising a ratio of phenylalanine to threonine of from 1:0.959 (1.042) to 1:1.433 (0.698). 19. The proteinaceous composition of embodiment 17 or 18, comprising 0.7-1.1 g tryptophan per 100 g of protein. 20. The proteinaceous composition of any one of embodiments 17-19, comprising a weight ratio of tryptophan to the sum of isoleucine, leucine, valine, phenylalanine, tyrosine, and methionine of from 1:30.327 (0.0330) to 1:45.304 (0.0221). 21. Formula for use in providing nutrition to an infant; and/or for use in promoting, assisting or achieving balanced growth or development in an infant and/or for use in preventing or reducing the risk of unbalanced growth or development in an infant; and/or for use in preventing or reducing the risk of obesity later in life in an infant, comprising administering a formula according to any one of embodiments 1-7 to said infant, preferably a term infant. 22. Formula for use according to embodiment 21, for use in promoting, assisting or achieving balanced growth or development of the brain of the infant and/or the cognitive function of the infant, preferably a term infant. 23. Formula for use according to embodiment 21, for use in promoting, assisting or achieving balanced growth or development of the body of an infant and/or the infant's body composition, preferably a term infant.

#The embodiments will be detailed here below.

#Proteinaceous Composition—Amino Acid Profile