Title:  Insulin supplemented infant formula

United States Patent:  6,399,090

Assignee:  Insotech Ltd. (Kibbutzhaabarot, IL)

Filed:  December 17, 2001

An infant formula in a powder or solution form including nutritional components and an insulin supplement. A method of feeding an infant including the steps of dissolving an infant formula powder containing nutritional components and an insulin supplement in water for obtaining a solution including said nutritional components and said insulin supplement and feeding the infant with the solution.

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 infants intestine. The addition of insulin to infant formula is safe for at least two reasons. First, the concentration of insulin is selected similar to that found in human milk. Second, oral insulin administration is already used in several human trials (17).

Thus, in accordance with one aspect of the present invention there is provided an infant formula in a powder or solution form which formula includes nutritional components and an insulin supplement.

In accordance with another aspect of the present invention there is provided a method of feeding an infant. The method is effected by executing the following steps. First an infant formula powder containing nutritional components and an insulin supplement is solubilized in water for obtaining a solution including the nutritional components and the insulin supplement. Second, the solution is fed to the infant.

As exemplified in the Examples section below, the nutritional components may include milk or soy derived nutritional components. They may additionally include one or more of the following ingredients: lactose, vegetable oils, skimmed milk powder, whey protein concentrate, Sodium, Calcium, Phosphorus, Potassium, Chloride, Iron, Magnesium, Taurine, Vitamins, Glucose syrup, soy protein isolate, Sucrose, Maltodextrine, Methionine, Taurine, Carnitine, and trace elements.

According to a preferred embodiment of the present invention, the insulin is selected from the following insulin types: recombinant insulin, synthetic insulin, purified natural insulin, biologically active insulin and insulin having an amino acid sequence of human insulin (e.g., human insulin). Some of these types are overlapping and therefore the insulin of choice may be categorized to more than a single type of the types listed. Human recombinant insulin is available in a pure form from Eli Lilly & Co, USA. Human natural purified insulin is available in a pure form from Novo Nordisk, Denmark. Crude extracts may also be useful, depending on the method of their manufacturing. Synthetic insulin may be manufactured using commercially available building units for Boc and Fmoc chemistry peptide synthesis, as well known in the art.

According to another preferred embodiment of the present invention the concentration of the insulin in the solution is similar to the concentration in human milk. Thus, according to a preferred embodiment the insulin concentration is in the range of about 25000-75000 .mu.U per 100 grams of the powder (which is diluted about 7.5 fold to form the solution) or 3000-10000 .mu.U per 100 milliliters of the solution, preferably 3000-6000, optimally about 4200 .mu.U per 100 milliliters of the solution.

Claim 1 of 24 Claims

What is claimed is:

1. 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/100 ml of solution or 8,300-750,000 micro units/100 grams of powder.

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