Patent Application
20230371563
The present invention relates to a granulated product based on an avocado fermentate particularly suitable for the production of food supplements and functional foods thanks to its high stability over time.
The avocado is the fruit of the Persea americana Mill., a tropical plant native to Mexico in Central America, and is today a food that is increasingly consumed and widespread in the human diet thanks to its high and valuable nutritional content.
Because of its unique chemical composition, which is particularly rich in mono-unsaturated fatty acids (also known as MUFA) and other nutrients such as vitamins, minerals, dietary fibre, phenolic compounds, carotene, thiamine, phytosterols and phytostanols, a diet rich in avocados is associated with hypoglycaemic, antihypertensive, antioxidant, anti-obesity, antimicrobial and liver-protective effects to the benefit of the body. According to a number of recent studies (see for example “The Fertility Diet” by Jorge E. Chavarro, M.D., Walter C. Willett, M.D. and Patrick J. Skerrett, (McGraw-Hill)), avocado is also a food that can play a protective role and stimulate female fertility.
There is therefore an objective interest in the beneficial properties associated with avocado intake and, thanks to these properties, the avocado is now not only popular as a food but also increasingly being studied as an ingredient in food supplements and functional foods.
Fermentation is also known to lead to a change in the composition of the product, often increasing the concentration of certain nutrients, resulting in fermented products characterized by higher digestibility and greater bioavailability.
Compositions containing an avocado fermentate are therefore also the subject-matter of interest and study.
CN107853522 describes for example a nutrient solution comprising from 75 to 95 parts of avocado fermentate with protective properties for the uterus.
However, it is also known that fermented products, such as for example avocado fermentates, are typically subject to significant alterations in the composition and chemical-physical properties over time, which reduce the content of their highly bioavailable nutrients, thus compromising the efficacy thereof.
In order to cope with this application and functional limitation, the industry usually resorts to the adoption of special precautions in order to slow down said alterations (e.g. to the addition of stabilising additives), which often lead to an undesirable change in the composition of the products and an increase in production costs, or even limits the use of said fermentates only in short-term final products. In fact, there is therefore a strong technical limitation to the use of fermented products of plant origin, such as avocado fermentates, in products such as food supplements and functional foods, especially in long-term products.
The aim of the present invention is therefore to provide a product based on an avocado fermentate, which can be effectively used in food supplements and functional foods thanks to the ability of not undergoing significant alterations in composition and of maintaining a high content of highly bioavailable nutrients over time.
The Applicant has now found that this aim can be achieved by preparing a granulate of an avocado fermentate with a suitable binder.
In particular, in a first aspect thereof the present invention refers to a granulated product comprising an avocado fermentate and at least one binder selected from the group consisting of: a maltodextrin, a cellulose or a derivative thereof, a sugar, a fructooligosaccharide (FOS), acacia, polyvinylpyrrolidone (PVP), and a fibre.
The Applicant has in fact found that by conveniently identifying a final form and by combining the avocado fermentate with a suitable type of binder, it is possible to obtain a product comprising an avocado fermentate capable of ensuring an adequate stability over time, and therefore of being effectively used in food supplements and functional foods by virtue of the absence of significant variations in the composition and chemical-physical properties, which would otherwise reduce the content of highly bioavailable nutrients, thus compromising the efficacy thereof.
In a further aspect thereof, the present invention further refers to a composition comprising the granulated product according to the present invention and at least one suitable food excipient.
In fact, thanks to the increased stability of the granulated product over time according to the present invention, it is in fact possible to use said product by exploiting its increased concentration of nutrients and their greater bioavailability for the preparation of food supplements and functional foods.
In accordance with a further aspect, the present invention therefore also refers to the use of the granulated product or composition according to the present invention as a food supplement or as a functional food.
Furthermore, in accordance with a still further aspect, the present invention refers to the use of the granulated product or composition according to the present invention as a substance with a hypoglycaemic effect for the treatment of hyperglycaemia, with an antihypertensive effect for the treatment of hypertension, with an antioxidant effect for the treatment of oxidative stress, with an anti-obesity effect for the treatment of obesity, as an active substance for the antimicrobial treatment and for the liver protection treatment, in a male or female subject, and as an active substance in the treatment for the improvement, restoration, or enhancement of fertility in a male or female subject, as well.
Finally, in a still further aspect, the present invention refers to the use of the granulated product or composition according to the present invention as an effective substance in improving the general state of health, in reducing symptoms of fatigue and tiredness, for the treatment of premenstrual disorders (abdominal bloating, breast tension, irritability), menstrual pain (dysmenorrhoea), dyspareunia (pain during sexual intercourse) and catamenial headache (menstrual headache), as well as for the treatment of regularisation of the menstrual cycle by reducing its quantity and duration and regularising its rhythm.
The increased concentration of nutrients, and their increased bioavailability in the avocado fermentate, in fact enable the granulated product and composition according to the present invention to show said beneficial effects on the body.
In a first aspect thereof the present invention refers to a granulated product comprising an avocado fermentate and at least one binder selected from the group consisting of: a maltodextrin, a cellulose or a derivative thereof, a sugar, a fructooligosaccharide (FOS), acacia, polyvinylpyrrolidone (PVP), and a fibre.
For the purposes of the present invention, by avocado fermentate it is meant the product obtained by fermenting fresh avocado pulp which may also comprise unfermented fresh avocado pulp (or fractions thereof), usually at a concentration by weight relative to the final fermented product not exceeding 10% by weight.
The Applicant has in fact found that by conveniently identifying a final form and by combining the avocado fermentate with a suitable type of binder, it is possible to obtain a product comprising an avocado fermentate capable of ensuring an adequate stability over time, and therefore of being effectively used in food supplements and functional foods by virtue of the absence of significant variations in the composition and chemical-physical properties, which would otherwise reduce the content of highly bioavailable nutrients, thus compromising the efficacy thereof.
Within the context of the present description and following claims, all the numerical magnitudes indicating quantities, parameters, percentages, and so on are to be considered preceded in every circumstance by the term “about” unless indicated otherwise. Further, all the ranges of numerical magnitudes include all the possible combinations of maximum and minimum numerical values and all the possible intermediate ranges, as well as those indicated below.
Within the scope of the present invention, when reference is made to “avocado”, this means the fruit of Persea americana Mill.
In this description and in subsequent claims, the term “functional food” is understood to indicate those products, including isolated nutrients, food supplements, herbal products, meal replacements and fresh or transformed foods, that are rich in molecules with beneficial and protective properties for the body, with actions on a nutritional and physiological level.
The present invention can be presented in one or more of its aspects or one or more of the preferred characteristics reported below, which can be combined with one another according to the application requirements.
The granulated product according to the present invention comprises an avocado fermentate and at least one binder selected from the group consisting of: a maltodextrin, a cellulose or a derivative thereof, a sugar, a fructooligosaccharide (FOS), acacia, polyvinylpyrrolidone (PVP), and a fibre.
Preferably the at least one binder is a maltodextrin, more preferably a maize maltodextrin, or the at least one binder is a sugar, preferably isomalt or dextrose, more preferably isomalt.
When the binder is a cellulose derivative, it is preferably methylcellulose, ethylcellulose or carboxymethylcellulose.
The preparation of an avocado fermentate is a technique well known to the person skilled in the art, and within the scope of the present invention, the latter may use any of said fermentation techniques for obtaining an avocado fermentate.
In a preferred embodiment of the present invention, said fermentate is obtained by fermenting fresh avocado pulp, preferably diluted with water, in the presence of at least one fermentation agent selected from the group consisting of: a yeast and a Lactobacillus. Preferably, said at least one yeast is of the genus Saccharomyces, even more preferably it is a Saccharomyces boulardii.
Preferably, in the granulated product according to the present invention the weight ratio of said avocado fermentate to said at least one binder ranges from 1:5 to 1:1.
In a preferred embodiment, in the granulated product according to the present invention the weight ratio of said avocado fermentate to said at least one binder ranges from 1:4 to 1:2, more preferably from 1:3.5 to 1:2.5, optimally about 1:3.
In another preferred embodiment, in the granulated product according to the present invention the weight ratio of said avocado fermentate to said at least one binder ranges from 1:2 to 1:1, more preferably from 1:1.5 to 1:1, optimally about 1:1.25.
The Applicant has found that said weight ratios are optimal for obtaining a granulated product that does not undergo significant alterations in composition and preserves a high content of highly bioavailable nutrients over time.
Preferably, the granulated product according to the present invention has a particle size such that 100% of the particles have a diameter of less than 2 mm (i.e. pass through a 10 mesh sieve).
Preferably, the granulated product according to the present invention comprises less than 10% by weight, more preferably from 3% to 6% by weight of water.
Among the advantages of the granulated product according to the present invention it is included the fact that it is easy to obtain. In fact, the granulated product according to the present invention is obtainable according to a process that involves a limited number of steps.
In one embodiment said process includes the following steps:
All of the above steps can be carried out in any manner known to the persons killed in the art, without any particular difficulty, adapting the operating conditions to the specific application requirements of the case.
Intermediate processing steps (e.g. concentration, pasteurisation, filtration, washing, drying) and intermediate storage or conditioning may also be envisaged, in accordance with the usual methods for processing fermented products based on vegetable pulp.
As regards the fermentation of avocado pulp, this is a technique well known to the person skilled in the art, and within the scope of the present invention, the latter may use any of said fermentation techniques for obtaining an avocado fermentate.
In a preferred embodiment of the present invention, said fermentation of fresh avocado pulp, preferably diluted with water, is a fermentation carried out in the presence of at least one fermentation agent selected from the group consisting of: a yeast, and a Lactobacillus. Preferably, said at least one yeast is of the genus Saccharomyces, even more preferably it is Saccharomyces boulardii.
Granulation is also a transformation technique well known to the person skilled in the art, and within the scope of the present invention the skilled in the art can resort to any operating mode, adapting the operating conditions to the specific application needs of the case.
In a preferred embodiment, said granulation step is carried out at a controlled temperature of less than or equal to 40° C. in order to prevent phenomena of thermal degradation of the nutrients of the granulated product obtained therefrom.
Among the usable granulation techniques, a fluidised bed technique is preferably used, which allows to obtain a stable granulate which, in addition to being more flowable, is more soluble and therefore increases the bioavailability of the nutrients contained therein.
Optionally and advantageously, at the same time or after the granulation step, the process includes a drying step, in order to regulate the water content of the granulated product obtained.
In a further aspect thereof, the present invention further refers to a composition comprising the granulated product according to the present invention and at least one suitable food excipient.
In fact, thanks to the increased stability of the granulated product over time according to the present invention, it is in fact possible to use said product by exploiting its increased concentration of nutrients and their greater bioavailability for the preparation of food supplements and functional foods.
This stability of the granulate is to be considered exceptional, given that the fermented product subjected to granulation may also contain significant quantities of fresh, unfermented and therefore easily putrescible pulp.
Advantageously, said composition comprises, with respect to its total weight, between 70% and 99% by weight of granulated product.
Preferably, said composition comprises, with respect to the total weight of the composition, from 10% to 30% by weight, preferably from 15% to 25% by weight, of fermented avocado. In a preferred embodiment, said composition comprises from 100 to 1500 mg of fermented avocado.
In a preferred embodiment, the composition according to the present invention comprises at least one plant derivative selected from the group consisting of: a non-granulated fermentate, a pulp, a dehydrated pulp, a juice, preferably a dehydrated pulp.
Preferably, said at least one plant derivative is selected from the group consisting of: a non-granulated avocado fermentate, an avocado pulp, a dehydrated avocado pulp, an avocado juice, more preferably a dehydrated avocado pulp.
Preferably, the composition according to the present invention comprises at least one vitamin, preferably selected from the group consisting of: vitamin D, preferably D3, vitamin B, preferably B6 and/or B12.
Optionally, the composition according to the present invention may contain one or more of the other possible ingredients known in the art for food supplements and functional foods, such as for example flavourings, acidity correctors, e.g. citric acid, anti-caking agents, e.g. silicon dioxide, coenzyme Q-10, emulsifiers, e.g. polyoxyethylene sorbitan monooleate, zinc, zinc gluconate, sweeteners, e.g. sucralose, folic acid, maca root, amino acids such as for example L-arginine, bulking agents, e.g. cellulose and calcium phosphate, stabilisers, e.g. cross-linked sodium carboxymethylcellulose and fatty acids, glazing agents, e.g. polyvinyl alcohol, hydroxy-propyl-methylcellulose, calcium carbonate, and talc, colourants, e.g. chlorophyll and chlorophyllin complexes with copper, and riboflavin.
Said other possible ingredients known in the art may be added at any suitable step in the production of the composition according to the present invention, in manners known to the person skilled in the art for this purpose.
Preferably, the composition according to the present invention is prepared in the form of a capsule, powder, granulate, tablet, dragée, bar paste, syrup, aqueous solution, gel, or cream, depending on the application requirements and the chosen modality of intake.
In a preferred embodiment, the composition according to the present invention is prepared in powder form, preferably in a single-dose sachet format.
Alternatively, it is preferably in tablet form.
Advantageously said powder, granulate or tablet form comprises from 100 to 1500 mg of the fermented avocado of the invention per unit dose.
In a particularly preferred embodiment, the composition according to the present invention is prepared in powder form in a single-dose sachet comprising 400 or 1000 mg of said fermented avocado.
Advantageously, the composition according to the present invention is prepared in powder form in a single-dose sachet comprising the granulated product in a concentration by weight with respect to the total weight of the powder contained in the sachet comprised between 18 and 22%, alternatively comprised between 70 and 75%.
In a further particularly preferred embodiment, the composition according to the present invention is prepared in tablet form comprising 300 mg of said fermented avocado.
Advantageously, when the composition according to the present invention is prepared in tablet form, the granulated product is present in a concentration by weight with respect to the total weight of the powder contained in the sachet comprised between 97 and 99%.
The increased stability over time of the granulated product according to the present invention makes it possible to use said product or the composition containing it by exploiting its increased concentration of nutrients and their increased bioavailability for the preparation of food supplements and functional foods.
In accordance with a further aspect, the present invention therefore also refers to the use of the granulated product or composition according to the present invention as a food supplement or as a functional food.
Furthermore, in accordance with a still further aspect, the present invention refers to the use of the granulated product or composition according to the present invention as a substance with a hypoglycaemic effect for the treatment of hyperglycaemia, with an antihypertensive effect for the treatment of hypertension, with an antioxidant effect for the treatment of oxidative stress, with an anti-obesity effect for the treatment of obesity, as an active substance for the antimicrobial treatment and for the liver protection treatment, in a male or female subject, and as an active substance in the treatment for the improvement, restoration, or enhancement of fertility in a male or female subject, as well.
Finally, in a still further aspect, the present invention refers to the use of the granulated product or composition according to the present invention as an effective substance in improving the general state of health, in reducing symptoms of fatigue and tiredness, for the treatment of premenstrual disorders (abdominal bloating, breast tension, irritability), menstrual pain (dysmenorrhoea), dyspareunia (pain during sexual intercourse) and catamenial headache (menstrual headache), as well as for the treatment of regularisation of the menstrual cycle by reducing its quantity and duration and regularising its rhythm.
The increased concentration of nutrients and their greater bioavailability in the fermented avocado granulate in fact enable the composition according to the present invention to exhibit beneficial effects on female and male fertility.
The invention is now described by means of some examples to be considered for non-limiting illustrating purposes thereof.
1000 grams of an avocado pulp coming from a Sicilian cultivation were introduced into a stainless steel reaction mixer provided with a stirring system. 400 grams of water and 2 grams of Saccharomyces boulardii yeast were added, keeping the system under stirring and at a controlled temperature in a range comprised between 30 and 40° C. until fermentation was complete.
Subsequently, 10 parts by weight of the avocado fermentate thus obtained were fed to a fluidised bed granulation plant where it was granulated at a temperature of 40° C. in the presence of 30 parts by weight of maize maltodextrin, resulting in a granulated product with a particle size such that 100% of the particles were less than 2 mm in diameter.
During granulation, the granulated product was dried up to a water content of approximately 4.3% by weight.
The granulate of the avocado fermentate was then characterised compositionally. The values of the main parameters of interest are shown in Table 1 below.
0.430 ± 0.091 mg/100 g
399 ± 3 kcal/100 g
As is evident from the data shown in Table 1, the granulated product contains in its lipid fraction a very high concentration of the beneficial MUFAs, which are particularly valuable in the formulation of supplements and functional foods.
The granulated product thus obtained was then subjected to stability tests over time.
Specifically, the product was subjected to stability tests under the following conditions:
The results of the tests under the three different conditions are shown in Tables 2a, 2b and 2c below, respectively.
As is evident from the data shown in Tables 2a, 2b and 2c, the granulated product showed excellent stability over time under all the experimental conditions tested, thus confirming its possibility of use for the preparation of compositions to be used for the manufacture of supplement products.
10 parts by weight of the avocado fermentate obtained according to the fermentation procedure of example 1 were fed to a fluidised bed granulation plant and granulated therein at a temperature of 40° C. in the presence of 30 parts by weight of binder.
Granulation tests were carried out with different binders and their usability for granulating fermented avocado was evaluated based on the observation of obtaining processable granules. In other words, the compliance or non-compliance of the granules obtained was assessed on the basis of their hygroscopicity, flowability and ease of drying; essential parameters for the subsequent processing of the granules.
Table 3 below shows the binders used and the results obtained in the granulation.
As is evident from the results obtained, not all binders could be used for the granulation of the avocado fermentate. In the cases of non-compliance, this resulted in jelly-like preparations that were difficult to dry, or very viscous products that were not sufficiently flowable for subsequent manufacture of the preparation.
On the other hand, excellent performance was found in particular when using maize maltodextrin and isomalt.
The granulated product according to Example 1, having a weight ratio of avocado fermentate to maltodextrin of 1:3, was used for the preparation of a powder containing furthermore inositol, Coenzyme Q10, zinc gluconate, vitamin B6, folic acid, vitamin D3, vitamin B12. The resulting powder was then packaged in single-dose sachets of approximately 5 grams (nominal value) with an average content as shown in Table 4.
The single-dose sachet thus prepared was then subjected to stability tests over time. Specifically, the product was subjected to stability tests under the following conditions:
As is evident from the data in Tables 5a, 5b and 5c, the powder composition comprising the granulated product showed, under all the experimental conditions tested, excellent stability over time, with the values of all the observation parameters perfectly within the required specifications, thus confirming its possibility to formulate the granulated product in a form, such as the powder form in the single-dose sachet format, characterised by a marked ease of absorption, and therefore suitable for marketing.
The granulated product according to Example 1, having a weight ratio of avocado fermentate to maltodextrin of 1:3, was used for the preparation of tablets of approximately 1.3 grams (nominal value) containing furthermore Coenzyme Q10, zinc gluconate, vitamin B6, folic acid, vitamin D3, Vitamin B12, and having an average content as shown in Table 6.
The tablets thus prepared were then subjected to stability tests over time. Specifically, the product was subjected to the following conditions:
The results obtained under the three different experimental conditions are shown in Tables 7a, 7b and 7c below.
As is evident from the data shown in Tables 7a, 7b and 7c, the tablet composition comprising the granulated product also showed excellent stability over time, with the values of all the observation parameters perfectly within the required specifications over time, thus confirming its possibility to formulate the avocado fermentate also in this form in order to make available a supplement characterised by the presence of active ingredients endowed with many properties, including therapeutic ones, in a form suitable for marketing and easy to take for subjects in need of this type of supplement.
For the preparation of the granulated product to be used in this powder composition, the avocado pulp was subjected to the same fermentation and then to the granulation process as described in example 1, wherein the maize maltodextrin was replaced however by isomalt, so as to obtain a weight ratio of avocado fermentate to isomalt of 1:1.25.
This granulate was then used to prepare a powder containing furthermore folic acid, Coenzyme Q10, zinc gluconate, vitamin B6, vitamin B12, vitamin D3, L-arginine and maca root.
The resulting powder was then packaged in single-dose stick-packs of approximately 2.1 grams (nominal value) with an average content as shown in Table 8.
This composition proved to be particularly effective for use by male patients.
In order to test the efficacy of the product and gather useful information on the benefits that the patients exhibited by taking it, a study was carried out on 36 women, aged 33 to 42, who took the product for a period of 1 to 6 months.
Patients were asked to rate how they felt after the period of taking the product in relation to their general state of health and the symptoms of tiredness and fatigue.
In particular, in order to assess the general state of health, they were asked to express how they felt at the end of the treatment cycle and a score from 1 to 4 was given depending on their answer, as follows:
As regards instead to the assessment of tiredness and fatigue symptoms at the end of the treatment, it was asked how they perceived these symptoms by asking them to choose from the following statements, each of which was again in this case matched to a relative score:
Table 9 below shows all the scores obtained during the tests.
The processing of the data obtained in these tests, as regards the first observation parameter, highlighted that the product had obtained an average score of 3.3, i.e. an improved general state of health had been recognised by the patient, qualitatively included in the judgement between “improved” and “greatly improved”. However, this major improvement was at the same level throughout the treatment period, as the averages calculated for the patients who had taken the product for 1, 3 or 6 months were 3.3, 3.2 and 3.3 respectively, and thus almost constant.
This showed that daily use of the product over a long period of time allows maintaining high benefits for the patient's general state of health.
With regard to the symptoms of fatigue and tiredness, an average score of 1.9 was obtained, when calculated over the entire observation period of the patients.
Much more significant is the calculation of the average score values determined for the three single observation periods, i.e. relative to the patients who had taken the product for 1, 3 or 6 months, which were 1.8, 1.9 and 2.7 respectively; these average values, which were also related to the duration of the treatment period, showed that the efficacy of the product on tiredness and fatigue symptoms was increasing over time. Thus, patients who had continued the treatment for up to 3 and 6 months experienced the greatest benefit from this product in reducing these symptoms, reporting that tiredness had been significantly reduced or that they did not feel tired at all.
In this case a study was carried out on 30 women who typically complained of premenstrual symptoms and dysmenorrhoea.
The women were aged between 33 and 42 and took the product for a period comprised between 1 and 6 months.
At the end of the treatment, the patients were asked to rate on a scale of 0 to 10 (where 0 corresponded to no improvement and 10 corresponded to a significant improvement in symptoms) how they felt after the period of taking the product, particularly in relation to the typical premenstrual disorders (abdominal bloating, breast tension, irritability) and to menstrual pain (dysmenorrhoea).
Table 10 below shows all the scores obtained during the tests.
The processing of the data obtained in these tests, as regards the first observation parameter, that is premenstrual disorders, highlighted that the product had obtained a very high average score, equal to 7.5 on a scale from 0 to 10. Incidentally, the calculation of the same average score as a function of the period of treatment with the product did not give results that significantly deviated from this value.
Similarly, in the case of the assessment of dysmenorrhoea, the patients expressed themselves even more favourably on average, with an average value of 7.7 on a scale from 0 to 10, again without any particular variability in the result as a function the period of treatment.
The product was therefore effective in reducing symptoms linked to premenstrual disorders as well as in reducing dysmenorrhoea.
In this case a study was carried out on 19 women who typically complained of dyspareunia (i.e. pain during sexual intercourse).
The women were aged between 33 and 42 and took the product for a period comprised between 1 and 6 months.
At the end of the treatment, the patients were asked to rate on a scale of 0 to 10 (where 0 corresponded to no improvement and 10 corresponded to a significant improvement in symptoms) how they felt after the period of taking the product, particularly in relation to pain during sexual intercourse.
Table 11 below shows all the scores obtained during the tests.
The processing of the data obtained in these tests highlighted that the product again had achieved a very significant average score equal to 6.9; this average score even reached the score of 8 in women who had followed the treatment for 6 months, also highlighting the significant long-term benefits of the product.
The product was therefore effective in reducing the painful symptoms of sexual intercourse (dyspareunia).
In this case a study was carried out on 22 women who typically complained of catamenial headaches (i.e. menstrual headaches).
The women were aged between 33 and 42 and took the product for a period comprised between 1 and 6 months.
At the end of the treatment, the patients were asked to rate on a scale of 0 to 10 (where 0 corresponded to no improvement and 10 corresponded to a significant improvement in symptoms) how they felt after the period of taking the product, particularly in relation to pain during sexual intercourse.
Table 12 below shows all the scores obtained during the tests.
The processing of the data obtained in these tests highlighted that the product had a very high average score, equal to 7.6; this average score even reached the average score of 9 in women who had followed the treatment for 6 months, highlighting also the significant long-term benefits of the product.
The product was therefore also effective in reducing the painful symptoms of catamenial headache.
In this case, a study was carried out on 20 women aged between 35 and 42 who took the product for a period comprised between 1 and 6 months.
At the end of the treatment, the patients were asked to rate on a scale of 0 to 10 (where 0 corresponded to no improvement and 10 corresponded to a significant improvement in symptoms) how they felt after the period of taking the product, particularly in relation to the observation parameters.
They were then asked to assess whether the quantity and duration of the cycle had decreased and (for patients who had taken the product for at least 3 months) whether it had become more regular.
Table 13 below shows all the scores obtained during the tests.
The processing of the data obtained in these tests highlighted that the product had obtained the following average scores for the parameters observed:
In all cases, and therefore for all the observation parameters, the average values calculated as a function of the period of treatment with the product increased with the time of treatment, highlighting values of maximum benefit after 6 months of use, demonstrating that daily use of the product over a long period of time provides fundamental support in regularising the woman's menstrual cycle.
The product was therefore incredibly effective in a plurality of situations, particularly in improving the general state of health, in reducing symptoms of fatigue and tiredness, in reducing premenstrual disorders (abdominal bloating, breast tenderness, irritability), menstrual pain (dysmenorrhea), dyspareunia (pain in sexual intercourse), catamenial headache (menstruation headache), as well as in regularising the menstrual cycle by reducing its quantity and duration and regulating its rhythm.
About 32 women were enrolled, aged between 35 and 42 classified as infertile (looking for pregnancy for more than two years) with at least one previous failed attempt at assisted reproduction.
The women had all normal menstruation but had AMH (Anti-Müllerian Hormone) values ranging from 2.3 μg/l to 0.89 μg/l.
After 3 months of treatment with the product referred to in example 3 supplemented with 400 μg of folic acid, 63.2% of the women showed a positive outcome to the treatment, with 23.8% of the women conceiving spontaneously while waiting for the PMA treatment to be carried out, and 39.4% having a positive pregnancy test after transfer, with developmental pregnancy in 22% of the cases.
The result of the study highlighted a surprising efficacy of the product according to the invention in treating women with fertility problems.
| Number | Date | Country | Kind |
|---|---|---|---|
| 102020000022102 | Sep 2020 | IT | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2021/058497 | 9/17/2021 | WO |
