COMPOSITION FOR REDUCING CARDIOVASCULAR RISK

Abstract

The present invention relates to a composition comprising an extract of a plant belonging to the genus Malus, an extract of Olea europaea and policosanols and to the use thereof in reducing plasma cholesterol levels and cardiovascular risk.

Claims

1. A composition comprising an effective amount of a mixture of: an extract of a plant belonging to the genus Malus; an extract of Olea europaea; and policosanols.

2. The composition according to claim 1, wherein said extract of a plant belonging to the genus Malus is an extract of Malus pumila var. Annurca or Malus domestica var. Annurca.

3. The composition according to claim 1, comprising, for single dose unit: from 1 mg to 5500 mg of an extract of a plant belonging to the genus Malus; from 1 mg to 8000 mg of an extract of Olea europaea; and from 0.1 mg to 1000 mg of policosanols.

4. The composition according to claim 1 comprising, for single dose unit: from 10 mg to 3000 mg of an extract of a plant belonging to the genus Malus; from 2.5 mg to 4000 mg of an extract of Olea europaea; and from 1 mg to 800 mg of policosanols.

5. The composition according to claim 1 comprising, for single dose unit: from 50 mg to 1000 mg of an extract of a plant belonging to the genus Malus; from 10 mg to 1000 mg of an extract of Olea europaea; and from 2 mg to 200 mg of policosanols.

6. The composition according to claim 1 in the form of a solid or liquid composition for oral use.

7. The composition according to claim 6, in a form selected from powder, oral soluble powder, granulate, hard capsule, soft-gel capsule, tablet, sachet, solution, suspension, syrup, gel stick or bottle.

8. A method of reducing plasma cholesterol levels and cardiovascular risk both in humans and animals, wherein said method of reducing comprises administering the composition a according to claim 1 to a subject in need thereof.

9. The method according to claim 8, wherein said method is a method for the treatment of hypercholesterolaemia in subjects resistant or intolerant to statins.

10. The method according to claim 8, wherein said method is a method for the prevention of hypercholesterolaemia in subjects with a risk factor for mild or moderate cardiovascular disorders.

11. The method according to claim 8, wherein said method is a method for the treatment of hypercholesterolaemia in subjects resistant or intolerant to statins and with a risk factor for mild or moderate cardiovascular disorders.

12. The method according to claim 8, wherein said method allows to obtain a decrease in the total cholesterol value at an amount comprised from 5% to 40%.

13. The method according to claim 8, wherein said method allows to obtain a decrease in the LDL value at an amount comprised from 10% to 40%.

14. The method according to claim 8, wherein said method allows to obtain an increase in the HDL value at an amount comprised from 15% to 40%.

15. A formulation in the form of a medical device, dietary supplement, nutraceutical, dietary or nutritional composition, food product, beverage, food, medicated food, food for special medical purposes, or pharmaceutical composition, or even in the form of a simple, complementary, complete feed, intended for particular nutritional purposes or medicated, wherein said formulation comprises a composition according to claim 1 and one or more food or pharmaceutical grade technological additives or excipients.

16. The method according to claim 12, wherein said method allows to obtain a decrease in the total cholesterol value at an amount comprised from 15% to 30%.

17. The method according to claim 13, wherein said method allows to obtain a decrease in the LDL value at an amount comprised from 20% to 30%.

18. The method according to claim 14, wherein said method allows to obtain an increase in the HDL value at an amount comprised from 25% to 30%.

Description

EXAMPLES

[0082] Some examples of daily doses of the active components of the compositions subject of the present invention are now provided for illustrative purposes. Daily doses are intended to be administered in a suitable oral dosage form and divided into one or more dose units such as, for example, a capsule, a tablet or a sachet.

Example 1

[0083]

TABLE-US-00001 Active ingredient Amount for single dose unit Annurca Apple 800 mg  Policosanols 10 mg Olea Europaea e.s. 25 mg

Example 2

[0084]

TABLE-US-00002 Active ingredient Amount for single dose unit Annurca Apple 500 mg Policosanols  30 mg Olea Europaea e.s. 100 mg

Example 3

[0085]

TABLE-US-00003 Active ingredient Amount for single dose unit Annurca Apple 400 mg  Policosanols 20 mg Olea Europaea e.s. 50 mg

Example 4

[0086]

TABLE-US-00004 Active ingredient Amount for single dose unit Annurca Apple 300 mg  Policosanols 15 mg Olea Europaea e.s. 80 mg

[0087] Preferred embodiments of the present invention (FRns) are reported below. [0088] FR1. A composition comprising or, alternatively, consisting of an extract of a plant belonging to the genus Malus, an extract of Olea europaea, and policosanols. [0089] FR2. The composition according to FR1, wherein the extract of a plant belonging to the genus Malus is an extract of Malus pumila var. Annurca or Malus domestica var. Annurca. [0090] FR3. The composition according to FR1 or FR2, comprising: [0091] from 1 mg to 5500 mg of an extract of a plant belonging to the genus Malus, preferably for single dose unit;

[0092] from 1 mg to 8000 mg of an extract of Olea europaea and from 0.1 mg to 1000 mg of policosanols, preferably for single dose unit. [0093] FR4. The composition according to any one of the preceding FRs comprising: [0094] from 10 mg to 3000 mg of an extract of a plant belonging to the genus Malus, preferably for single dose unit;

[0095] from 2.5 mg to 4000 mg of an extract of Olea europaea and from 1 mg to 800 mg of policosanols, preferably for single dose unit. [0096] FR5. The composition according to any one of the preceding FRs comprising: [0097] from 50 mg to 1000 mg of an extract of a plant belonging to the genus Malus, preferably for single dose unit; [0098] from 10 mg to 1000 mg of an extract of Olea europaea, preferably for single dose unit; and from 2 mg to 200 mg of policosanols, preferably for single dose unit. [0099] FR6. The composition according to any one of the preceding FRs in the form of a solid or liquid composition for oral use. [0100] FR7. The composition according to FR6, in a form selected from powder, oral soluble powder, granulate, hard capsule, soft-gel capsule, tablet, sachet, solution, suspension, syrup, gel stick or bottle. [0101] FR8. The composition according to any one of the preceding FRs, wherein said composition is for use in reducing plasma cholesterol levels and cardiovascular risk in both humans and animals. [0102] FR9. The composition according to FR8, wherein said composition is for use in a method for the treatment of hypercholesterolaemia in patients resistant or intolerant to statins. [0103] FR10. The composition according to FR9, wherein said composition is for use in a method for the prevention of hypercholesterolaemia in patients with a risk factor for mild or moderate cardiovascular disorders. [0104] FR11. The composition according to FR10, wherein said composition is for use in a method for the treatment of hypercholesterolaemia in patients resistant or intolerant to statins and/or in a method for the prevention of hypercholesterolaemia in patients with a risk factor for mild or moderate cardiovascular disorders. [0105] FR12. The composition according to any one of FRs 8 to 11, wherein said composition allows to obtain a decrease in the total cholesterol value, preferably at an amount comprised from 5% to 40%; more preferably comprised from 10% to 35%; even more preferably from 15% to 30%, for example about 20% or about 25%. [0106] FR13. The composition according to any one of FRs 8 to 12, wherein said composition allows to obtain a decrease in the LDL value, preferably at an amount comprised from 10% to 40%; more preferably comprised from 15% to 35%; even more preferably from 20% to 30%, for example about 25%. [0107] FR14. The composition according to any one of FRs 8 to 13, wherein said composition allows to obtain an increase in the HDL value, preferably at an amount comprised from 15% to 40%; more preferably comprised from 20% to 35%; even more preferably from 25% to 30%. [0108] FR15. A formulation in the form of a medical device, dietary supplement, nutraceutical, dietary or nutritional composition, food product, beverage, food, medicated food, food for special medical purposes, or pharmaceutical composition, or even in the form of a simple, complementary, complete feed, intended for particular nutritional purposes or medicated, wherein said formulation comprises a composition according to any one of FRs 1 to 14 and, optionally, one or more food or pharmaceutical grade technological additives or excipients.