Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2002-03-04
2004-05-11
Tate, Chris (Department: 1654)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C514S002600
Reexamination Certificate
active
06733770
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an enteral composition containing peptides in an adapted profile size, bioactive peptides, intact proteins, and free amino acids intended for specific gastro-intestinal maturation in premature mammals.
BACKGROUND TO THE INVENTION
Nutritional compositions based upon hydrolysates of proteins such as milk or soy, are commonly used in infant and clinical nutrition and particularly in hypoallergenic formulas and, formulas for patients suffering from various intestinal absorption problems. It is also known to use free amino acids in nutritional compositions for example for patients suffering from particular diseases or conditions such as inflammatory bowel disease, intractable diarrhoea, short bowel syndrome, and the like. Accordingly, amino acids are used either alone or in combination with protein or protein hydrolysates. Protein hydrolysates or free amino acid mixtures are also mainly used in, particular cases such as allergy to whole proteins.
Another interest in using protein hydrolysates in nutrition is due to the fact that they are more rapidly absorbed in the intestine than whole protein or free amino acids. However, it is not clear whether this faster absorption translates into better nitrogen utilisation since studies carried out to date have provided conflicting results (Collin-Vidal et al; 1994
; Endocrinol. Metab
., 30, E 907-914). Further, this interest is in the sense of providing a source of amino acids to meet the general amino acids needs of the patient and not to specifically provide for the needs of individual gastro-intestinal maturation.
SUMMARY OF THE INVENTION
Accordingly, on one aspect, this invention provides a nutritional enteral composition intended for favoring the growth and maturation of non-mature gastro-intestinal tracts of young mammals, which contains as a protein source a mixture of dietary protein hydrolysates and intact proteins being partly in the form of bioactive peptides.
In this composition, the dietary protein hydrolysates are preferably in the form of a mixture of different size peptides, free amino acids or a mixture thereof. The dietary protein hydrolysates may be hydrolysates of animal proteins (such as milk proteins, meat proteins and egg proteins), or vegetable proteins (such as soy proteins, wheat proteins, rice proteins, and pea proteins). The preferred source is milk protein. The dietary protein hydrolysates can be used as such or like peptide fractions isolated from them.
The hydrolysed proteins may comprise at least 5% (by weight, of the total protein content calculated as Nitrogen×6.25) of hydrolysate having a degree of hydrolysis of about 40 and at least 5% of hydrolysates having a lesser degree of hydrolysis. Free amino acids are preferably in an amount of about 0 to 20% by weight of the total protein content (N×6.25).
The intact proteins may be individual or enriched animal or vegetable protein fractions comprising whole milk, caseins, whey proteins, soy proteins or rice proteins, for example. They are preferably in an amount of at least about 5% of the total protein content N×6.25).
The intact protein fraction may contain bioactive peptides such as TGF-&bgr;2 or a source of bioactive peptides such as beta-casein liberated in the gut by enzymatic hydrolysis. The final TGF-&bgr;2 concentration may be in the range of 0.1 to 4 ng/mg total protein, preferably about 1 to 2.5 ng/mg.
The nutritional composition may also contain a source of fat and a source of carbohydrates. This composition preferably contains a source of protein providing 5 to 30% of the total energy, a source of carbohydrates which provides 40 to 80% of the total energy, a source of lipids which provides 5 to 55% of the total energy, minerals and vitamins to meet daily requirements.
In another aspect, this invention provides the use of a selected mixture of dietary protein hydrolysates and intact proteins being partly in the form of bioactive peptides for the preparation of a nutritional enteral composition for favoring the growth and maturation of non- or premature gastro-intestinal tracts of young mammals.
The nutritional composition also intends to cover very high nutrient needs for growth and development during that stage. It ensures optimal digestion and utilization (for tissue accretion) of the protein source and intends to minimize the nitrogen waste of the organism. Moreover, a mixture of intact protein, protein hydrolysates, bioactive peptides and free amino acids provides a better source of amino acids to meet the general amino acid needs of the patient in addition to specifically favor the maturation of individual organs.
Embodiments of the invention are now described by way of example only.
DETAILED DESCRIPTION OF THE INVENTION
In the specification, the term “degree of hydrolysis” (DH) means the percentage of nitrogen in the form of free alpha-amino nitrogen as compared to total nitrogen. It is a measure of the extent to which the protein has been hydrolysed.
The term bioactive peptide relates to i) a protein or peptide present as such in the preparation and demonstrating specific fictional properties or ii) a protein or peptide containing an amino acid sequence with specific properties, this sequence being liberated in the gastro-intestinal tract during the natural process of digestion.
According to a first aspect of the invention, the nutritional composition comprises as a source of protein a selected mixture of intact protein being partly in the form of bioactive peptides and dietary protein hydrolysates having a degree of hydrolysis in the range of about 5% to about 50% and free amino acids. The non-protein nitrogen concentration of the protein source can be comprised between 10% and 95% of the total nitrogen. Such protein source maximizes the area of the intestine in which the protein is digested and optimizes protein synthesis in the gut and peripheral tissues.
The nutritional composition can also contain a carbohydrate sources a fat source, vitamins and minerals.
The intact protein may be any suitable dietary protein; for example animal proteins (such as milk proteins, meat proteins and egg proteins); vegetable proteins (such as soy protein, wheat protein, rice protein, and pea protein); or combinations thereof. Milk proteins such as cased and whey protein are particularly preferred. They are preferably in an amount at least of about 5% of the total protein content (calculated as Nitrogen×6.25). Dietary protein in the form of intact protein is found to increase the rate of muscle protein synthesis as compared to protein hydrolysates.
The dietary protein hydrolysates may come from any suitable dietary protein; for example animal proteins (such as milk proteins, meat proteins and egg proteins); vegetable proteins (such as soy protein, wheat protein, rice protein, and pea protein); or combinations thereof. Milk proteins such as casein and whey protein are particularly preferred. The hydrolysed dietary proteins may comprise at least 5% (by weight, of the total protein content calculated as Nitrogen×6.25) of hydrolysate having a degree of hydrolysis of about 40 and at least 5% of hydrolysates having a lesser degree of hydrolysis. In particular, hydrolysates having a degree of hydrolysis of about 10% to about 15%, are found to increase relative weight of the liver as compared to free amino acid mixes. Hydrolysates having a degree of hydrolysis of about 15% to about 25% are found to increase the concentration of protein in the jejunum, the relative weight of the jejunum and the rate of protein synthesis in the jejunum. Highly hydrolysed protein which has a degree of hydrolysis of greater than 25% or which contains more than 25% by weight of di- and tri-peptides, more preferably greater than 30%, is found to increase the rate of protein synthesis in the jejunum and the duodenum; particularly the duodenum.
The diet, protein hydrolysates may be produced using procedures which are well known in the art or may be obtained commercially. For example, nutritional formulas containi
Ballevre Olivier
Finot Paul-Andre
Garcia-Rodenas Clara L.
Haschke Ferdinand
Maire Jean-Claude
Bell Boyd & Lloyd LLC
Nestec S.A.
Tate Chris
Winston Randall
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