BE1000017B1 - COMPOSITION COMPRISING AT LEAST ONE PROBIOTIC - Google Patents

Abstract

The present invention relates to a composition based on at least one probiotic, characterized in that it is used for the curative treatment of overweight or the preventive treatment of weight gain in humans during smoking cessation or having consumed tobacco, preferably during and / or after diet.

Description

Composition comprising at least one probiotic

The present invention relates to a composition comprising at least one probiotic element, preferably in the living state, used for the curative treatment of excess body weight or the preventive treatment of weight gain in a human being weaning from tobacco or have used tobacco, preferably during and / or after eating.

For the purposes of the present invention, the term "probiotic element" is intended to mean a substance derived from the probiotic or a probiotic constituent, or the bacterial entity, whole or partial, of probiotic.

In the context of the present invention, the term "in the living state" means a concentration of bacteria in the composition of between 108 and 1013 cfu per gram of composition.

By the terms "a human being being weaned from tobacco" and "a human being having consumed tobacco" is meant, within the meaning of the present invention, a person reducing his consumption (weaning) or having consumed (preferably after stopping consumption) at least one tobacco active substance, for example nicotine, for a predetermined period of time.

More particularly, by the term "person having consumed tobacco" is meant within the meaning of the present invention, a person weaned (that is to say having stopped smoking).

It should also be noted that while the most common mode of smoking is smoking (eg, pipe, cigarettes, cigars, etc.), the above terms are not limited to this mode of smoking. of tobacco intake most commonly encountered.

Thus, tobacco consumption, for example, by oral absorption (e.g., by chewing nicotine chewing gums) is also considered according to the present invention.

For the purposes of the present invention, the term "overweight" means that the human has an abnormal and / or excessive accumulation of body fat, mainly abdominal, which presents a risk to his health. In the context of the present invention, the term "overweight" also includes the particular and extreme case of the state of obesity in humans.

It is difficult to develop a simple index that measures overweight and obesity at the panel level of a given population. For example, the scale used to measure the index of overweight and obesity in children and adolescents, because their body experiences a number of physiological changes related to their growth, differs from the one used in 'adult. Therefore, depending on the age, the WHO (World Health Organization) makes available to the public, different methods of measuring body weight according to the age of the individual or the average age of the sample of individuals. As an illustration, overweight can be evaluated in adults on the basis of Body Mass Index (BMI), which is a simple measure of weight compared to the size commonly used to estimate body weight. overweight and obesity in adults. It corresponds to the weight divided by the square of the size, expressed in kg / m2. BMI has the advantage of being applicable to both sexes and all adult age groups. However, it should be considered as an approximate indication because it does not necessarily correspond to the same percentage of fat mass according to individuals.

In this context, the WHO defines, on the basis of GMI, the following threshold values for determining whether an adult is overweight or obese: - a normal state of weight corresponds to a BMI between 20 and 25; a state of overweight corresponds to a BMI between 25 and 30; and - a state of obesity corresponds to a BMI equal to or greater than 30.

However, it should be noted that MGM gives no indication as to the distribution of abdominal fat vs. subcutaneous fat.

This index, although it has the advantage of standardizing the classification for both sexes and all age groups of adult individuals, can preferably be interpreted in a complementary manner with another indicator which may be, for example, the measurement of the waist of the individual.

Thus, an adult male individual with a waist circumference greater than 100 cm is considered to be overweight. This threshold is 88 cm in the adult woman.

This parameter can be generalized to all age groups by measuring the waist circumference (A) / hip circumference (H).

Overweight is observed for a ratio greater than 1 in the male individual and greater than 0.85 in the female individual.

The term "treatment" applies in the context of this invention since overweight in humans and in particular human obesity, has been recognized as a disease by the WHO.

By the term "curative" is meant, within the meaning of the present invention, the action that aims to reduce body weight and / or reduce body weight gain in humans who have consumed tobacco or weaning of tobacco.

The curative treatment therefore involves the action that aims to achieve, preferably during and / or after diet, a healthy body weight in humans, that is to say with a lower risk to health, in a range. of predetermined values, based, for example on the BMI, which is between 20 and 24, preferably equal to 22.

For the purposes of the present invention, the term "preventive" is intended to mean the action which aims to stabilize body weight and thus to prevent or limit body weight gain in humans who have consumed tobacco or who weaning of tobacco. Particularly in overweight or overweight humans, preferably during and / or after diet.

Preventive treatment also involves the action which aims to maintain, preferably during and / or after diet, a stable body weight, preferably considered normal in humans, within a predetermined constant range of values, based, for example , on BMI (as a reminder, between 20-25), but normal body weight can also be interpreted in light of the A / H ratio of less than 0.85 in the female individual, and less than 1, 00 in the male individual.

By the term "lesser risk to health", it is to be understood in the context of the present invention that, at a body weight considered normal, the risk of developing a metabolic syndrome is negligible.

Currently, worldwide, weight gain, leading to overweight and obesity is linked to more deaths than underweight. Thus, 65% of the world's population lives in countries where overweight and obesity kill more people than underweight (this figure covers all high-income countries and most middle-income countries).

It has furthermore been demonstrated that a high BMI is a factor that promotes, on the one hand, the metabolic syndrome defined in the context of the present invention as an association of health risk indicators: high blood pressure, high blood pressure, hypertriglyceridaemia, low HDL cholesterol, android obesity, and elevated blood glucose. These indicators are in fact a low definition is common to the current three main definitions known: that of WHO (published in 1998 and amended in 1999), that of the National Cholesterol Education Program (NCEP-ATPIII) published in 2001, and that of the International Diabetes Federation published in 2005.

In practice, the metabolic syndrome is reflected in the following indicators, in a non-exhaustive way: - an abnormally high insulin level; - type 2 diabetes; - hypercholesterolemia (associated with a low level of "good" HDL cholesterol); - hypertension; - a significant increase in body weight gain over time, especially if it is abdominal obesity; hypertriglyceridemia; - hepatic steatosis; - the development of a systemic inflammatory state; and - hypertrophy of the adipocytes, and, on the other hand, the risk of chronic diseases such as: - musculoskeletal disorders, in particular osteoarthritis; or - certain types of cancer.

Currently, the problem of uncontrolled weight gain no longer targets only healthy individuals who are likely to gain weight, but especially those already overweight, and one of the main causes of which is stopping smoking or taking tobacco. .

The problem of uncontrolled weight gain leading to overweight and linked to the cessation of smoking in humans remains a societal problem that has a significant impact on global health.

There is therefore a need to have a treatment that allows the cure of overweight and obesity or the prevention of weight gain in human beings related to the cessation of tobacco consumption. Preferably, this treatment should be low-binding when it is known that a main reason for weight gain due to cessation of smoking is the lack of adherence to a specific diet associated with treatment that can be sometimes heavy. This is particularly the case when we know that stopping smoking leads the individual to compensate for this lack by consuming more nutrients.

In particular, the present invention is part of a suggested cause-effect relationship which associates with a modification of the microbiotic intestinal flora the phenomenon of weight gain in humans being weaned from tobacco or having tobacco consumption (Biedermann et al., 2013. PLOSone, 8 (3): e59260-1 - e59260-8)

In his article, Biedermann suggests, without proving it, that the microbiotic intestinal flora contributes to keeping the host body healthy: the balanced state of the intestinal microbiotic actually contributes to the regulation of homeostasis. and microbiotic intestinal function, and the immune system, the imbalance of the microbiotic intestinal flora seen in people who have stopped smoking or have used tobacco may be interpreted as the cause of the emergence of the metabolic syndrome.

However, this relationship remains an assumption that has not yet been verified. Therefore, currently, there is no relevant literature that describes the curative and / or preventive action of probiotic on weight gain and / or overweight in humans being weaned or having consumed tobacco. tobacco.

It has furthermore been observed that the composition according to the invention makes it possible, in particular, for the curative or preventive treatment of the disturbance of the intestinal flora and the inflammatory diseases associated with this disturbance in the human being being weaned from tobacco or having consumed tobacco. .

The present composition therefore advantageously targets the curative or preventive treatment of metabolic syndrome related to smoking cessation or cessation of smoking in humans.

It has thus been demonstrated, according to the present invention, that the composition according to the invention has in particular the following effects on the body of the individual having consumed tobacco or being weaned of tobacco, which are accompanied by a reduction or prevention of taking or regaining body weight, preferably during and / or after a diet, or reduction in body weight: - improvement of insulin sensitivity; - a reduction in the development of the abdominal and subcutaneous fat mass; a reduction in the size of the adipocytes; a reduction in the cellular infiltration of white adipose tissues, in particular by proinflammatory macrophages; - a reduction of inflammatory markers; - limitation of steatosis of the liver; and - a limitation or reduction in the rate of "bad" cholesterol.

As can be seen, the composition according to the invention acts on various factors related to weight gain in the individual in the process of weaning tobacco or having consumed tobacco, which is quite remarkable.

In the context of the present invention, it has also been demonstrated the preventive and curative action on weight gain and the action on the metabolic syndrome in overweight humans, not only probiotics in the living state or not, but also compounds from this probiotic.

In this context, the composition according to the invention may further comprise at least one or a combination of at least two components, said at least one component corresponding, in the context of this particular embodiment, to said probiotic element, each component being selected from the group consisting of cell wall constituents, cell organelles, nucleic acids, cell membrane components, and cell metabolites. As an illustration and not limitation, the constituents of the cell wall are selected from the group consisting of peptiglycans, proteins, polysaccharides, teichoic acid, or a combination thereof. By way of illustration and not limitation, the metabolites are chosen from the group consisting of organic acids, inorganic acids, proteins, peptides, amino acids, enzymes, lipids, carbohydrates, glycolipids, glycoproteins, vitamins, salts, metals, or a combination thereof.

Preferably, said probiotic is Bifidobacterium animalis ssp. lactis No. LMG P-28149.

The strain according to the invention was deposited by the BCCM (.Belgian Coordinated Collections of Micro-organisms) and the LMG (.Laboratorium for Microbiology - Bacteriënverzameling) on January 27, 2014 according to the Budapest Treaty, under the number LMG P-28149 .

In a particular embodiment, the composition according to the invention comprises butyrate, or at least one of its derivatives, and / or propionate, or at least one of its derivatives, the induction of said butyrate and / or said propionate being favored by said Bifidobacterium animalis ssp. lactis No. LMG P-28149.

Optionally, the composition according to the invention comprises at least one second probiotic, said second probiotic being selected from the group consisting of the following probiotics: Archaea, Firmicutes, Bacteroidetes, Proteobacteria, Actinobacteria, Verrucomicrobia, Fusobacteria, Metanobacteria, Spirochaetes, Fibrobacter, Deferribacteres, Deinococcus, Thermus, Cyanobacteria, Methanobrevibacterium, Peptostreptococcus, Ruminococcus, Coprococcus, Subdolingranulum, Dorea, Bulleidia, Anaerofustis, Gemella, Roseburia, Catenibacterium, Dialister, Anaerotruncus, Staphylococcus, Micrococcus, Propionibacterium, Enterobacteriaceae (non-pathogenic), Faecalibacterium, Bacteroides, Parabacteroides , Prevotella, Eubacterium, Akkermansia, Bacillus, Butyrivibrio, and Clostridium, or a combination thereof.

Preferably, the composition according to the invention comprises at least one strain of fungus and / or yeast, said strain being chosen from the group consisting of Saccharomyces, Candida, Pichia, Debaryomyces, Torulopsis, Aspergillus, Rhizopus, Mu cor, and Penicillium.

Preferably, the composition according to the invention comprises a probiotic carrier phase wherein said probiotic and optionally said at least one additional probiotic are encapsulated.

Alternatively, the carrier phase comprises at least one substance selected from the group consisting of alginate, chitosan, pectin, pullulan, gelatin, carrageenan, agar gel or a combination thereof.

Preferably, said at least one substance is a hydrocolloid.

Advantageously, the composition according to the invention comprises at least one nutritive source selected from the group consisting of a monosaccharide, a polysaccharide, an amino acid, a peptide, a protein, a vitamin , a yeast extract, an alkali metal or alkaline earth metal halide salt, an antioxidant, glycerol, zinc acetate, zinc chloride, zinc lactate, ascorbic acid, citric acid, vegetable oil, milk fat, or a combination thereof.

In a particular embodiment, the composition according to the invention is a symbiotic composition comprising at least one prebiotic.

Preferably, said at least one prebiotic is chosen, in a non-limiting manner, from the group consisting of oligosaccharides, fructo-oligosaccharides, galacto-oligosaccharides, xylooligosaccharides, inulin or its derivatives, lactulose or its derivatives, mannan-oligosaccharides, immuno-oligosaccharides, or a combination thereof.

Preferably, the composition according to the invention comprises a first enteric coating covering said probiotic and said at least one additional probiotic. In particular, the first enteric coating is selected from the group consisting of ethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, Eudragit®, or a combination thereof.

Alternatively, the composition further comprises a second outer coating selected from the group consisting of alginate, chitosan, pectin, pullulan, gelatin, carrageenan, agar gel, cellulose, hemicellulose , ethyl cellulose, carboxymethyl cellulose, or a combination thereof.

In another possible embodiment, the composition according to the invention comprises one or more biocompatible excipients. Other embodiments of the composition according to the invention are indicated in the appended claims.

The present invention also relates to a food composition or a food based on the composition according to the invention.

For the purposes of the present invention, the term "food composition" is intended to mean a composition that is commonly found on the food market (for example, snacks, prepared meals, beverages, etc.). ). Other embodiments of the food composition according to the invention are indicated in the appended claims.

The present invention also relates to the composition according to the invention for use as a dietary supplement. For the purposes of the present invention, the term "food supplement" is intended to mean a foodstuff whose purpose is to provide an addition of nutrients or substances having a nutritional and / or physiological effect.

The present invention further relates to a therapeutic composition comprising at least one probiotic, for the curative treatment of overweight or the preventive treatment of weight gain in a human being weaning of tobacco or having consumed tobacco, preferably during and / or after diet.

Preferably, the therapeutic composition is intended for use by the respiratory route, preferably nasal or bronchial, oral, preferably sublingual, rectal, injectable, preferably intrathecally or cutaneously.

Optionally, the therapeutic composition according to the invention comprises at least one biocompatible excipient.

Preferably, the therapeutic composition is preferentially packaged in the form of tablets, globules, capsules, granules, powder, fluids, liquids, creams or sprays. Other embodiments of the therapeutic composition according to the invention are indicated in the appended claims. The invention further relates to a composition, preferably a food or a therapeutic composition, comprising at least one probiotic, for the curative treatment of overweight or the preventive treatment of weight gain in a human being who is being weaned from tobacco or who has consumed tobacco, preferably during and / or after diet. The invention also relates to a use of the composition according to the invention for the curative treatment of overweight or the preventive treatment of weight gain in a human being weaning of tobacco or having consumed tobacco, preferably during and / or after diet. Other forms of use of the composition according to the invention are indicated in the appended claims. The invention also relates to the composition according to the invention for use as a dietary supplement.

The present invention also relates to a process for the manufacture by fermentation of the particular strain LMG P-28149 of the probiotic Bifidobacterium animalis ssp. lactis being the subject of the composition according to the invention.

This method comprises at least one step of culturing said probiotic mentioned above in a culture medium comprising at least one milk protein (for example a whole milk, semi-skimmed or skimmed milk protein, a whey peptone). , a peptone of casein or another milk protein), at least one sugar or a mixture of sugars, which are chosen for example from lactose, glucose, galactose, fructose, maltodextrin, starch, trehalose and maltotriose, at least one amino sugar (e.g. glucosamine and galactosamine), at least one yeast extract and at least one egg extract.

Surprisingly, it has been shown, in the context of the present invention, that such a culture medium optimizes the efficacy of the strain LMG P-28149 of the probiotic Bifidobacterium animalis ssp. lactis, for which a curative or preventive action has been observed on body weight gain in a human being who has stopped smoking or has stopped smoking.

The present invention also relates to the use of the composition according to the invention for the curative or preventive treatment of body weight gain or overweight in a human being weaning tobacco or having consumed tobacco.

It is understood that the present invention is in no way limited to the embodiments described above and that many modifications can be made without departing from the scope of the appended claims.

Claims (22)

1. Composition comprising at least one probiotic element, preferably in the living state, characterized in that it is used for the curative treatment of overweight or the preventive treatment of body weight gain in humans being in progress cessation or having used tobacco, preferably during and / or after diet. 2. Composition according to claim 1, wherein said at least one probiotic element is derived from Bifidobacterium animalis ssp. lactis No. LMG P-28149. 3. Composition according to claim 1 or 2, comprising at least one additional probiotic chosen from the group consisting of the following probiotics: Archaea, Firmicutes, Bacteroidetes, Proteobacteria, Actinobacteria, Verrucomicrobia, Fusobacteria, Metanobacteria, Spirochaetes, Fibrobacter, Deferribacteres, Deinococcus, Thermus, Cyanobacteria, Methanobrevibacterium, Peptostreptococcus, Ruminococcus, Coprococcus, Subdolingranulum, Dorea, Bulleidia, Anaerofustis, Gemella, Roseburia, Catenibacterium, Dialister, Anaerotruncus, Staphylococcus, Micrococcus, Propionibacterium, Enterobacteriaceae, Faecalibacterium, Bacteroides, Parabacteroides, Prevotella, Eubacterium, Akkermansia, Bacillus, Butyrivibrio, and Clostridium, or a combination thereof. A composition according to any one of the preceding claims, wherein at least one strain of fungus and / or yeast is present, said strain being selected from the group consisting of Saccharomyces, Candida, Pichia, Debaryomyces, Torulopsis , Aspergillus, Rhizopus, Mucor, and Penicillium. 5. A composition according to any one of the preceding claims wherein said at least one probiotic and optionally said at least one additional probiotic are encapsulated in an encapsulating vehicle. The composition of claim 5, wherein said encapsulating vehicle comprises at least one substance selected from the group consisting of alginate, chitosan, pectin, pullulan, gelatin, carrageenan, agar gel. or a combination thereof. The composition of claim 6, wherein said at least one substance is a hydrocolloid. 8. A composition according to any one of the preceding claims, comprising at least one nutrient source selected from the group consisting of a monosaccharide, a polysaccharide, an amino acid, a peptide, a protein, a vitamin, a yeast extract, an alkali metal or alkaline earth metal halide salt, an antioxidant, glycerol, zinc acetate, zinc chloride, zinc lactate, ascorbic acid, citric acid, vegetable oil, milk fat, or a combination thereof. 9. Composition according to any one of the preceding claims, characterized in that it is a symbiotic composition comprising at least one prebiotic. 10. Composition according to any one of claims 1 to 9, comprising a first enteric coating covering said probiotic and optionally said at least one additional probiotic. The composition of claim 10, wherein said first enteric coating is selected from the group consisting of ethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, Eudragit®, or a combination thereof . A composition according to any one of the preceding claims comprising a second outer coating selected from the group consisting of alginate, chitosan, pectin, pullulan, gelatin, carrageenan, agar gel, cellulose, hemicellulose, ethyl cellulose, carboxymethyl cellulose, or a combination thereof. 13. Composition according to any one of the preceding claims, comprising one or more biocompatible excipients. 14. Composition according to any one of the preceding claims, for the curative treatment of overweight or the preventive treatment of body weight gain in humans being weaned from tobacco or who have consumed tobacco during and / or after dieting. . 15. Composition according to any one of the preceding claims, for use as a dietary supplement. 16. Food or food composition based on the composition according to any one of the preceding claims. 17. Therapeutic composition comprising at least one probiotic according to any one of claims 1 to 15. 18. Therapeutic composition according to claim 17, for use by the respiratory route, preferably nasal or bronchial, oral, preferably sublingual, rectal, injectable, preferably intrathecally or cutaneously. 19. Therapeutic composition according to claim 17 or claim 18, comprising at least one biocompatible excipient. 20. Therapeutic composition according to any one of claims 17 to 19, preferably packaged in the form of tablets, globules, capsules, granules, powder, fluids, liquids, creams or sprays. 21. Composition, comprising at least one probiotic, preferably a food or therapeutic agent, preferably based on the living state, for the curative or preventive treatment of the metabolic syndrome related to overweight in humans who have consumed tobacco or smoking cessation course. A composition according to any one of the preceding claims, wherein said probiotic element is selected from the group consisting of cell wall constituents, cell organelles, nucleic acids, cell membrane constituents, and cellular metabolites. .