HK1036384A - Dietary supplement derived from fermented milks for the prevention of osteoporosis - Google Patents

Description

Food fortifier from fermented milk for preventing osteoporosis

The present invention relates to a product for nutrition and dietary supplementation as a dietary supplement or a nutrition enhancer, which employs substances mainly of natural origin to supplement elements essential for nutrition, thereby well maintaining important body functions (e.g., formation and maintenance of bones, muscles, skin, related tissues, etc.).

More precisely, the present invention relates to a method for obtaining natural dietary supplements which have proven to be very effective in the prevention and treatment of osteoporosis and other diseases mainly caused by calcium, magnesium and potassium deficiency in the body.

With the current technical and scientific knowledge of the individual, it is well known that the proper supplementation of various nutrients, commonly known as "nutrients" (such as minerals, vitamins, proteins and others), the deficiency or imbalance of which is often accompanied by actual pathological conditions, in particular those of the "degenerative" and/or chronic type, which can affect parts of the body, such as in particular the bones and the blood vessels, is crucial for the normal development of the body tissues and for the vital functions of the body.

It is also known that the main nutrients are taken up by the diet, and therefore, if the latter are adequate and balanced enough, and if the body's absorption and conversion of these nutrients is in a normal functional state, it follows that there should be no problem in maintaining good health conditions. In fact, it often happens that the diet of an individual, even in industrialized countries, presents a problem of lack and/or excessive unbalance, which can cause serious damages to health over time. Many diseases treated with different drugs are also often caused by unbalanced nutrient intake, and it is well known that these diseases can be prevented, even cured, by restoring an already lost balance.

Moreover, it is also known that a large number of products, commonly defined as food enhancers, have been produced to solve the above-mentioned problems and are therefore a state of the art. These fortifiers consist of a combination of different substances (nutrients) obtained by mixing, according to a specific formulation, through chemical synthesis or extraction processes of different raw materials (vitamins, minerals of vegetable or animal origin), in the form of tablets or capsules or other orally administrable dosage forms. The administration of these formulations presents a series of drawbacks, the most important being: 1) the source of the nutrients used (obtained by synthesis or extraction) is generally not suitable for the human body; 2) absorption is difficult due to the source and type of raw materials used, substantially limiting the bioavailability of the administered substance; 3) the respective proportions of the different nutrients contained in the administered product are usually predetermined independently of each other, and should be taken into account without considering the actual balance between properties and metabolic processes, which constitutes one of the key factors for an effective balanced diet as described above, required for healthy conditions and physical state.

In view of the above, the inventors concluded that a solution to the above-mentioned problems, which is extremely useful for the health and balance of the body, should be sought in a completely natural production process, i.e. to "guide" chemically transformed microorganisms, such as lactobacilli and yeasts, specifically by biological methods, to influence them in a desired way.

The well-developed and healthy-maintained condition of the muscular-skeletal system, particularly the skeleton, is recognized as a fundamental, widespread health problem.

Dietary problems and the use of certain drugs, as well as degenerative processes due to aging, are associated with the induction of osteoporosis (including a decrease in bone density and elasticity with a consequent increase in fragility) and inflammatory and painful side-effects, and ultimately even the risk of causing a sudden fracture (in this case, not caused by significant, severe trauma). The "high risk" population is most notably women, especially menopausal or postmenopausal women, and individuals with a particular "genetic risk", the latter accounting for 15% or more of the total population as shown by specific analysis.

There are currently a number of drugs available for this disease, but it has been established that the best way to prevent and treat osteoporosis must be to properly supplement the diet with minerals such as calcium and magnesium, and possibly vitamin D₃. However, this "supplementation" is mainly achieved by the administration of poorly absorbed products, the biological quality of which is unsatisfactory, containing inorganic calcium or calcium which is not absorbed anyway in the intestine due to a series of factors, which hampers its absorption to a substantial extent. As an alternative to such supplementation, diets rich in milk and cheese products are often recommended; they provide an abundance of calcium (as well as magnesium), but unfortunately there are still many problems that are often underestimated, such as a) poor digestibility or lactose intolerance; b) excessive cholesterol levels; c) undesirable caloric and fat intake.

The inventors have therefore found a solution which allows the above problems to be better overcome by obtaining a product in the form of an enhancer which can prove to be effective, reliable and inexpensive, i.e. a product which: 1) ensuring a supply of appropriate amounts of calcium, magnesium and other nutrients that are useful to the bone and to the metabolism for the purpose of musculo-skeletal function; 2) ensure the absorption of different nutrients; 3) ensuring digestibility and avoiding intolerance; and 4) features of fully biocompatible biomaterials.

To this end, the inventors have found a method, which is also the subject of the present invention, depicted in the preamble of claim 1, the inventive features of which are disclosed in the characterizing part of said claim.

The invention also relates to dietary supplements obtainable by said method and to the use thereof for the prevention and treatment of osteoporosis and other diseases essentially caused by calcium, magnesium and potassium deficiency.

The process according to the invention makes it possible to obtain "nutrient complexes", which are defined as nutrients of natural origin, as a result of the biological processing of microorganisms (so-called "beneficial microorganisms", such as lactobacilli, etc.), containing all the required nutrients, in particular calcium, magnesium and potassium, with the desired good absorption, tolerance and efficacy characteristics. The inventors first selected products obtainable from different types of fermented milk, which differ in the type of milk (cow, sheep, goat, mare) and the type of microorganism used, as well as the form of the fermentation process carried out. A specific type of fermented product was thus identified, in the same class as a substance traditionally known by the middle east and eastern european countries under the name gavage yoghurt (Kefir), with characteristics most suitable for "nutrient complexes".

The Caucasian yoghurt is one kind of yoghurt, can be obtained by fermenting milk through double functions of various lactobacilli and yeasts, and can be used for obtaining a biological processing product with required characteristics through proper combination. The addition of a desired substance (such as calcium, but not exclusively) during fermentation allows "enrichment" of the nutrient complex, making it particularly useful for certain types of applications (such as the treatment of osteoporosis). The microorganisms process one or more minerals, fix them in their cells and ensure their bioavailability.

In order to achieve the desired objects, the inventors concluded, after carefully studying the conventional natural methods practiced in the above-mentioned fields, that a method for obtaining a natural food enhancer with high efficacy may be a method of processing in a predetermined order using an appropriate mixture of microorganisms and purposely adding useful substances during the processing, and appropriately adjusting the time and temperature of the various steps of the processing.

Operating in this manner, a method has been found which is suitable for producing highly effective dietary supplements which achieve an adequate level of fortification for practical therapeutic purposes.

As will be pointed out in the subsequent part of the present description, the dietary supplements obtained by the method according to the invention, which contain a broad spectrum and high concentrations of organic substances with beneficial effects, not only prove to be useful as an important means, as described hereinbefore, for the prevention and treatment of conditions caused by calcium, magnesium and potassium deficiencies, but also to exert an ancillary beneficial effect on a variety of other disorders caused by genetic as well as chemical functional imbalances.

We will now describe an embodiment of the method according to the invention, which is neither restrictive nor exclusive.

The method essentially comprises the following steps:

a) preparing a mixture comprising pasteurized milk of one or more types of animal origin at 18 ℃;

b) adding to said mixture 1.5-4.5% by weight of first particles consisting essentially of bacteria;

c) maintaining the mixture at 18-25 ℃ for an initial period of time of 6 to 12 hours, and subsequently adding 1-3% by weight of said pasteurized milk mixture after about half of the process;

d) adding to the mixture 2.5-6.5% by weight of a second granule consisting essentially of yeast;

e) maintaining the resulting mixture at 18-25 ℃ for a second period of time of 6 to 12 hours, to which 0.2-1.2% by weight of calcium and/or magnesium and/or potassium are added during the first half of said second period of time;

f) filtering off residual matrix consisting of particles introduced in the different steps of the process and particles formed during the process;

g) the mixture was dried after the filtration to give a powder.

The first and second particles may be obtained using conventional milk-inoculating procedures, fromCommercially available caucaso yogurt particles begin. For standardization of the particle composition, control and identification of bacteria is required, the first particles consisting essentially of bacteria can be referred to in textbooks m.motaghi et al (1997), Kandler-Weiss (1986) and Hardle (1986), and the second particles consisting essentially of yeast can be referred to in Barnet (1990). All of the above publications are incorporated herein by reference. An illustration of the composition of the particles can be derived from the attached tables a and B. The first particle (Table A) was predominantly the bacterium Lactobacillus brevis 10⁶-10⁷Lactobacillus casei 10⁶-10⁷Lactobacillus plantarum 10⁶-10⁷Lactobacillus kefir yoghurt 10⁸-10⁹(optionally "increasing" 20-30%) Lactobacillus malus 10⁷-10⁸(optionally "increasing" 20-30%) Acetobacter acidificus 10⁶-10⁷Leuconostoc mesenteroides 10⁵-10⁶Streptococcus lactis 10⁴-10⁵Others 10⁵-10⁶Lactic acid yeast 10³-10⁴Saccharomyces cerevisiae 10⁵-10⁶Brittle wall yeast 10⁴-10⁵Canagasuo sour milk candida 10⁴-10⁵The second granule (Table B) is mainly Lactobacillus brevis 10⁵-10⁶Lactobacillus casei 10⁵-10⁶Lactobacillus plantarum 10⁵-10⁶Lactobacillus kefir yoghurt 10⁶-10⁷Lactobacillus kefiranoides 10⁶-10⁷Acetobacter acidificans 10⁵-10⁶Leuconostoc mesenteroides 10⁴-10⁵Streptococcus lactis 10⁴-10⁵Others 10⁵-10⁶Lactic acid yeast 10⁵-10⁶Saccharomyces cerevisiae 10⁶-10⁷Brittle wall yeast 10⁵-10⁶Canagasuo sour milk candida 10⁶-10⁷Others 10⁵-10⁶

Due to the mixing of specific bacteria and yeasts, the obtained food enhancer has outstanding characteristics which are significantly superior to those of the caucasian yoghurt (and other yoghurts), mainly as follows:

1. in biological substances rich in minerals, such as calcium, magnesium and potassium, the dietary supplements are surprisingly much more abundant in "high-value" substances than others, which are complementary to their specific fortification and overall value, such as branched-chain amino acids, polysaccharides and vitamins. These nutrients have been shown to significantly enhance intestinal absorption of calcium and metabolism of various minerals.

2. The action of the microorganisms on lactose is to convert it into lactic acid, which in turn is a calcium absorption "enhancer", and furthermore reduces the risk of lactose intolerance. This should also be related to the fact that the microorganism itself produces an enzyme, galactosidase, rendering lactose digestible. Finally, they can essentially reduce cholesterol absorption, thereby protecting the body from well-known threats.

3. The presence of polysaccharides (slow intake carbohydrates) also generally makes the product suitable for diabetic and elderly patients. Branched chain amino acids are also important elements for elderly patients, since they have a basic function on the growth and maintenance of muscle fibers (thereby also providing additional assistance to the entire musculoskeletal system).

The following is a detailed description of the product ingredients. First, examples are given of formulations (nutrient complexes) selected using the fermentation process according to the invention (tables 1 to 5) aimed at supplementing minerals such as calcium, magnesium and potassium according to the criteria of the invention itself; the composition of the dietary supplements is then presented (Table 6), which are prepared by "purposefully enriching" the raw material substances and are suitable for preventive and therapeutic applications in the field of osteoporosis.

The composition of the fermented material obtained with the process according to the invention:

TABLE 1

General analysis

Ingredient% ±% protein 4515 moisture 510 fat (1) total lipid 42 fiber 32 carbohydrate 3010 mineral (ash) 138 per gram Heat 2.8

TABLE 2

Mineral (mg, per 100g product) ingredient (±) potassium 224020 phosphorus 132015 magnesium 18030 sodium 68015 calcium 166020 zinc 2.320 iron 4.510 chromium 146 μ g selenium 13.3 μ g copper 0.320 manganese trace

TABLE 3

Vitamins (mg, per 100g product)

Ingredient (+/-25%)

B₁(Thiamine) 6.6

B₂(Riboflavin) 5.6 Niacin 54B₆(pyridoxine hydrochloride) 4B₁₂50 μ g Folic acid 1.4 Biotin (H) 180 μ g inositol 300 Choline 453.3 para aminobenzoic acid 2.4

TABLE 4

Amino acid (mg, per 100g product) ingredient (+ -20%) arginine 3200 glutamic acid 13100 histidine 2000 isoleucine 4300 leucine 7500 lysine 6700 methionine 1400 phenylalanine 3500 threonine 5200 tryptophan 1800 tyrosine 3200 valine 4800

56700

TABLE 5

The total nucleic acid content (+ -30%) is 8-9%

Examples of dietary supplements for osteoporosis:

TABLE 6

Content (approx. 5% approximation) g value 100g cachets (10g) 2 tablets (12g) protein 454.55.40 carbohydrate 303.03.60 fat 10.10.12 total lipid 40.40.48 fiber 30.30.36 mineral 131.31.56 moisture 40.40.48 calorie 28028.033.60

The food fortifiers prepared according to the method of the present invention are proved to have the required characteristics effectively through extensive trial and experiment, and are obviously superior to the traditional calcium fortifiers obtained at present. The advantages which are particularly noteworthy are as follows:

● the content of calcium and other minerals in the obtained fortifier is higher than that of the conventional food fortifier.

● the mineral substance contained in the bone and body fortifier has high intestinal absorption and bioavailability, and thus has higher efficiency and efficacy than conventional products.

● the high tolerability of the fortifier is much higher than that of dairy products as it solves the lactose problem.

● the absorption of cholesterol is lower than that of the dairy products recommended by the osteoporotic diet.

● the fortifier contains nutrients of biological origin in their entirety and therefore functions optimally, not merely as a simple "mix" of substances that are not related to each other. Among the substances that provide the relevant "additional aid" to the mineral, many offer practical advantages that are not achieved by other generally recommended dietary supplements and nutrients:

branched chain amino acids (beneficial to the whole musculoskeletal system)

-polysaccharides (for the elderly and diabetics)

Vitamins (to make the nutritional structure more complete)

● the substance is obtained in the form of a dry powder by freeze-drying, has a pleasant taste, and can be formulated into very practical preparations such as chewable tablets and cachets, the ingredients of which are soluble in a liquid, and in particular, it also allows the administration of large doses of the product once a day. This is also because the resulting formulation may be any delayed or sustained release dosage form containing the excess substance.

● finally, the preparation obtained by the fermentation process of the "gavage yoghurt type" has proved to be ideal-and therefore completely different from other calcium and mineral fortifiers-for constituting a multifunctional "matrix", which is the basis for the preparation of food fortifiers for different fields of application, for the prevention and/or the adjuvant treatment of various deficiencies (poor dietary nutrition, metabolic dysfunction), immunodeficiency states, degenerative diseases (skeletal, cutaneous dystrophy), ageing, periods of physiological excess (menopause).

Studies by different researchers have shown that in all these applications, the multifunctional "life-gen" activity of the biological matrix of lactobacilli and yeasts and their immunostimulatory and bioprotective activities probably play an important role.

Claims (6)

1. A method for preparing a dietary supplement by natural fermentation, characterized in that the method comprises the steps of:

a) preparing a mixture comprising pasteurized milk of one or more types of animal origin at 18 ℃;

b) adding to said mixture 1.5-4.5% by weight of first particles consisting essentially of bacteria;

c) maintaining the mixture at 18-25 ℃ for an initial period of time of 6 to 12 hours, and subsequently adding 1-3% by weight of said pasteurized milk mixture after about half of the process;

d) adding to the mixture 2.5-6.5% by weight of a second granule consisting essentially of yeast;

e) maintaining the resulting mixture at 18-25 ℃ for a second period of time of 6 to 12 hours, to which 0.2-1.2% by weight of calcium and/or magnesium and/or potassium are added during the first half of said second period of time;

f) filtering off residual matrix consisting of particles introduced in the different steps of the process and particles formed during the process;

g) the mixture was dried after the filtration to give a powder.

2. The method of claim 1, wherein:

h) the mixture comprises 50-100 wt.% of cow's milk and 0-50 wt.% of at least one milk selected from the group consisting of sheep's milk, goat's milk and horse's milk;

i) the first particles, which consist essentially of bacteria, are of the type used to produce gavage yoghurt, contain: lactobacillus brevis 10⁶-10⁷Lactobacillus casei 10⁶-10⁷Lactobacillus plantarum 10⁶-10⁷Lactobacillus kefir yoghurt 10⁸-10⁹(optionally "increasing" 20-30%) Lactobacillus malus 10⁷-10⁸(optionally "increasing" 20-30%) Acetobacter acidificus 10⁶-10⁷Leuconostoc mesenteroides 10⁵-10⁶Streptococcus lactis 10⁴-10⁵Others 10⁵-10⁶Lactic acid yeast 10³-10⁴Saccharomyces cerevisiae 10⁵-10⁶Brittle wall yeast 10⁴-10⁵Canagasuo sour milk candida 10⁴-10⁵

l) after the introduction of said first granule, Lactobacillus kefir and Lactobacillus malus may be added in an amount of 20-30% by weight of the same species of bacteria already present in said first granule;

m) said second granules consisting essentially of yeasts contain: lactobacillus brevis 10⁵-10⁶Lactobacillus casei 10⁵-10⁶Lactobacillus plantarum 10⁵-10⁶Lactobacillus kefir yoghurt 10⁶-10⁷Lactobacillus kefiranoides 10⁶-10⁷Acetobacter acidificans 10⁵-10⁶Leuconostoc mesenteroides 10⁴-10⁵Streptococcus lactis 10⁴-10⁵Others 10⁵-10⁶Lactic acid yeast 10⁵-10⁶Saccharomyces cerevisiae 10⁶-10⁷Brittle wall yeast 10⁵-10⁶Canagasuo sour milk candida 10⁶-10⁷Others 10⁵-10⁶

3. The method of claim 2, wherein the initial mixture comprises 80% by weight cow's milk and 20% by weight sheep's milk.

4. The method of any preceding claim, characterized in that the method further comprises the steps of: adding a flavoring agent; optionally adding a binder to impart greater cohesion to the powder; the added powder is compacted to obtain chewable tablets.

5. A dietary supplement obtainable by the method of any preceding claim.

6. Use of a dietary supplement obtained by the method according to the preceding claim, for the preparation of a composition for the prevention and treatment of osteoporosis and other diseases caused by calcium, magnesium and potassium deficiency in the body.