Compositions for enhancing immune function in a pediatric subject

Inventors

Wittke, Anja • Lipmann, Hugh

Assignees

Mead Johnson Nutrition Co

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Publication Number

US-11013759-B2

Patent

Publication Date

2021-05-25

Expiration Date


Abstract

Compositions for and methods of increasing the number of neutrophils in a pediatric subject and stimulating the immune system of a pediatric subject.

Core Innovation

The invention relates to a powder composition for enhancing immune function in a pediatric subject. The composition comprises a milk-based matrix comprising casein, whey protein, lactose, or any combination thereof, and includes an insoluble microparticulate β-1,3;1,6-glucan in an amount between about 0.010 and about 0.050 g per 100 g of the composition. The composition is formulated with defined proportions of a fat source, a carbohydrate source, and a protein source in the stated g/100 Kcal ranges.

The invention further provides compositions and administration where the insoluble microparticulate β-1,3;1,6-glucan is delivered in the milk-based matrix to stimulate the immune system of the pediatric subject. The disclosed formulations include optional functional ingredients and defined prebiotic compositions, including galacto-oligosaccharide and polydextrose, with a total amount range stated for the prebiotic. Additional nutritional components can be included, including long chain polyunsaturated fatty acids comprising docosahexaenoic acid and arachidonic acid in a defined weight ratio.

The disclosed implementation is supported by reported in vivo murine study outcomes in the patent content, which describe oral β-glucan combined with a milk-based formula matrix increasing peripheral neutrophil counts, increasing neutrophil respiratory burst, and elevating IL-6 levels, with a stated synergy between these immune response measures. A mechanistic rationale is discussed via uptake in Peyer’s patches and neutrophil priming, and delivery forms include nutritionally complete infant formula and children’s nutritional products with the described milk matrix and insoluble microparticulate β-glucan.

Claims Coverage

The independent claims present three core inventive approaches. Across the independent claims, the inventive features revolve around a powdered milk-based nutritional composition using a defined amount of insoluble microparticulate β-1,3;1,6-glucan in a casein/whey protein/lactose matrix, and methods that administer this composition to stimulate immune function, including increasing neutrophils.

Powdered milk-based β-glucan composition for pediatric immune enhancement

A composition for enhancing immune function in a pediatric subject in powder form comprising a milk-based matrix comprising casein, whey protein, lactose, or any combination thereof; defined g/100 Kcal ranges of fat, carbohydrate, and protein sources; and insoluble microparticulate β-1,3;1,6-glucan present in an amount between about 0.010 and about 0.050 g per 100 g of the composition.

Administration of powdered milk-based insoluble microparticulate β-1,3;1,6-glucan to stimulate pediatric immune system

A method for stimulating the immune system of a pediatric subject comprising administering to the pediatric subject a powdered milk-based nutritional composition comprising β-glucan in a milk-based matrix comprising casein, whey protein, lactose, or any combination thereof, wherein the β-glucan is insoluble microparticulate β-1,3;1,6-glucan present in an amount between about 0.010 and about 0.050 g per 100 g of the composition, and wherein administration stimulates the immune system of the pediatric subject.

Increasing neutrophils by administering powdered milk-based insoluble microparticulate β-1,3;1,6-glucan

A method for increasing the number of neutrophils in a pediatric subject comprising administering to the pediatric subject a powdered milk-based nutritional composition comprising β-glucan in a milk-based matrix comprising casein, whey protein, lactose, or any combination thereof, wherein the β-glucan is insoluble microparticulate β-1,3;1,6-glucan present in an amount between about 0.010 and about 0.050 g per 100 g of the composition, and wherein administration of the nutritional composition stimulates the immune system of the pediatric subject.

Overall, the claim set centers on powdered pediatric milk-based nutritional compositions containing insoluble microparticulate β-1,3;1,6-glucan at about 0.010 to about 0.050 g per 100 g in a matrix of casein, whey protein, and/or lactose, with independent method claims directed to immune stimulation and, in one independent claim, increasing neutrophils.

Stated Advantages

Enhances immune function in a pediatric subject.

Stimulates the immune system of the pediatric subject.

Increases the number of neutrophils in the pediatric subject.

Increases peripheral neutrophil counts and neutrophil respiratory burst (synergy) and elevates IL-6 levels.

Documented Applications

Use of oral β-glucan combined with a milk-based formula matrix in a murine study context, reporting increased peripheral neutrophil counts, increased neutrophil respiratory burst, and elevated IL-6 levels.

Delivery in nutritionally complete infant formula and children’s nutritional products, using a milk-based matrix and insoluble microparticulate β-1,3;1,6-glucan.

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