Title: Insulin supplemented infant formula
United States Patent: 6,365,177
Inventors: Shahadeh; Naim (Kfar Yasif, IL)
Assignee: Insotech Ltd. (Maabarot, IL)
Appl. No.: 701652
Filed: November 30, 2000
PCT Filed: June 3, 1999
PCT NO: PCT/US99/12594
371 Date: November 30, 2000
102(e) Date: November 30, 2000
PCT PUB.NO.: WO99/62558
PCT PUB. Date: December 9, 1999
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
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
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
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 22 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 the infant a chance of the infant developing diabetes is reduced,
wherein said insulin is in a concentration range of about 25000-75000 .mu.U
per 100 grams powder or 3000-10000 .mu.U per 100 milliliters solution.
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