IP Library Granted Patent US 11,986,003
Granted Patent B2
US 11,986,003 · App. 17/678,672 · Granted May 21, 2024

Nutritional composition and infant formula for promoting de novo myelination

Inventors: Nora Schneider (Epalinges, CH); Jonas Hauser (Lausanne, CH); Sean Deoni (Providence, RI); Tamas Bartfai (Stockholm, SE); Jonathan O'Regan (County Kerry, IE)
Assignee: Societe des Produits Nestle S.A.
A23L33/40A23L33/12A23L33/15A23L33/16A23L33/30A24B15/38A61K9/0095A61K31/14A61K31/202A61K31/519A61K31/661A61K31/70A61K31/714A61K33/00A61K33/06A61K33/26A61K33/30A61K33/42A61K45/06A61P25/28A23V2002/00A23V2200/322A23V2250/1564A23V2250/1578A23V2250/1588A23V2250/1592A23V2250/161A23V2250/1618A23V2250/1642A23V2250/1846A23V2250/185A23V2250/1852A23V2250/1862A23V2250/1886A23V2250/5424A23V2250/7056A23V2250/706
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Quick Facts
Patent No.
US 11,986,003
App. No.
17/678,672
Granted
May 21, 2024
Kind
B2
Abstract

A synthetic nutritional composition comprising a phospholipid and/or a metabolic precursor and/or metabolite thereof for use to promote, support or optimise de novo myelination, in particular the de novo myelination trajectory, and/or brain structure, and/or brain connectivity, and/or intellectual potential and/or cognitive potential, and/or learning potential and/or cognitive functioning in a subject, in particular a formula fed subject.

Claims (21)

1. A method to promote, support or optimise de novo myelination, and/or brain structure, and/or brain connectivity, and/or intellectual potential, and/or cognitive potential, and/or learning potential and cognitive function in a formula fed subject, wherein the brain structure refers to an amount and/or a spatial distribution of myelinated matter throughout the brain of the formula fed subject and/or in specific brain regions of the formula fed subject, and wherein the cognitive function is optimised if scores of the formula fed subject in a standardized neurodevelopmental test are less than one standard deviation different from that of an exclusively breastfed subject of a well-nourished mother, the method comprising administering a synthetic nutritional composition comprising a phospholipid and/or a metabolic precursor and/or metabolite thereof to the formula fed subject.

2. The method according to claim 1 wherein the formula fed subject is a human infant or child.

3. The method according to claim 1 wherein the phospholipid is a compound of formula (I) or a mixture of compounds of formula (I)

wherein,

R 1 is O;

X is NH or O;

R 2 is a C 2 -C 44 saturated or unsaturated, linear or branched acyl group;

R 3 is a substituent of formula (II) or formula (III):

Wherein, R 5 is a C 2 -C 44 saturated or unsaturated, linear or branched acyl group and

R 6 is a C 2 -C 44 saturated alkyl or alkenyl group; and

R 4 is selected from; a C 5 or C 6 substituted or unsubstituted cyclic alkyl or alkenyl group, or,

—(CH 2 ) n —R 7 , wherein n is an integer ranging from 1 to 4, in particular 1 to 2 and R 7 is —N(CH3)3+, NH3+, or a substituent of formula (IV) and,

4. The method according to claim 3 wherein the phospholipid is selected from the group consisting of phosphatidylcholine, phosphatidylinositole, phosphatidylserine, phosphatidylethanolamine, and sphingomyelin, and any mixture of any of the foregoing.

5. The method according to claim 4 wherein, the composition comprises sphingomyelin in an amount greater than 300 mg/kg dry weight of the composition.

6. The method according to claim 1 wherein the composition further comprises an ingredient selected from the group consisting of a vitamin, a mineral, choline, and a fatty acid derivative wherein, the fatty acid derivative is a compound comprising a fatty acid other than a phospholipid.

7. The method according to claim 6 wherein the vitamin is selected from the group consisting of vitamin B12, folic acid, and combinations thereof; the mineral is selected from the group consisting of iron, zinc, calcium, phosphorus, copper and combinations thereof; and wherein the fatty acid derivative comprises a fatty acid selected from the group consisting of docosahexaenoic acid, arachidonic acid, stearic acid, nervonic acid, and combinations thereof.

8. The method according to claim 6 wherein if iron is present in the composition it is in an amount greater than 5 mg/100 g dry weight of the composition, wherein, if a fatty acid derivative comprising DHA is present in the composition it is in the composition in a an amount of 60 to 350 mg/100 g dry weight of the composition, and wherein if a fatty acid derivative is arachidonic acid in the composition it is in an amount of 60 to 350 mg/100 g dry weight of the composition, wherein if folic acid is in the composition it is present in amount of at least 100 mcg/kg, wherein if vitamin B12 is present in the composition it is present in amount of at least 5 mcg/100 g, wherein all weights are by dry weight of the composition.

9. The method according to claim 1 wherein the composition is in a form selected from the group consisting of an infant formula, a growing up milk, a composition for infants that is intended to be added or diluted with human breast milk, and a food stuff intended for consumption by an infant and/or child either alone or in combination with human breast milk.

10. The method according to claim 1 wherein the phospholipid is administered to a subject separately, sequentially and/or simultaneously with an ingredient selected from the group consisting of: folic acid, vitamin B12, iron, and a fatty acid derivative, other than a phospholipid.

11. A synthetic nutritional composition comprising a phospholipid metabolic precursor or metabolite thereof, and choline and/or a vitamin, and/or a mineral, and/or a fatty acid derivative, other than a phospholipid, comprising docosahexaenoic acid and/or arachidonic acid and/or nervonic acid and/or stearic acid wherein, if sphingomyelin is present in the composition it is present in an amount of at least 300 mg/kg, wherein if folic acid is present in the composition it is present in amount of at least 100 mcg/kg, wherein if vitamin B12 is present in the composition it is present in amount of at least 5 mcg/100 g, wherein if iron is present in the composition it is present in an amount of at least 5 mg/100 g, wherein, if the composition comprises a fatty acid derivative comprising docosahexaenoic acid it is present in the composition in an amount of 60 to 350 mg/100 g, wherein if a fatty acid derivative comprising arachidonic acid is present in the composition it is in an amount of 60 to 350 mg/100 g, wherein all weights are by dry weight of the composition and wherein, the composition is a composition selected from the group consisting of an infant formula, a growing up milk, a composition for infants that is intended to be added or diluted with human breast milk, and a food stuff intended for consumption by an infant and/or child either alone or in combination with human breast milk.

12. A synthetic nutritional composition as defined in claim 11 wherein the composition comprises a fatty acid derivative comprising DHA in a concentration of 1023 mg/kg, a fatty acid derivative comprising ARA in a concentration of 1023 mg/kg, vitamin B12 in a concentration of 54 mcg/kg, folic acid in a concentration of 1698 mcg/kg, sphingomyelin in a concentration of 814 mg/kg and iron in a concentration of 67 mg/kg.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 25, 2024
From: SCHNEIDER, NORA; HAUSER, JONAS; DEONI, SEAN; BARTFAI, TAMAS; O'REGAN, JONATHAN
To: NESTEC S.A.
Reel/Frame 066241/0476 →
MERGER Recorded Jan 25, 2024
From: NESTEC S.A.
To: SOCIETE DES PRODUITS NESTLE S.A.
Reel/Frame 066241/0492 →
Priority Claims (5)
EP 15199752 · Dec 14, 2015 · regional
EP 15199757 · Dec 14, 2015 · regional
EP 15199758 · Dec 14, 2015 · regional
EP 15199764 · Dec 14, 2015 · regional
EP 15199769 · Dec 14, 2015 · regional
Continuity (8)
Continuation 16061121
Provisional Application 62328052 · Apr 27, 2016
Provisional Application 62315198 · Mar 30, 2016
Provisional Application 62315224 · Mar 30, 2016
Provisional Application 62315249 · Mar 30, 2016
Provisional Application 62315238 · Mar 30, 2016
Provisional Application 62315187 · Mar 30, 2016
Related Publication 20220175009A1 · Jun 9, 2022