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Title:
COMPOSITION COMPRISING RED BEET EXTRACT
Document Type and Number:
WIPO Patent Application WO/2022/029614
Kind Code:
A1
Abstract:
The present invention relates to a composition comprising a red beet extract, citrulline or a salt thereof, and arginine or a salt thereof. In particular, the composition comprises a concentration of red beet extract higher than 30% by weight, and a weight ratio between the red beet extract and citrulline or a salt thereof in the range from 1 to 3. The composition, administered before training, thanks to its vasodilating properties, allows to significantly improve athletes' sports performance. The composition is also stable, easily processable, and has an excellent palatability, while being safe and effective for use in sports supplementation.

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Inventors:
TACCONI EDOARDO (IT)
POLITI BARBARA (IT)
Application Number:
PCT/IB2021/057081
Publication Date:
February 10, 2022
Filing Date:
August 03, 2021
Export Citation:
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Assignee:
GENSAN S R L (IT)
International Classes:
A23L33/175; A23L33/105; A61K31/198; A61K31/21
Domestic Patent References:
WO2019183028A12019-09-26
WO2020231906A12020-11-19
Foreign References:
US20060292134A12006-12-28
EP2210600A12010-07-28
Other References:
DATABASE GNPD [online] MINTEL; 4 December 2015 (2015-12-04), ANONYMOUS: "Male Physical Response Nitric Oxide Performance Booster", XP055791271, retrieved from www.gnpd.com Database accession no. 3586061
DATABASE GNPD [online] MINTEL; 7 September 2018 (2018-09-07), ANONYMOUS: "Pre-Workout Boost", XP055791278, retrieved from https://www.gnpd.com/sinatra/recordpage/5950801/ Database accession no. 5950801
ANONYMOUS: "Nitrate salts vs beetroot: How do they compare nutritionally? | Prospector", 3 November 2017 (2017-11-03), pages 1 - 5, XP055791562, Retrieved from the Internet [retrieved on 20210330]
DATABASE FSTA [online] FSTA; 1 February 2017 (2017-02-01), ROUX-MALLOUF T LE ET AL: "FS-2017-07-Ge2883 Effect of acute NO pathway supplementation on flow mediated dilation of the lower limb assessed by near infrared spectroscopy.", XP055791387, Database accession no. FS-2017-07-Ge2883
Attorney, Agent or Firm:
CATTANEO, Elisabetta et al. (IT)
Download PDF:
Claims:
CLAIMS

1. A composition comprising:

- a red beet extract,

- citrulline or a salt thereof, and

- arginine or a salt thereof, wherein the red beet extract is present in a concentration higher than 30% by weight and the weight ratio between the red beet extract and citrulline or a salt thereof, expressed as citrulline, is in the range from 1 to 3.

2. The composition according to claim 1 , wherein citrulline or a salt thereof is L- citrulline or a salt thereof, preferably L-citrulline DL-malate.

3. The composition according to claim 1 or 2, wherein arginine or a salt thereof is L-arginine or a salt thereof, preferably L-arginine alpha-ketoglutarate.

4. The composition according to any one of claims 1 to 3, wherein the beet extract is present in a concentration in the range from 40 to 45% by weight.

5. The composition according to any one of claims from 1 to 4, wherein the weight ratio between the red beet extract and citrulline or a salt thereof, expressed as citrulline, is in the range from 1 .5 to 2.5.

6. The composition according to any one of claims from 1 to 5, wherein citrulline or a salt thereof is present in a higher amount with respect to arginine or a salt thereof.

7. The composition according to any one of claims from 1 to 6, wherein the weight ratio between the amount of citrulline or a salt thereof and the amount of arginine or a salt thereof, expressed as citrulline and arginine, respectively, is in the range from 2.5 to 3.5, preferably of about 3.

8. The composition according to any one of claims 1 to 7, wherein the concentration of citrulline or a salt thereof, expressed as citrulline, is at least equal to 15% by weight, preferably in the range from 15 to 30% by weight, even more preferably in the range from 20 to 25% by weight.

9. The composition according to any one of claims from 1 to 8, wherein the concentration of arginine or a salt thereof, expressed as arginine, is higher than 5% by weight, preferably in the range from 7 to 8% by weight.

10. The composition according to any one of claims from 1 to 9 further comprising an antioxidant, preferably N-acetyl-L-cysteine, preferably in a concentration in the range from 0.5 to 1 % by weight, more preferably in the range from 0.6 to 0.8% by weight.

11. The composition according to any one of claims 1 to 10 further comprising a carbohydrate, preferably a highly branched cyclic dextrin, more preferably in a concentration in the range from 5 to 10% by weight, preferably in the range from 6 to 7% by weight.

12. The composition according to any one of claims from 1 to 11 comprising a stabilizer, preferably silicon dioxide, preferably in a concentration of at least 2% by weight, preferably of about 3% by weight.

13. The composition according to any one of claims 1 to 12 comprising a concentration of red beet extract in the range from 40 to 45% by weight, a weight ratio between the red beet extract and citrulline or a salt thereof, expressed as citrulline, in the range from 1.5 to 2.5, and a weight ratio between the amount of citrulline or a salt thereof and the amount of arginine or a salt thereof, expressed as citrulline and arginine, respectively, in the range from 2.5 to 3.5, a concentration of N-acetylcysteine in the range from 0.6 to 0.8% by weight, a concentration of highly branched cyclic dextrins in the range from 6 to 7% by weight, and a concentration of silicon dioxide equal to about 3% by weight.

14. The composition according to claim 1 , wherein said composition consists of

- red beet extract,

- citrulline or a salt thereof, and

- arginine or a salt thereof, wherein the concentration of red beet extract is in the range from 45 to 65% by weight, preferably in the range from 48 to 60% by weight, the concentration of citrulline or a salt thereof, expressed as citrulline, is in the range from 20 to 35% by weight, preferably in the range from 25 to 32% by weight, the concentration of arginine or a salt thereof, expressed as arginine, is in the range from 7 to 12% by weight, preferably in the range from 8 to 11 % by weight.

15. The composition according to claim 1 , wherein said composition consists of red beet extract, L-citrulline DL-malate and L-arginine alpha-ketoglutarate, wherein the concentration of red beet extract is in the range from 48 to 51 % by weight, the concentration of L-citrulline DL-malate, expressed as citrulline, is in the range from 25 to 28% by weight, the concentration of L-arginine alphaketoglutarate, expressed as arginine, is in the range of 8 to 9% by weight.

16. A food supplement comprising the composition according to any one of claims 1 to 15.

17. The food supplement according to claim 16 in the form of a powder to be reconstituted for oral administration.

18. The food supplement according to claim 17, wherein the unitary dosage is 10 g of powder to be reconstituted in 100 ml of water. 19. Use of the food supplement according to any one of claims from 16 to 18 to aid or improve vasodilation in a healthy subject before or during physical activity, preferably in the pre-workout phase.

Description:
COMPOSITION COMPRISING RED BEET EXTRACT

DESCRIPTION

FIELD OF THE INVENTION

The present invention relates to a composition comprising a red beet extract, citrulline or a salt thereof, and arginine or a salt thereof.

The composition, administered before training, thanks to its vasodilating properties, allows to significantly improve athletes’ sports performance. The composition is also stable, easily processable, and has an excellent palatability, while being safe and effective for use in sports supplementation.

STATE OF THE ART

It is known that athletes, especially in the body building and endurance sectors, need to be properly supplemented in the so-called pre-workout to optimize performance during very intense sports activities.

This supplementation allows to optimize energies in the pre-com petition phase and to improve performance of those who practice both endurance and power sports. To improve this warm-up phase, it is well known how important it is to support vasodilation at the muscle level, vasodilation that induces an increase in blood circulation. Since blood is responsible for transporting oxygen, transporting nutrients to the muscles, and removing CO2 and waste metabolites, the increase in blood flow increases the athlete’s ability to work for longer periods, positively impacting on its resistance to fatigue and effort, and also accelerating recovery times.

Blood vessels vasodilation is the result of relaxation of the smooth muscles covering them and is closely related to the presence of nitric oxide. Nitric oxide is physiologically produced by the body through synthesis of the amino acid L- arginine and secreted by the endothelial cells, which cover the inner walls of blood with consequent vasodilation.

Nitric oxide also has other important positive effects at the metabolic level, for example on immune response, erectile dysfunction, brain functions such as memory and depression, blood pressure and inflammation, in combating cardiovascular diseases, as well as on mitigation of some consequences resulting from type 2 diabetes, and also positive anti-thrombotic effects.

Nitric oxide, being a gaseous molecule at room temperature, cannot be directly supplemented due to its chemical nature, in fact there are no supplement containining it, but it is rather generated through administration of precursors thereof.

To date, the best known and used precursors for indirect supplementation of nitric oxide are L-arginine, L-citrulline and nitrates.

The physiological synthesis of nitric oxide, in fact, requires the presence of arginine and citrulline (endogenous synthesis), but the human body is able to physiologically synthesize nitric oxide also using nitrates taken with food (exogenous synthesis).

L-arginine is an essential amino acid in children and non-essential in adulthood; in addition to being a precursor of nitric oxide in the body, it also helps to reduce accumulation of ammonia formed during physical activity.

Other beneficial effects of L-arginine or salts thereof, such as hydrochloride, on appetite, energy status, sleep quality, mood, cognitive brain functions and, of course, blood circulation are known.

L-citrulline is a non-essential amino acid, of the alpha type, involved in the urea cycle and having a direct activity on the immune system.

Transformed into arginine in the body, it stimulates both the immune and cardiovascular systems, promoting - in the latter case - vasodilation, by increasing the availability of nitric oxide, and consequently improving the elasticity of blood vessels. Precisely for this reason, citrulline is also a good remedy for erectile dysfunction and has even anti-atherosclerotic and blood vessel protective activities, as well as increasing the body’s metabolic rate, decreasing muscle fatigue and enhancing aerobic performance. Finally, citrulline is also able to speed up recovery in case of psychophysical stress.

Arginine and citrulline have always been used in the world of dietary supplementation, alone or in combination with many other ingredients.

For example, US7645742 describes compositions of arginine and citrulline, also in combination with creatinine, D-ribose, L-carnitine, and pyruvate, to increase cellular energy and therefore increase performance, endurance, and intensity of athletes’ physical activities as well as their muscle mass.

US7939113 describes compositions based on citrulline in combination with aspartic acid and creatine, optionally also containing L-arginine, L-leucine, or L- valine, again to increase vasodilation in athletes.

Yet two more recent patent applications, LIS20190167657 and US20200000768, describe compositions, comprising also arginine and citrulline, having therapeutic purposes, for the treatment of sexual dysfunctions in the first case, and for the treatment of hypertension, cholesterol lowering, and generally for the cardiovascular system health in the second case.

Finally, in the patent application EP3320895 the two ingredients are used in specific weight ratios within formulations of supplements capable of causing, after their intake, the rapid increase of arginine content in the blood, to rapidly counteract muscle fatigue and sensation of exercise fatigue.

On this topic, in addition to the references cited above, there is a copious bibliography and numerous patent applications on the possible associations of these two amino acids or salts thereof, also and mostly in combination with another enormous amount of ingredients, for the formulation of products intended for supplementation.

As regards the other source of nitric oxide, namely nitrates, they are normally present in green leafy vegetables, and in particular also in red beet, whose juice has been studied precisely due to their high presence.

Beet root extract is also known for its effects on cognitive functions, blood pressure, inflammation, and detoxification processes.

By virtue of said properties, these active ingredients have also been studied, even in combination with one another, such as in US20200077689, within complex multi-ingredient compositions, for the formulation of preparations intended for use both as supplements and drugs.

As apparent, today there is still great interest in the supplementation sector and, specifically, in the sports supplementation sector.

In this sector, there are today dozens and dozens of products, even with very complex formulations, aimed at satisfying specific needs of use.

For the specific use in the workout phase, the need for products that are able to properly promote vasodilation, optimize the energy developed, and therefore allow better control and duration of athletic performance, is still particularly felt.

The aim of the following invention is therefore to provide a product optimized for sports supplementation, in particular for the pre-workout phase, which is capable of promoting vasodilation, has adequate palatability and organoleptic properties and is at the same time easily formulated and processable from an industrial point of view.

SUMMARY OF THE INVENTION

The inventors of the present invention have surprisingly found that the association of high amounts of red beet extract, in the presence of citrulline or a salt thereof and arginine or a salt thereof, and with particular weight ratios between the beet extract content and the citrulline content, made it possible to obtain a product for athletic supplementation, capable of guaranteeing adequate vasodilation and consequently excellent athletic performance in the subsequent training or competition phase.

The invention therefore concerns a composition comprising:

- a red beet extract,

- citrulline or a salt thereof, and

- arginine or a salt thereof, wherein the red beet extract is present in a concentration higher than 30% by weight and the weight ratio between the red beet extract and citrulline or a salt thereof, expressed as citrulline, is in the range from 1 to 3.

A further object of the present invention is also a food supplement comprising the composition of the invention.

In a further aspect, the invention also concerns the use of the composition of the invention as an ingredient in a food supplement.

In a still further aspect, the invention also concerns the use of the composition of the invention for the preparation of a food supplement.

In an advantageous embodiment of the invention, the supplement is in the form of a powder to be reconstituted in water for oral use.

Under another aspect, the invention also concerns the use of the supplement of the invention to aid or improve vasodilation in a healthy subject before or during physical activity, preferably in the pre-workout phase.

DETAILED DESCRIPTION OF THE INVENTION

Therefore, the invention concerns a composition comprising:

- a red beet extract,

- citrulline or a salt thereof, and

- arginine or a salt thereof, wherein the red beet extract is present in a concentration higher than 30% by weight and the weight ratio between the red beet extract and citrulline or a salt thereof, expressed as citrulline, is in the range from 1 to 3.

For the aims of the present invention, red beet extract is to be understood as an extract, obtained by extraction with water, of leaves and/or roots of red beet, wherein the concentration of nitrates present in said extract is of at least 2% by weight.

Preferably said extract is obtained from red beet roots.

Preferably the concentration of nitrates in this extract is of at least 4% by weight, even more preferably at least 6% by weight.

In an advantageous embodiment of the invention, such red beet extract contains a percentage of oxalates lower than 1 % by weight.

Furthermore, for the aims of the present invention, any indication of concentration or amount by weight of a certain component is to be understood as referring to the total weight of the composition.

The inventors of the present invention have surprisingly found that the selection of these specific ingredients, in the amounts and ratios indicated, allowed to obtain a perfectly balanced product for athletic supplementation, preferably in the pre- workout phase, capable of guaranteeing adequate vasodilation and therefore excellent athletic performance in the subsequent training or competition phase.

For the aims of the present invention, pre-workout phase is intended to mean the phase preceding the training or competition sessions, or more generally the phase preceding the start of physical exercise.

When in the present invention a concentration or amount by weight of a certain component is indicated, it is meant the concentration or amount by weight with respect to the total weight of the composition. Preferably, the composition of the invention comprises a red beet extract in a concentration in the range from 40 to 45% by weight.

Preferably, the citrulline or a salt thereof used in the composition of the invention is L-citrulline, even more preferably the L-citrulline DL-malate salt thereof.

Preferably, the arginine or a salt thereof used in the composition of the invention is L-arginine, even more preferably the L-arginine alpha-ketoglutarate salt thereof. Advantageously, in the composition of the invention, the weight ratio between the red beet extract and citrulline or a salt thereof, expressed as citrulline, is in the range from 1 .5 to 2.5.

In a preferred advantageous embodiment of the invention, wherein the red beet extract concentration was in the range from 40 to 45% by weight, and the weight ratio between the red beet extract and citrulline or a salt thereof, expressed as citrulline, was in the range from 1.5 to 2.5, the best performances of the compositions in terms of vasodilation induced in athletes, preferably in the preworkout phase, and consequent performances achieved by them in subsequent training sessions or competition, were obtained.

Preferably, in the composition of the invention citrulline or a salt thereof is present in a higher amount than arginine or a salt thereof.

More preferably, the weight ratio between the amount of citrulline or a salt thereof and the amount of arginine or a salt thereof, expressed as citrulline and as arginine respectively, is in the range from 2.5 to 3.5, even more preferably of about 3.

The inventors of the present invention observed that, when the composition of the invention comprised a red beet extract concentration in the range from 40 to 45% by weight, a weight ratio between the red beet extract and citrulline or a salt thereof, expressed as citrulline, in the range from 1.5 to 2.5 and a weight ratio between the amount of citrulline or a salt thereof and the amount of arginine or a salt thereof, expressed as citrulline and as arginine, respectively, in the range from 2.5 to 3.5 , even more preferably of about 3, the best results in terms of vasodilation during physical activity, preferably in the pre-workout phase, and the best athletic performance in subsequent physical activities were obtained.

Preferably the composition according to the invention comprises a concentration of citrulline or a salt thereof, expressed as citrulline, at least equal to about 15% by weight, more preferably in the range from 15 to 30% by weight, even more preferably in the range from 20 to 25% by weight.

Preferably, the composition according to the invention comprises a concentration of arginine or a salt thereof, expressed as arginine, higher than 5% by weight, more preferably in the range from 7 to 8% by weight.

In a further preferred embodiment of the invention, therefore, the composition comprises a concentration of red beet extract in the range from 40 to 45% by weight, a concentration of citrulline or a salt thereof, expressed as citrulline, in the range from 20 to 25% by weight, a concentration of arginine or a salt thereof, expressed as arginine, in the range from 7 to 8% by weight.

In a still further preferred embodiment of the invention, the composition consists of red beet extract, citrulline or a salt thereof and arginine or a salt thereof.

According to this embodiment, wherein the composition according to the invention consists of red beet extract, citrulline or a salt thereof and arginine or a salt thereof, the composition comprises a concentration of red beet extract in the range from 45 to 65% by weight, preferably in the range from 48 to 60% by weight, a concentration of citrulline or a salt thereof, expressed as citrulline, in the range from 20 to 35% by weight, preferably in the range from 25 to 32% by weight, a concentration of arginine or a salt thereof, expressed as arginine, in the range from 7 to 12% by weight, preferably in the range from 8 to 11 % by weight.

According to a still further preferred embodiment, the composition of the invention consists of red beet extract, L-citrulline DL-malate and L-arginine alphaketoglutarate, wherein the concentration of red beet extract is in the range from 48 to 51 % by weight, the concentration of L-citrulline DL-malate, expressed as citrulline, is in the range from 25 to 28% by weight, the concentration of L-arginine alpha-ketoglutarate, expressed as arginine, is in the range from 8 to 9% by weight. This composition consisting of red beet extract, citrulline or a salt thereof and arginine or a salt thereof can be effectively used, due to its balanced formula, as an ingredient to be added to other active ingredients or excipients for making more complex formulations, which can be used as food supplements or supplements for sports use.

In a preferred embodiment of the invention, the composition of the invention may also contain antioxidants.

These, in fact, play an important function for vasodilation, because nitric oxide is a rapidly degraded gas and, therefore, their presence allows an extension of its halflife by reducing the degradation rate and counteracting free radicals.

An antioxidant that can be employed for this type of function is, for example, N- acetylcysteine which has an action on glutathione reformation, extending nitric oxide half-life.

Therefore, in a preferred embodiment of the invention, the composition of the invention further comprises N-acetylcysteine.

More preferably, the composition of the invention comprises N-acetylcysteine in a concentration in the range from 0.5 to 1 % by weight, preferably in the range from 0.6 to 0.8% by weight.

Therefore, in an advantageous embodiment of the invention, the composition comprises a red beet extract in a concentration higher than 30% by weight, a weight ratio between the beet extract and citrulline or a salt thereof, expressed as citrulline, in the range from 1 to 3, a weight ratio between the amount of citrulline or a salt thereof and the amount of arginine or a salt thereof, expressed as citrulline and as arginine, respectively, in the range from 2.5 to 3.5, and N-acetylcysteine in a concentration in the range from 0.6 to 0.8% by weight.

The composition of the invention may also contain vitamins, mineral salts, carbohydrates, phytonutrients, and generally any other ingredient with a supplementation function.

In an advantageous embodiment, the composition of the invention comprises, in particular, carbohydrates.

In fact, carbohydrates contribute to the recovery of normal muscle function (contraction) after intense and prolonged physical exercise, which leads to muscle fatigue, and depletion of glycogen stores in skeletal muscles.

Preferably, the carbohydrates used in the composition of the invention are highly branched cyclic dextrins.

Preferably, said highly branched cyclic dextrins are present in a concentration in the range from 5% to 10% by weight, more preferably in the range from 6% to 7% by weight. Therefore, in an advantageous embodiment of the invention, the composition comprises a red beet extract in a concentration higher than 30% by weight, a weight ratio between the red beet extract and citrulline or a salt thereof, expressed as citrulline, in the range from 1 to 3, a weight ratio between the amount of citrulline or a salt thereof and the amount of arginine or a salt thereof, expressed as citrulline and as arginine, respectively, in the range from 2.5 to 3.5, and highly branched cyclic dextrins in a concentration in the range from 6% to 7% by weight.

The composition of the invention further contains excipients of various types, such as sweeteners, stabilizers, diluents, acidifiers and flavours.

Among sweeteners, for example, acesulfame K, sucralose, steviol glycosides or stevia can be mentioned, also in combination with each other.

The composition of the invention may also comprise stabilizers.

In fact, given the hygroscopicity of some of its ingredients, in particular citrulline, which tends to make the product unstable and difficult to process, it is particularly important to control the humidity of the composition, for example by adding stabilizing excipients which, by limiting the absorption of water by the composition, especially if in the form of powder, prevent the same from packing, agglomerating and becoming not very smooth and therefore difficult to machine.

Preferably, the composition of the invention therefore comprises silicon dioxide, which is an agent capable of controlling the composition hygroscopicity.

In particular, the inventors of the present invention observed that, when silicon dioxide was contained in a concentration equal to at least 2% by weight, preferably about 3%, the composition, in the form of powder, proved to be particularly stable and easily machinable.

Therefore, in an advantageous embodiment of the invention, the composition comprises a red beet extract in a concentration higher than 30% by weight, a weight ratio between the red beet extract and citrulline or a salt thereof, expressed as citrulline, in the range from 1 to 3, a weight ratio between the amount of citrulline or a salt thereof and the amount of arginine or a salt thereof, expressed as citrulline and as arginine, respectively, in the range from 2.5 to 3.5 and silicon dioxide in a concentration of at least about 2%by weight, preferably of about 3%.

Finally, in a particularly preferred form of the invention, the composition comprises a concentration of red beet extract in the range from 40 to 45% by weight, a weight ratio between the red beet extract and citrulline or a salt thereof, expressed as citrulline, in the range from 1.5 to 2.5, and a weight ratio between the amount of citrulline or a salt thereof and the amount of arginine or a salt thereof, expressed as citrulline and as arginine, respectively, in the range from 2.5 to 3.5, a concentration of N-acetylcysteine in the range from 0.6 to 0.8% by weight, a concentration of highly branched cyclic dextrins in the range from 6 to 7% by weight and a concentration of silicon dioxide equal to about 3% by weight.

In all embodiments, the composition of the invention was found to be palatable and pleasant to the taste, with excellent organoleptic characteristics, stable, easy to prepare and to produce.

The object of the present invention is also a food supplement comprising the composition of the invention.

The invention therefore also concerns the use of the composition of the invention for the preparation of a food supplement.

The composition of the invention can therefore be used as an ingredient of a food supplement to be added together with other active ingredients and/or excipients suitable for the final formulation of the supplement itself.

Preferably, said food supplement is in the form of a powder to be reconstituted for oral administration.

In an advantageous embodiment of the invention, when said supplement in powder form comprises red beet, L-citrulline DL-malate, L-arginine alpha-ketoglutarate, N- acetyl-L-cysteine, branched cyclic dextrins and silicon dioxide, it is prepared following the method of progressive dilutions, i.e. by mixing, in sequence, silicon dioxide, L-citrulline DL-malate, L-arginine alpha-ketoglutarate and N-acetyl-L- cysteine, preferably in about 5 minutes, and then adding to such mixture thus obtained, the red beet extract together with the flavoring agents, sweeteners and branched cyclic dextrins, always with the method of progressive dilutions and mixing, preferably for about 10 minutes, until a homogeneous mixture is obtained. In making the formulations of the invention, the sequence of addition of the ingredients is particularly important, and above all the initial presence of an adequate amount of silicon dioxide, an agent present with the aim of containing the hygroscopicity of the mixture and guaranteeing stability and machinability thereof, given the presence of particularly hygroscopic ingredients.

Said powder supplement can be advantageously contained in a multidose tin comprising, in addition to the powder composition, a suitable dispenser.

The format of said tin may be of 250 g, 500 g or 1000 g of powder, preferably 500 g of powder.

Advantageously, the food supplement in powder form has a unitary dosage of 10 g of powder to be reconstituted in 100 ml of water.

The dose that the athlete can take will be calculated on the basis of the body weight; typically for an athlete with a body weight of 70-80 kg it is recommended to take a unitary dose of 10 g of supplement to be dissolved in 100 ml of water, for an athlete with a body weight of 80-90 kg it is recommended to take two unitary doses of 10 g, for a total of 20 g of supplement, to be dissolved in 200 ml of water and in the case of an athlete with a body weight of over 90 kg, it is recommended to take three unitary doses of 10 g , for a total of 30 g of supplement, to be dissolved in 300 ml of water.

The supplement should preferably be taken about 30-45 minutes before the training or competition session.

Therefore, a further object of the present invention is the use of the supplement of the invention to aid or improve vasodilation in a healthy subject before or during physical activity, preferably in the pre-workout phase.

In the experimental part, illustrative and non-limiting examples will be provided to support the invention.

Experimental part

Example 1: Preparation of compositions comprising red beet extract, citrulline and arginine.

For the preparation of two different powder compositions A and B comprising red beet extract, citrulline and arginine the ingredients listed in the following Table 1 were used.

Table 1 - Ingredients of compositions A and B.

The red beet extract was an extract commercially available under the trade name Trubeet® sold by Bio-gen.

The compositions were prepared with the method of progressive dilutions by mixing, in sequence, silicon dioxide, L-citrulline DL-malate, L-arginine alphaketoglutarate and N-acetylcysteine in a time of about 5 minutes.

Red beet extract was added to the mixture thus obtained together with flavours and sweeteners, again with the method of progressive dilutions, and mixing for about 10 minutes until a homogeneous mixture was obtained.

In making the formulations of the invention, the sequence of addition of the ingredients was particularly important, and above all the initial presence of an adequate amount of silicon dioxide, an agent present with the aim of containing the hygroscopicity of the mixture and guaranteeing stability and machinability thereof, given the presence of particularly hygroscopic ingredients, such as L- citrulline-DL-malate.

In particular, it was found that mixture B, with a higher silicon dioxide content, was more stable and more machinable than mixture A.

The technical performances of these compositions were also evaluated. A unitary dose of 10 g of the two compositions A and B, was dissolved in 100 ml of water and administered to two different groups of 10 athletes (each group consisted of healthy adult subjects aged between 18 and 65 years), about 30-45 minutes before the performance, then visually assessing, at the end of the training session, their vasodilating effect on the muscles, then also observing in particular the relief and definition of the veins on the muscles. Fatigue resistance was also evaluated. The performance evaluations were expressed by the athletes themselves using a rating scale that ranged from unsatisfactory (+) to excellent (+++++). A result ranging from sufficient (+++) to excellent (+++++) was considered acceptable. The athletes were also asked to evaluate the palatability of the compositions, using a scale ranging from * (not pleasant enough) to ** (pleasant). Only those compositions that had obtained the ** (pleasant) rating were considered acceptable. In the test, the two compositions were not found to be particularly performing in terms of muscle definition, that was not yet optimal, and therefore the vasodilator effect was not yet the desired one (performance from +++ upwards); however, composition B was better than composition A.

Further tests were therefore carried out. Example 2: Preparation of the composition of the invention

For the preparation of four further powder compositions C, D, E and F, comprising red beet extract, citrulline and arginine, the ingredients listed in the following Table

2 were used.

Table 2 - Ingredients of compositions C, D, E and F The red beet extract was an extract commercially available under the trade name Trubeet® sold by Bio-gen.

The compositions were prepared with the method of progressive dilutions by mixing, in sequence, silicon dioxide (where present), L-citrulline DL-malate, L- arginine alpha-ketoglutarate and N-acetylcysteine (where present) in a time of about 5 minutes.

Red beet extract was added to the mixture thus obtained together with flavours, sweeteners and branched cyclic dextrin, again with the method of progressive dilutions, and mixing for about 10 minutes until a homogeneous mixture was obtained.

In making the formulations of the invention, the sequence of addition of the ingredients was confirmed to be particularly important, above all the initial presence of an adequate amount of silicon dioxide, an agent present with the aim of containing the hygroscopicity of the mixture and guaranteeing stability and machinability thereof, given the presence of particularly hygroscopic ingredients.

It was found that concentrations of silicon dioxide equal to at least 2% by weight guaranteed the possibility to obtain easily machinable powders, with the right degree of smoothness and a controlled and acceptable hygroscopicity.

The technical performances of these four compositions were evaluated. A unitary dose of 10 g of the four compositions C, D, E and F, was dissolved in 100 ml of water and administered to four different groups of athletes consisting of 10 individuals each (healthy adult subjects aged between 18 and 65 years), about SO- 45 minutes before the performance, then visually assessing, at the end of the training session, their vasodilating effect on the muscles, then observing the relief and definition of the veins on the muscles. Fatigue resistance was also evaluated. These performance evaluations were expressed by the athletes themselves using a rating scale that ranged from unsatisfactory (+) to excellent (+++++). A result ranging from sufficient (+++) to excellent (+++++) was considered acceptable. The athletes were also asked to evaluate the palatability of the compositions, using a scale ranging from * (not pleasant enough) to ** (pleasant). Only those compositions that had obtained the ** (pleasant) rating were considered acceptable.

The three compositions C, D and E, characterized, in addition to high concentrations of red beet extract, always higher than 30% by weight, and in particular between 40 and 45% by weight, also by a weight ratio between the amount of this extract and L-citrulline-DL-malate (expressed as citrulline) between 1.5 and 2.5%, provided performance that met expectations (performance assessed of at least +++ and palatability assessed **). In particular, compositions C and E gave the best results (performance evaluated +++++ and ++++, respectively). Composition F that, contrarily to compositions C, D and E, had a much lower percentage by weight of red beet extract was the one which gave the worst performance results.

It was apparent that the identified specific compositional balance between the concentration of red beet extract and the concentration of citrulline or a salt thereof was particularly important in determining the effectiveness of the composition.

Also significant was the weight ratio between citrulline or a salt thereof (expressed as citrulline) and arginine or a salt thereof (expressed as arginine), with a value of about 3, in the higher performance compositions C and E.

It is also important to note that, unlike what is known in the prior art and can be inferred from the observation of the formulations on the market, in which the content of arginine is typically always higher than that of citrulline (when present), in the compositions of the invention very high-performance results are obtained instead with a concentration of citrulline in the composition significantly higher than the concentration of arginine.

Finally, the three compositions, thanks to the presence of appropriate amounts, preferably in the range from 6 to 7% (weight/weight) of highly branched cyclic dextrins, finally proved to be perfectly balanced in terms of energy intake.

Finally, the compositions C, D, E and F also exhibited excellent palatability, a result that had not been possible to achieve, for example, with compositions A and B of Example 1 in which stevia was mainly used as a sweetener.

Below, Table 3 provides a summary of the results achieved by the tests in the case of the 6 formulations tested, according to the specific weight percentages of the three main ingredients, as well as their relative weight ratios.

Table 3 - Elaboration of the results obtained in the use tests of 6 compositions as a function of the composition by weight of the three main ingredients, red beet extract, citrulline and arginine. Performance rating scale legend: + (not satisfactory), ++ (poor), +++ (sufficient), ++++ (very good), +++++ (excellent). Palatability rating scale legend: + (not pleasant enough), ++ (pleasant).

As apparent, Composition C was shown to be the best, and therefore the most performing with respect to all observation parameters.

Example 3: Preparation of a composition containing red beet extract, L- arginine and L-citrulline.

For the preparation of a powder composition G, comprising exclusively red beet extract, citrulline and arginine, the ingredients in the percentages listed in the following Table 4 were used.

Table 4 - Ingredients of composition G.

The red beet extract was an extract commercially available under the trade name Trubeet® sold by Bio-gen.

The composition was prepared with the method of progressive dilutions by mixing, in sequence, L-citrulline DL-malate and L-arginine alpha-ketoglutarate in a time of about 5 minutes. The red beet extract was then added to the mixture thus obtained, by mixing for about 10 minutes until a homogeneous mixture was obtained.

Given the hygroscopic nature of some ingredients, such as in particular L-citru II ine- DL-malate, the preparation and packaging process was performed under controlled humidity conditions.