Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
2002-04-22
2004-08-17
Wilson, James O. (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S053000, C426S580000, C426S583000, C426S801000, C562S444000, C562S560000, C548S344100, C548S496000
Reexamination Certificate
active
06777391
ABSTRACT:
This invention relates to a composition for an infant formula having a low threonine content; a method of producing the composition; use of the composition in the manufacture of a medicament or nutritional product for addressing the nutritional needs and providing healthy growth of an infant; and a method of addressing the nutritional needs and providing healthy growth of an infant which comprises administering an effective amount of the composition.
Within the context of this application the word “comprises” is taken to mean “includes, among other things” and it is not intended to mean “consists of only”.
Mother's milk is recommended for all infants. However, in some cases mother's milk is not available and infant formulae must be used. Normal, full-term infants are usually fed cow's-milk-based formulas. These formulas contain a mixture of casein and whey as protein sources and they provide nutrition for infants, however they do not provide a protein concentration and an amino acid profile equivalent to that of mother's milk. In addition these standard formulae are not suitable for pre-term infants and those having adverse reactions to protein in cow's milk formula or to lactose.
An alternatives to cow's milk formula is soy formula; particularly for infants who are lactose intolerant. However, soy is not as good a protein source as cow's milk. Also, infants do not absorb some minerals, such as calcium, as efficiently from soy formulae.
A further alternative formula is based on hydrolysed protein. These formulas are hypoallergenic and have a decreased likelihood of an allergic reaction.
Ideally, to be as close as possible to human milk, the protein in infant formulae may be derived from both whey and casein in an appropriate ratio. However, a problem with conventional formulae having these proteins is that they have a high protein concentration to ensure that the infant gets the necessary amount of all essential amino acids. The protein concentration is higher than the concentration normally found in human milk and it may not be beneficial for an infant because an infant's metabolism is susceptible to overloading with nitrogen from its protein intake.
To address this problem, formulae having improved amino acid profiles have been suggested, for example those having hydrolysed whey proteins. However, until now there has not been a composition having a protein concentration equivalent to the concentration in human milk and a good amino acid profile.
The present invention addresses the problems set out above.
Accordingly, the invention provides a composition for an infant formula having a low threonine content which comprises all of:
i) acid whey protein or sweet whey protein from which caseino-glyco-macropeptide has been removed; and
ii) free arginine; and
iii) free histidine; and
iv) free tyrosine or tryptophan rich milk protein or free tryptophan or a mixture thereof.
In a second aspect the invention provides a method of producing the composition which comprises the step of blending whey protein together with free arginine; free histidine; and free tyrosine or tryptophan rich milk protein, free tryptophan or a mixture thereof and homogenising the blended mixture.
In a third aspect the invention provides use of an embodiment of the composition in the manufacture of a medicament or nutritional product for addressing the nutritional needs and providing healthy growth of an infant.
In a forth aspect the invention provides a method of addressing the nutritional needs and providing healthy growth of an infant which comprises administering an effective amount of an embodiment of the composition.
Preferably the protein source has a threonine content of less than about 8 g/16 gN, more preferably it is less than about 6 g/16 gN.
Preferably an embodiment of the composition comprises from about 9.0 to about 10.0 w/w % of protein, more preferably about 9.5% w/w %. This corresponds to about 1.8 g protein/100 kcal. This provides the advantage of a lower protein concentration relative to known formulae. An advantage provided by this concentration of protein is that it is equivalent to the amount of protein generally present in human milk and it corresponds to the lower limit tolerated by codex alimentarius.
Preferably an embodiment of the composition comprises about 6% to about 50% by weight of whey protein, more preferably about 20% to 40% whey protein, most preferably 30% whey protein.
Preferably the composition also comprises casein protein. An advantage provided by casein is that it has the ability to form curd which enhances the feeling of satiety. Preferably it comprises from about 20% to about 40% casein protein, more preferably about 30%. Preferably, the ratio of whey protein to casein protein is about 60%:about 40% to about 70%:about 30%, most preferably it is about 70%:about 30%.
Preferably the whey protein is acid whey protein or sweet whey protein. In general, acid whey protein is preferred from a nutritional point of view since it has a lower threonine content and this is closer to that of human milk.
Preferably, the sweet whey protein is sweet whey protein from which caseino-glyo-macropeptide has been removed. This provides the advantage of a reduced threonine content and an increased tryptophan content as compared to normal sweet whey and is therefore suitable as a protein source for infants.
Preferably, the whey protein is substantially free of lactose. This has the advantage that the infant formula has reduced levels of lysine blockage. Preferably, the level of lysine blockage is less than 10%.
Preferably an embodiment of the composition comprises protein which is non-hydrolysed. In alternative embodiments it is hydrolysed.
Preferably an embodiment of the composition comprises up to about 4% by weight of arginine; up to about 4% tyrosine or tryptophan; up to about 4% histidine. More preferably an embodiment of the composition comprises about 0.1% to about 3% by weight of arginine; about 0.2% to about 1% tyrosine or tryptophan; about 0.1% to about 2% histidine. More preferably an embodiment of the composition comprises about 0.1% to about 2% by weight of arginine; about 0.2% to about 0.5% tyrosine or tryptophan; about 0.1% to about 1.5% histidine. Suprisingly, it has been found that by supplementing with the free amino acids arginine, tyrosine, and histidine, the protein source has an amino acid profile which is close to that of human milk. This provides the advantage of mimicking the nutritional benefits of natural human milk for addressing the nutritional needs and providing healthy growth of an infant.
Preferably the concentration of tryptophan in the composition is at least about 135 mg/g and the concentration of threonine in the composition is less than about 350 mg/g. Preferably the threonine concentration corresponds to about 4.9 g per 100 g protein to about 5.1 g per 100 g protein
Preferably, tryptophan rich milk protein has a level of about 5% or more of amino acids as tryptophan. More preferably it is about 10% or more.
Preferably the free amino acids are in free base form.
Preferably an embodiment of the composition comprises a lipid source, a carbohydrate source, and a protein source. This provides the advantage that the composition is as close as possible in content to mothers milk.
The lipid source may contain medium chain triglycerides.
The carbohydrate source may include lactose. The lactose may be the sole source of carbohydrates.
In one embodiment the composition is suitable for a pre-term infant formula and comprises up to about 0.1% by weight histidine, about 0.1% to about 0.3% by weight arginine, and about 0.3 to about 0.5% by weight tryptophan.
In an alternative embodiment the composition is suitable for a full-term, hypoallergenic infant formula in which the protein source preferably comprises about 0.2% to about 0.4% by weight histidine, about 1% to about 2% by weight arginine, and about 0.2% to about 0.4% by weight tryptophan.
In an embodiment which comprises hydrolysed protein, the protein source preferably com
Ballevre Olivier
Haschke Ferdinand
Jost Rolf
Kratky Zdenek
Kuslys Martinas
Bell Boyd & Lloyd LLC
McIntosh III Traviss C.
Nestec S.A.
Wilson James O.
LandOfFree
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