FOOD SUPPLEMENT, FOR AS ADJUVANT, FOR PREVENTING VASCULAR DEMENTIA

Abstract

Association comprising: dry extract of Bacopa monnieri, Astaxanthin, Vitamin E, L-theanine and dry extract of Centella asiatica for use as an adjuvant in the prevention of vascular dementia, as it is able to reduce the main modifiable risk factors of cognitive vascular impairment (VCI).

Claims

1-6. (canceled)

7. A method for the prevention of vascular dementia comprising orally administering, as an adjuvant, to a subject in need thereof an association consisting of a dry extract of Bacopa monnieri, astaxanthin, vitamin E, L-theanine and a dry extract of Centella asiatica and optionally at least one of the following active ingredients selected from the group consisting of palmitoylethalonamide (PEA), eleutherococcus and Theobroma cacao, wherein said association is in the form of an oral formulation containing said association as the only active ingredient in combination with suitable excipients and/or diluents, and in said oral formulation: Bacopa monnieri is contained in an amount between 70 to 200 mg with a minimum titre in bacosides of 10%; astaxanthin is contained in said association with a minimum content of 1 mg; vitamin E is contained in said association in a maximum amount of 60 mg; L-theanine is contained in the said combination in amounts ranging from 150 to 300 mg; Centella asiatica is present in amounts of 75 to 250 mg with a minimum titre in tot terpen (as asiaticoside) of 10%.

8. A method for reducing the main modifiable risk factors of vascular cognitive impairment (VCI) comprising orally administering, as an adjuvant, an association consisting of Bacopa Monnieri, astaxanthin, vitamin E, L-theanine and Centella asiatica and optionally at least one of the following active ingredients selected from the group consisting of palmitoylethalonamide (PEA), eleutherococcus and Theobroma cacao wherein said association is in the form of an oral formulation, said oral formulation containing said association as the only active ingredient in combination with suitable excipients and/or diluents, and in said oral formulation: Bacopa monnieri is contained in an amount between 70 to 200 mg with a minimum titre in bacosides of 10%; astaxanthin is contained in said association in a minimum content of 1 mg; vitamin E is contained in said association in a maximum amount of 60 mg; L-theanine is contained in the said association in amounts ranging from 150 to 300 mg; Centella asiatica is present in amounts of 75 to 250 mg with a minimum titre in tot terpen (as asiaticoside) of 10%.

9. The method according to claim 8, wherein said main risk factors are neuro-inflammation due to oxidative stress, alteration of oxygen supply and neuronal trophic alteration or alteration of neurotransmission mediated by acetylcholine.

10. The method according to claim 7, wherein said association consists of dry extract of Bacopa Monnieri, astaxanthin, vitamin E, L-theanine and dry extract of Centella asiatica.

11. The method according to claim 7, wherein said oral formulation is a food supplement.

12. The method according to claim 7, wherein said oral formulation, is administered once or twice a day.

13. The method according to claim 7, wherein said oral formulation is a tablet.

14. The method according to claim 7, wherein said Bacopa monnieri is contained in an amount of 100 mg.

15. The method according to claim 7, wherein in said Bacopa monnieri the minimum titre in bacoside is 20%.

16. The method according to claim 7, wherein said astaxanthin is contained in said association with a minimum content of 2 mg.

17. The method according to claim 7, wherein said vitamin E is vitamin acetate.

18. The method according to claim 7, wherein said vitamin E is contained in said association in a maximum amount of 30 mg.

19. The method according to claim 7, wherein said theanine is contained in said combination in amounts of 200 mg.

20. The method according to claim 7, wherein said Centella asiatica is present in amount of 150 mg.

21. The method according to claim 8, wherein said oral formulation is a tablet.

22. The method according to claim 8, wherein said Bacopa monnieri is contained in an amount of 100 mg.

23. The method according to claim 8, wherein in said Bacopa monnieri the minimum titre in bacoside is 20%.

24. The method according to claim 8, wherein said astaxanthin is contained in said association with a minimum content of 2 mg.

25. The method according to claim 8, wherein said vitamin E is vitamin acetate.

26. The method according to claim 8, wherein said vitamin E is contained in said association in a maximum amount of 30 mg.

27. The method according to claim 8, wherein said theanine is contained in said combination in amounts of 200 mg.

28. The method according to claim 8, wherein said Centella asiatica is present in amount of 150 mg.

Description

DESCRIPTION OF THE FIGURES

[0039] FIG. 1 shows the results at time T0, i.e., at the beginning of the study and at time T1 after 3 months, of the MoCa test (Montreal Cognitive Assessment Test) conducted on a total of 35 patients with mild VCI of which: 20 represent the control group, while the remaining 15 represent the treated group to which the supplement has been administered once a day as a tablet, whose composition is given in example 1.

[0040] FIG. 2 shows the results of the Geriatric Depression Scale (GDS) test at time T0 at the beginning of the study and time T1 after 3 months in 14 patients who received the supplement as a tablet once daily, whose composition is shown in the example.

[0041] FIG. 3 shows the results at time T0 at the beginning of the study and time T1 after 3 months of the Trail Making A (TMTA) test conducted on 9 patients who received the supplement as a tablet once daily, whose composition is shown in the example.

DETAILED DESCRIPTION OF THE INVENTION

[0042] For the purposes of the present invention the definition “comprising” does not exclude the possibility that after such definition there are additional components in addition to those expressly listed after such definition; on the contrary the definition “consisting of” excludes the possibility that there are additional components in addition to those expressly listed after such definition.

[0043] According to a preferred solution of the association for use object of the present invention, the association consists of the aforementioned 4 active substances Bacopa monnieri, Astaxanthin, Vitamin E, L-theanine and dry extract of Centella asiatica.

[0044] According to another particularly preferred solution, in addition to the aforementioned active ingredients, the association for use according to the present invention consists not only of the aforementioned four active ingredients but also optionally at least one of the following active ingredients selected from Palmitoylethanolamide (PEA), Eleuterococcus, Theobroma cacao.

[0045] The association is administered for use according to the present invention in the form of an oral formulation, which contains it as the only active ingredient in combination with suitable excipients and/or diluents.

[0046] More preferably said oral formulation is a food supplement.

[0047] Still more preferably said oral formulation or food supplement is in tablet form.

[0048] The oral formulation, preferably in tablet form, for use according to the present invention contains as the only active ingredient the aforesaid association in which: [0049] the dry extract of Bacopa monnieri is contained in an amount between 70 to 200 mg, more preferably 100 mg with a minimum titre in bacosides of 10%, preferably 20%; [0050] astaxanthin is contained in said association with a minimum content of 1 mg, preferably 5 mg; [0051] vitamin E, preferably as vitamin E acetate, is contained in said association in a maximum amount of 60 mg, preferably 30 mg; [0052] L-theanine is contained in said association in amounts ranging from 150 to 300 mg, more preferably 200 mg [0053] Dry extract of Centella asiatica in amounts of 75 to 250 mg, more preferably 150 mg with a minimum titre in tot terpen (as asiaticoside) of 10%.

[0054] The astaxanthin is preferably contained in a dry extract of Haematococcus pluvialis Flotow algae with a minimum astaxanthin titre of 2%, more preferably 5%.

[0055] Preferably the tablet containing as the only active ingredient the association for use according to the present invention is administered 1 or 2 times daily.

[0056] The composition of the food supplement in the form of a tablet containing as the only active ingredient the association for use according to the present invention is shown below in example 1 for illustrative purposes, and example 2 shows a clinical study demonstrating the efficacy of the tablet, whose composition is reported in example 1, against VCI and thus in the prevention of vascular dementia.

Example 1—Food Supplement Formula in the Form of a Coated Tablet

[0057]

TABLE-US-00001 For a 1.1 g tablet ACTIVE INGREDIENTS L-Theanine 98% 200 mg Centella (Centella asiatica (l.) urb., leaves) dry 150 mg extract Vitamin E acetate 30 mg Bacopa (Bacopa monnieri (1.) pennel, leaves) dry extract 100 mg 20% Haematococcus pluvialis Flotow - Astaxanthin powder 5% 2 mg astaxanthin EXCIPIENTS Cellulose - E 460 (i) 250 mg Calcium phosphates - E 341 (ii) 220 mg Cross-linked sodium carboxymethylcellulose - E 468 30 mg Silicon dioxide - E 551 20 mg Fatty acid magnesium salts - E 470b 20 mg Sepifilm White LP 770 White 17.6 mg Glycerol - E 422 3.5 mg Iron oxides and hydroxides - E172 1.9 mg

Example 2—Clinical Study

[0058] The purpose of the present study is to verify whether the supplement object of the present invention, administered in the form of swallowable tablets once a day, can promote cognitive functions and memory in subjects with vascular cognitive impairment (VCI), preventing the aggravation of neuronal damage.

[0059] No. Patients Tested and Inclusion/Exclusion Criteria.

[0060] Data from 35 patients with VCI, which can be hypothesized on the basis of co-morbidity with vascular disorders (small vessel disease, arterial hypertension, atherosclerosis, micro stroke or mild stroke, etc.) and/or metabolic diseases, are analysed, together with a raw MoCA test score between 15 and 24 (+1 point on schooling <13 years) and interview with the caregiver attesting to changes in cognitive function and memory. The patients are of both sexes and over the age of 60.

[0061] Of the 35 patients, 15 belong to the group which took the supplement object of the invention, 20 patients belong to a control group which did not take the supplement.

[0062] All the patients with previous hospitalizations for stroke and haemorrhagic stroke, patients with other primary neurological disorders such as multiple sclerosis, Parkinson's disease, encephalitis and Alzheimer's disease sufficient to explain cognitive impairment, patients with sufficiently severe conditions such as brain tumours and major depression, patients with an active diagnosis of drug or alcohol abuse/dependence, patients with kidney disease, patients already treated with medications to manage cognitive impairment and dementias, patients treated with benzodiazepines and neuroleptic drugs, patients with known or suspected intolerance to at least one of the components of the product were excluded from the trial.

[0063] Dosage: 1 tablet/day (on a full stomach).

[0064] Data over 3 consecutive months of observation [0065] T0.fwdarw.baseline [0066] T1.fwdarw.after three months of observation

[0067] The efficacy of the supplement object of the present invention was evaluated through the analysis of the MOCA questionnaire of the treated group versus the untreated control group: [0068] Montreal Cognitive Assessment scale (MoCA): It is a fairly quick tool, used as screening for mild cognitive impairment, often on a vascular basis. It allows to verify different functional areas: attention, concentration, executive functions, memory, language, visual-constructive skills, abstraction, calculation, orientation. Score range: 0-30 points (zero worst case, 30 no cognitive impairment (CI)) [0069] GDS test (Geriatric depression scale): questionnaires which measure depressed mood in geriatric subjects. It has a score ranging from a minimum of “zero” (absent disorder) to a maximum of “thirty” (worst disorder). The severity of depression is therefore represented as follows: 0 to 10 absent, 11 to 16 mild/moderate depression, 17 or higher severe depression. [0070] Trail Making A (TMT-A) test evaluates the capacity for spatial planning in a visual-motor type task. The subject must sequentially join the numbers 1 through 25 with a pencil. The task must be completed as quickly as possible. Errors must be corrected immediately by the examiner.

[0071] Results

[0072] The results obtained for the three tests are shown in FIGS. 1,2 and 3, respectively.

[0073] FIG. 1 (MoCA test) shows the score rise from 19 to 21 in the first trimester in the group treated with the supplement object of the invention. These data suggest an impacting action of the supplement of the present invention in the quarter; on the contrary, there is a slight deterioration in the control group.

[0074] FIG. 2: The GDS test conducted on 14 patients shows that the mood disorder has changed from mild/moderate (12) to absent (10).

[0075] FIG. 3: The TMT-A test conducted on 9 patients shows that the mean execution time of 81 sec at T0 is reduced to approximately 70 sec. Again, the supplement object of the present invention acts positively in the quarter.

CONCLUSIONS

[0076] Specifically, it improves the response to tests on the status of global memory investigated through MoCA tests (attention concentration, executive functions, memory, language, visual-constructive skills, abstraction, calculation, orientation), it also improves the capacity of spatial planning in a visual-motor type task (TMT-A). Subjects have a higher perception of psychic/humoral well-being (GDS).

BIBLIOGRAFIA

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