WO2025238499A1

WO2025238499A1 - Nutraceutical and/or functional product and related preparation method

Info

Publication number: WO2025238499A1
Application number: PCT/IB2025/054879
Authority: WO
Inventors: Roberto BALZARI
Original assignee: Individual
Current assignee: Individual
Priority date: 2024-05-16
Filing date: 2025-05-09
Publication date: 2025-11-20
Anticipated expiration: 2026-11-16

Abstract

A nutraceutical and/or functional product in the form of a gel, and a method of preparing it, comprising at least a carrier gel and a chelating and/or adsorbing mineral in powder form homogeneously mixed with the carrier gel.

Description

NUTRACEUTICAL AND/OR FUNCTIONAL PRODUCT AND RELATED PREPARATION METHOD

TECHNICAL FIELD

The present invention relates to a method for preparing a nutraceutical and/or functional product (for human use) in the form of a gel, the respective nutraceutical and/or functional product (for human use) in gel form, and a unit dosage form (for oral use) of said nutraceutical and/or functional product in gel form.

PRIOR ART

Nutraceutical and/or functional products are known to be used as food supplements and/or in the health sector for oral use, e.g. having a chelating/detoxifying effect on the body and digestive system, in order to remove certain substances such as alcohol, toxins, heavy metals, free radicals or other harmful substances that may have accumulated in the (human) body or have been ingested.

For instance, such nutraceutical and/or functional products are taken orally, e.g. in the form of solid capsules and tablets, and must be swallowed whole with a significant amount of water or in the form of a powder that must first be suspended and dispersed in water and then drunk.

Such nutraceutical and/or functional products, however, are not always effective in the said chelating/detoxifying action, as they are unlikely to reach the digestive tract intact/still active and/or are difficult to administer.

A felt need in the industry is to increase the efficacy and effective availability of such nutraceutical and/or functional products in the digestive system of the human body. DISCLOSURE OF THE INVENTION

An object of the present invention is to solve this and other needs (that will become clear below) of the prior art, with a simple, rational and cost-effective solution.

Such aims are achieved by the characteristics of the invention reported in the independent claims. The dependent claims outline preferred and/or particularly advantageous aspects of the invention.

BEST MODE TO IMPLEMENT THE INVENTION

According to an aspect, the invention relates to a nutraceutical and/or functional product (for human use that can be administered orally).

A nutraceutical (or food) product, in the most common meaning of the term, is a product (mostly of natural origin) for human use, administered orally, the main purpose of which is to aid, improve, trigger and promote physiological processes in the body.

A nutraceutical product, in the context of the present invention, includes a food product, i.e. a food in the most generic sense of the term, a dietary supplement or a functional food.

By way of example, a nutraceutical product is any substance, mixture of substances, whether processed, partially processed or unprocessed, intended for or suitable for ingestion (by humans).

A functional (food) product means a (food) product, e.g. intended for or suitable for ingestion (by humans), which may imply a targeted beneficial effect on one or more physiological functions or processes of the body.

The nutraceutical and/or functional product is in the form of a gel (e.g. stable at a temperature comprised between 4°C and 40°C), i.e. it has a fluid/pasty consistency defined by a predetermined density typical of gels.

The nutraceutical and/or functional product comprises at least a carrier gel and a chelating and/or adsorbing mineral in powder form homogeneously mixed with the carrier gel, i.e. it comprises/is defined by a suspension of particles (or granules) of chelating and/or adsorbing mineral powder in the (neutral) carrier gel.

The chelating mineral comprises or preferably consists of a (food-grade) zeolite, preferably clinoptilolite.

Clinoptilolite is a mineral (with a crystalline and microporous and/or nanoporous structure) of the zeolite class that consists (predominantly) of a hydrated sodium, potassium and calcium aluminium silicon aluminate (plus possible impurities).

Zeolite, or clinoptilolite, has absorbing, adsorbing, chelating and ion exchange properties. In the field of application of the present invention, zeolite, i.e. clinoptilolite, has the ability to cleanse the body of harmful substances accumulated therein by trapping them within its porous structure. This purifying/detoxifying activity is attributed to the ability of zeolite (particularly clinoptilolite) to bind, chelate or exchange with the cations it contains, harmful substances such as alcohol (ethanol), heavy metals, toxins, free radicals and other substances potentially harmful to the human body.

It has been observed that the effect of zeolite, particularly clinoptilolite, is to limit the absorption and/or accumulation of these harmful substances by the body allowing them to be evacuated.

For example, it has been observed (from in vitro and in vivo tests) that the effect of zeolite, in particular clinoptilolite, on the absorption of alcohol (ethanol), or other harmful substances, taken in by an individual (e.g. through the intake of alcoholic beverages) occurs predominantly in the digestive system (stomach and/or intestines), effectively preventing it from being absorbed (and metabolised) in the liver and blood.

Moreover, zeolite, particularly clinoptilolite, has the important property of not releasing the harmful substance (e.g. alcohol, heavy metals, toxins, free radicals) adsorbed, in detail the adsorption/chelation process triggered by zeolite in particular by clinoptilolite, is not reversible (as is the case with other chelating substances, such as activated carbon or spirulina algae, which once “full” of chelated harmful substances are “emptied”, giving rise to accumulation and release cycles).

For example, it was observed that about 1 g of zeolite, particularly clinoptilolite, ad- sorbs/absorbs about 5mL of ethanol (equivalent to 4 g of ethanol).

Zeolite, i.e. clinoptilolite, can be activated/treated beforehand by means of an activation process (i.e. a process known as KLS-5) that increases its digestibility.

The chelating and/or adsorbing mineral, i.e. (zeolite or) clinoptilolite has a particle size comprised between 35 pm and 100 pm, preferably comprising granules with different (variable) particle sizes within said size range comprised between 35 pm and 100 pm.

Advantageously, the variability of the particle size of zeolite, and clinoptilolite in particular, within the aforementioned range allows for different sized granules (within the same unit dose to be ingested), which allows the adsorbent/chelating effect of zeolite to be maximised, as it has been observed that certain particle size distributions (or particles of a certain size) are more effective in certain sections of the digestive tract (e.g. in the stomach) and other certain particle size distributions (or particles of a certain size) are more effective in other certain sections of the digestive tract (e.g. in the intestine).

Preferably, the chelating and/or adsorbing mineral, i.e. (zeolite or) clinoptilolite, is present in a percentage, by weight with respect to the total weight of the nutraceutical and/or functional product, comprised between 30% and 50%, preferably in a percentage comprised between 35% and 40%, more preferably in a percentage of 37%.

As mentioned above, the chelating and/or adsorbing mineral is finely and homogeneously dispersed in the carrier gel, which has the function of transporting the chelating and/or adsorbing mineral to the body’s digestive system, effectively occluding and/or occupying its microporosity and/or nanoporosity.

Moreover, the carrier gel being rapidly disintegratable/digestible in the body’s digestive system dissolves rapidly, leaving the chelating and/or adsorbing mineral free to perform its chelating and/or adsorbing function in the body’s digestive system (stomach and/or intestine).

According to a preferred aspect of the invention, the carrier gel comprises a carrier liquid, preferably consisting of water.

The carrier liquid, i.e. water, is used to make the carrier gel.

For example, the carrier liquid, i.e. water, is present, preferably, in a percentage, by weight with respect to the total weight of the product, comprised between 30% and 40%, more preferably 36% +/- 1 % or 39.4% +/- 0.5%.

The carrier gel also includes a thickener, preferably selected from the group consisting of xanthan, guar gum, agar agar or mixtures thereof.

More preferably, the thickener is xanthan.

The thickener is present, preferably, in a percentage, by weight with respect to the total weight of the product, comprised between 0.2% and 1 %, preferably 0.6% +/- 0.1 %.

Optionally, the carrier gel comprises a flavouring and/or seasoning substance selected from the group consisting of dehydrated fruit (e.g. mango, strawberry, pineapple, etc.) and a flavouring of natural or synthetic origin (e.g. a cola or other flavour) or mixtures thereof.

For example, if the flavouring and/or seasoning substance is dehydrated fruit, it is present, preferably, in a proportion, by weight with respect to the total weight of the product, comprised between 2% and 6%, preferably 4%.

In the event that the flavouring and/or seasoning substance is a flavouring of natural or synthetic origin, it is present in a proportion, by weight with respect to the total weight of the product, comprised between 0.3% and 0.7%, preferably 0.5%.

Again, the carrier gel may optionally comprise at least one preservative substance, wherein the preservative substance is preferably potassium sorbate.

Preferably, the preservative substance - where provided - is present in a percentage, by weight with respect to the total weight of the product, comprised between 0.0002% and 0.0006%, preferably 0.0004%; Optionally, the carrier gel may comprise a sweetener, wherein the sweetener is selected from the group consisting of xylitol, sugar, erythritol and mixtures thereof.

For example, the sweetener is xylitol.

Advantageously, the sweetener is preferably present in a percentage, by weight with respect to the total weight of the product, comprised between 3% and 6%, more preferably 4.6%.

According to an advantageous aspect of the invention, an active (or functional) element may be added to the nutraceutical and/or functional product.

In this case, for example, the nutraceutical and/or functional product may additionally comprise at least one active (or functional) element, preferably an active (or functional) mineral selected from the group consisting of Zinc and Sulphur (preferably in the form of Methylsulfonylmethane - MSM) or mixtures and/or co-presences thereof.

For example, a first active element may be an active mineral consisting of Zinc (food grade), present, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 0.03% and 0.09%, more preferably 0.06%.

Zinc has the function, among others, of stimulating the activation of the body’s own enzymes for metabolising ethyl alcohol.

Additionally, a second active element may be an active mineral consisting of Sulphur (Methylsulphonylmethane), preferably present in a percentage, by weight with respect to the total weight of the product, comprised between 3% and 5%, more preferably 4.1 %.

Sulphur, in addition to other advantages and benefits for the body, has the function of controlling blood sugar.

According to an advantageous aspect of the invention, the nutraceutical and/or functional product may further comprise at least one wetting agent, preferably glycerol.

For example, the function of the wetting agent (i.e. glycerol) is to keep the nutraceutical and/or functional product moist.

At the same time, a secondary function of the wetting agent (i.e. glycerol) is to act as a laxative agent, useful in promoting the evacuation from the body’s digestive system of the chelating and/or adsorbing mineral that has carried out its chelating action against the alcohol and/or harmful substances it is designed to treat.

For example, the wetting agent is present, preferably, in a percentage, by weight with respect to the total weight of the product, comprised between 10% and 16%, more preferably 13%.

According to an advantageous aspect of the invention, the nutraceutical and/or functional product may further comprise a diuretic, preferably escin.

For example, the diuretic is present, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 0.00005, and 0.0002%, more preferably 0.0001 %.

The invention also makes available a unit dosage form of the nutraceutical and/or functional product as described above, wherein the unit dosage form contains an amount comprised between 3 g and 7 g, preferably 5 +/- 0.1 g, of chelating and/or adsorbing mineral.

In practice, the nutraceutical and/or functional product is suitable for oral administration and may be presented, for consumption, in unit (discrete) dosages of edible and/or swallowable gel (gel particle suspension) arranged, for example, within a sachet, packet, bottle or similar container (preferably single-dose and/or disposable), e.g. to be opened and consumed on the spot.

Each of these unit dosages has, for example, a total weight of 13.5 g.

A first example of a nutraceutical and/or functional product (wherein all the percentages below are percentages by weight of the total weight of the nutraceutical and/or functional product) comprises:

- a carrier gel consisting of: water (36%); dehydrated fruit (4%); possible sweetener, e.g. xylitol (4.6%); thickener, e.g. xanthan (0.6%); preservative, e.g. potassium sorbate (0.0004%);

- chelating mineral, preferably clinoptilolite zeolite (37%);

- first active element, e.g. Sulphur (0.06%);

- second active element, e.g. Zinc (4.1 %); and

- wetting agent, e.g. glycerol (13%).

A second example of a nutraceutical and/or functional product (wherein all the percentages below are percentages by weight of the total weight of the nutraceutical and/or functional product) comprises:

- a carrier gel consisting of: water (39.4%); flavouring (0.5%); possible sweetener, e.g. xylitol (4.6%); thickener, e.g. xanthan (0.7%); preservative, e.g. potassium sorbate (0.0004%);

- chelating mineral, preferably clinoptilolite zeolite (37%);

- first active element, e.g. Sulphur (0.06%);

- second active element, e.g. Zinc (4.1 %); and

- wetting agent, e.g. glycerol (13%).

A further aspect of the invention provides a method for preparing a nutraceutical and/or functional product (for human use that can be administered orally) in the form of a gel that comprises:

- first preparing a carrier gel containing a carrier liquid, preferably water (e.g. present in a percentage, by weight with respect to the total weight of the product, comprised between 30% and 40%, more preferably 36% +/- 1 % or 39.4% +/- 0.5%) and a thickener e.g. selected from the group consisting of xanthan, guar gum, agar agar or mixtures thereof, more preferably xanthan (e.g. present in a percentage, by weight with respect to the total weight of the product, comprised between 0.2% and 1 %, more preferably equal to 0.6% +/- 0.1 %).

For example, the preparation of the carrier gel is carried out using a food pasteuriser.

The preparation of the carrier gel may involve adding to the carrier liquid at least one a flavouring and/or seasoning substance selected from the group consisting of dehydrated fruit, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 2% and 6%, preferably 4%, and a flavouring of natural or synthetic origin, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 0.3% and 0.7%, preferably 0.5%, or mixtures thereof;

The step of preparing the carrier gel may involve adding at least one preservative substance to the carrier liquid, whereby preferably the preservative substance is potassium sorbate (e.g. in a percentage, by weight with respect to the total weight of the product, comprised between 0.0002% and 0.0006%, preferably 0.0004%).

The step of preparing the carrier gel may involve adding at least one sweetener to the carrier liquid, wherein the sweetener is selected from the group consisting of xylitol, sugar, erythritol and mixtures thereof, preferably xylitol (in a percentage, by weight with respect to the total weight of the product, comprised between 3% and 6%, preferably 4.6%).

Operationally, the step of preparing the carrier gel may involve: o heating (first alone) the carrier liquid, preferably with the addition of the preservative substance and/or sweetener, to a temperature less than the boiling point thereof, preferably to 82°C, o cooling the carrier liquid according to a predefined cooling ramp, preferably by arranging the heated carrier liquid in a refrigerated room (e.g. a cold room) placed at a temperature of 4°C; o adding (while stirring), while the carrier liquid is cooling (i.e. before it reaches 4°C) the thickening substance and, preferably, the flavouring and/or seasoning substance, resulting in said carrier gel upon completion of cooling.

The resulting carrier gel is stable and workable.

At this point, the method involves:

- preparing (or having previously prepared) a chelating and/or adsorbing mineral in powder form, wherein the chelating mineral preferably has a particle size comprised between 35 pm and 100 pm; and

- adding and mixing the chelating and/or adsorbing mineral in powder form (previously prepared) to the carrier gel.

As mentioned, the chelating and/or adsorbing mineral is (consisting of or comprises) preferably a zeolite, preferably clinoptilolite.

Preferably, the chelating and/or adsorbing mineral, i.e. zeolite, preferably clinoptilolite, is present in a percentage, by weight with respect to the total weight of the nutraceutical and/or functional product, comprised between 30% and 50%, preferably in a percentage comprised between 35% and 40%, more preferably in a percentage of 37%.

As mentioned, the chelating and/or adsorbing mineral, i.e. (zeolite or) clinoptilolite, has a particle size in the range comprised between 35 pm and 100 pm, preferably comprising granules with different (variable) particle sizes within this size range comprised between 35 pm and 100 pm.

The chelating and/or adsorbing mineral, i.e. (zeolite or) clinoptilolite, in powder form is finely and homogeneously dispersed in the carrier gel by stirring.

In this way, the pores of the chelating and/or adsorbing mineral, i.e. the (zeolite or) clinoptilolite are “trickedVoccluded by the (neutral) carrier gel that incorporates the said chelating and/or adsorbing mineral granules, i.e. the (zeolite or) clinoptilolite.

The method can, then, further:

- adding and mixing at least one active element, preferably an active mineral selected from the group consisting of zinc, sulphur or mixtures thereof (Methylsulpho- nylmethane, to the carrier gel, previously fortified with the chelating and/or adsorbing mineral (i.e. clinoptilolite).

For example, the first active element may be an active mineral consisting of Zinc (food grade), added, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 0.03% and 0.09%, more preferably 0.06%.

Additionally, the second active element may be an active mineral consisting of Sulphur (Methylsulphonylmethane), preferably added in a percentage, by weight with respect to the total weight of the product, comprised between 3% and 5%, more preferably 4.1 %. The method may further comprise:

- adding and mixing at least one wetting agent, preferably glycerol, to the carrier gel, previously fortified with the chelating and/or adsorbing mineral (and the active element).

For example, the wetting agent is added, preferably, in a percentage, by weight with respect to the total weight of the product, comprised between 10% and 16%, more preferably 13%.

Again, by way of non-limiting example, the method may further comprise:

- adding and mixing at least one diuretic, preferably escin, to the carrier gel, previously fortified with the chelating and/or adsorbing mineral (and the active element).

For example, the diuretic may preferably be present in a percentage, by weight with respect to the total weight of the product, comprised between 0.00005% and 0.0002%, more preferably 0.0001 %.

Once the nutraceutical and/or functional product is ready (and homogeneously mixed), it is in the form of a gel, namely a powder homogeneously dispersed in a (flavoured) carrier gel matrix, e.g. stable at temperatures comprised between 4°C and 40°C.

This nutraceutical and/or functional product can be dosed (and packaged) for making unit dosage forms as described above.

The method can then be concluded with the packaging of one or more (finished) dosage forms in special single-dose packs (sachets).

Claims

1. A method for preparing a nutraceutical and/or functional product, preferably for human use that can be administered orally, in the form of a gel that comprises:

- preparing a carrier gel containing a carrier liquid, preferably water, and a thickener;

- optionally, preparing a chelating and/or adsorbing mineral in powder form, wherein the chelating mineral has a particle size comprised between 35 pm and 100 pm; and

- adding and mixing a chelating and/or adsorbing mineral in powder form to the carrier gel.

2. The method according to claim 1 , wherein the step of preparing the carrier gel comprises adding to the carrier liquid at least one flavouring and/or seasoning substance selected from the group consisting of dehydrated fruit and a flavouring of natural or synthetic origin or mixtures thereof.

3. The method according to claim 1 or 2, wherein the step of preparing the carrier gel involves adding at least one preservative substance to the carrier liquid, wherein preferably the preservative substance is potassium sorbate.

4. The method according to any one of the preceding claims, wherein the thickener is selected from the group consisting of xanthan, guar gum, agar agar or mixtures thereof.

5. The method according to any one of the preceding claims, wherein the step of preparing the carrier gel involves adding at least one sweetener to the carrier liquid, wherein the sweetener is selected from the group consisting of xylitol, sugar, erythritol and mixtures thereof.

6. The method according to any one of the preceding claims, wherein the step of preparing the carrier gel comprises heating the carrier liquid, preferably with the addition of the preservative substance and/or the sweetener, to a temperature less than the boiling point thereof, preferably to 82°C, cooling the liquid according to a predefined cooling ramp, preferably by arranging the heated carrier liquid in a refrigerated room placed at a temperature of 4°C; adding, while the carrier liquid is cooling, the thickening substance and, preferably, the flavouring and/or seasoning substance, resulting in said carrier gel upon completion of cooling.

7. The method according to claim 1 or any one of the preceding claims, where the chelating mineral is a zeolite, preferably clinoptilolite.

8. The method according to any one of the preceding claims, which further comprises:

- adding and mixing at least one active element, preferably an active mineral selected from the group consisting of zinc, sulphur or mixtures thereof, to the carrier gel, previously fortified with the chelating and/or adsorbing mineral.

9. The method according to any one of the preceding claims, which further comprises:

- adding and mixing at least one wetting agent, preferably glycerol, to the carrier gel, previously fortified with the chelating and/or adsorbing mineral.

10. A nutraceutical and/or functional product, preferably for human use that can be administered orally, in the form of a gel comprising at least a carrier gel and a chelating and/or adsorbing mineral in powder form homogeneously mixed with the carrier gel.

11. The product according to claim 10, wherein the chelating and/or adsorbing mineral is present in a percentage, by weight with respect to the total weight of the product, comprised between 30% and 50%, preferably in a percentage comprised between 35% and 40%, more preferably in a percentage of 37%.

12. The product according to claim 10 or 1 1 , wherein the carrier gel comprises:

- a carrier liquid, optionally water, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 30% and 40%, more preferably 36%;

- a thickening agent, optionally selected from the group consisting of xanthan, guar gum, agar agar or mixtures thereof, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 0.2% and 1 %, preferably 0.6%;

- optionally, a flavouring and/or seasoning substance selected from the group consisting of dehydrated fruit, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 2% and 6%, preferably 4%, and a flavouring of natural or synthetic origin, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 0.3% and 0.7%, preferably 0.5%, or mixtures thereof;

- optionally, a preservative substance, wherein preferably the preservative substance is potassium sorbate, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 0.0002% and 0.0006%, preferably 0.0004%; - optionally, a sweetener, whereby the sweetener is selected from the group consisting of xylitol, sugar, erythritol and mixtures thereof, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 3% and 6%, preferably 4.6%.

13. The product according to any one of claims 10-12, wherein the chelating mineral is a zeolite, preferably clinoptilolite.

14. The product according to any one of claims 10-13, wherein the chelating mineral has a particle size comprised between 35 pm and 100 pm, preferably comprising granules having different particle sizes in the size range comprised between 35 pm and 100 pm.

15. The product according to any one of claims 10-14, further comprising at least one active element, preferably an active mineral selected from the group consisting of zinc, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 0.03% and 0.09%, more preferably 0.06%; sulphur, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 3% and 5%, more preferably 4.1 %; or mixtures thereof.

16. The product according to any one of claims 10-15, further comprising at least one wetting agent, preferably glycerol, preferably in a percentage, by weight with respect to the total weight of the product, comprised between 10% and 16%, more preferably 13%.

17. A unit dosage form of the product as claimed in any one of claims 10 to 16, wherein the unit dosage form contains from 3 g to 7 g, preferably equal to 5 +/- 0.1 g of chelating and/or adsorbing mineral.