Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2001-12-17
2002-06-04
Webman, Edward J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C514S003100, C514S866000, C424S439000
Reexamination Certificate
active
06399090
ABSTRACT:
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to an infant formula and, more particularly, to an insulin supplemented infant formula.
Breastfeeding, the natural feeding mode, has multiple beneficial effects on the infant. First, it is known to be the most suitable diet for infant's nutritional requirements. Second, it provides the infant with immune protection against a wide range of infection related diseases (1). Third, as it contains active insulin molecules it protects the infant against the development of Type-1 diabetes (2-3). Fourth, insulin present in milk enhances small intestinal growth and development (4).
Type-1 diabetes, which is insulin dependent diabetes mellitus (IDDM), is the consequence of progressive autoimmune pancreatic &bgr; cell destruction during an initially asymptomatic period that may extend many years (5-6). The etiology is multifactorial, with genetic and environmental factors contributing to the autoimmune destruction of the &bgr; cells. The fact that concordance for IDDM in monozygotic twins is not more than 30-50% (7) and that 90% of patients with newly diagnosed IDDM do not have an affected first-degree relative having IDDM (8), as well as the sudden increase in incidence of IDDM witnessed over the last ten years (9), have been taken as indication of the importance of environmental factors in triggering the development of the autoimmune process in genetically susceptible individuals.
Many studies show that type I diabetes is related to cow's milk consumption and neonatal feeding practices (2,10). In the case-control studies (including a study conducted in the Juvenile Diabetes Unit of the Rambam Medical Center, Haifa, Israel), patients with type I diabetes were more likely to have been breast-fed for less than 3 months and to have been exposed to cow's milk proteins before 3 months of age (3). Moreover, the immune system of patients with IDDM recognizes cow's milk proteins, as demonstrated by antibodies assays and lymphocytes activity tests (11). These data emphasize the importance of diet and orally administered proteins on the development of autoimmune diabetes.
In animal models, It has been shown that oral feeding of a specific antigen can suppress the immune system and cause an antigen-specific reduction in many types of immune responses, including T cell proliferation; delayed type hypersensitivity, and antibody production (12-15). Oral administration of insulin generates active cellular mechanisms that suppress the development of autoimmune diabetes (16). These results have paved the way to the “oral tolerance approach” and oral insulin treatment is already taking place in human trials planned to prevent type 1 diabetes in high risk groups (17).
As shown below, prior art infant formulas, although attempting to mimic as much as possible breast milk, are very low in immunologically recognizable insulin as compared with human milk. The level of active insulin in these formulas is probably zero, due to the harsh conditions associated with their manufacture.
There is thus a widely recognized need for, and it would be highly advantageous to have, an infant formula supplemented with insulin.
SUMMARY OF THE INVENTION
According to one aspect of the present invention there is provided an infant formula in a powder or solution form comprising nutritional components and an insulin supplement such that when the infant formula is fed to an infant a chance of the infant of developing diabetes is reduced;
wherein said insulin is in a concentration range of about 1,000 to 100,000 micro units/100ml of solution or 8,300-750,000 micro units/100 grams of powder.
According to another aspect of the present invention there is provided a method of feeding an infant comprising the steps of dissolving an infant formula powder containing nutritional components and an insulin supplement in water for obtaining a solution including the nutritional components and the insulin supplement and feeding the infant with the solution thereby reducing a chance of the infant of developing diabetes;
wherein said insulin is in a concentration range of about 1,000 to 100,000 micro units/100ml of solution or 8,300-750,000 micro units/100 grams of powder.
According to further features in preferred embodiments of the invention described below, the insulin is recombinant insulin.
According to still further features in the described preferred embodiments the insulin is synthetic.
According to still further features in the described preferred embodiments the insulin is purified natural insulin.
According to still further features in the described preferred embodiments the insulin is biologically active.
According to still further features in the described preferred embodiments the insulin is in a concentration range of about 17,000 to 400,000 &mgr;U per 100 grams of said powder or 2,000-55,000 &mgr;U per 100 milliliters of said solution.
According to still further features in the described preferred embodiments the insulin has an amino acid sequence of human insulin.
According to still further features in the described preferred embodiments at least some of the nutritional components are derived from milk or soy.
The present invention successfully addresses the shortcomings of the presently known configurations by providing an infant formula which is more similar to human milk, protects from the development of Type-1 diabetes and improve the development and maturation of infants intestine.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention is of an infant formula supplemented with insulin, preferably human insulin, which can be used to feed infants. Specifically, the present invention can be used to protect infants of syndromes associated with feed devoid of insulin fed to them in the first year of their lives. The present invention renders infant formulas more similar to human milk.
The principles and operation of an infant formula according to the present invention may be better understood with reference to the drawings and accompanying descriptions.
Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
Epidemiological and experimental animal data suggest that insulin content in infant diet may play an important role in preventing autoimmune diabetes and improving intestinal development.
It is shown in the Examples section hereinunder that the level of immunologically recognized insulin in a variety of commonly used infant formulas is very low, at least four to ten times lower as compared with human milk, probably even lower. Although not tested, the level of active insulin in such formulas is expected to be zero due to the harsh conditions associated with their manufacture. Soy-based infant formulas, are devoid of milk content, and are therefore completely devoid of both immunologically recognizable insulin, not to mention active insulin.
Moreover, it has been shown that exposure to bovine insulin present in fresh cow milk, which differs from human insulin only by three amino acids, may break the tolerance to insulin and lead to autoimmune diabetes (18),
To overcome these two obstacles in infant feeding: the lack of insulin in infant formulas and the risk to break immune tolerance to insulin when using fresh cow milk, it is herein suggest for the first time to add human insulin to infant formula.
Addition of insulin to infant formula leads for the following beneficial effects. First, it renders the infant formula more similar to human milk. Second, it protects from the development of Type-1 diabetes. Third, it improve the development and maturation of i
Friedman Mark M.
Insotech Ltd.
Nguyen Helen
Webman Edward J.
LandOfFree
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