NUTRACEUTICAL COMPOSITIONS FOR DYSMETABOLIC DISEASES

Abstract

The present invention relates to a composition comprising: extract of flowers, leaves, roots and/or seeds of Nelumbo nucifera; Saccharomyces, preferably selected from S. cerevisiae and S. boulardii; Bacillus coagulans; mineral salts; group B and C vitamins; optionally garlic, optionally taurine. The use of said composition in the prevention and/or treatment of the dysmetabolic syndrome is also claimed.

Claims

1. A composition comprising: an extract of flowers, leaves, roots and/or seeds of Nelumbo nucifera; Saccharomyces; Bacillus coagulans; one or more mineral salts; group B and C vitamins; optionally garlic; and optionally taurine.

2. The composition according to claim 1, comprising: the extract of flowers, leaves, roots and/or seeds of Nelumbo nucifera in an amount between 0.4% and 30% w/w; the Saccharomyces in an amount of between about 110.sup.8 and 110.sup.12 cells/ml of total composition; the Bacillus coagulans, in an amount of between about 110.sup.8 and 110.sup.12 cells/ml of total composition; the one or more mineral salts in an amount of between about 1% and about 50% w/w; Vitamin B6 in an amount of between about 0.1% and about 3% w/w; Vitamin B9 in an amount of between about 510.sup.4% and 1010.sup.3%w/w; Vitamin B12 in an amount of between about 210.sup.2% and 0.4% w/w; Vitamin C in an amount of between about 0.2% and 13% w/w; the garlic in an amount of between about 0% and 90% w/w; and the taurine in an amount of between about 0% and 90% w/w.

3. The composition according to claim 1 comprising: the extract of flowers, leaves, roots and/or seeds of Nelumbo nucifera in an amount between 10 and 20% w/w; the Saccharomyces, in an amount of between about 110.sup.9 and 110.sup.11 cells/ml of total composition; the Bacillus coagulans, in an amount of between about 110.sup.8 and 110.sup.10 cells/ml of total composition; magnesium in an amount of between about 10% and about 30% w/w; Vitamin B6 in an amount of between about 0.8% and about 2% w/w; Vitamin B9 in an amount of about 0.001% w/w; Vitamin B12 in an amount of between about 0.01% and 0.4% w/w; Vitamin C in an amount of between about 1% and 9% w/w; garlic in an amount of between about 0% and 40% w/w; and taurine in an amount of between about 0% and 40% w/w.

4. The composition according to claim 1, comprising: 1 to 4 mg of lotus flower extract, 110.sup.9 to 910.sup.9 cells of the Saccharomyces cerevisiae, 110.sup.8 to 910.sup.8 cells of the Bacillus coagulans, 80 to 200 mg magnesium, 0.05 to 0.30 mg Vitamin B6, about 0.0001 mg Vitamin B9, 0.005 to 0.05 mg Vitamin B12, 0.1 to 1 mg Vitamin C, and excipients, based on 1 g of the composition.

5. A method of treating a dysmetabolic disease, the method comprising administering the composition of claim 1 to a subject in need thereof.

6. A method of maintaining the tegumentary apparatus and skin structures, body hair, nails and hair, the method comprising administering the composition of claim 1 to a subject in need thereof.

7. A method for treating seborrhea, acne, and/or psoriasis, the method comprising administering the composition of claim 1 to a subject in need thereof.

8. A pharmaceutical formulation comprising the composition according to claim 1.

9. The pharmaceutical formulation according to claim 8, in the form of gel, cream or ointment.

10. The pharmaceutical formulation according to claim 8, further comprising one or more excipients for oral administration.

11. A method of treating a dysmetabolic syndrome, the method comprising administering the pharmaceutical formulation of claim 8 to a subject in need thereof 1 to 10 times daily.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0018] The invention relates to a composition capable of preventing and treating the dysmetabolic syndrome, i.e. of intervening in hyperglycemia, hypertension, hypercholesterolemia, triglyceridemia and excess body weight.

[0019] The composition comprises:

extract of flowers, leaves, roots and/or seeds of lotus, Nelumbo nucifera;
mineral salts, preferably magnesium;
probiotics selected from the group comprising: Saccharomyces, Bacillus coagulans;
group B and/or C vitamins.

[0020] In a further embodiment, said composition also comprises garlic.

[0021] In a further embodiment, said composition also comprises taurine.

[0022] The composition according to the present invention has surprisingly proved capable of promoting assimilation of the vitamins and minerals taken through food and contained in the composition of the present invention.

[0023] The probiotic Saccharomyces has been selected herein as it is a rich and complete source of B vitamins, selenium, chromium, glutathione, sulfur, essential amino acids, phosphorus, potassium and magnesium. It also contains vanadium, chrome, molybdenum and nickel. The cellular membrane of Saccharomyces is very rich in -glucans and in particular of -(1, 3) or (1, 4) glucans.

[0024] Bacillus coagulans is extremely resistant, where it resists to the external environment, to the gastric acid pH and to the basic intestinal pH and survives many handling processes, such as food cooking, due to its ability to form endospores. This probiotic has a high capacity to adhere to the gastro-intestinal mucosa. Its presence ensures greater production of lactic acid necessary to maintain the balance of the gastrointestinal bacterial flora, in addition to metabolizing glucose.

[0025] In one embodiment, said composition comprises: [0026] extract of flowers, leaves, roots and/or seeds of Nelumbo nucifera between 0.4% and 30% w/w; [0027] Saccharomyces, preferably selected from S. cerevisiae and S. boulardii, in amounts of about 110.sup.8 to 110.sup.12 cells/ml of total composition; [0028] Bacillus coagulans, in amounts of about 110.sup.7 to 110.sup.12 cells/ml of total composition; [0029] Mineral salts in amounts of about 1% to about 50% w/w; [0030] Vitamin B6 in amounts of about 0.1% to about 3% w/w; [0031] Vitamin B9 in amounts of about 510.sup.4% to 1010.sup.3% w/w; [0032] Vitamin B12 in amounts of about 210.sup.2% to 0.4% w/w; [0033] Vitamin C in amounts of about 0.2% to 13% w/w; [0034] Garlic in amounts of about 0% to 90% w/w; [0035] Taurine in amounts of about 0% to 90% w/w.

[0036] In a preferred embodiment, said composition comprises: [0037] extract of flowers, leaves, roots and/or seeds of Nelumbo nucifera between 10 and 20% w/w; [0038] Saccharomyces, preferably selected from S. cerevisiae and S. boulardii, in amounts of about 110.sup.9 to 110.sup.11 cells/ml of total composition; [0039] Bacillus coagulans, in amounts of about 110.sup.8 to 110.sup.10 cells/ml of total composition; [0040] Magnesium in amounts of about 10% to about 30% w/w; [0041] Vitamin B6 in amounts of about 0.8% to about 2% w/w; [0042] Vitamin B9 about 0.001% w/w; [0043] Vitamin B12 in amounts of about 0.01% to 0.4% w/w; [0044] Vitamin C in amounts of about 1% to 9% w/w; [0045] Garlic in amounts of about 0% to 40% w/w; [0046] Taurine in amounts of about 0% to 40% w/w.

[0047] In a further embodiment, said composition comprises: [0048] extract of flowers, leaves, roots and/or seeds of Nelumbo nucifera between 12 and 17% w/w; [0049] Saccharomyces, preferably selected from S. cerevisiae and S. boulardii, about 110.sup.9 cells/ml of total composition; [0050] Bacillus coagulans, about 10.sup.8 cells/ml of total composition; [0051] Magnesium in amounts of about 15% to about 20% w/w; [0052] Vitamin B6 in amounts of about 1.2% to about 1.7% w/w; [0053] Vitamin B9 about 0.001% w/w; [0054] Vitamin B12 in amounts of about 0.08% to 0.2% w/w; [0055] Vitamin C in amounts of about 3% to 8% w/w; [0056] Garlic in amounts of about 0% to 40% w/w; [0057] Taurine in amounts of about 0% to 40% w/w.

[0058] In a preferred embodiment, said composition comprises, on 1 g of the total preparation: 1 to 4 mg of lotus flower extract, 1*10{circumflex over ()}.sup.9 to 9*10{circumflex over ()}.sup.9 cells of Saccharomyces cerevisiae, 1*10{circumflex over ()}.sup.8 to 9*10{circumflex over ()}.sup.8 cells of Bacillus coagulans, 80 to 200 mg Magnesium, 0.05 to 0.30 mg Vitamin B6, about 0.0001 mg Vitamin B9, 0.005 to 0.05 mg Vitamin B12, 0.1 to 1 mg Vitamin C, excipients as needed to 1 g.

[0059] A further aspect of the present invention is a formulation to be used as a food supplement which comprises the composition according to the present invention. Typically, said composition is in the form of a chewable tablet or a tablet which disintegrates in the mouth, liquid, powder, powder contained in a sachet, soft gelatin capsule, or hard gelatin capsule. In some embodiments, the polymers of the invention are provided as pharmaceutical compositions as in the form of liquid compositions. In various embodiments, the pharmaceutical composition contains a polymer dispersed in a suitable liquid excipient. Suitable liquid excipients are known in the art; see, for example, Remington's Pharmaceutical Sciences. In a preferred embodiment, the formulation is a hard capsule.

[0060] Typically, each capsule contains from 150 to 400 mg of Nelumbo nucifera, or from 200 to 350 mg, or 300 mg.

[0061] In a preferred embodiment, said pharmaceutical formulation is in capsule form. Said formulation is taken from 1 to 10 times a day, preferably from 2 to 5 times a day, even more preferably 3 times a day for use in the prevention and/or treatment of the dysmetabolic syndrome.

[0062] The present invention further relates to a method for preventing and/or treating the dysmetabolic syndrome, where said method comprises administering the composition described in the present invention. In a preferred embodiment, said administration is topical.

[0063] In a further embodiment, the composition has a topical use. It is then formulated with excipients known to those skilled in the art in the form of a gel, cream or ointment.

[0064] The formulation for topical use according to the present invention has proved to be particularly advantageous, where the composition surprisingly maximizes the bioavailability of -glucans, delivered therein by probiotics. Furthermore, the composition according to the present invention maximizes the bioavailability of active ingredients useful for maintaining the good health of skin, hair, nails and teeth.

[0065] The surprising effects of the composition according to the present invention are explained by: [0066] Availability directly in the host intestine of the active ingredients in high doses which promote the increase in growth rate, vitality and survival of probiotics. [0067] Permanence over time of the active ingredients in the host intestine, obtained due to the probiotics. [0068] Synergistic effect of the active ingredients which form the composition, where the proliferation of probiotics and the absorption of the active ingredients are promoted. [0069] Administration of the composition according to the present invention does not lead to the onset of side effects.

[0070] Surprisingly, the composition according to the present invention has proved to be useful in maintaining the integumentary apparatus and cutaneous appendages (hair, nails and hair), also showing precious dermatological actions in improving pathologies such as seborrhea and acne and the effects of psoriasis on the skin.

EXAMPLES

[0071] Example 1: preparation and characterization of lotus leaf extract Lotus leaves are extracted by methods known in the art, for example with a mixture of methyl alcohol and 1% hydrochloric acid (50:50, v/v) by sonication for 15 minutes. After centrifugation, the supernatant is filtered and subjected to liquid chromatography. The sample comprises: [0072] N-nornuciferine: from 0.820.02 mg/g to 1.430.01 mg/g [0073] O-nornuciferine: from 2.350.01 mg/g to 4.470.01 mg/g [0074] Nuciferine: from 4.830.03 mg/g to 7.610.04 mg/g [0075] Remerine: from 0.310.01 mg/g to 0.620.01 mg/g

[0076] Example 2: preparation of a composition according to the present invention.

1.5 mg of lotus flower extract, obtained as per example 1, are mixed with about 2*10{circumflex over ()}.sup.9 cells of Saccharomyces cerevisiae, about 10{circumflex over ()}.sup.8 cells of Bacillus coagulans, 120 mg Magnesium, 0.15 mg Vitamin B6, 0.0001 mg Vitamin B9, 0.01 mg Vitamin B12, 0.5 mg Vitamin C. The composition is increased to 1 g with excipients known in the art.

[0077] Example 3: use of the composition according to the present invention

[0078] The formulation according to example 2 is administered 3 times a day to 50 patients with MS for a prolonged period of 3 months. Symptom remission was observed in 75% of subjects treated.