Composition of a food supplement in capsule form

Description

1. COMPOSITION OF A FOOD SUPPLEMENT IN CAPSULE FORM. The present invention relates to a food supplement composition in capsule form. The present invention also relates to a method for preparing a food supplement composition in capsule form. The action of probiotics as a food supplement has been known for years. Probiotics are specific live microorganisms, mainly bacteria and sometimes yeasts, which provide health benefits to a consumer when consumed in adequate quantities. Among the many effects of probiotics, it is also known that they help maintain or establish the balance of the human intestinal flora. The gut flora, also called the gut microbiota, contributes, among other things, to digestion and the development of the immune system. It is composed of a multitude of microorganisms, mainly bacteria, but also yeasts.Fungi and even viruses. The gut flora maintains a delicate balance between all these microorganisms, which can be easily disrupted by numerous factors, such as taking antibiotics, changes in diet, travel, fatigue, stress, or aging. It is therefore important to preserve the balance of the gut flora to maintain good overall health. For example, one can cite the study "Implication of gut flora in energy metabolism, Nathalie M. Delzenne, Patrice D. Cani, MedSci(Paris) 2008;24:505–510," which indicates that the gut flora is now considered an organ in its own right, playing a key role in energy metabolism. Furthermore, the number of bacterial cells present in the gastrointestinal tract far exceeds all other bacterial communities in the human body. Finally, although an individual's gut flora profile is acquired at birth, it is possible to rebalance this flora to contribute to an improvement in metabolic status. Thus,The intake of probiotics helps to restore, strengthen, and maintain the intestinal flora by introducing beneficial and specific live bacteria and / or yeasts into the body. The action of plant extracts to normalize intestinal transit is also known. Indeed, certain plants, such as blueberry, rhubarb, peppermint, ginger, turmeric, or dandelion, possess beneficial properties that facilitate digestion. These plant extracts offer a natural solution to support the digestive system and therefore the intestinal flora. Plant extracts can be used in the form of diluted liquid beverages, liquid concentrates, or even combined in formulations with other compounds. For example, certain probiotics and plant extracts can be combined to synergistically enhance their positive impact on the gut flora. Probiotics and plant extracts can be consumed separately or in various forms, such as powders or liquids. For example, a consumer concerned about their gut flora,wishing to rebalance this flora, or simply wanting to improve one's health, can take a first course of probiotics available in various pharmaceutical forms, including capsules, orodispersible powder, tablets, gummies, lozenges, and in combination, also take a concentrated liquid beverage or plant extracts. It is, however, well known that some food supplements, particularly probiotics or plant extracts, can have an unpleasant taste, requiring the use of a taste masker or flavoring to mask the taste. For this reason, administration in capsule form offers numerous advantages; by encapsulating the compounds / ingredients in the capsule, the unpleasant taste is masked and administration is carried out directly into the consumer's gastrointestinal tract. Furthermore, for obvious reasons of practicality, ease of administration, and extended shelf life,Administration in the form of a single capsule comprising both a probiotic part and a plant part is often preferred.10 Unfortunately, some incompatibilities exist when formulating a capsule composition comprising both probiotics and plant extracts. Such capsule formulations comprising both probiotics and plant extracts deserve improvement.15 There is therefore a real need to provide a food supplement composition, in capsule form, comprising both probiotics and plant extracts which maintains both the efficacy of the probiotics and the efficacy of the plant extract, while ensuring their stability and optimal release in the body.20 The invention aims to overcome these drawbacks by providing a food supplement composition in capsule form comprising at least a first probiotic fraction, a second probiotic fraction in pore form, and a concentrated blueberry extract.wherein said first probiotic fraction comprises at least one strain being Saccharomyces boulardii CNCMI-1079, at least one strain being Lacticase ibacterium rhamnosus Rosell-11, at least one strain being Bifidobacterium longum Rosell-175 and at least one strain being Lactobacillus helveticus Rosell-52, said second probiotic fraction in spore form 2024 / 5948 BE2024 / 5948 4 comprises at least one strain being Bacillus coagulans MTCC5856, said food supplement composition in capsule form having a moisture content of less than or equal to 10%, preferably less than or equal to 9%, preferably less than or equal to 8%, preferably less than or equal to 7%, more preferably less than or equal to 6%, even more preferably less than or equal to 5.5%. As can be seen, the composition of the food supplement in capsule form according to the present invention has a first probiotic fraction comprising at least 3 strains of bacteria (Lacticase Ibacterium rhamnosus Rosell-11,Bifidobacterium longum Rosell-175 and Lactobacillus helveticus Rosell-52) and at least one yeast (Saccharomyces boulardii CNCMI-1079). The 3 strains of bacteria present in the first probiotic fraction are effective in balancing the intestinal flora, notably thanks to their resistance to stomach acid, which allows them to reach the intestines alive and proliferate there. Furthermore, each bacterium plays a specific role when present in the body. Indeed, Lacticase Ibacterium rhamnosus Rosell-11 strengthens the intestinal barrier and reduces inflammation by adhering to intestinal epithelial cells, thus preventing the adhesion of pathogens and contributing directly to a healthy microbiota balance. Bifidobacterium longum Rosell-175 reduces inflammation by producing metabolites that strengthen the immune response of the intestinal microbiota, while stimulating the production of intestinal epithelial cells responsible for nutrient absorption, thus contributing to better digestive health. Finally,Lactobacillus 25 helveticus Rosell-52 has an antipathogenic effect against certain undesirable bacteria, as well as a beneficial action on mental health by influencing the relationship between the gut and the brain, reducing stress. The yeast in the first probiotic fraction is a non-colonizing yeast. It will not adhere to the intestinal wall and therefore will not permanently colonize the intestine. As a result, the balance of the intestinal flora will not be disturbed by its presence and the risk of candidiasis will be limited. However, Saccharomyces boulardii CNCMI-1079 has a good ability to reach high concentrations in the intestines, thanks in part to its resistance to stomach acid, allowing it to reach the five intestines alive. Once in the intestines, Saccharomyces boulardii CNCMI-1079 enhances the immune response by secreting metabolites that reduce inflammation.neutralize toxins and stimulate the growth of intestinal cells. The combination of at least these 3 strains of bacteria10 (Lacticase ibacterium rhamnosus Rosell-11, Bifidobacterium longum Rosell-175 and Lactobacillus helveticus Rosell-52) and the yeast Saccharomyces boulardii CNCM I-1079 allows us to discover several essential aspects of intestinal health, offering a synergy which complementaryly targets the strengthening of the intestinal barrier, the modulation of the immune system, the reduction of inflammation, the improvement of mental health and the stimulation of intestinal cell growth. The composition according to the present invention also comprises a second probiotic fraction in the form of pore-forming bacteria comprising at least one spore-forming bacterium (Bacillus coagulans MTCC5856).20 The spore-forming bacterium of the second probiotic fraction is capable of forming a resistant structure, called a pore, which it envelops and protects. This property allows it to survive in a dormant state under specific conditions.such as an acidic environment or high temperatures, including tropical ones. The pore protects the bacterium from external aggressions and allows it to remain alive during its passage through the stomach. Once in the intestine, Bacillus coagulans is reactivated and begins to multiply, proliferating to exert its beneficial effects on the intestinal flora. Indeed, the intestines present conditions favorable to spore germination, such as a sufficiently high humidity level, specific nutrients available in sufficient quantities, and a suitable temperature. Thanks to this upstream protection of the intestine, Bacillus coagulans is particularly suitable for travel medicine, guaranteeing its survival and effectiveness even in extreme climates. The beneficial effects of Bacillus coagulans MTCC5856 on the intestinal flora are numerous. This spore-forming bacterium stimulates the immune system,It produces antipathogenic metabolites and promotes the growth of beneficial microorganisms while inhibiting that of pathogens. Bacillus coagulans thus helps reduce intestinal inflammation and maintain the balance of the gut flora. The combination of at least this spore-forming bacterial strain (Bacillus coagulans MTCC5856) with the components of the first probiotic fraction further supports the balance of the gut flora, while ensuring the effectiveness of the composition in extreme climates. Administering this combination of bacterial and yeast strains to the human body provides an additional 15 beneficial probiotics to the intestines, thus helping to restore the loss or degradation of the gut flora that has occurred over time. The composition according to the present invention comprises, finally, concentrated blueberry extract. This fruit has been used traditionally for many years due to its beneficial effects on intestinal transit. Indeed, thanks to its 20 bioactive components such as fibers, tannins, and antioxidants,Bilberry supports the normalization of transit. Tannins, with their astringent properties, tighten tissues and mucous membranes, calming inflammation and slowing transit. They also possess antibacterial and antifungal actions that neutralize pathogens. Antioxidants, particularly the 25 anthocyanins, neutralize free radicals that can potentially damage intestinal cells, reducing oxidative stress, and have anti-inflammatory properties, reducing intestinal inflammation. These bioactive components therefore allow bilberry to have a positive impact on intestinal morphology, by regulating transit, reducing oxidative stress, and alleviating intestinal inflammation. Bilberry is present in the composition in the form of a concentrated extract.in order to maximize the neuron in bioactive components and to optimize the effectiveness of the composition according to the present invention.5 The combination of concentrated blueberry extract with probiotics further supports the balance of the intestinal flora, also acting on intestinal morphology. In a particularly surprising way, the capsule-form food supplement composition according to the present invention10 synergistically presents both the effects of the probiotics found in the first probiotic fraction and in the second probiotic fraction in pore form, as well as the effects of concentrated bilberry extract, resulting in a composition that is particularly effective in supporting the balance of the intestinal flora, from its various components.15 Indeed, the fact that the probiotics arrive alive in the intestines and the synergy between the different components of the composition (probiotics and concentrated bilberry extract) allows it to act on a wide range of factors influencing the balance of the intestinal flora,such as reducing inflammation, strengthening the immune response, stimulating the production of intestinal epithelial cells, protecting against pathogens, and regulating intestinal transit, thus contributing to better digestive and intestinal health. Furthermore, unlike previous solutions that use compounds with separate administration or present the aforementioned drawbacks and incompatibilities, the inventors have, in a particularly surprising way, succeeded in formulating a composition that combines both types of compounds, probiotics and plant extract, in the same capsule. This is made possible by a moisture content of less than or equal to 10%, preferably less than or equal to 9%, preferably less than or equal to 8%, preferably less than or equal to 7%, more preferably less than or equal to 6%, and even more preferably less than or equal to 5.5%. Thus, it is possible to provide a capsule which includes probiotics (bacteria,bacteria (spore-forming and yeast) and concentrated plant extract (blueberry), which avoids the disturbance and / or reactivation of probiotics by water before they are released into the body. Thus, and in a particularly advantageous way, the concentrated blueberry extract of the composition according to the invention makes it possible, both to provide a high content of bioactive components in order to optimize their effectiveness, while having a reduced moisture content in order to avoid the disturbance and reactivation of probiotics directly in the capsule of the invention, this ultimately improving its effectiveness in supporting the intestinal flora. Advantageously, the first probiotic fraction of the food supplement composition in capsule form according to the present invention comprises, in addition, at least one additive selected from group 15 comprising vitamin D3 (cholecalciferol), maltodextrins, magnesium stearate and L-ascorbic acid, preferably at least two of said additives, preferably at least three of said additives,Preferably, at least four of said additives. The presence of vitamin D3 (cholecalciferol) in composition 20 provides additional support to the immune system, among other things due to its crucial role in regulating immune responses. Equally advantageously, the second probiotic fraction in pore form of the food supplement composition in capsule form according to the present invention comprises at least one additive, for example, 25 maltodextrins. Preferably, the food supplement composition in capsule form according to the present invention further comprises at least one fructo-oligosaccharide. 2024 / 5948 BE2024 / 5948 9 The presence of fructo-oligosaccharide in the composition ensures the growth of beneficial bacteria and yeasts, acting as a prebiotic, promoting their multiplication and effectiveness in the intestine. The combination of bacteria, yeasts, fructo-5 oligosaccharide, and concentrated bilberry extract results in a greatly improved action to restore,To strengthen and maintain the intestinal flora. Preferably, the composition of the food supplement in capsule form according to the present invention further comprises at least one magnesium stearate added and / or at least one silicon dioxide. More preferably, said capsule of the food supplement composition in capsule form is a capsule composed of hydroxypropyl methylcellulose, gellan gum, and sodium citrate. In a particular embodiment, the first probiotic fraction 15 of the food supplement composition in capsule form according to the present invention comprises: - at least 1 billion (1x109), preferably at least 2 billion (2x109), preferably at least 3 billion (3x109), preferably at least 4 billion (4x109), preferably at least 520 billion (5x109), plus preferably at least 6 billion (6x109) of cells from at least one strain being Saccharomyces boulardii CNCMI-1079, and / or - at least 1 billion (1x109), preferably at least 2 billion (2x109),more preferably at least 3 billion (3x109) cells of at least one strain being LacticaseibacteriumrhamnosusRosell-11, and / or 25 - at least 1 billion (1x109), preferably at least 2 billion (2x109), more preferably at least 3 billion (3x109) cells of at least one strain being Bifidobacterium longumRosell-175, and / or 2024 / 5948 BE2024 / 5948 10 - at least 1 billion (1x109), preferably at least 2 billion (2x109), more preferably at least 3 billion (3x109) cells of at least one strain being Lactobacillus helveticusRosell-52. According to the present invention, it is understood that the quantities of compounds in the composition of a food supplement in capsule form, number of cells and masses, are expressed per capsule. In a similarly particular embodiment, the composition of a food supplement in capsule form according to the present invention comprises: - between 370 and 410 mg, preferably between 380 and 400 mg, more preferably between 385 and 395 mg, even more preferably 390 mg of said first probiotic fraction,and / or - between 5 and 35 mg, preferably between 10 and 30 mg, more preferably between 15 and 25 mg, even more preferably between 20 mg of said second probiotic fraction in spore form, and / or - between 2 and 7 mg, preferably between 3 and 6 mg, more preferably between 4 and 5 mg, even more preferably between 4 and 4.5 mg of said concentrated blueberry extract, and / or - between 35 and 65 mg, preferably between 40 and 60 mg, more preferably between 45 and 55 mg, even more preferably between 50 mg of said fructo-oligosaccharides, and / or - between 8 and 13 mg, preferably between 9 and 12 mg, more preferably between 10 and 11 mg, even more preferably between 10.5 and 11 mg of said magnesium stearates, and / or -between 1 and 7 mg, preferably between 2 and 6 mg, more preferably between 3 and 5 mg, even more preferably between 4 mg of said silica dioxide, 2024 / 5948 BE2024 / 5948 11 -between 100 and 110 mg, preferably between 102 and 108 mg, more preferably between 103 and 106 mg, even more preferably between 104 mg of said capsule. Preferably,said concentrated blueberry extract with an extraction ratio between 60 / 1 and 150 / 1, preferably between 70 / 1 and 140 / 1, 5 more preferably between 80 / 1 and 130 / 1. In one embodiment of the present invention, said food supplement composition in capsule form comprises: - 390 mg of said first probiotic fraction, said first probiotic fraction comprising: 10 or at least 6 billion (6 x 10⁹) cells of at least one strain being Saccharomyces boulardii CNCMI-1079, and or at least 3 billion (3 x 10⁹) cells of at least one strain being Lacticase Ibacterium rhamnosus Rosell-11, and or at least 3 billion (3 x 10⁹) cells of at least one strain being Bifidobacterium longum Rosell-175, and or at least 3 billion (3 x 10⁹) cells of at least one strain being Lactobacillus helveticus Rosell-52, and o1.25μg of said vitamin D3 (cholecalciferol), and o36.89mg of said maltodextrins, and 20 o3.9mg of said magnesium stearates, and o1.56mg of said L-ascorbic acid, and -20mg of said second probiotic fraction in spore form,said second probiotic fraction in pore form comprising: 25 or at least 300 million (3 x 10⁸) cells of at least one strain being Bacillus coagulans MTCC5856, and 2024 / 5948 BE2024 / 5948 12 or 17.5 mg of said malodextrins, and -4.29 mg of said concentrated bilberry extract, said concentrated bilberry extract having an extraction ratio between 80 / 1 and 130 / 1, and -50 mg of said at least one fructo-oligosaccharide, and -10.71 mg of said at least one additional magnesium stearate, and -4 mg of said at least one silicon dioxide, and -104 mg of said capsule, said capsule being composed of 100.83 mg of said hydroxypropylmethylcellulose, 2.86 mg of said gellan gum, and 0.31 mg of said sodium citrate, said food supplement composition in capsule form having a moisture content less than or equal to 5.5%. Advantageously, this composition according to the present invention is a complete and natural composition to support the intestinal flora.particularly thanks to a very high concentration of microorganisms15 per capsule. Other embodiments of the food supplement composition in capsule form according to the invention are indicated in the attached claims. The invention also relates to a process for preparing a food supplement composition in the form of capsules according to the invention, comprising the following steps: - a first step of mixing a concentrated blueberry extract with a first part of fructo-oligosaccharides to form a premix, and - a second step of mixing a first probiotic fraction comprising at least one strain being Saccharomyces boulardii CNCMI-1079, at least one strain being Lacticaseibacteriumrhamnosus Rosell- 2024 / 5948 BE2024 / 5948 13 11, at least one strain being Bifidobacterium longum Rosell-175 and at least one strain being Lactobacillushelveticus Rosell-52, with a second probiotic fraction in the form of pores comprising at least one strain being Bacillus coagulans MTCC5856,and a second part of fructo-oligosaccharides with said premix to form a first formulation, 5 and - a sieving step of magnesium stearates and silica dioxides to form sieved magnesium stearates and silica dioxides, and - a third step of mixing said magnesium stearates and silica dioxides with said first formulation to form a second formulation, and - a encapsulation step of said second formulation, to form said food supplement composition in capsule form. 15 Advantageously, the second mixing step is carried out in a rotary mixer during a first predetermined period of time of between 15 minutes and 1 hour, preferably between 30 minutes and 1 hour, advantageously about 45 minutes. Equally advantageously, the third mixing step is carried out in a rotary mixer during a second predetermined time period of between 1 and 30 minutes, preferably between 1 and 15 minutes, advantageously about 5 minutes. Preferably,The process includes in addition a packaging step following the encapsulation step, said packaging step allowing to obtain boxes of capsules, each of said boxes comprising between 5 and 100 capsules, preferably between 10 and 80 capsules, preferably between 15 and 60 capsules, preferably 15, 30 or 60 capsules. 2024 / 5948 BE2024 / 5948 14 It is clearly understood that the packaging according to the present invention may vary depending on the product, for example 1 capsule, 2 capsules, 3 capsules, 4 capsules, 5 capsules, 6 capsules, 7 capsules, 8 capsules, 9 capsules, 10 capsules, 11 capsules, 12 capsules, 13 capsules, 14 capsules, 15 capsules, 16 capsules, 17 capsules, 18 capsules, 19 capsules, 20 capsules, 21 capsules, 22 capsules, 23 capsules, 24 capsules, 255 capsules, 26 capsules, 27 capsules, 28 capsules, 29 capsules, 30 capsules, 31 capsules, 32 capsules, 33 capsules, 34 capsules, 35 capsules, 36 capsules, 37 capsules, 38 capsules, 39 capsules, 40 capsules, 41 capsules, 42 capsules, 43 capsules, 44 capsules, 45 capsules, 46 capsules, 47 capsules, 48 ​​capsules, 49 capsules, 50 capsules, 51 capsules, 52 capsules, 53 capsules, 54 capsules, 55 capsules, 56 capsules, 57 capsules, 58 capsules59 capsules, 6010 capsules, 61 capsules, 62 capsules, 63 capsules, 64 capsules, 65 capsules, 66 capsules, 67 capsules, 68 capsules, 69 capsules, 70 capsules, 71 capsules, 72 capsules, 73 capsules, 74 capsules, 75 capsules, 76 capsules, 77 capsules, 78 capsules, 79 capsules, 80 capsules, 81 capsules, 82 capsules, 83 capsules, 84 capsules, 85 capsules, 86 capsules, 87 capsules, 88 capsules, 89 capsules, 90 capsules, 91 capsules, 92 capsules, 93 capsules, 94 capsules, 9515 capsules, 96 capsules, 97 capsules, 98 capsules, 99 capsules, 100 capsules, in one box or in several boxes. Other embodiments of the process for preparing a food supplement composition in capsule form according to the invention are indicated in the attached claims. 20 Other features, details, and advantages of the invention will become apparent from the description given below, by way of non-limiting example. Examples: The inventors have implemented a process for preparing the 25 food supplement composition in capsule form according to the invention as follows,in particular comprising the following steps: - a first step of mixing a concentrated blueberry extract with a first portion of fructo-oligosaccharides to form a premix, the first mixing step being a manual mixture carried out in a bag, and - a second step of mixing a first probiotic fraction comprising at least one strain of Saccharomyces boulardii CNCMI-1079, at least one strain of Lacticase ibacterium rhamnosus Rosell-511, at least one strain of Bifidobacterium longum Rosell-175 and at least one strain of Lactobacillus helveticus Rosell-52, with a second probiotic fraction in pore form comprising at least one strain being Bacillus coagulans MTCC5856 and a second part of fructo-oligosaccharides with the said premix to form a first formulation, the second mixing step being carried out in a rotary mixer for a first predetermined period of time of approximately 45 minutes,and - a sieving step of magnesium stearate and silica dioxides to form sieved magnesium stearates and silica dioxides, and - a third step of mixing said magnesium stearate and silica dioxides with said first formulation to form a second formulation, the third mixing step being carried out in a rotary mixer for a second predetermined period of time of approximately 5 minutes, and - a encapsulation step of said second formulation, to form said food supplement composition in capsule form, and - a packaging step allowing the production of 25 boxes of capsules, each of said boxes comprising 15, 30 or 60 capsules. The preparation process according to the present invention makes it possible to obtain a food supplement composition in capsule form ready for distribution and use. 2024 / 5948 BE2024 / 5948 16 Thus, the inventors have produced a food supplement composition in capsule form comprising: - 390 mg of a first probiotic fraction,this first probiotic fraction comprising: oat least 6 billion (6x109) cells of a strain of Saccharomyces boulardii CNCMI-1079, and oat least 3 billion (3x109) cells of a strain of Lacticaseibacterium rhamnosus Rosell-11, and oat least 3 billion (3x109) cells of a strain of Bifidobacterium longum Rosell-175, and oat least 3 billion (3x109) cells of a strain of Lactobacillus helveticus Rosell-52, and o1.25 μg of vitamin D3 (cholecalciferol), and o36.89 mg of maltodextrins, and o3.9 mg of magnesium stearate, and o15 o1.56 mg of L-ascorbic acid, and -20 mg of a second probiotic fraction in the form of spores,cettedeuxièmefractionprobioticiquesousformede sporescomprenant: oaumoins300millions(3x108)decellulesd'unesouche20 étantBacilluscoagulansMTCC5856,et o17.5mgdemalodextrines,et -4.29mgd'unextraitdemyrtilleconcentré,cetextraitdemyrtilleconcentréayantunratiod'extractioncomprisentre80 / 1et 130 / 1,et25 -50mgdefructo-oligosaccharides,et -10,71mgdestéaratedmagnesiumadditionnel,et -4mgdedioxydesilice,and -104mg of a capsule, this capsule being composed of 100.83mg of hydroxypropylmethylcellulose, 2.86mg of gellan gum and 300.31mg of sodium citrate. 2024 / 5948 BE2024 / 5948 17 This food supplement composition in capsule form, prepared by the inventors, has a moisture content of 5.5% or less. The composition according to the present invention makes it possible to positively influence the balance of the intestinal flora by reducing inflammation, strengthening the immune response, stimulating the production of intestinal epithelial cells, protecting against pathogens and regulating intestinal transit. It therefore contributes to better digestive and intestinal health. It is understood that the present invention is in no way limited to the embodiments described above and that many modifications may be made to it without departing from the scope of the claims 10 annexed 2024 / 5948 BE2024 / 5948,