This is an interesting patent because the assignee of this patent is the
infant formula maker Maabarot. They are stating that insulin, present in human
milk, protects against the development of type I diabetes. Rather interesting
statement since this fact seems to be one item of dispute in the breastfeeding
Ad campaign. Nemours Foundation has a patent invented by Susan M. Kirwin in
which they use a human milk component-leptin- to treat diabetes among other
problems.( patent # 6475984--"Administration of Leptin" filed in 1999). There
are other patents that use various human milk proteins to treat diabetes, such
as prosaposin.
Valerie W. McClain, IBCLC
http://www.uspto.gov/patft/index.html
patent # 6365177
"Insulin supplemented infant formula"
inventor: Naim Shahadeh
assignee: Insotech (Maabarot)
file date: 2000
"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 .beta. 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 .beta. 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."
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