Soy hydrolysate based nutritional formulations

Food or edible material: processes – compositions – and products – Products per se – or processes of preparing or treating... – Beverage or beverage concentrate

Reexamination Certificate

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Details

C426S656000, C426S801000, C426S661000

Reexamination Certificate

active

06808736

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates generally to products for providing nutritional support. More specifically, the present invention relates to infant formulas and other specialized nutritional supplements.
It is of course known to provide enteral nutrition to an individual. Such nutrition can be provided to either afford the complete nutrition requirements to the individual or as a supplement. In a similar vein, these products can either be directed to the population in general or individuals having special requirements. For example, due to disease states or other abnormalities, individuals may not be able to tolerate certain components that may be typical of most nutritional formulations.
One type of enteral nutrition is infant formulas. Infant formulas are designed to provide nutritional support to pre-term, full-term, and post-term babies. Typically, infant formulas are directed to individuals under the age of 12 months. These formulas are either designed as a substitute for or a supplement to human breast milk. Such formulations can provide the total nutritional support for an infant or they can be used to supplement an infant's diet.
Similar to the adult population, some infants are allergic to milk-based products. For example, a number of individuals have an intolerance to regular milk formulas. This is typically due to the proteins and/or lactose in the regular milk formulas. It is therefore known to provide infant formulas based on soy proteins; soy can be used as a substitute for milk.
Additionally, infants do not have fully developed digestive systems. Certain nutritional components, for example, protein, may be difficult for infants to digest during their early development.
SUMMARY OF THE INVENTION
The present invention provides improved nutritional formulations. In a preferred embodiment, the present invention provides an infant formula that is preferably lactose free as well as is designed to be more easily digested by infants.
To this end, in an embodiment, the present invention provides an infant formula that is lactose free comprising hydrolyzed soy protein isolate.
In an embodiment, the soy hydrolysate isolate has a degree of hydrolysis of approximately 4 to about 10%.
In an embodiment, a stabilizer system is provided based on rice starch.
In an embodiment, a stabilizer system is provided based on corn starch.
In an embodiment, the soy hydrolysate isolate comprises not less than 50% by weight of the protein of the formula.
In an embodiment, based on a ready-to-use basis, the formula includes approximately 0.5 to about 5% by weight protein.
In an embodiment based on a ready-to-use basis: the formula includes approximately 0.5% to about 5% by weight protein; approximately 1% to about 10% carbohydrate; and approximately 1% to about 10% fat.
In another embodiment, the present invention provides an infant formula including: a protein source that provides approximately 0.5 to about 10% based on weight of the formula and includes soy hydrolysate isolate; a carbohydrate source; a fat source; a stabilizer system; and vitamins and minerals.
Additionally, in an embodiment, the present invention provides a method of providing an infant formula that is lactose free and more easily digested by an infant than at least some other lactose free infant formulas comprising the steps of using as a protein source soy hydrolysate.
An advantage of the present invention is to provide an improved infant formula.
Another advantage of the present invention is to provide an improved infant formula for infants that is easier to digest.
Still further, an advantage of the present invention is to provide a lactose-free infant formula.
Furthermore, an advantage of the present invention is to provide an infant formula that functions as a comfort product.
Moreover, an advantage of the present invention is to provide an enteral formulation that is more easily digested.
A further advantage of the present invention is to provide a method for providing nutrition to an individual having lactose intolerance.
Additional features and advantages of the present invention will be described in and apparent from the detailed description of the invention.


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21 CFR Part 105. Revised as of Apr. 1, 1982, p. 58-61.*
21 Code of Federal Regulations Parts 100-169, Revised as of Apr. 1, 1982 p 59-62.*
21 CFR 105.65-105.66 Infant Foods, Apr. 1, 1982.

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