US2013052274A1PendingUtilityA1

Nutritional compositions including exogenous vitamin k2

Assignee: BOLSTER DOUGLAS RICHARDPriority: Sep 14, 2009Filed: Sep 1, 2010Published: Feb 28, 2013
Est. expirySep 14, 2029(~3.1 yrs left)· nominal 20-yr term from priority
A61P 5/26A61P 37/08A61P 43/00A61P 29/00A61P 3/02A61P 25/00A61P 29/02A61P 13/12A61P 19/00A61P 19/08A61P 1/00A61P 21/00A61P 1/04A61K 33/00A61K 33/26A61K 45/06A61K 31/593A23L 33/135A61K 33/42C12Q 2600/106A61K 33/32A23L 33/16A23V 2002/00A61K 31/122A23L 33/40A61K 33/30A23L 33/10A61K 33/06A23L 2/52A23L 33/15A61K 33/34C12Q 1/6883A23L 33/175
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Claims

Abstract

Nutritional compositions and methods of making and using the nutritional compositions are provided. In a general embodiment, the present disclosure provides a nutritional composition including exogenous vitamin K2. The nutritional compositions may further include an additional component selected from the group consisting of phosphorus, magnesium, zinc, iron, copper, manganese, calcium, vitamin D, osteopontin and combinations thereof.

Claims

exact text as granted — not AI-modified
1 . A nutritional composition comprising:
 an effective amount of exogenous vitamin K2; and   a component selected from the group consisting of phosphorus, magnesium, zinc, iron, copper, manganese, calcium, vitamin D, osteopontin and combinations thereof.   
     
     
         2 . The nutritional composition of  claim 1 , wherein the exogenous vitamin K2 is selected from the group consisting of MK-4, MK-7 and combinations thereof. 
     
     
         3 . The nutritional composition of  claim 1 , wherein the exogenous vitamin K2 is MK-7. 
     
     
         4 . The composition of  claim 1 , wherein the effective amount of exogenous vitamin K2 is from about 1 μg to about 100  82  g. 
     
     
         5 . The composition of  claim 1 , wherein the effective amount of exogenous vitamin K2 is from about 20 μg to about 90 μg. 
     
     
         6 . The composition of  claim 1 , wherein the effective amount of exogenous vitamin K2 is from about 50 μg to about 80 μg. 
     
     
         7 . The nutritional composition of  claim 1  further comprising at least one component selected from the group consisting of prebiotic, probiotics, symbiotic, amino acid, protein, nucleotides, a fish oil, non-marine omega-3 fatty acid containing dietary fat source, phytonutrients, antioxidant, and combinations thereof. 
     
     
         8 . The nutritional composition of  claim 7 , wherein the amino acid is selected from the group consisting of proline, hydroxyproline, hydroxytyrosine, hydroxylysine and hydroxyserine and combinations thereof. 
     
     
         9 . A method of improving musculoskeletal health in pediatric patients comprising:
 administering to a child in need of same a nutritional composition comprising an effective amount of exogenous vitamin K2 and a component selected from the group consisting of phosphorus, magnesium, zinc, iron, copper, manganese, calcium, vitamin D, osteopontin and combinations thereof.   
     
     
         10 . (canceled) 
     
     
         11 . The method of  claim 9 , wherein the patient has at least one condition selected from the group consisting of developmental delay, failure-to-thrive, inflammatory bowel disease, Crohn's disease, Crohn's Disease-associated osteopenia, Colitis, ulcerative colitis, celiac disease, gluten intolerance, neuromuscular dysfunction, cystic fibrosis, renal dysfunction, androgen deficiency, severe food allergy, short bowel syndrome, and combinations thereof. 
     
     
         12 . The method of  claim 9  wherein the step of improving musculoskeletal health is improved bone health. 
     
     
         13 . The method of  claim 12  wherein the improved bone health is selected from the group consisting of normal growth, treating delayed linear growth, preventing delayed linear growth, improved bone quality, improved bone strength, improved mineralization of the bone, improved microarchitecture of the bone, improved bone density, reduction in fracture risk, improvement in bone organic matrix constituents, improved elasticity of the bone, faster healing time after fracture, better quality of innate fracture repair, and combinations thereof. 
     
     
         14 . The method of  claim 12 , wherein the patient has osteopenia. 
     
     
         15 . The method of  claim 14 , wherein the osteopenia is due to at least one condition selected from the group consisting of developmental delay, failure-to-thrive, inflammatory bowel disease, Crohn's disease, Crohn's Disease-associated osteopenia, Colitis, ulcerative colitis, celiac disease, gluten intolerance, neuromuscular dysfunction, cystic fibrosis, renal dysfunction, androgen deficiency, severe food allergy, short bowel syndrome, Of and combinations thereof. 
     
     
         16 . The method of  claim 9 , wherein the nutritional composition is in an administrable form selected from the group consisting of pharmaceutical formulations, nutritional formulations, tube-feed formulations, dietary supplements, functional foods and beverage products. 
     
     
         17 . The method of  claim 12  wherein the improved bone health is promoting bone growth in a pediatric patient having an underlying medical condition. 
     
     
         18 . The method of  claim 17 , wherein the underlying medical condition is selected from the group consisting of developmental delay, failure-to-thrive, inflammatory bowel disease, Crohns disease, ulcerative colitis, celiac disease, gluten intolerance, neuromuscular dysfunction, cystic fibrosis, renal dysfunction and androgen deficiency, severe food allergy, short bowel syndrome and combinations thereof. 
     
     
         19 . The method of  claim 9  wherein the step of improving musculoskeletal health is improved muscle health. 
     
     
         20 . The method of  claim 19 , wherein the step of improving muscle health is selected from the group consisting of: maintaining of lean body mass, increasing of lean body mass, slowing the rate of decrease of lean body mass, improved mobility, improved metabolic function of the muscle, and combinations thereof. 
     
     
         21 . A method of improving musculoskeletal in pediatric patients comprising:
 determining the patient's genetic predisposition to determine the likely efficacy of treatment with exogenous Vitamin K2; and   if determined to be efficacious, administering to a child in need of same a nutritional composition comprising an effective amount of exogenous vitamin K2 and a component selected from the group consisting of phosphorus, magnesium, zinc, iron, copper, manganese, calcium, vitamin D, osteopontin and combinations thereof.   
     
     
         22 . The method of  claim 21  wherein the genetic predisposition is determining the genotype. 
     
     
         23 . The method of  claim 21  wherein the genetic predisposition is used to determine the dosage of the exogenous Vitamin K2. 
     
     
         24 . (canceled) 
     
     
         25 . The method of  claim 21 , wherein the patient has at least one condition selected from the group consisting of developmental delay, failure-to-thrive, inflammatory bowel disease, Crohn's disease, Crohn's Disease-associated osteopenia, Colitis, ulcerative colitis, celiac disease, gluten intolerance, neuromuscular dysfunction, cystic fibrosis, renal dysfunction, androgen deficiency, severe food allergy, short bowel syndrome, and combinations thereof. 
     
     
         26 . The method of  claim 21  wherein the step of improving musculoskeletal health is improved bone health. 
     
     
         27 . The method of  claim 26  wherein the improved bone health is selected from the group consisting of normal growth, treating delayed linear growth, preventing delayed linear growth, promoting bone growth in a pediatric patient having an underlying medical condition, improved bone quality, improved bone strength, improved mineralization of the bone, improved microarchitecture of the bone, improved bone density, reduction in fracture risk, improvement in bone organic matrix constituents, improved elasticity of the bone, faster healing time after fracture, better quality of innate fracture repair, and combinations thereof. 
     
     
         28 . The method of  claim 26 , wherein the step of improved bone health is promoting bone growth in a pediatric patient having an underlying medical condition selected from the group consisting of developmental delay, failure-to-thrive, inflammatory bowel disease, Crohns disease, ulcerative colitis, celiac disease, gluten intolerance, neuromuscular dysfunction, cystic fibrosis, renal dysfunction and androgen deficiency, severe food allergy, short bowel syndrome and combinations thereof. 
     
     
         29 . The method of  claim 26 , wherein the patient has osteopenia. 
     
     
         30 . The method of  claim 30 , wherein the osteopenia is due to at least one condition selected from the group consisting of developmental delay, failure-to-thrive, inflammatory bowel disease, Crohn's disease, Crohn's Disease-associated osteopenia, Colitis, ulcerative colitis, celiac disease, gluten intolerance, neuromuscular dysfunction, cystic fibrosis, renal dysfunction, androgen deficiency, severe food allergy, short bowel syndrome, and combinations thereof. 
     
     
         31 . The method of  claim 21  wherein the step of improving musculoskeletal health is improved muscle health. 
     
     
         32 . The method of  claim 31 , wherein the step of improving muscle health is selected from the group consisting of: maintaining of lean body mass, increasing of lean body mass, slowing the rate of decrease of lean body mass, improved mobility, improved metabolic function of the muscle, and combinations thereof.

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