Compositions based on clay and beepollen, method for preparing same and nutritional and therapeutic uses thereof

Abstract

The present invention relates to complexes of beepollen and clay, as well as to their preparation methods and to their therapeutic uses or as a food supplement, a functional food, in human and animal healthcare.

Claims

1. A combination consisting of: beepollen and clay, in the form of a beepollen/clay complex formed by mechanical mixing and passing the mixture through a sieve having a predetermined mesh size, in which, if stored without freezing, the properties of fresh beepollen are preserved after storage without freezing when compared to uncomplexed beepollen.

2. The combination according to claim 1, such that the clay is selected from clays of the kind: kaolinites, smectites, illites and chlorites or fibrous minerals.

3. The combination according to claim 1, such that the clay is montmorillonite.

4. The combination according to claim 1, comprising: from 4% to 90% of beepollen; from 10% to 96% of clay; and the percentages being understood by weight.

5. The combination according to claim 1, comprising: from 20% to 40% of beepollen; and from 60% to 80% of clay.

6. The combination according to claim 1, such that it has a grain size of less than 500 μm, a humidity level of less than 15% and/or a water activity (wa) of less than 0.75.

7. A method for preparing a combination according to claim 1, comprising: mechanically mixing beepollen and clay; and then passing the mixture through a sieve having a predetermined mesh size, whereby the properties of fresh beepollen are preserved after storage and without freezing compared to uncomplexed beepollen.

8. A pharmaceutical composition comprising: a combination according to claim 1, and optionally one or several pharmaceutically acceptable excipients.

9. A method for treating osteoporosis, cardiovascular diseases, cancers, liver and metabolism disorders, circulatory disorders, menopausal symptoms, disorders of the nervous system, disorders of the gastrointestinal system, ocular disorders, fatigue, articular disorders, urinary disorders, prostate disorders, nutritional disorders, dermatological and cosmetodermatological disorders and hydro-electrolytic imbalances including administering a combination according to claim 1.

10. A food composition comprising: a combination according to claim 1.

11. A gelatin capsule containing a combination of clay and beepollen according to claim 1.

12. A drug comprising as a carrier, a combination of clay and of beepollen according to claim 1.

13. A method according to claim 9 wherein the method is for treating prostate disorders that is benign hypertrophia of the prostate, chronic prostatitis, prostatodynia and prostate cancer.

14. A method of treatment during convalescence or post-surgery comprising administering a combination of claim 1.

15. A method of improving in physical conditions comprising administering a combination of claim 1.

Description

EXAMPLE 1

Preparation of Beepollen/Clay Complexes

(1) Hardware:

(2) Precision electronic scales—Mettler Toledo PG803

(3) Stirrer—IKA Labotechnik Eurostar

(4) Glass beaker 250 mL—Bomex

(5) Spoon-shaped curved spatula, in stainless steel 18/8—Labo-moderne

(6) Suppliers of Raw Materials:

(7) Sunflower beepollen frozen under nitrogen gas: Pollenergie, La Grabère—47450 Saint-Hilaire de Lusignan; Tel. 05 53 68 11 11—Fax. 05 53 68 11 12

(8) Montmorillonite clay, Argiletz, 14 route d'Echampeau—77 440 Liz-sur-Ourcq, Tel. 01 60 61 20 88—Fax. 01 60 61 27 39.

(9) 9 different compositions (%) of the complex were made: 100 clay/0 beepollen, 90 clay/10 beepollen, 80 clay/20 beepollen, 66.66 clay/33.33 beepollen, 50 clay/50 beepollen, 33.33 clay/66.66 beepollen, 20 clay/80 beepollen, 10 clay/90 beepollen, 0 clay/100 beepollen.

(10) The illustrative operating procedure is described in more detail hereafter:

(11) For preparing 150 g of beepollen/clay complex: the proportion of each of the components is 66.66% of clay for 33.33% of beepollen. Weigh 100 g of clay in a 250 mL beaker; Weigh 50 g of frozen beepollen in a 250 mL beaker; The parts of the stirrer are preferably dried in order to avoid hydration of the complex; Mix the clay; Add the beepollen and leave mixing on for 30 seconds.

(12) The desired grain size is obtained by sifting by means of a sieve with a mesh of 500 μm.

(13) If a threshold is placed at 10% of the maximum effect, a window is determined in which the complexes have a significant effect, corresponding to: beepollen: from 4.5% to 87.6% with preference for 33.33%; clay from 95.5% to 12.4% with preference for 66.66%.

(14) The thereby prepared complexes were characterized. Their product characteristics may be summarized in the table hereafter:

(15) TABLE-US-00001 ANALYSES SPECIFICATIONS Aspect Powder Color Grey-green Odor Specific Taste Bitter Texture Granular Grain size Less than 500 μm Foreign bodies Absent Density NA Ph NA Humidity Less than 15% Wa Less than 0.75 Viscosity NA Energy value 50 kcal/100 g< <400 kcal/100 g Lipids 1%< <5% Carbohydrates 15%< <28% Proteins 3%< <11%

(16) Tests for evaluating the efficiency of the complex on the synergy of the components were conducted. The composition with 66.66% of clay and 33.33% of beepollen has maximum efficiency.

EXAMPLE 2

Study of the Properties of the Beepollen/Clay Complex of Example 1

(17) Counting the Total Lactic Bacteria

(18) The species of lactic bacteria contained in the beepollen are not clearly identified. The test which gave the possibility of counting the largest majority of the species of lactic bacteria (ISO 15214 standard) was therefore used. Lactic bacteria of the ingredients (clay and beepollen): In order to evaluate the advantages of the beepollen/clay complex, the arbitrary amount of lactic bacteria of each of the ingredients was estimated first of all.

(19) The clay has 0 CFU/g.

(20) The beepollen has 152 CFU/g. Lactic bacteria of the beepollen/clay complex: By means of the specific counting on beepollen and clay, the amount of lactic bacteria of the complex (by taking into account the clay and beepollen proportion of the complex) was therefore estimated (FIG. 1).

(21) Thus, the beepollen/clay complex should, according to our estimation contain 50.7 CFU/g.

(22) Now, the measurements show that the beepollen/clay complex contained 481 CFU/g.

(23) The complex has 9.5 times more lactic bacteria than the estimation.

(24) Development of Fungi

(25) Fungus is an ambiguous vernacular name which designates certain filamentary microscopic microorganisms from the kingdom of mycetes. There exist thousands of different varieties of them. They are pluricellular organisms which may attain up to 35 meters in length.

(26) Some fungi are sources of food intoxication by the mycotoxins which they secrete (patulin, etc.). Fungi of the ingredients (clay and beepollen): In order to evaluate the advantages of the beepollen/clay complex, the amount of fungi from each of the ingredients was estimated first of all.

(27) The clay has 0 fungus/g.

(28) The beepollen has 2,900 fungi/g. Fungi of the beepollen-clay complex: By the specific counting on beepollen and on clay, the amount of fungi of the complex (by taking into account the clay and beepollen proportion of the complex) was estimated (FIG. 2).

(29) Thus, the beepollen/clay complex should, according to this estimation, contain 967 fungi/g. Now, measurements show that the beepollen/clay complex contained 350 fungi/g.

(30) Absorbing Power of the Beepollen/Clay Complex

(31) The absorbing power was measured according to the following procedure: 1) Place a filter on a beaker containing water. The water gradually moistens the filter which is only slightly immersed in the water. 2) Delicately deposit the clay (or the beepollen or the complex) on the paper filter. The directly deposited material in contact with the paper filter absorbs water. 3) By capillarity, the absorption of water is gradually achieved towards the center of the deposited material. 4) The clay becomes completely impregnated with water. The weight difference between dry clay and humid clay gives the absorption capacity of the clay.

(32) In a first phase, the absorption capacity of each of the ingredients was measured: the clay has the capacity of absorbing 74.38% of its weight; the beepollen has the capacity of absorbing 19.46% of its weight.

(33) By measuring the specific absorption capacity of the beepollen and of the clay, the absorption capacity of the complex was estimated by taking into account the clay and beepollen proportion of the complex. Thus, the beepollen-clay complex should, according to this estimation, absorb 56% of its weight. Now, the measurement shows that the beepollen-clay complex absorbs 65.5% of its weight. The beepollen-clay complex therefore has an absorbing power which is 9.5% greater than the estimation (FIG. 3).

(34) The absorption rate was also measured for each of the ingredients at different times after putting them in contact with water and by evaluating at different points, the slope of the curve. Thus, the clay has a greater absorption rate than the beepollen. By measuring the specific absorption rate of the beepollen and of the clay, the absorption capacity of the complex at different measured times was estimated by taking into account the clay and beepollen proportion of the complex. The measurements conducted with the complex show that the beepollen/clay complex absorbs water faster than the estimation stemming from the sum of both ingredients (within two hours of time, the absorbed percentage is 2.2 times greater), and also faster than clay alone (within two hours of time, the absorbed percentage is 1.8 times greater). Therefore there is a synergistic effect of the beepollen and of the clay on the absorption capacity (FIG. 4).

(35) Retention Capacity of the Beepollen/Clay Complex

(36) In order to evaluate the retention capacity (the products, clay, beepollen and complex) were left to absorb the maximum of water. Thus, the volume of absorbed water for each product (corresponding to the values obtained during the absorption measurement) was determined, and then the products were left to naturally dehydrate (controlled room temperature and humidity level) and the water loss was calculated (percentage relatively to the absorbed volume). The results show that: beepollen dehydrates more rapidly than clay; clay completely (and only) loses the water that it has absorbed while beepollen not only loses the absorbed water but also the water contained in the beepollen grain.

(37) After maximum absorption, the material was withdrawn from the contact with water. The water loss is then measured at different times and illustrated as a percentage of maximum absorbed water. By the measurements of the water retention capacities for the different ingredients, the retention capacity of the beepollen-clay complex was estimated. The measurements obtained experimentally with the complex show a more significant retention power than the one estimated considering the respective proportions and capacities of its components. The complex retains liquids better than the estimation (FIG. 5).

(38) After more than 5 days at room temperature (controlled humidity), the complex retains 15% of its weight in addition to what is expected. The formulation of beepollen and of clay gives the possibility of obtaining a product for which the retention capacity is potentialized. These characteristics show the possibility of adding products which will be preserved in the final product.

(39) Adsorption Capacity

(40) The adsorbing power may be determined by gradual introduction of a colored reagent (cation) into an aqueous suspension of clay until saturation. A methylene blue test was conducted: it is a colored cation which was adsorbed preferentially by clays of the montmorillonite type. It is a test commonly used in geotechnics for determining the cleanliness of a sol and the clay proportion which it contains (NF P 94-068).

(41) The test is carried out by successively adding doses of a methylene blue solution into an aqueous suspension of clay and by checking the adsorption of the colored solution by a spot test on a paper filter in order to detect the presence of free coloring agent. Methylene blue has the property of being rapidly adsorbed by clay. As long as the methylene blue is adsorbed, it does not color the water of the solution. This is checked by depositing a drop on a paper filter: the center of the spot is bright blue (a clay having adsorbed the blue) and the halo of the spot remains colorless. From a certain dose of methylene blue, the halo also becomes colored: this is the sign that all the clay has depleted its adsorption capacity (saturation). The consumed amount of blue is therefore an indication of the adsorption capacity of the tested product. The blue value is expressed by the amount of blue in consumed grams per gram of product.

(42) 3 g of clay (montmorillonite) are homogenized in 20 mL of demineralized water. Successive additions of 1 mL of 10 g/L methylene blue solution are performed until saturation. The saturation corresponds to the moment when a blue halo is formed on the paper filter; the result is confirmed by repeating the spot test every minute for 5 minutes without adding any methylene blue solution.

(43) It is noted that the blue halo slightly persists from an addition of 19 mL of methylene blue. By taking this value, it is possible to determine the blue value of clay as being 63.6 mg of blue/g of clay.

(44) 3 g of beepollen are homogenized in 20 mL of demineralized water. As the beepollen does not have any adsorbing properties, successive additions of 0.1 mL (and then of 1 mL starting from 1 mL) of 10 g/L methylene blue solution are performed. The saturation corresponds to the moment when a blue halo is formed on the paper filter; the result is confirmed by repeating the spot test every minute for 5 minutes without adding any methylene blue solution. The blue halo slightly persists as soon as 0.1 mL of methylene blue are added. Therefore, the beepollen does not have any adsorbing capacity (0 mg of blue/g of beepollen).

(45) 3 g of beepollen-clay complex are homogenized in 20 mL of demineralized water. Successive additions of 1 mL of 10 g/L methylene blue solution are performed until saturation. Saturation corresponds to the moment when a blue halo is formed on the paper filter. The result is confirmed by repeating the test of the spot every minute for 5 minutes. At 12 mL of added blue, the halo slightly persists even after 25 minutes. This is the saturation volume. The blue value of the beepollen-clay complex is therefore 42.2 mg of blue/g of clay (FIG. 6).

(46) These results show that the estimated adsorption capacity of the complex is compliant with the measured adsorbing power. Nevertheless, this test also shows that the blue halo initially visible disappears over time. This shows that exchanges occur between the beepollen and the clay.

(47) Balance of the Synergies Between the Clay and the Beepollen

(48) Being aware of the intrinsic properties of beepollen and of clay, the following properties of the beepollen/clay complex were established. The results greatly exceed the estimations and confirm the synergies exerted by the combination of the beepollen and of the clay.

(49) The whole of the advantages (/estimations) is illustrated in the following table:

(50) TABLE-US-00002 ABSORPTION +9.5% Prevents dehydration of the beepollen grain RETENTION +15% May retain substances ADSORPTION = May retain active molecules and lactic ferments EXCHANGE CAPACITY 200% Promotes beepollen—clay exchanges LACTIC FERMENTS ×9.5 Increases the load of lactic bacteria FUNGI /3 Reduces the formation of fungi Greater effect/estimations Synergy of the beepollen/clay complex

(51) These characteristics confirm the extremely interesting properties of the complex since the characteristics of beepollen are preserved and certain contributions such as that of lactic ferments are potentialized. The retention capacities will also allow addition of new molecules/substances which will be adsorbed by the complex.

(52) Examples 1 and 2 were repeated with other types of clays: kaolinites, illites, fibrous minerals.

(53) The results are summarized in the following table:

(54) TABLE-US-00003 Representative Exchange Lactic clay Absorption Retention Adsorption capacity ferments Fungi Kaolinites Kaolin +11% +1% = 20% ×3   /1.3 Illites Illite +12% +2% = 55% ×2.5 /1.2 Smectites Montmorillonite +9.5%  +15% = 200% ×9.5 /3   Chlorites Attapulgite +17% +5% = 240% ×3.5 /1.5 or fibrous minerals

EXAMPLE 3

Preparation of a Gelatin Capsule

(55) A capsule with a hard casing, or gelatin capsule, including a prefabricated casing consisting of two cylindrical portions open at one end and the bottom of which is hemi-spherical, was prepared. The complex in solid form (powder or granules) is introduced into one of the two portions, and the second one is then fitted on to the first. The capsules Vcaps®, marketed by Pfizer, were used for this purpose. The skin of the gelatin capsule is hypromellose, certified to be without starch, without gluten and without preservatives.

(56) The gelatin capsule comprises 500 mg of the beepollen/clay complex according to Example 1 per gelatin capsule. Illustratively, a gelatin capsule may comprise: clay: more than 50% by weight beepollen: 25% to 50% by weight hypromellose: 10% to 25% by weight titanium dioxide: 0.1% to 1% copper and chlorophyllin complex: less than 0.1% by weight.

(57) All these ingredients are compliant with the use within the scope of a food supplement.

EXAMPLE 4

Characterization of the Gelatin Capsules

(58) energy value: 129 kcal/100 g lipids: 1.97% carbohydrates: 21.4% proteins: 6.42% ash: 62%.

(59) The physical characteristics were also determined:. grain size: 500 μm; foreign bodies: absent.

(60) The following chemical characteristics were obtained: pesticides, heavy metals, nitrites and nitrates: compliant with the European regulations in effect pH: not applicable humidity: 7.13% water activity wa: 0.675 at 24.4° C. viscosity: not applicable density: not applicable.