Formulations for nutritional support in subjects in need thereof

Abstract

Formulations having a protein component, in which the protein contains one or more digestion-aiding proteins, and / or one or more immunoprotective proteins. The formulations may also contain a fat component, a carbohydrate component, and vitamins and minerals. These formulations can be used to provide nutritional support to a subject, either as dietary supplements or as a primary source of nutrition, such as for an infant formula.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 15 / 829,703, now U.S. Pat. No. 11,197,917, filed on Dec. 1, 2017 and titled “FORMULATIONS FOR NUTRITIONAL SUPPORT IN SUBJECTS IN NEED THEREOF”, which is incorporated herein by reference in its entirety.FIELD OF THE DISCLOSURE[0002]The disclosure relates to formulations that can provide nutritional support to a subject, for example, as a dietary supplement or as a primary source of nutrition. In some applications, the formulation may be used in an exempt infant formula, infant formula, or medical food.BACKGROUND[0003]While it is generally recommended that infants are fed breast milk, in many cases breast feeding is not feasible or adequate, or the parent(s) choose not to breast feed. To this end, infant formulas have been developed with the primary objective of providing the nutrition that infants would otherwise receive from breast milk.[0004]However, many infant formul...

AI Technical Summary

Benefits of technology

[0154]In embodiments of the invention, the formulation may be administered to infants who were born prematurely. The formulation may be administered until a time that matches full-term gestation. Or, the formulation may be delivered to an infant until at least about three months corrected age, about six months corrected age, about nine months corrected age, about one year corrected age, about 15 months corrected age, about 18 months corrected age, about 21 months corrected age, about two years corrected age, or iterations therebetween. In some embodiments, the formulation may be delivered to a subject as long as is necessary to correct nutritional deficiencies.

Problems solved by technology

While it is generally recommended that infants are fed breast milk, in many cases breast feeding is not feasible or adequate, or the parent(s) choose not to breast feed.

However, many infant formulas on the market are not formulated to provide the full nutritional and health benefits seen with breast milk, which is primarily due to the proteins included in these formulas.

These proteins are often absent or in insufficient quantities in current infant formulas.

Moreover, cow-based infant formulas are often missing proteases that help break down proteins and aid in digestion, which can make infant formulas difficult to digest and tolerate.

But these formulas are made up of nearly all protein hydrolysates, and may neglect important bioactive peptides that are a bi-product of digestion of intact protein.

These 100% hydrolyzed formulas also lack important intact bioactive proteins present in both bovine milk and human milk, such as lactoferrin and osteopontin, which have important immunity-protective properties.

On the other hand, the few infant formulas that incorporate any bioactive protein supporting immunity are typically made up of only intact proteins and are not specifically formulated for easy digestion such as by including partially hydrolyzed proteins.