FR3148143A1 - DIETARY COMPOSITION - Google Patents

Abstract

The invention relates to a dietary oral composition comprising a combination of three edible ingredients, said ingredients being (i) an extract of the seed of Ceratonia siliqua, preferably locust bean gum, (ii) a polysaccharide of Xanthomonas campestris, preferably xanthan gum and (iii) an extract of cactus of the genus Opuntia, more particularly an extract originating from one or more cladodes of the species Opuntia ficus indica. Abstract figure: Figure 2

Description

DIETARY COMPOSITION

The invention relates to a dietary oral composition comprising a combination of three edible ingredients, and its use for dietary treatments. The invention also relates to a non-therapeutic method for controlling the body weight of a human or an animal.

The number of people affected by overweight or obesity is constantly increasing worldwide. Indeed, the population suffering from overweight (BMI ≥ 25 kg/m2) and obesity (body mass index, BMI ≥ 30 kg/m2) has now exceeded that of the population suffering from underweight [cf. Collaboration, NRF Trends in adult body-mass index in 200 countries from 1975 to 2014: a pooled analysis of 1698 population-based measurement studies with 19·2 million participants , The Lancet 387, 1377–1396, 2016].

According to the World Health Organization, in 2016 more than 1.9 billion adults aged 18 and over were overweight. Of these, more than 650 million were obese. In 2020, 39 million children under 5 years of age are overweight or obese [cf. Obesity and overweight , https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight).

The consequences in terms of morbidity and mortality are considerable.

In addition to the physical disabilities and psychological problems induced by overweight and obesity, excess weight in a subject considerably increases the risk of developing chronic diseases, such as cardiovascular diseases, cancers and diabetes.

In general, the treatment of obesity or overweight focuses mainly on the administration of medication and/or surgical interventions. But these treatments are invasive and accompanied by risks. Furthermore, these treatments cannot guarantee sustainable weight loss over time.

Part of the research is now focusing on other types of treatments and in particular on preventive treatments.

Overweight and obesity are essentially linked to malnutrition. Thus, nutritional prevention strategies can effectively combat overweight and obesity. In particular, strategies or treatments aimed at increasing the feeling of satiety and/or fullness in a subject (human or animal) are explored.

In particular, it has been shown that regular ingestion of dietary fiber can reduce the risk of developing overweight or obesity. Indeed, dietary fiber promotes a feeling of prolonged and/or increased satiety. This is linked, at least partially, to the molecular weight and viscosity of these fibers [cf. Kristensen, M., & Jensen, MG, 2011, Dietary fibers in the regulation of appetite and food intake - Importance of viscosity , Appetite, 56(1), 65-70].

Other research focuses on the physicochemical and textural characteristics of foods, including their form (solid or liquid), their lubricity and/or their degree of heterogeneity, with a view to establishing links between these characteristics and appetite suppression. It appears that manipulations of food texture, in particular increasing viscosity, have an effect on feelings of satiation and fullness [cf. Stribiţcaia, E., Evans, CE, Gibbons, C., Blundell, J., & Sarkar, A., 2020, Food texture influences on satiety: systematic review and meta-analysis , Scientific reports, 10(1), 1-18].

There is therefore a need to develop formulations capable of acting directly or indirectly on the texture of foods, and in particular on an increase in viscosity.

However, the ingredients available on the pharmaceutical and agri-food market are extremely numerous and diversified. A targeted selection with a view to increasing viscosity is complex and generally does not provide satisfactory results.

The present invention improves the situation.

Thus, the invention relates to a dietary oral composition comprising a combination of three edible ingredients, said ingredients being (i) an extract of the seed of Ceratonia siliqua , (ii) a polysaccharide of Xanthomonas campestris and (iii) an extract of cactus of the genus Opuntia .

According to a preferred embodiment, the extract derived from the seed of Ceratonia siliqua is carob gum (L). In another preferred embodiment, the polysaccharide of Xanthomonas campestris is xanthan gum (X). In another preferred embodiment, the cactus of the genus Opuntia is the species Opuntia ficus indica (O). More particularly, the extract of cactus of the genus Opuntia comes from one or more cladodes of Opuntia ficus indica (O). In a particularly preferred embodiment, the composition of the invention comprises the combination of L, X and O. In another particularly preferred embodiment, the composition of the invention is constituted by the combination of L, X and O.

In these preferred embodiments, the weight proportion of said Carob Gum (L) is between 30% and 90%, the weight proportion of said Xanthan Gum (X) is between 10% and 40%, and the weight proportion of said Opuntia ficus-indica is between 10% and 30%. More preferably, the weight proportion of said Carob Gum (L) is between 40% and 50%, the weight proportion of said Xanthan Gum (X) is between 25% and 35%, and the weight proportion of said Opuntia ficus-indica is between 20% and 30%, preferably between 22% and 28%. Preferably, the weight proportion of said Carob Gum (L) is 45%, the weight proportion of said Xanthan Gum (X) is 30%, and the weight proportion of said Opuntia ficus indica is 25%.

In a particularly preferred embodiment, the composition consists of said combination of three ingredients, i.e. preferably 100% of the composition comes from the ingredients L, X, and O cited above, and preferably in a ratio L:X:O of 45:30:25.

The invention also relates to the composition for use in the treatment and/or prevention of a condition chosen from obesity and a metabolic disease in a human or an animal. The invention also relates to a use of the composition for overweight subjects.

Preferably, the composition of the invention is in powder form. The composition may also be in a form chosen from a tablet, a cachet, a capsule, a granule, a gelatin capsule, a dragee, chewing gum, a paste, a drink, a syrup. This promotes oral intake.

The invention also relates to a food product, or food supplement, or dietary supplement, or meal replacement, or drink, or drink supplement, or pharmaceutical product, comprising the composition described above.

In addition, the invention relates to a non-therapeutic method for controlling the body weight of a human or an animal. The method comprises administering, preferably before or during a meal, to the human or animal, an effective amount of an oral dietary composition described above.

Other advantages and characteristics of the invention will appear on reading the detailed description below and on the attached drawings in which:

shows the respective viscosity of the three ingredients L, X, O of the composition of the invention and their combinations at 21°C;

shows the respective viscosity of the three ingredients L, X, O of the composition of the invention and their combinations at 37°C;

shows a comparison between the viscosity of the combination of the two ingredients L, X and the composition of the invention comprising L, X, O at respectively a pH = 6 and a pH = 4, at a temperature of 21°C;

shows a comparison between the viscosity of the combination of the two ingredients L, X and the composition of the invention comprising L, X, O at respectively a pH = 6 and a pH = 4, at a temperature of 37°C. ;

shows the evolution of the viscosity of the composition of the invention as a function of the proportion of xanthan gum (X) at a temperature of 21°C;

shows the evolution of the viscosity of the composition of the invention as a function of the proportion of xanthan gum (X) at a temperature of 37°C;

shows the numerical details (proportions) of Figures 5 and 6;

shows the evolution of the viscosity of the composition of the invention as a function of the proportion of Opuntia ficus indica (O) at a temperature of 21°C;

shows the evolution of the viscosity of the composition of the invention as a function of the proportion of Opuntia ficus indica (O) at a temperature of 37°C;

shows the numerical details (proportions) of figures 8 and 9;

shows a comparative test between a product of the state of the art and a composition according to the present invention at 21°C; and

shows a comparative test between a product of the state of the art and a composition according to the present invention at 37°C.

The figures and the description below contain, for the most part, elements of a certain nature. The figures are an integral part of the description, and may therefore not only serve to better understand the present invention, but also contribute to its definition, where appropriate.

Subjects affected by overweight or obesity may in particular submit to a diet. A diet includes in particular a temporary, total or partial abstention from food for personal and/or therapeutic reasons. More generally, "dietetics" designates a part of medicine and hygiene which is interested in adapting the diet to the particular needs of individuals. A dietary composition is thus a product or food supplement contributing to this hygiene. The present invention falls within the scope of dietary compositions, for example compositions of the appetite suppressant type and/or providing a feeling of satiety or satiation. The composition of the invention is thus intended in particular for the food industry, the food supplement industry and/or the pharmaceutical industry.

The terms "edible ingredient(s)" designate one or more foods, products or elements that can be ingested by a human or an animal per os , that is to say orally or more generally by gastrointestinal route. The edible ingredient(s) are not toxic to humans or animals. The composition of the invention comprises edible ingredients.

An edible ingredient, when it comes from a plant, can be in solid or liquid form. Very generally, it can include leaves, a root, a stem, a fruit, flowers or even the exudate or sap of a plant, whether processed or not. It can be all or only one or more parts of these elements.

The term "extract" refers to the edible part(s) of a plant, whether or not transformed by an extraction process, present in the composition of the invention. More generally, the extract may be raw or modified by an extraction process commonly used in the field of food supplements and which retains the desired biological properties. In a preferred embodiment of the invention, the extract is in the form of powder or flour obtained by grinding a part of the plant. In particular, for one of the essential ingredients of the invention (L), this involves grinding the seed, preferably grinding the endosperm with or without the seed coat.

An extraction process may include dehydration or cold drying so that the edible part is transformed into a format suitable for human consumption. Other processes may include cutting up certain parts of the plants, or supplementing with solid/liquid extraction based on a solvent such as water and/or ethanol. Other complementary steps may relate to purification by passage through a filter membrane or absorption resin or ion exchangers. Plant extracts may thus be found in the form of powder or granules in particular. Processes may also include washing, disinfecting, bleaching, drying and/or cooking parts of plants. The extracts may therefore also be found, for example, in the form of a suspension, aqueous solution or dispersion. Furthermore, extracts may be in the form of a "plant totum", i.e. a whole plant or part of it, dehydrated by drying and then crushed.

The composition of the invention may be in different forms suitable for oral ingestion. In particular, the composition may be in the form of tablets, capsules, powder, liquid or even in the form of syrup. Thus, the composition of the invention may comprise pharmaceutically acceptable vehicle or carrier substances and/or compatible with the agri-food market. The composition may further comprise ingredients such as diluent, adjuvant, excipient, preservative, filler, disintegrating agent, wetting agent, emulsifier, anti-caking agent, suspending agent, taste intensifier, aromatic agent, odorant, antibacterial agent, anti-yeast agents, lubricating agent and dispersing agent. Formulation techniques are described in particular in the book Remington: The Science and Practice of Pharmacy, 19th Edition, ISBN-13: 978-0912734040 or in the book Design of dietary supplements: Market, development, regulation and effectiveness, ISBN-13: 978-2743022211.

The dietary composition of the invention is mainly intended for the food supplement market. In particular, it is intended to provide a food product ( foodstuff in English), a food supplement ( food supplement in English), a dietary supplement ( dietary supplement in English), a beverage ( beverage in English), a beverage supplement ( beverage supplement in English). However, the invention is also intended for the pharmaceutical market. Thus, it is intended to provide a pharmaceutical product ( pharmaceutical product in English) in the usual form.

During its research, the Applicant turned to food ingredients and additives providing a satiety or filling effect, and/or exhibiting viscosity properties.

Thus, konjac has been shown to increase satiety in humans, in correlation with its impact on food viscosity. Konjac is an edible and soluble fiber derived from the root of Amorphophallus konjac [cf. Vuksan, V., Panahi, S., Lyon, M., Rogovik, AL, Jenkins, AL, & Leiter, LA, 2009, Viscosity of fiber preloads affects food intake in adolescents , Nutrition, Metabolism and Cardiovascular Diseases, 19(7), 498-503 ; Shang, L., Wang, Y., Ren, Y., Ai, T., Zhou, P., Hu, L., Wang, L., Li, Y., Li, B., 2020, In vitro gastric emptying characteristics of konjac glucomannan with different viscosity and its effects on appetite regulation , Food & function, 11(9), 7596-7610]. However, the results of konjac treatments are not satisfactory.

Furthermore, locust bean gum and xanthan gum are known for their respective viscosifying activities in food formulations. The combination of locust bean gum and xanthan has also been studied [cf. Copetti, G., Grassi, M., Lapasin, R., & Pricl, S., 1997, Synergistic gelation of xanthan gum with locust bean gum: a rheological investigation , Glycoconjugate journal, 14, 951-961 ; Craig, D.Q., Kee, A., Tamburic, S., & Barnes, D., 1997, An investigation into the temperature dependence of the rheological synergy between xanthan gum and locust bean gum mixtures , Journal of Biomaterials Science, Polymer Edition, 8(5), 377-389]. However, locust bean gum requires heat treatment to trigger its rheological power, and generally the results for xanthan gum, locust bean gum and/or their combination are not satisfactory, particularly in terms of viscosity.

Overall, although a correlation between viscosity and satiety has been demonstrated, the magnitude of the impact remains relatively modest [cf. Stribiţcaia et al. 2020 cited above].

Consequently, there is a need to propose new formulations that are satiating and/or provide a satiety effect. The Applicant has developed a composition that meets this need.

For this purpose, the Applicant carried out a very large number of tests with different combinations of edible ingredients. It observed that a combination of carob gum, xanthan and Opuntia cladodes provided unexpectedly high values of viscosity in aqueous solution.

• (i) un extrait de la graine deCeratonia siliqua, plus particulièrement de la gomme de caroube (L) ;
• (ii) un polysaccharide deXanthomonas campestris, plus particulièrement de la gomme xanthane (X) ; et
• (iii) un extrait de cactus du genreOpuntia, plus particulièrement provenant de l’espèceOpuntia ficus indica(O).

Thus, the present invention relates to a dietary oral composition comprising a combination of three edible ingredients. The specifically selected ingredients are:

• (i) an extract of the seed of Ceratonia siliqua , more particularly locust bean gum (L);
• (ii) a polysaccharide of Xanthomonas campestris , more particularly xanthan gum (X); and
• (iii) an extract of cactus of the genus Opuntia , more particularly from the species Opuntia ficus indica (O).

The Applicant has discovered, not without surprise, that the interaction between the selected ingredients (L, X, O) produces a technical effect which goes beyond the sum of the technical effects which these ingredients produce individually. Thus, the interaction between the three ingredients has a synergistic effect. And, this effect is not predictable in view of the individual properties of each of the ingredients of the invention taken alone.

The Applicant has thus developed a specific edible composition having an unexpected synergistic activity on viscosity during gastric transit in order to improve the feeling of fullness and satiety. In a preferred embodiment, the composition contains the specific combination of carob gum (polysaccharide of the endosperm of the carob seed Ceratonia siliqua ; denoted "L" in the present description), xanthan gum (polysaccharide of Xanthomonas campestris ; denoted "X" in the present description) and prickly pear powder (cladode of Opuntia ficus indica ; denoted "O" in the present description).

Locust bean gum is often referred to in the field by its English names "Locust bean gum" And "Carob gum". Xanthan gum is often referred to in the field by its English names "Xanthan gum" or simply by "Xanthan(e)". The production of xanthan is obtained by aerobic fermentation ofXanthomonas campestris.Xanthomonas campestrisis a species of Proteobacteria of the family ofXanthomonadaceae. L'Opuntia Ficus Indicais often referred to in the field by the terms "Nopal", "Opuntia cladodes", "Prickly Pear" Or "Prickly pear".

In order to study and demonstrate the synergistic effect of the three ingredients of the invention, the Applicant took into account the fact that satiety occurs during the absorption of the meal, that is to say in particular when the food passes through the stomach. It therefore took a closer look at this transit.

During transit through the stomach, hot foods generally remain at about the same temperature with little or no impact on the temperature of the bolus (also called "food bolus") in the stomach (around 37°C). In contrast, cold foods generally lower the temperature of the bolus. The bolus is then gradually warmed to the body's equilibrium temperature (around 37°C).

Therefore, the Applicant takes into account both the body equilibrium temperature of 37°C and a lower temperature of 21°C to assess the strength of the synergistic effect in the context of food absorption and specific stomach conditions.

The results show that at equal concentration, the combination of the three ingredients of the invention provided a higher viscosity than the compounds alone or even than the combination of two of them.

There shows the respective viscosity of the three ingredients of the invention and their combinations at 21°C.

Carob gum is designated "L", xanthan gum is designated "X" and extract from Opuntia Ficus Indica cladode(s) is designated "O".

More specifically, the locust bean gum is the product called Naltive™ LBG S3 available from the company NEXIRA. The extract from Opuntia Ficus Indica cladode(s) is the product NeOpuntia™ available from the company NEXIRA.

Xanthan gum is a generic gum available in the food industry. Directive 95/2/EC on food additives other than colours and sweeteners authorises the use of this xanthan gum under the reference E415. Its CAS number is 11138-66-2.

The respective concentrations are 1% in water, at pH = 6 and at 21°C.

Viscosity measurement is carried out with a DV-II+ Pro type viscometer with S03 spindle ( Spindle S03 ) available from Brookfield , at 20 RPM (Rotation Per Minute).

There shows the respective viscosity of the three ingredients of the invention and their combinations at 37°C.

The designation of the ingredients (L, X, O), the products and equipment(s) used are those described in relation to the .

The respective concentrations are 1% in water, at pH = 6 and at 37°C.

Figures 1 and 2 demonstrate a synergistic effect of the composition of the invention comprising the combination of the three ingredients L, X, and O, both at 21°C and at 37°C.

During the first hour after eating a meal, food passes into the intestine where the pH drops locally from about pH = 6 to about pH = 4, within about 1 hour.

There shows a comparison between the viscosity of the combination of the two ingredients L, X and the composition of the invention comprising L, X, O, respectively at a pH = 6 and a pH = 4, and at a temperature of 21°C.

The respective concentrations are 1% in water.

Viscosity measurement is performed with a DV-II+ Pro type viscometer with S03 spindle ( Spindle S03 ) available from Brookfield , at 20 RPM.

There shows a comparison between the viscosity of the LX combination and the composition of the invention LXO, respectively at pH = 6 and at pH = 4, and at a temperature of 37°C.

The respective concentrations are 1% in water.

Viscosity measurement is performed with a DV-II+ Pro type viscometer with S03 spindle ( Spindle S03 ) available from Brookfield , at 20 RPM.

Figures 3 and 4 demonstrate that despite a pH equal to 4, the resulting synergy of the combination of the three ingredients of the invention remains powerful, even in the context of a one-hour gastric phase.

The Applicant was interested in the relative proportions of each ingredient for the composition of the invention.

Viscosity tests were carried out according to the individual ratio of each of the ingredients of the composition of the invention. The X and O ranges were evaluated separately.

There shows the evolution of the viscosity of the composition of the invention as a function of the proportion of xanthan gum (X) at a temperature of 21°C.

The experiment was carried out for 1 hour at pH = 6.

Viscosity measurement is performed with a DV-II+ Pro type viscometer with S03 spindle ( Spindle S03 ) available from Brookfield , at 20 RPM.

There shows the evolution of the viscosity of the composition of the invention as a function of the proportion of xanthan gum (X) at a temperature of 37°C.

The experiment was carried out for 1 hour at pH = 6.

Viscosity measurement is performed with a DV-II+ Pro type viscometer with S03 spindle ( Spindle S03 ) available from Brookfield , at 20 RPM.

There shows a table with the numerical details (proportions) of Figures 5 and 6.

In this figure, LGB (for " Locust Bean Gum ") represents carob gum.

There shows the evolution of the viscosity of the composition of the invention as a function of the proportion of Opuntia ficus indica (O) at a temperature of 21°C.

Viscosity measurement is performed with a DV-II+ Pro type viscometer with S03 spindle ( Spindle S03 ) available from Brookfield , at 20 RPM.

There shows the evolution of the viscosity of the composition of the invention as a function of the proportion of Opuntia ficus indica (O) at a temperature of 37°C.

Viscosity measurement is performed with a DV-II+ Pro type viscometer with S03 spindle ( Spindle S03 ) available from Brookfield , at 20 RPM.

There shows a table with the numerical details (proportions) of Figures 8 and 9.

In this figure, LGB (for " Locust Bean Gum ") represents carob bean gum (L).

It is apparent from Figures 5 to 10 that a composition of the invention having a L:X:O ratio of 45:30:25 is particularly preferred. This applies in particular in view of the increase in the temperature of the food during transit in the stomach from 21°C to 37°C.

There shows a comparative test between a product of the state of the art and a composition according to the present invention at 21°C.

More particularly, the test makes it possible to compare konjac with a preferred embodiment of the composition of the invention.

The konjac used for this comparative test is the product Glucomannan de Konjac 95 available from the company NEXIRA.

A composition of the invention is used here in an embodiment in which the proportions L, X, O are respectively 45:30:25.

The test uses aqueous solutions in which the concentrations of konjac, as well as the composition of the invention, are each 0.5%. The respective concentrations are therefore 0.5% in water.

The pH is equal to 6.

Viscosity measurement is performed with a DV-II+ Pro type viscometer with S03 spindle ( Spindle S03 ) available from Brookfield , at 20 RPM.

There shows a comparative test between a prior art product and the composition of the present invention at 37°C.

The konjac and the composition of the invention used are of the same nature as those relating to the The operating conditions are also identical, except for the temperature.

The comparison shown in Figures 11 and 12 between the viscosity of konjac and that of the composition of the present invention (LXO), highlights the superiority of the latter at the two gastric stabilization temperatures, namely 21°C and 37°C.

The composition of the invention is essentially intended to be used before, at the beginning or during the ingestion of a meal. A first preferred example of application of the composition is in the form of a powder intended to be previously dispersed in a drink (type " doy pack " or " stickpack "). A second example is the presence of the composition of the invention in capsules or formulated directly with food.

Claims (11)

A dietary oral composition comprising a combination of three edible ingredients, said ingredients being (i) an extract of the seed of Ceratonia siliqua , (ii) a polysaccharide of Xanthomonas campestris and (iii) an extract of cactus of the genus Opuntia . Composition according to claim 1, wherein the extract derived from the seed of Ceratonia siliqua is locust bean gum (L). Composition according to one of the preceding claims, in which the polysaccharide of Xanthomonas campestris is xanthan gum (X). Composition according to one of the preceding claims, in which the cactus of the genus Opuntia is the species Opuntia ficus indica (O). Composition according to one of the preceding claims, in which the cactus extract of the genus Opuntia comes from one or more cladodes of the species Opuntia ficus indica (O). Composition according to one of claims 2 to 5, in which the proportion by weight of said Carob Gum (L) is between 30% and 90%, the proportion by weight of said Xanthan Gum (X) is between 10% and 40%, and the proportion by weight of said Opuntia ficus-indica is between 10% and 30%. A composition according to claim 6, wherein the weight proportion of said Carob Gum (L) is 45%, the weight proportion of said Xanthan Gum (X) is 30%, and the weight proportion of said Opuntia ficus-indica is 25%. Composition according to one of the preceding claims consisting of said combination of three ingredients. Composition according to one of the preceding claims for use in the treatment and/or prevention of a condition chosen from obesity and a metabolic disease in a human or an animal. Composition according to one of the preceding claims, in a form chosen from a tablet, a cachet, a capsule, a granule, a gelatin capsule, a dragee, chewing gum, a paste, a drink, a syrup, and preferably in the form of powder or flour. Food product, or food supplement, or dietary supplement, or meal replacement, or drink, or drink supplement, or pharmaceutical product, comprising the composition according to one of the preceding claims.