Composition of plant extracts for use in the management of prediabetes

Abstract

The invention relates to a composition that can be used, in particular, as a food ingredient, food supplement, or medicinal product for the prevention of the risk of developing type 2 diabetes, said composition comprising a plant extract selected from each of the following plant families: - Fabaceae, - Lauraceae, - Cannabaceae, - Salicaceae. Figure 4

Description

Title of the invention: Composition of plant extracts for use in the treatment of prediabetes technical field

[0001] The invention falls within the field of preventive medicine and in particular in the prevention of the risk of developing type 2 diabetes. The invention relates more particularly to a composition of plant extracts which can be used in particular as a food ingredient, food supplement or medicine. Previous technique

[0002] Insulin is a hypoglycemic protein hormone produced by the body. It promotes glucose storage in peripheral tissues such as skeletal muscle and adipose tissue, and reduces endogenous glucose production by the liver. In a healthy individual, the peak in plasma glucose resulting from the absorption of dietary glucose triggers the release of insulin from pancreatic cells. The amount of insulin thus produced allows blood glucose levels to be rapidly restored to normal through its actions on the liver and peripheral tissues.

[0003] Prediabetic subjects initially exhibit glucose intolerance due to the progressive development of resistance in the liver and peripheral tissues to the action of insulin, also known as insulin resistance. To compensate for this loss of sensitivity, the pancreas overproduces insulin, which allows fasting blood glucose levels to return to normal.

[0004] Alongside the development of insulin resistance, there is a progressive loss of functional cell mass in the pancreas. Eventually, this loss of functional cell mass becomes so significant that the pancreas is no longer able to compensate for the loss of insulin sensitivity, thus leading to the onset of type 2 diabetes.

[0005] Hyperglycemia in prediabetics can thus be considered as a delayed manifestation of a long pathophysiological process extending over several years, starting from the establishment of resistance to the action of insulin, passing through a progressive loss of the functional mass of insulin-secreting cells and ultimately leading to pancreatic decompensation at the basis of hyperglycemia and the diagnosis of diabetes.

[0006] It is now accepted that cardiovascular complications (MI, stroke, PAD) associated with type 2 diabetes occur from the prediabetes stage, even before the appearance of frank hyperglycemia greater than 1.26 g / 1 which reveals diabetes.

[0007] Screening patients at the prediabetes stage and preventing the progression from prediabetes to type 2 diabetes is therefore a major public health issue.

[0008] The risk of developing type 2 diabetes is greater in patients with moderate fasting hyperglycemia and / or glucose intolerance, the risk being obviously increased in those who combine both moderate fasting hyperglycemia and glucose intolerance.

[0009] Also, several approaches have been studied to prevent the onset of type 2 diabetes in at-risk patients, with blood glucose levels between 1.10 and 1.25g / l.

[0010] The first approach consists of practicing a healthy diet and regular physical exercise in order to reduce the risk of switching from insulin resistance to type 2 diabetes, particularly in obese or overweight people.

[0011] Another approach is to use drugs such as Metformin, to date the most used drug to prevent type 2 diabetes, which reduces insulin resistance in the carbohydrate-intolerant organism and decreases hepatic gluconeogenesis.

[0012] Other drugs have also shown some efficacy such as Acarbose, an inhibitor of alpha glucosidase, an enteric enzyme that releases glucose from the largest carbohydrates, and Thiazolidinediones which constitute a new class of antidiabetics improving peripheral sensitivity to insulin and reducing blood glucose, lipemia and insulinemia but promoting weight gain.

[0013] There is now a need to develop other types of therapeutic approaches in the prevention of the risk of developing type 2 diabetes. Description of the invention

[0014] The objective of the invention is therefore to solve the aforementioned problem by proposing a natural composition based on plant extracts intended to prevent the onset of type 2 diabetes, particularly in patients at the prediabetic stage.

[0015] To this end, the invention relates to a composition comprising a plant extract selected from each of the following plant families:

[0016] - the Fabaceae,

[0017] - the Lauraceae,

[0018] - the Cannabaceae,

[0019] - the Salicaceae.

[0020] The composition according to the invention plays a role in particular in improving insulin sensitivity, in glucose uptake and in regulating blood glucose in prediabetic subjects.

[0021] The composition according to the invention may also include the following characteristics:

[0022] - the plant extracts from the Fabaceae family are extracts of fenugreek, the extracts of plants from the Lauraceae family are bay leaf extracts, extracts of plants from the Cannabaceae family are hop extracts and extracts of plants from the Salicaceae family are black poplar extracts;

[0023] - said at least one extract of fenugreek represents by mass from 15 to 35%, said at less a bay leaf extract represents by mass from 15 to 35%, said at least a hop extract represents by mass from 15 to 35%, and said at least a black poplar extract represents by mass from 15 to 35%, the percentages being expressed by mass relative to the mass of the composition;

[0024] - the plant extracts are in equal proportion;

[0025] - at least one active ingredient chosen from vitamins, amino acids and mineral salts;

[0026] - the composition is in a liquid, solid or gelling form, suitable for being taken orally;

[0027] - the composition is used in the treatment of prediabetes.

[0028] The invention also extends to a food ingredient, a food supplement a medication or a drug comprising a composition according to the invention. Brief description of the drawings

[0029] The present invention will be better understood and other advantages will become apparent upon reading the detailed description illustrated by the accompanying drawings, in which:

[0030] [Fig-1] - [Fig. 1] graphically represents the evolution of weight gain and food intake during the duration of treatment in the different groups of Ob / Ob mice;

[0031] [Fig.2] - [Fig.2] graphically represents a comparison of the initial weight in the different groups of Ob / Ob mice and the percentage of the evolution of weight gain in the different groups of Ob / Ob mice;

[0032] [Fig.3] - [Fig.3] graphically represents the evolution of glucose level and water intake in the different groups of Ob / Ob mice;

[0033] [Fig.4] - [Fig.4] graphically represents the evolution of blood glucose levels on day 7 and after gavage in the different groups of Ob / Ob mice, the area under the blood glucose curve and the level of insulin sensitivity;

[0034] [Fig.5] - [Fig.5] graphically represents the evolution of blood glucose levels on day 21 and after gavage in the different groups of Ob / Ob mice, the area under the blood glucose curve and the level of insulin resistance;

[0035] [Fig.6] - [Fig.6] graphically represents the results of an insulin tolerance test on day 25 of treatment and a histogram showing the level of insulin-induced hypoglycemia for the Metformin and Vehicle groups in Ob / Ob mice;

[0036] [Fig.7] - [Fig.7] graphically represents in the form of a histogram the blood glucose levels, total weight, liver weight, fat mass weight, subcutaneous weight, and epididymal weight of Ob / Ob mice after their killing at the end of the 31st day of treatment;

[0037] [Fig.8] - [Fig.8] graphically represents the evolution of the weight of C57BL6 mice with or without a high-lipid diet;

[0038] [Fig.9] - [Fig.9] graphically represents the evolution of the blood glucose level during the duration of treatment in the different groups of C57BL6 mice;

[0039] [Fig. 10] - the [Fig. 10] graphically represents the blood glucose level and the weight of the mice after 8 weeks of treatment in the different groups of C57BL6 mice;

[0040] [Fig. 11] - the [Fig. 11] graphically represents the weight of C57BL6 mice in the different mouse groups during the duration of the treatment;

[0041] [Fig. 12] - the [Fig. 12] graphically represents the amount of food taken by the C57BL6 mice in the different mouse groups during the duration of the treatment;

[0042] [Fig. 13] - the [Fig. 13] graphically represents the blood glucose level of C57BL6 mice in the different mouse groups during the treatment period;

[0043] [Fig. 14] - the [Fig. 14] graphically represents the amount of water taken in by the C57BL6 mice in the different mouse groups during the duration of the treatment;

[0044] [Fig. 15] - the [Fig. 15] graphically represents the evolution of the glucose level on the 7th day of treatment and after gavage in the different groups of C57BL6 mice;

[0045] [Fig. 16] - the [Fig. 16] graphically represents the area under the blood glucose curve on day 7 of treatment after gavage in the different groups of C57BL6 mice;

[0046] [Fig. 17] - the [Fig. 17] graphically represents fasting plasma glucose and the level of insulin resistance on day 7 of treatment after gavage in the different groups of C57BL6 mice;

[0047] [Fig. 18] - [Fig. 18] graphically represents the evolution of the glucose level on day 21 and after gavage in the different groups of C57BL6 mice,

[0048] [Fig. 19] - the [Fig. 19] graphically represents the area under the blood glucose curve on day 21 of treatment after gavage in the different groups of C57BL6 mice;

[0049] [Fig.20] - [Fig.20] graphically represents the fasting plasma glucose level and the level of insulin resistance on day 21 of treatment after gavage in the different groups of C57BL6 mice

[0050] [Fig.21] - [Fig.21] graphically represents the evolution of insulin tolerance on day 25 of treatment in the different groups of C57BL6 mice;

[0051] [Fig.22] - Fig.22 graphically represents the area under the blood glucose curve on day 25 of insulin resistance treatment in the different groups of C57BL6 mouse

[0052] [Fig.23] - [Fig.23] graphically represents in the form of a histogram the weight of the liver, the length of the small intestine, the epididymal and subcutaneous weight of C57BL6 mice after their killing at the end of the 30th day of treatment. Detailed description of the invention

[0053] The composition according to the invention is intended to regulate the parameters of carbohydrate function in the context of prediabetes in animals, including humans.

[0054] Prediabetes is understood to mean an intermediate state between normal glucose homeostasis and established type 2 diabetes, including two clinical entities: moderate fasting hyperglycemia (between 1.10 g / L and 1.26 g / L in humans) and glucose intolerance (defined here as a 2H blood glucose level after a 75 g oral glucose load of between 1.40 g / L and 2 g / L in humans).

[0055] The composition according to the invention includes, in particular, a plant extract selected from each of the following plant families:

[0056] - the Fabaceae,

[0057] - the Lauraceae,

[0058] - the Cannabaceae,

[0059] - the Salicaceae.

[0060] Without restricting the scope of the invention, nutritionally acceptable active ingredients, such as vitamins, amino acids and minerals, may be added to the composition according to the invention.

[0061] The composition according to the invention may be in the form of a solution, an aqueous suspension to be added to drinking water or to a liquid food, or in dry form, adsorbed on a powdered support, or in the form of capsules or tablets, as well as any other form of supply to human nutrition.

[0062] The composition according to the invention may in particular be used as a food supplement or for any other food use.

[0063] The composition according to the invention was extracted using a conventional extraction process involving the following steps:

[0064] - introducing a mixture of water into a tank, the volume of the water mixture cor corresponding to one-third of the tank's volume;

[0065] - introduce the aromatic plants into the tank;

[0066] - let it macerate;

[0067] - raise the temperature, while regularly stirring the mixture;

[0068] - allow to cool then filter the mixture;

[0069] - optionally add additional active ingredients (mineral salts, vitamins, acids amino acids);

[0070] - shake the extract to obtain a homogeneous composition.

[0071] The composition thus obtained is optionally sprayed into a mixer containing a powdered food support before being packaged.

[0072] In a particular embodiment according to the invention, plant extracts from the Fabaceae family are fenugreek extracts, plant extracts from the Lauraceae family are bay leaf extracts, plant extracts from the Cannabaceae family are hop extracts, and plant extracts from the Salicaceae family are black poplar extracts.

[0073] In another particular embodiment according to the invention, said at least one extract of fenugreek represents by mass from 15 to 35%, said at least one extract of bay leaf represents by mass from 15 to 35%, said at least one extract of hops represents by mass from 15 to 35%, and said at least one extract of black poplar represents by mass from 15 to 35%, the percentages being expressed by mass relative to the mass of the composition.

[0074] More specifically, the plant extracts may be in substantially equal proportions, which will be used in the study presented below to show the effectiveness of the composition according to the invention on glucose homeostasis in mice.

[0075] The use of the composition as a food ingredient, food supplement and medicine will depend, for example, on the level of insulin resistance of the subject to be treated and therefore on an appropriate dosage.

[0076] Thanks to its effect on glucose homeostasis, the composition according to the invention can play a role on the blood glucose of prediabetics but also on the blood glucose of confirmed diabetics.

[0077] Study of the effect of the composition according to the invention on glucose homeostasis in male Ob / Ob mice: Study models

[0078] The study was carried out on the 6-week-old Ob / Ob male mouse model.

[0079] The ob / ob or obese mouse is a mutant mouse that feeds excessively due to mutations in the gene responsible for leptin production, it becomes profoundly obese. This is an animal model of type 1 diabetes. The identification of the mutated gene in ob led to the discovery of the hormone leptin, which is important in appetite control. Description of the experimental protocol

[0080] The ob / ob mice used for the study initially underwent an acclimatization phase and were then separated into four study groups of twelve mice after randomization based on weight and blood glucose (random fed).

[0081] Group 1 is a negative control group in which a placebo was administered to the mice. The placebo is a vehicle solution comprising the same solution in which the plant extracts are diluted, administered by oral gavage, twice a day at a dose of 5 ml / kg.

[0082] Group 2 is a positive control group in which a solution of Metformin diluted equally in the same solution in which the plant extracts are diluted was administered by oral gavage to mice at a dose of 150mg / kg, i.e. 5ml / kg of a solution at a concentration of 30mg / ml, twice a day.

[0083] Group 3 is a test group of the composition according to the invention in which the composition, comprising 50% plant extract and 50% vehicle solution (Dose 1), was administered by oral gavage at 5ml / kg, twice a day.

[0084] Group 4 is a test group of the composition according to the invention, comprising 100% plant extract (Dose 2) was administered by oral gavage at 5ml / kg, twice a day.

[0085] Group 4 is thus half as concentrated in plant extract as group 3.

[0086] The chronology summarizing the main stages of the study is recalled below:

[0087] The study was carried out over 30 days with weekly measurements of food intake, water intake (per cage) and monitoring of weight and blood glucose levels of the mice.

[0088] During the study, on days 7 and 21, an oral glucose tolerance test (oGTT) and a measurement of insulin resistance (HOMA IR) are performed, and on day 25, an insulin tolerance test.

[0089] On the 30th day, the mice are killed with exsanguination and freezing of the plasma, weighing and retrieval of the liver (frozen and fixed in PFA Paraformaldehyde), weighing and retrieval of the pancreas (a part (8 mice) is frozen in an acid / ethanol mixture and another part (4 mice) is fixed in PFA) and finally collection of the feces.

[0090] Control of body weight and food intake of mice:

[0091] During the 30 days of treatment, metformin and plant extracts did not have major effects on the body weight or food intake of the mice, see [Fig.1].

[0092] Control of the percentage of weight gain relative to the initial weight of the mice:

[0093] The percentage representation of the initial weight nevertheless reveals that the mice of the The vehicle group exhibited a different growth curve compared to the mice in the other three groups, with greater weight gain during the first 15 days of the study. At the final time point, however, there was no statistically significant difference in weight gain between the four groups, as shown in [Fig. 2]. Blood glucose measurement and water consumption

[0094] Weekly blood glucose measurements under fed conditions reveal that plant extracts such as metformin improve glucose homeostasis in treated mice compared to vehicle mice, as seen in [Fig.3].

[0095] Similarly, water consumption, which is an indirect reflection of the diabetic state, is significantly reduced in the metformin (**** P<0.0001), dose 1 (* P=0.0126), dose 2 (* P= 0.0277) groups compared to the control group, also visible in [Fig.3]. Measurement of glucose tolerance

[0096] Glucose tolerance was measured at 7 and 21 days of treatment. After an overnight fast, the mice were weighed, a blood sample was taken and blood glucose levels were measured, then the mice received oral gavage of D-glucose at a dose of 0.5g / Kg, blood glucose levels were measured at 15, 30, 60 and 120 minutes.

[0097] A pharmacokinetic (AUC) measurement on glucose tolerance and an insulin resistance measurement were performed.

[0098] On day 7 (see [Fig.4]):

[0099] From 7 days of treatment, glucose tolerance is significantly improved in the metformin, dose 1 and dose 2 groups. The HOMA-IR measurement also shows a significant reduction in insulin resistance in the metformin and dose 2 groups.

[0100] On day 21 (see [Fig.5]):

[0101] The measurement carried out on day 7 was confirmed during the second test carried out after 21 days and shows a significantly improved glucose tolerance in the metformin, dose 1 and dose 2 groups and a significant reduction in insulin resistance in the metformin, dose 1 and dose 2 groups. Measurement of insulin tolerance

[0102] Insulin tolerance was measured on day 25 of the study, see [Fig. 6]. Mice were fasted overnight. Mice were weighed and blood glucose levels were measured at 0, 15, 30, 60, 90, 150, and 210 minutes after intraperitoneal (IP) injection of insulin (2 U / kg).

[0103] The data obtained show an increase in blood glucose levels in the metformin and vehicle groups between time points t0 and t+15 minutes, probably related to the stress induced by the intraperitoneal injection. The plant extract dose 1 and dose 2 groups showed a significant reduction in their insulin resistance compared to the vehicle group. No significant effect was observed between the vehicle and metformin groups due to the large initial increase in blood glucose levels. Killing the mice:

[0104] At the end of the 30-day treatment period, the mice were killed after a fast of 3 hours (gastric emptying) and several organs were collected for further studies (liver, pancreas, adipose tissue and muscle). The final data are shown in [Fig.7].

[0105] With the exception of blood glucose, the other parameters measured are not statistically different between the 4 experimental groups.

[0106] In conclusion, this study demonstrates that administering plant extracts to Ob / Ob mice (groups 3 and 4) significantly improves glucose homeostasis compared to Ob / Ob mice treated with the vehicle solution (group 1). This effect appears to be independent of food intake. Both doses had an antidiabetic effect, but the second dose had a more rapid onset of action.

[0107] Effect of the composition according to the invention on glucose homeostasis in male C57BL6 / J mice. Study models

[0108] The study was carried out on the 7-week-old male C57BL6 / J mouse model.

[0109] The C57BL6 / J mouse, often called "C57 black 6", is an inbred strain laboratory mouse current.

[0110] This is a mouse model widely used to study human diseases, particularly because of its ease of reproduction and robustness. Description of the experimental protocol

[0111] The C57BL6 / J mice used in the study were housed in an animal facility with lighting regulated on a 12h / 12h cycle, and controlled temperature and humidity. The mice had free access to water and a standard balanced diet.

[0112] After one week of acclimatization, the mice were randomized based on their weight and blood glucose levels in the "fed state" and divided into two experimental groups. They were fed either a standard control diet (n=12) or a high-fat diet (n=48; Research Diet TD12492; 60 kcal from fat) for a period of 8 weeks. Weight and blood glucose levels were measured every 15 days.

[0113] After 8 weeks, body weight and blood glucose levels were measured. Mice on a high-fat diet were randomized based on their weight and blood glucose levels in the "fed state" and separated into 4 experimental groups, see [Fig. 10].

[0114] Group 0 is a negative control group in which the mice were on a standard diet and received a placebo comprising a vehicle solution (the same as the solution used to dilute the plant extracts), administered by oral gavage, twice a day and at a dose of 5ml / kg.

[0115] Group 1 is a negative control group in which the mice were on a high-fat diet and received a placebo comprising a vehicle solution (the same as the solution used to dilute the plant extracts), administered by oral gavage, twice a day and at a dose of 5ml / kg.

[0116] Group 2 is a positive control group in which a solution of Metformin, diluted also in the same solution in which the plant extracts are diluted, was administered by oral gavage to mice at a dose of 150mg / kg, i.e. 5ml / kg of a solution at a concentration of 30mg / ml, twice a day.

[0117] Group 3 is a test group of the composition according to the invention in which the composition, comprising 50% of plant extract (Dose 1) and 50% of the vehicle solution, was administered by oral gavage at 5ml / kg, twice a day.

[0118] Group 4 is a test group of the composition according to the invention, comprising 100% plant extract (Dose 2), was administered by oral gavage at 5ml / kg, twice a day.

[0119] Group 4 is thus half as concentrated in plant extract as group 3.

[0120] Control of body weight and food intake of mice:

[0121] This period under a high-fat diet made it possible to induce an increase in body mass, see [Fig.8].

[0122] No significant change in blood glucose measured under the "Random-fed" condition was observed, see [Fig.9].

[0123] The weight of the mice, blood glucose in the fed state and food and water intake were measured once a week, see [Fig. 11].

[0124] No significant effect of the treatments on the body weight of mice fed with the high-fat diet was observed.

[0125] The measurement of cumulative food intake does not reveal any major difference, as seen in [Fig. 12]. It is nevertheless noteworthy that mice receiving metformin exhibit a slight but significant reduction in cumulative food intake compared to other mice on a high-fat diet. Blood glucose measurement and water consumption

[0126] In contrast, the blood glucose measurement, shown in [Fig. 13], reveals a significant effect on blood glucose in the fed state. Indeed, metformin and the extracts at doses 1 and 2 rapidly and durably reduce blood glucose levels in mice on a high-fat diet. Only metformin had a notable effect on cumulative water consumption, see [Fig. 14]. Measurement of glucose tolerance

[0127] Seven days after the start of gavage feeding, an initial oral glucose tolerance test (oGTT) was performed. After a 12-hour fast, the mice's weight was measured to determine the glucose dose to be administered. Initial blood glucose levels were measured using a glucometer. A blood sample was taken to... The fasting insulin level was assessed. After oral glucose administration (2 g / kg), blood glucose levels were measured at 15 minutes, 30 minutes, 60 minutes, and 120 minutes. A second blood sample was taken 30 minutes after the glucose administration. This initial dynamic test allowed for the determination of glucose tolerance (oGTT + AUC), HOMA-IR (fasting insulin x fasting blood glucose / 22.5), and the insulin response to glucose.

[0128] This first test reveals few differences after 7 days of gavage between the groups on the high-lipid diet, see [Fig. 15]. Only the AUC of the HFD + Metformin group is significantly different from the HFD-Vehicle group, see [Fig. 16].

[0129] However, from seven days of treatment, a significant difference in fasting insulin concentrations and HOMA-IR is observed between control “HFD” Vehicle mice and “HFD” mice treated with extracts at dose 2, in [Fig. 17].

[0130] A second oGTT was carried out under the same conditions after 21 days of treatment, see figures 18 and 19. It is observed that plant extracts such as metformin have a significant effect and improve glucose tolerance in mice on a high-lipid diet. Measurement of insulin resistance

[0131] Consistently, a significant reduction in fasting insulinemia and HOMA-IR was observed in mice on a high-fat diet after treatment with metformin and plant extracts, see [Fig.20].

[0132] Four days after the oGTT (day 25), an insulin tolerance test was performed. Mice were fasted for 6 hours and then weighed to determine the volume of insulin to be injected. An initial blood glucose measurement, as shown in [Fig. 21], was taken at baseline, and then the mice received an intraperitoneal (IP) injection of insulin (0.75 U / kg). The glycemic response was monitored at t+30, t+60, t+90, t+120, t+150, and t+180 minutes.

[0133] This test allowed us to demonstrate that the extracts (at dose 1) and metformin induce a significant improvement in insulin sensitivity in mice on a high-fat diet, see [Fig. 22]. A downward trend is also observed in mice treated with dose 2, although this does not reach statistical significance. Killing of mice:

[0134] On day 30, the mice were anesthetized by an intraperitoneal injection of xylazine / ketamine (80 / 10 mg / kg), and then a cardiac puncture was performed to collect as much blood as possible. The mice were euthanized by cervical dislocation. The large lobe of the liver was dissected into three parts: one piece was fixed in 4% PFA, and the other two were transferred to cryotubes, frozen in liquid nitrogen, and then stored at -80°C. The blood was centrifuged, and the plasma was transferred to cryotubes. The pancreas of each mouse was dissected and cut in half. One half was fixed in 4% PFA, and the other half was homogenized in an acid-ethanol solution to allow for the quantification of pancreatic insulin content. Subcutaneous and epididymal adipose tissue was also weighed, and a biopsy was stored at -80°C while another was fixed in PFA for further analysis. A muscle biopsy was also taken and stored at -80°C for further analysis. Feces collected per cage during the last three days were retrieved, lyophilized, and stored at -80°C for potential analysis of fecal lipid excretion.

[0135] Organ weighing revealed no significant difference between the vehicle-treated “HFD” groups and the metformin- and plant-extract-treated “HFD” groups. A downward trend in adipose tissue weight was observed in the metformin-treated group, as shown in [Fig. 23].

[0136] In conclusion, the data obtained confirm the data observed in ob / ob mice and show that plant extracts have a significant effect on glucose homeostasis in C57BL / 6 J mice fed a high-fat diet by improving glucose tolerance and insulin sensitivity.

[0137] Thus, the composition according to the invention has shown an improvement in both insulin resistance and glucose uptake in mice.

[0138] The effect of the composition according to the invention on the expression of mouse genes is also being studied via a transcriptomic approach from samples taken from the Ob / Ob and C57BL6 / J mouse groups used in the two studies mentioned above.

[0139] Finally, a clinical study is also planned to verify the stabilizing effect of carbohydrate homeostasis of the composition according to the invention on humans and its preventive role in the shift towards type 2 diabetes.

Claims

Demands

1. Composition for its use in the treatment of prediabetes comprising a plant extract selected from each of the following plant families: - Fabaceae, - Lauraaceae, - Cannabaceae, - Salicaceae.

2. Composition according to claim 1, characterized in that the plant extracts of the Fabaceae family are fenugreek extracts, the plant extracts of the Lauraceae family are bay leaf extracts, the plant extracts of the Cannabaceae family are hop extracts and the plant extracts of the Salicaceae family are black poplar extracts.

3. Composition according to claim 2, characterized in that said at least one extract of fenugreek represents by mass from 15 to 35%, said at least one extract of bay leaf represents by mass from 15 to 35%, said at least one extract of hops represents by mass from 15 to 35%, and said at least one extract of black poplar represents by mass from 15 to 35%, the percentages being expressed by mass relative to the mass of the composition.

4. Composition according to claim 3, characterized in that the plant extracts are in equal proportion.

5. Composition according to any one of the preceding claims, characterized in that it comprises at least one active ingredient selected from vitamins, amino acids and mineral salts.

6. Composition according to any one of claims 1 to 5, characterized in that it is in a liquid, solid or gelling form, suitable for oral administration.

7. Food supplement comprising a composition according to any one of claims 1 to 6.

8. Food ingredient comprising a composition according to any one of claims 1 to 6.

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