NUTRACEUTIC COMPOSITION COMPRISING LIMONENE AND A DRY EXTRACT OF COCOA FIBRE FOR THE TREATMENT OF OBESITY

Abstract

A nutraceutical composition comprising natural or synthetic limonene or an essential oil having a content of limonene of at least 30% by weight and cocoa fibre is described for human or veterinary use in the treatment of obesity.

Claims

1. A nutraceutical composition comprising natural or synthetic limonene or an essential oil having a content of limonene of at least 30% by weight and cocoa fibre.

2. The composition according to claim 1, wherein the essential oil is orange essential oil.

3. The composition according to claim 2, wherein the cocoa fibre is cocoa fibre powder or dry cocoa extract or cocoa bean powder or powder obtained from cocoa bean pericarp.

4. The composition according to claim 3, wherein the limonene or the essential oil are present in a quantity comprised between 5% and 50% by weight.

5. The composition according to claim 4, wherein the cocoa fibre is present in a quantity comprised between 50% and 95% by weight.

6. The composition according to claim 5, wherein the fibre has a grain size comprised in a range of from -1 to +8 of the Krumbein phi scale.

7. A process for the preparation of the composition according to claim 1, comprising mixing limonene or essential oil with cocoa fibre under continuous stirring in order to form solid spherical lumps of variable dimensions, followed by a breaking step by mechanical action.

8. A process for treating obesity, comprising the step of administering the composition according to claim 1 for human or veterinary therapeutic use in the treatment of obesity.

9. The process according to claim 7, further comprising the step of mixing the limonene or essential oil and cocoa fibre after the breaking step, until complete dissolution of the lumps.

10. The composition according to claim 5, wherein quantity of the cocoa fibre is comprised between 75% and 90% by weight.

11. The composition according to claim 4, wherein the quantity of the limonene or the essential oil is comprised between 10% and 25% by weight.

12. The composition according to claim 1, wherein the cocoa fibre is present in a quantity comprised between 50% and 95% by weight.

13. The composition according to claim 12, wherein quantity of the cocoa fibre is comprised between 75% and 90% by weight.

14. The composition according to claim 1, wherein the limonene or the essential oil are present in a quantity comprised between 5% and 50% by weight.

15. The composition according to claim 14, wherein the quantity of the limonene or the essential oil is comprised between 10% and 25% by weight.

16. The composition according to claim 1, wherein the cocoa fibre is cocoa fibre powder or dry cocoa extract or cocoa bean powder or powder obtained from cocoa bean pericarp.

17. The composition according to claim 1, wherein the cocoa fibre has a grain size comprised in a range of from -1 to +8 of the Krumbein phi scale.

Description

[0025] A further object of the present invention is therefore the use of a nutraceutical composition comprising natural or synthetic limonene or an essential oil having a content of limonene of at least 30% by weight and cocoa fibre for human or veterinary therapeutic use in the treatment of obesity.

[0026] In one embodiment, the composition for use in the treatment of obesity comprises also at least one pharmaceutically acceptable carrier that allows its formulation in conventional dosage forms, such as for example tablets, granules, capsules or suspensions for oral administration.

[0027] The preparation of these dosage forms and the selection of the pharmaceutically acceptable carriers are comprised within the knowledge of the skilled person.

[0028] The dose of the compositions according to the invention for human or veterinary use is preferably comprised between 5 mg and 10 g/day of composition, for example on the basis of the species, means of administration, age and weight of the subject.

[0029] By way of example and without limiting the scope of the invention, preferred embodiments of the composition according to the invention are described below.

Example 1

[0030] Composition comprising: [0031] natural or synthetic limonene; [0032] cocoa fibre powder or dry cocoa extract or cocoa bean powder or powder obtained from cocoa bean pericarp. 60 g of cocoa fibre are added to 10 g of natural or synthetic limonene.

[0033] After the addition of cocoa fibre to the natural or synthetic limonene, under continuous stirring, solid spherical lumps of variable dimensions are formed.

[0034] The lumps are broken by mechanical action (using for example a vibromixer or similar instrument designed to break the lumps) and the mixture is mixed until complete dissolution of the aggregates.

[0035] With reference to the above-mentioned examples, some results are reported below of animal and/or clinical trials supporting the therapeutic use.

[0036] Demonstration of the slimming effect according to example 1 in the treatment of obesity.

[0037] The composition of example 1 has been administered to a group of mice with obesity induced by a high lipid diet, with a dose of 60 mg/day for a cycle with a duration of 6 weeks.

[0038] The effectiveness of the treatment was demonstrated by monitoring the weight of the animals, which were well fed with a weight-gaining diet with a high lipid content. After 6 weeks of treatment, the group of animals treated had an average weight reduced by 12% compared with the group of control animals. The animals treated also showed lower blood sugar and triglyceride levels compared with the control group.

[0039] Demonstration of the slimming effect of limonene in obese mice.

[0040] Animal feed having a concentration of 0.5% in limonene corresponding to a daily dose of 0.6 g/kg of weight in humans. After 12 weeks of high lipid diet that caused obesity, mice were administered ad libitum, animal feed containing 0.5% of limonene for 2 weeks. The efficacy of the treatment was demonstrated by decreasing the size of both white and brown adipocytes, by reducing the serum triglycerides up to 47% and by preventing the accumulation of lipids in the cells.

[0041] The present invention therefore relates to a new mixing of natural or synthetic limonene or of essential oil having a content of limonene of at least 30% by weight, as active ingredient, with cocoa fibre used for the treatment of obesity in human or animals.

[0042] The composition is a damp powder (hygroscopic) which releases the active component in the area of interest. The specific cocoa fibre composition allows a partial and gradual release of limonene in the small intestine during transit where it is absorbed and exerts its important action on lipid and glycemic profile in obese individuals. In the large intestine, the oily remaining component, harnessed in fibre, is released when the fibre is degraded by the intestinal bacterial component.

[0043] At this moment, the remaining part of the active ingredient modulates the subject metabolism by acting on the intestinal microbiota.

[0044] Such a dual effect is obtained by using cocoa fibre but not with other vegetable fibres which convey the active ingredient almost exclusively through the colon but do not allow it to be absorbed.

[0045] The fibre also prevents the evaporation of the essential oil component and therefore allows it to be encapsulated in wrappers of any type.

[0046] The compositions according to the present invention are particularly advantageous since the obtained mixture is stable and the active component of the mixture (essential oils, components thereof or vegetable origin extracts which they contain, including synthetic analogues) is absorbed on a matrix which eliminates the majority of, or completely, the negative effects on the mucus, allowing a slow and controlled release, in particular along the whole intestinal tract.

[0047] The particular cocoa fibre composition allows to release the active partially in the small intestine where it is absorbed and can act systemically, partially in the colon where it can act topically. This characteristic is the basis for the efficacy of the composition.

[0048] From a biological point of view, the mixture according to the invention allows the active ingredient to be taken free of the side effects which there would be without mixing. It also allows a slower release of the active ingredient (retard effect), which while starting in the stomach, continues in the small and large intestine where the fibre is demolished by the intestinal microbiota (bacterial flora) and the active ingredient may perform its slimming effect along with its germicidal, fungicidal, antibacterial, anti-inflammatory, anti-parasite and antibiotic actions.