MXPA00012300A - Dietary supplement derived from fermented milks for the prevention of osteoporosis - Google Patents

Abstract

A process is described for manufacturing dietary supplements (food integrators) by means of a natural fermentation, including the following steps:a) preparation of a"mix"at a 18°Centigrade temperature, containing one or more types of pasteurized milk from animal origin;b) introduction in such a"basic material"of a 1.5-4.5%in weight of polysaccharide"grains"mainly formed"friendly bacteria";c) maintenance of the previous substance at a 18-25°Centigrade temperature for a first period of 6-12 hours then adding a quantity of 1-3%in weight of a second pool of polysaccharide"grains", mainly formed by yeasts;d) maintenance of the substance at 18-25°C during a second period of 6-12 hours, by adding again 2.5.-6.5%in weight of"grains"mainly formed by yeasts, then adding some minerals (calcium, magnesium, etc.) in proportion 0.2-1.2%of weight;e) separation, by filtration, of different components of the substance, among whose a"residual matrix"composed by grains of polysaccharides containing bacteria and yeasts;f) drying of the substance, after filtration, for obtaining a fine powder;g) preparation of various dietary supplements, presented in tablets or"sachets"or other formulations, useful in the treatment of osteoporosis and other degenerative conditions.

Description

DIETETIC SUPPLEMENT DERIVED FROM FERMENTED MILKS FOR THE PREVENTION OF THE OSTEOPOROSIS Description of the Invention The present invention relates to products that are used as dietary supplements or nutritional supplements for the supplementation of nutrition and diet by taking substances, mainly of natural origin, which provide the necessary elements for nutrition and in this way for the proper maintenance of the essential functions of the body (such as the formation and preservation of bones, muscles, skin, related tissues and the like). More particularly, the present invention relates to a process for obtaining a natural dietary supplement that has proven to be very effective for the prevention and treatment of osteoporosis and other diseases primarily due to deficiencies of calcium, magnesium and potassium in the body. In the current state of our technical and scientific knowledge, it is well known that an adequate supply of a variety of nutritional substances, Ref: 125315 commonly called ^ nutrients "(such as minerals, vitamins, proteins, and others) are of fundamental importance for the proper development of bodily tissues and for the vital functions of the body, and that the deficiencies or imbalances of these nutrients are normally concomitant with the current pathological conditions (particularly those of a 'degenerative' and / or chronic type that can affect various parts of the body, for example the skeleton and the blood vessels, etc.) It is also known that the main nutrients are ingested with the diet, and therefore that, if the latter are sufficiently appropriate and balanced, and if the body is in a normal operating state in terms of assimilation and conversion of these nutrients, there should be no problems with respect to maintaining the conditions of good health from this point of view.In fact, it often happens that the diet of an individual, and in cluso, in fact, especially in industrialized countries, presents imbalances due to deficiencies and / or excesses that over a period of time can cause serious damage to health. Many diseases, which are then treated. with different drugs, are also due to unbalanced nutritional intake and it is well known that these can be prevented and even cured by restoring lost balance. It is also known, moreover, that the various products that commonly come under the definition of dietary supplements have been produced and used to solve the aforementioned problems and that, therefore, they are a familiar aspect of the current state of the art. These supplements consist of combinations of various substances (nutrients) that are obtained through the processes of chemical synthesis or extraction of various materials (vitamins, minerals of vegetable or animal origin) that are formed into compounds in a particular formula and are presented in the form of tablets or capsules, or other types of preparations that can be taken orally. The administration of these preparations presents a complete range of drawbacks, the most important of which are: (1) the origin of the nutrients that are used (obtained by synthesis or extraction), which are normally unsuitable for the human body; (2) difficulties of assimilation due to the source and the materials that are used, which limit substantially the bioavailability of the substances that are administered; (3) the respective proportions of the various nutrients that are present in the product that is administered, which are commonly predetermined independently from each other, without due consideration of the balance that is in fact found in nature and in the processes metabolic, and that constitute one of the key factors for the aforementioned balanced diet that is required for the effective conditions of health and well-being of the body. As a consequence of the considerations described in this, the inventor of the present invention concludes that the solutions to the aforementioned problems that are effectively useful for the health and balance of the body should be sought in processes of completely natural preparation, by 'directing' exclusively the chemical transformations carried out biologically by microorganisms such as, for example, lactobacteria and yeasts, in order to influence them in the way they are required, the condition of a good development and maintenance of the health of the musculoskeletal system and in The particularity of bones is recognized as a fundamental health problem, and widely widespread. It is related to both the problems of diet and the use of certain drugs, as well as the manifestation of degenerative processes as a result of aging that can lead to the onset of osteoporosis (which consists of a reduced density and elasticity of the bones with an increase consequent in its fragility) and collateral conditions of an inflammatory and painful type that even lead to a final risk of sudden fractures (in this case they are not due to any obvious serious trauma). The subjects that are most 'at risk' are women, particularly during the post-menopausal period, and those individuals with a particular 'genetic risk' whose specific analyzes have identified them as being present in 15% or more of the population general. A variety of effective drugs against this disease is currently available, but now it has been established that the best method for both prevention and therapy of osteoporosis must necessarily involve adequate dietary supplementation based on minerals such as calcium and magnesium with the possible addition of vitamin D3. However, this 'supplementation' is in most cases implemented by administering poorly assimilable products and an unsatisfactory biological quality containing inorganic calcium or calcium which, in any case, is not absorbed in the intestines due to a number of factors They block its absorption to a substantial degree.As an alternative to this supplementation, diets rich in dairy products and cheese are usually recommended, they provide a good supply of calcium (and also magnesium), but unfortunately have several problems that normally they are underestimated, such as: (a) problems of poor digestion or even lactose intolerance, (b) excessively high cholesterol levels, (c) unwanted intake of calories and fats, the inventor of the present invention therefore seeks a solution that can provide a product that has better ability to overcome the problems previously e mentioned, in the form of a supplement that is demonstrably effective, reliable and economical, that is, by developing a product that: (1) guarantees the supply of adequate amounts of calcium, magnesium and other nutrients that are useful for bone and metabolism for the purposes of musculoskeletal functions; (2) ensure an assimilation of the various nutrients; (3) ensure digestion capacity and avoid intolerance; and (4) has the characteristics of a fully biocompatible biological substance. For this purpose, the inventor has discovered a process that is the subject of the present invention, which is outlined in the preamble of claim 1 and of which its inventive characteristics are described in the characterizing part of this claim. The present invention also relates to dietary supplements that can be obtained by this process and its use for the prevention and therapy of osteoporosis and other diseases due substantially to deficiencies of calcium, magnesium and potassium. The process according to the invention makes it possible to obtain a 'nutrient complex', by means of whose definition a nutritional substance of natural origin is implied, which is the result of a biological processing by microorganisms (the so-called "beneficial microorganisms", such as lactobacilli, etc.), which contain all the desired nutrients, and particularly calcium, magnesium and potassium, with the desired characteristics of good assimilation, tolerance and efficacy.The inventor begins to select the products that can obtained from various types of fermented milk, which are products that differ so much from the type of milk (from cow, sheep, goat, mare) and the type of microorganisms that are used, as well as the methods by which the fermentation process is carried out. A particular type of fermentation product is identified in this way, which is comparable to a substance that is traditionally known in the countries of the Middle East and Eastern Europe under the name of Kefir, which is endowed with optimal characteristics in the manner of a "nutritional complex." Kefir is a type of yogurt, which can be obtained through the fermentation of milk through the dual action of a variety of lactobacilli and yeasts, of which the appropriate combination makes it possible to obtain a product biologically processed with the required characteristics The addition, during the fermentation process, of the desired substances (for example, although not exclusively, calcium) allows the 'enrichment' of the nutrient complex so that it can be used specifically for a certain type of application (for example, for the treatment of osteoporosis). or more of the minerals, fixing them in their cells and ensuring their bioavailability.To achieve the desired objectives, the inventor, after meticulously studying the natural and traditional processes implemented in the areas mentioned above, concludes that natural food supplements with a highly effective action can be obtained through the work of processing an appropriate mixture of microorganisms in a predetermined sequence, by modifying these processes with specifically directed additions of useful substances and by appropriately modifying the times and temperatures of the various stages of these processes. this way, you discover a process which is suitable to produce dietary supplements that present a high degree of effectiveness that reach an adequate level so that the supplements can be used for current therapeutic purposes. As indicated in the following part of this description, a dietary supplement that can be obtained by means of the processes according to the present invention, as a result of a broad spectrum and high concentrations of organic substances with beneficial effects they contain, not only proves useful. as a principal measure, as indicated above, for the prevention and therapy of conditions due to deficiencies of calcium, magnesium and potassium, but also exerts a secondary beneficial action in various different disorders that are generated by genetic factors in combination with functional imbalances of a chemical nature. We now describe a modality, which is neither mandatory nor exclusive, of the processes according to the present invention. This process essentially comprises the following steps: a) preparing a mixture at 18 ° C comprising one or more types of pasteurized milk of animal origin; b) add to this mixture 1.5-4.5% by weight of the first granules consisting predominantly of bacteria; c) maintaining the mixture at 18-25 ° C for an initial period of time ranging from 6 to 12 hours and subsequently adding, after about half the process, 1-3% by weight of this pasteurized milk mixture; d) adding to the mixture 2.5-6.5% by weight of the second granules consisting predominantly of yeasts; e) keep the mixture obtained in this way at 18-25 ° C for a second period of time ranging from 6 to 12 hours and add to this calcium and / or magnesium and / or potassium in amounts of 0.2-1.2% by weight during the first half of this second period of time; f) filtering a residual matrix consisting of the granules that are introduced in the various stages of the process and the granules that are formed during the process itself; g) Dry the mixture after filtration to obtain a powder.

These first and second granules can be obtained by means of a conventional milk inoculation process, starting with commercially available Kefir granules. For the control and identification of bacteria for the normalization of the contents of these granules, reference can be made to the texts by M. Motaghi et al. (1997), Kandler-Weiss (1986) and Hardle (1986) for the first granules consisting mainly of bacteria, and the Barnet method (1990) for the second granules consisting mainly of yeasts. All the aforementioned publications are incorporated herein for reference. A profile indicative of the contents of these granules can be deduced from the attached Tables A and B.

Tables First granules Mainly (Table A) Lactobacillus bacteria 106-107 bre vi s Lactobacillus 106-107 casei Lactobacillus 106-107 plantarum Lactobacillus 108-109 (optionally, kefir 'addition' of 20-30%) Lactobacillus 107-108 (optionally, kefirano faciens "addition" of 20-30% Acetobacter aceti 106-107 Leuconostoc 105-106 mesenteroids Streptococcus 104-105 lactis Others 105-106 Saccharomyces 103-104 lactis Sacch aromyc e 105-106 cerevisiae Saccharomyces 104-105 fragilis Candida kefir 104-10 £ Seconds granules Mainly Table B yeasts Lactobacillus 10 5-1 i06 brevis Lactobacillus 105-106 caseí Lactobacillus 105-106 plantarum Lactobacillus 106-107 kefir Lactobacillus 106-107 kefir ano faciens Acetobacter aceti 105-106 Leuconostoc 104-105 mesenteroids Streptococcus 10 -105 lactis Others 105-10É Saccharomyces 105-106 lactis Saccharomyces 10d-107 cerevisiae Saccharomyces 105-106 fragilis Candida kefir 106-107 Other _ 105-106 The distinguishing characteristics of a dietary supplement obtained in this way, due to the particular mixture of bacilli and yeasts, which improve in an extraordinary way the Kefir previously mentioned (as well as other types of yogurt) are mainly the following: 1. Among the biological substances with high content of minerals such as calcium, magnesium and potassium, this dietary supplement surprisingly presents a profile that is much richer in other 'noble' substances, as an attribute to specific supplementation and of general value, such as amino acids of branched chains, polysaccharides and vitamins, these nutrients have been shown to significantly enhance the intestinal absorption of calcium and the metabolism of various minerals 2. The effect of microorganisms on lactose causes their conversion into lactic acid, which , in turn, is an 'intensifier' of calcium absorption, in addition to reducing s risks of lactose intolerance. This must be added to the fact that the microorganisms themselves produce an enzyme, galactosidase, which makes lactose digestible.

Finally, they are able to substantially reduce the absorption of cholesterol, and therefore protect the body against a well-known threat. 3. The presence of polysaccharides (slow-picking carbohydrates) also makes this product suitable for diabetics and for elderly patients in general. Branched chain amino acids are also important elements for elderly individuals by virtue of their basic function of growth and maintenance of muscle fibers (and therefore again provide additional support for the entire musculoskeletal system). Below is a detailed indicative profile of the constituents of the product in question. First, an example is given (Tables 1 to 5) of a formulation (nutrient complex) that is selected using a fermentation process according to the invention, which has the purpose of providing a supplementation of minerals such as calcium, magnesium and potassium, according to the criterion of the invention itself; this follows by the presentation (Table 6) of the composition of a dietary supplement, which is produced by means of 'specifically directed enrichment' of the raw material and which is suitable for therapeutic and preventive applications in the field of osteoporosis: Composition of fermentation substances obtained by means of the processes according to the invention.

Table 1 General Analysis Constituents% ±% Protein 45 15 Humidity 5 10 Fat (1) Total lipids 4 2 Fiber 3 2 Carbohydrates 30 10 8 Minerals (ashes) 13 Calories per gram 2.8 Table 2 Minerals (mg per 100 g of product) Constituents (±%) Potassium 2240 20 Phosphorus 1320 15 Magnesium 180 30 Sodium 680 15 Calcium 1660 20 Zinc 2.3 20 Iron 4.5 10 Chromium 146 μg Selenium 13.3 μg Copper 0.3 20 Manganese Traces Table 3 Vitamins (mg per 100 g of product) Constituents (+ 25%) Bi (thiamine) 6.6 B2 (riboflavin) 5.6 Niacin 54 B6 (pyridoxine HCl) 4 B12 50 μg Folic Acid 1.4 Biotin (H) 180 μg Inositol 300 Hill 453.3 Para-aminobenzoic acid 2.4 Table 4 Amino acids (mg per 100 g of product) Constituents (+ 20%) Arginine 3200 Glutamic Acid 13100 Histidine 2000 Isoleucine 4300 Leucine 7500 Lysine '6700 Methionine 1400 Phenylalanine 3500 Threonine 5200 Triptofan 1800 Tyrosine 3200 Valine 4800 56700 Table 5 Constituent Nucleic Acids (+ 30%) Total 8-9% Example of dietary supplement for osteoplasia.

Table 6 Content (for roughness 5% approximation) Value in g 100 g Sachet 2 tablets! (10 g) (12 g) Protein 45 4.5 5.40 I! Carbohydrates 30 3.0 3.60 1 Fat 1 0.1 0.12 Total lipids 4 0.4 0.48 i Fiber 3 0.3 0.36 Minerals 13. 1.3 1.56 Humidity 4 0.4 0.48 1 Calories 280 28.0 33.60 Dietary supplements that are produced by the process of the present invention have been tested, and extensively analyzed, and demonstrate that they possess in an effective way the desired characteristics, which allow remarkable advantages over the traditional calcium supplements that are to be obtained. The main advantages that are particularly worth mentioning are as follows: • The presence, in the supplements obtained in this way, of substantial amounts of calcium and other minerals in greater quantities than in the commonly used dietary supplements. • A high degree of intestinal absorption and bioavailability of the minerals that are contained in the supplement for the bones and the body and, therefore, a greater efficiency and efficacy in comparison to the commonly used products. • A high degree of tolerance to the supplement, much higher than that of dairy products, as a result of solving the problem of lactose. • Lower amounts of cholesterol that is absorbed compared to the various dairy products that are recommended in diets for osteoporosis. • Optimal efficacy due to the presence in the supplement of a complete nutritional profile of biological origin, and not a simple 'mixture' of substances unrelated to each other. additional "that operate along with the mineral profile, a variety of these confer current advantages to be achieved that are unattainable in the other commonly recommended dietary supplements and nutritional substances: - branched chain amino acids (beneficial to the entire musculoskeletal system) - polysaccharides ( advantageous for the elderly and for diabetics) - vitamins (which complete the nutritional profile) • The substance, which can be obtained by lyophilization as a dry powder with a pleasant taste, is presented in very practical formulations, such as chewable tablets and sachets with the contents to be dissolved in liquids, with, among other things, also allow high doses of the product to be administered by a single daily administration.This is also because the formulation that is obtained makes any prolonged or delayed release form of the substance is superflu • Finally, the formulation derived from the fermentation process' Kéfir type "has proven to be ideal, and consequently differs completely from the others calcium and mineral supplements, for constituting a multifunctional 'substrate' as the basis for producing dietary supplements in various areas of application for preventive and / or supportive treatments in various conditions of deficiencies (poor nutritional diets, metabolic dysfunctions), immunodeficient states , degenerative diseases (of the bones, skin dystrophy), senility, physiological transition periods (menopause) In all these applications, an important role is probably played in the multifunctional 'probiotic' activity of the biological matrix of lactobacilli and yeasts and their immunostimulant and bioprotective activity as studied by various researchers.

It is noted that in relation to this date, the best known method for the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects or products to which it refers.

Claims (6)

CLAIMS Having described the invention as above, the content of the following claims is claimed as property:

1. A process for the preparation of dietary supplements by natural fermentation, characterized in that it comprises the following steps: a) preparing a mixture at 18 ° C comprising one or more types of pasteurized milk of animal origin; b) add to this mixture 1.5-4.5% by weight of the first granules consisting predominantly of bacteria; c) maintaining the mixture at 18-25 ° C for an initial period of time ranging from 6 to 12 hours and subsequently adding, after about half the process, 1-3% by weight of this pasteurized milk mixture; d) adding to the mixture 2.5-6.5% by weight of the second granules consisting predominantly of yeasts; e) keep the mixture obtained in this way at 18-25 ° C for a second period of time ranging from 6 to 12 hours and add to it, calcium and / or magnesium and / or potassium in amounts of 1-2% by weight during the first half of this second period of time; f) filtering a residual matrix consisting of the granules that are introduced in the various stages of the process and the granules that are formed during the process itself; g) Dry the mixture after filtration to obtain a powder.

2. The process according to claim 1, characterized in that: h) the mixture comprises 50-100% by weight of cow's milk and 0-50% by weight of • at least one milk selected from a group consisting of sheep's milk, goat's milk, and mare's milk; i) the first granules consisting predominantly of bacteria are of the type used for the production of Kefir and contain: Lactobacillus brevis 106-107 Lactobacill us casei 106-107 106-107 Lactobacill us plantarum Lactobacill us kefir 10 -10- (optionally, "addition" of 20-30%) Lactobacill us 107-108 (optionally, "addition" kefir year Faciens 20-30% Acetobacter aceti 106- 107 Leuconostoc 105-106 mesenteroids Streptococcus lactis 104-105 Others 105-106 Saccharomyces lactis 103-104 Saccharomyces 105-106 cerevisiae Saccharomyces fragili s 104-105 Candida kefir 104-105 1) After the introduction of the first granules, Lactobacill us kefir and Lactobacillus kefiranofaciens bacteria can be added in amounts of 20-30% by weight of bacteria of the same species that are already present in the first granules. m) the second granules consist predominantly of yeasts containing: Lactobacill us brevis 105-106 Lactobacill us casei 105-106 105-106 Lactobacill us plantarum Lactobacill us kefir 106-107 106- 107 Lactobacill us Acetobacter aceti kefirano faci ens 105-106 Leuconostoc mesenteroides Streptococcus lactis 104-105 104-105 105- Other 106 Saccharomyces lactis 10 5- -1t n06 Saccharomyces 106-107 cerevi siae Saccharomyces fragili s 105-10d Candi da kefir 106-107 Others 105-106

3. The process according to claim 2, characterized in that the initial mixture comprises 80% by weight of cow's milk and 20% by weight of sheep's milk.

4. The process according to any of the preceding claims, characterized in that it also comprises the following steps: add flavoring agents, optionally add an adherent agent to confer the powder a greater cohesion and compact the powder that is added in this way to obtain chewable tablets.

5. A dietary supplement obtained by the process described according to any of the preceding claims.

6. Use of a dietary supplement obtained via the process according to the preceding claims for preparing a composition for the prevention and treatment of osteoporosis and other diseases due to calcium deficiency, magnesium and potassium in the body. SUMMARY OF THE INVENTION A process for manufacturing dietary supplements (food integrators) by means of natural fermentation is described which includes the following steps: a) preparing a 'mixture' at 18 ° C containing one or more types of pasteurized milk of origin animal; b) introduction in this 'basic material' of 1.5-4.5% by weight of 'granules' of polysaccharides that are formed mainly from 'friendly bacteria'; c) maintenance of the previous substance at 18-25 ° C temperature for a first period of time of 6-12 hours and then adding an amount of 1-3% by weight of a second combination of 'granules' of polysaccharides, which they are formed mainly of yeasts, d) maintenance of the substance at 18-25 ° C during a second period of time of 6-12 hours, again when adding 2.5-6.5% by weight of 'granules' that are formed mainly by yeast, and then add some minerals (calcium, magnesium, etc.) in a proportion of 0.2-1.2% by weight; e) separation, by filtration, of the different components of the substances, among which there is a 'residual matrix' composed of polysaccharide granules containing bacteria and yeasts, f) drying the substance, after the filtration, to obtain a fine powder; g) preparation of the various dietary supplements, which are presented in tablets or "sachets" or other formulations, useful for the treatment of osteoporosis and other degenerative conditions.