Nutritional compositions containing synergistic combination and uses thereof
Inventors
Berg, Brian • Jouni, Zeina • Wittke, Anja • Waworuntu, Rosaline • Chichlowski, Maciej
Assignees
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Publication Number
US-9609888-B2
Publication Date
2017-04-04
Expiration Date
Abstract
A composition and method for enhancing brain development in a pediatric subject, the method including administering to the pediatric subject a nutritional composition having up to about 7 g/100 kcal of a fat or lipid source, wherein the fat or lipid source includes at least about 0.5 mg/100 kcal of milk or non-milk polar lipids; up to about 5 g/100 kcal of a protein source; at least about 15 mg/100 kcal of lactoferrin from a non-human source; about 0.015 g/100 kcal to about 0.15 g/100 kcal of a prebiotic composition including polydextrose and/or galactooligosaccharide; and at least about 5 mg/100 kcal of a source of long chain polyunsaturated fatty acids.
Core Innovation
The disclosure describes milk-based pediatric nutritional compositions and related administration methods for enhancing brain development in a pediatric subject. The compositions include a fat or lipid source comprising polar lipids that include gangliosides and phospholipids, with gangliosides present at a level of about 0.5 mg/100 kcal to about 18 mg/100 kcal and phospholipids present at a level of about 20 mg/100 kcal to about 250 mg/100 kcal. The compositions further include a protein source, a preservative, and a prebiotic composition.
The nutritional composition includes at least about 15 mg/100 kcal of lactoferrin from a non-human source and a prebiotic composition in which at least 20% of the prebiotic composition comprises polydextrose, galactooligosaccharide or a combination thereof. The compositions additionally include at least about 5 mg/100 kcal of a source of long chain polyunsaturated fatty acids comprising docosahexaenoic acid. The disclosure provides quantitative ranges and formulation examples consistent with these components.
The disclosure presents biological rationale and experimental results in animal models linking the combination of components to gut microbiota and brain-related endpoints. The results described include changes in gut microbiota, attenuation of visceral pain hypersensitivity, and modulation of brain neurotransmitters and amino acids. Behavioral testing described in the disclosure includes assessments such as social interaction, episodic-like memory, and anxiety-like behavior, together with reported lactoferrin dose-related learning improvements under aversive conditions.
The method and composition claims are directed to achieving enhanced brain development by administering or providing the specified nutritional composition to a pediatric subject. Dependent refinements further narrow aspects such as the quantitative ranges for prebiotic composition amount, lactoferrin concentration ranges, specified polar-lipid sub-ranges, the type of lactoferrin, and the nutritional composition type such as an infant formula or a growing up milk.
Claims Coverage
The independent claims are directed to two categories: a method of enhancing brain development in a pediatric subject and a nutritional composition for enhancing brain development in a pediatric subject. Across the independent claims, the coverage centers on five inventive components: specified polar lipids, non-human lactoferrin, a prebiotic composition enriched in polydextrose and/or galactooligosaccharide, a DHA-containing long-chain polyunsaturated fatty acid source, and a nutritional composition including a fat/lipid source, a protein source, and a preservative.
Polar lipids comprising gangliosides and phospholipids in specified levels
The method comprises administering a nutritional composition with a fat or lipid source comprising at least about 0.5 mg/100 kcal polar lipids, wherein the polar lipids comprise gangliosides and phospholipids, with gangliosides present at about 0.5 mg/100 kcal to about 18 mg/100 kcal and phospholipids present at about 20 mg/100 kcal to about 250 mg/100 kcal.
Non-human lactoferrin at a minimum level
The method comprises administering a nutritional composition including at least about 15 mg/100 kcal of lactoferrin from a non-human source.
Prebiotic composition enriched in polydextrose and/or galactooligosaccharide
The method comprises administering a nutritional composition including a prebiotic composition wherein at least 20% of the prebiotic composition comprises polydextrose, galactooligosaccharide or a combination thereof.
Long-chain polyunsaturated fatty acid source comprising docosahexaenoic acid
The method comprises administering a nutritional composition including at least about 5 mg/100 kcal of a source of long chain polyunsaturated fatty acids comprising docosahexaenoic acid.
Complete pediatric nutritional composition including protein and a preservative
The method comprises administering a nutritional composition comprising up to about 7 g/100 kcal of a fat or lipid source, up to about 5 g/100 kcal of a protein source, the specified lactoferrin, the specified prebiotic composition, the specified DHA-containing long-chain polyunsaturated fatty acid source, and a preservative.
The independent claims broadly cover administering or providing a pediatric nutritional composition that combines specified polar lipids, non-human lactoferrin, a prebiotic fraction enriched for polydextrose and/or galactooligosaccharide, and a DHA-containing long-chain polyunsaturated fatty acid source, together within a defined nutritional matrix that includes a protein source and a preservative.
Stated Advantages
Enhancing brain development in a pediatric subject.
Reported improvements and modulation of brain-related endpoints in animal model testing, including attenuation of visceral pain hypersensitivity and modulation of brain neurotransmitters and amino acids.
Behavioral improvements described in the disclosure, including social interaction, episodic-like memory, and reduced anxiety-like behavior.
Lactoferrin dose-related improvements in learning under aversive conditions.
Documented Applications
Administering or providing the nutritional composition to a pediatric subject to enhance brain development.
Animal model use in which gut microbiota are assessed and brain-related and behavioral outcomes are measured following administration of the described composition [procedural detail omitted for safety].
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