ES2575736T3 - Composition of extracts rich in ellagitannins for sexual well-being - Google Patents

Description

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DESCRIPTION

Composition of extracts rich in ellagitannins for sexual well-being Field of the invention

The present invention relates to a composition consisting of extracts rich in ellagitannins originating from plant extracts of the Fagaceae family, for use in improving the health or sexual well-being of both sexes, the sexual potency of the males, the treatment or prevention of sexual dysfunction in both sexes.

Background of the invention

When a boy is just over twenty years old, it is easy to take for granted maximum sexual performance. As time passes, the biological system of the male body changes, and you can notice that their sexual stamina, performance and even pleasure begin to diminish. "Prepare the mood" may begin to require a little effort. Many women have problems with sex when they reach menopause and their ovaries produce smaller amounts of sex hormones. Lower estrogen levels can cause vaginal tissue dryness, and less androgens lead to less desire and sexual arousal. An important difference that affects sexual desire is that men have testosterone levels that are 20 to 30 times what a woman has. Testosterone levels in men decline gradually over time, but do not experience a sharp decrease as in women due to menopause. In men and women, testosterone and other androgens act to increase desire.

Treatment with drugs, such as those used for hypertension and hyperlipidemia, can have negative effects on sexual function and interest. Vaginal dryness is progressively more frequent with age, and vaginal infections are more common with increasing age in diabetic women. They can produce sexual dysfunction (DS), loss of interest, and a difficult or painful intercourse that can be associated with anxiety and fear, contributing to the absence of motivation.

The Fagaceae family, the beech family, comprises approximately 900 species of perennial and deciduous trees and shrubs, which are characterized by simple leaves alternated with pinnated nerviacion, unisexual flowers in the form of catkins, and fruits in the form of walnuts in Cup shape (cupula). The leaves of the fagaceae are often lobed and petioles and stipules are usually present. The fruits lack endosperm and are supported by scales or spines of shells that may or may not enclose the complete nut, which may consist of one to seven seeds. The best-known group of this family is the oaks, the genus Quercus, whose fruit is a walnut without valves (usually containing a seed) called an acorn. The shell of the acorn in the majority of the oaks forms only a cup in which the nut sits.

Some members of the Fagaceae have important economic uses. Many species of oaks, chestnuts, and beeches (Quercus, Castanea, and Fagus genera respectively) are commonly used as wood for floors, furniture, cabinets, and wine barrels. The cork for wine bottle stoppers and a different uses mine are prepared from the cork bark of cork oaks, Quercus suber. The chestnuts, a tasty snack enjoyed by many during the winter, are the fruits of the Castanea genus. Numerous species of var. Genus are important ornamentals, and wood chips of the genus Fagus are often used as a beer flavoring.

There continues to be a need for an effective, natural and safe composition to improve the health or sexual well-being of both sexes, the sexual potency of men, the treatment of sexual dysfunction.

Summary of the invention

In one aspect of the present invention there is provided a composition consisting of extracts rich in ellagitannins originating from plant extracts of the family Fagaceae, in which said extracts are natural extracts having more than 50% w / w of ellagitannins based on in the dry extract or having ellagitannins at a concentration of at least 10% of the total weight of said composition, for use in a method for the treatment or prevention of sexual dysfunction in both sexes.

Another aspect of the invention resides in a composition which, when administered, offers both sexes a safe and natural means of preserving and maintaining sensitivity, duration and sexual enjoyment. This includes a mixture or composition consisting of extracts rich in ellagitannins originating from plants of the Fagaceae family. When the mixture is administered, or taken daily for a period of time, sexual health or sexual well-being improves towards the end of the period of time.

In another aspect, the present invention provides oral administration in the form of a dietary supplement or a food supplement, a food preparation, a beverage, a medicament or for a topical preparation comprising the composition of the present invention.

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In a further aspect, there is provided the use of a composition consisting of extracts rich in ellagitannins originated from plant extracts of the Fagaceae family, in which said extracts are natural extracts having more than 50% w / w of ellagitannins based on the dry extract or having ellagitannins at a concentration of at least 10% of the total weight of said composition, for the improvement of health or sexual well-being or sexual potency in both sexes.

Detailed description of the invention

Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, suitable methods and materials are described below. In addition, the materials, procedures, and examples are illustrative only and are not intended to be limiting.

In case of conflict, the present descriptive memory will be preferred, including the definitions. Unless otherwise indicated, all the technical and scientific terms used in this document have the same meaning as commonly understood by a person normally expert in the technique to which the present subject matter belongs. As used herein, the following definitions are provided in order to facilitate understanding of the present invention.

The term "comprises" is generally used in the sense of includes, that is, that allows the presence of one or more features or components.

As used in the specification and claims, the singular form "a", "an" and "the" include plural references unless the context clearly indicates otherwise.

The term "extract", as used herein, includes any preparation obtained from plants, fruits, roots or vegetables, using an extraction procedure.

The term "food preparation" generally refers to the material of both vegetable and animal origin, or of synthetic sources, which contain essential nutrients such as carbohydrates, protein, fat, vitamins, mineral, etc., used in the body of an animal. organism to sustain growth, repair, and vital procedures and to provide energy.

A "diet or food supplement" refers to a product that contains substances similar to vitamins, minerals, foods, botanical compounds, amino acids, and is intended to supplement the usual intake of these substances. Dietary supplements are found in pills, tablets, capsules, powders or in liquid form and are understood to be ingested by mouth.

The term "nutraceutical" refers to any substance that is a food or a part of a food and provides medical or health benefits, including the prevention and treatment of the disease. Such products can range from isolated nutrients, dietary supplements and specific diets to foods designed by genetic engineering, herbal products, and processed foods such as cereals, soups and beverages. It also refers to an isolated or purified product from food, and generally sold in medicinal forms not usually associated with food, and which has been shown to have, for example, a physiological benefit or to provide protection against diseases similar to chronic diseases.

The term "beverage" means a liquid for drinking, which may be water, flavored water, non-alcoholic beverages, alcoholic beverages, healthy beverages, or an enriched type beverage based on a dairy product (milk) or fruit juice.

"Pharmaceutically acceptable excipients or carriers" are any materials that do not interfere with the pharmacological activity of the active ingredient (s) or degrade the bodily functions of the subject to which they can be administered, but facilitate the manufacture of forms Pharmaceuticals or the administration of the composition. Examples of pharmaceutically acceptable excipients include, but are not limited to, maltodextrin, calcium phosphate, and fused silica. The pharmaceutically acceptable excipients also include flavorings, as well as various additives such as different vitamins and minerals, all solvents, dispersion media, coatings, isotonic and delaying absorption agents, sweeteners and the like, non-toxic auxiliary substances such as wetting agents. or emulsifiers, pH buffering agents and the like, such as, for example, sodium acetate, sorbitan monolaurate, triethanolamine oleate, and inert ingredients such as talc and magnesium stearate which are standardized excipients in the manufacture of tablets, capsules and other Pharmaceutical forms.

As used herein, the terms "subject" or "patient" are well known in the art and are used interchangeably to refer to a mammal, including dog, cat, rat, mouse, monkey, cow, horse , goat, sheep, pigs, camel, and, more preferably, a human being. In some embodiments, the subject is a subject in need of treatment or a subject with a disease or disorder. However, in other embodiments, the subject may be a normal subject. The term does not denote a specific age or sex. In this way, it is intended that both adult and newborn subjects, both male and female, be covered.

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The term "an effective amount" refers to an amount necessary to obtain a physiological effect. The physiological effect can be achieved by the application of a dose or by repeated applications. The dosage administered may, of course, vary depending on known factors, such as the physiological characteristics of the particular composition; the age, health and weight of the subject; the nature and extent of the symptoms; the type of concurrent treatment; the frequency of treatment; and the desired effect and can be adjusted by a person skilled in the art.

As used herein, the terms "prevention" and "prevent" when referring to a disorder or symptom, refer to a reduction in the risk or the likelihood of a subject mairnfero develop such disorder, symptoms, ailments , or indicators after the treatment according to the invention, or a reduction in the risk or probability that a mammal subject presents said disorder, symptoms, ailments, or indicators once the subject has been treated according to the invention. and cured or restored to a normal state.

As used herein, the terms "treatment" or "treating", when referring to sexual dysfunction, health or sexual well-being, sexual potency in both sexes, refers to inhibiting or reducing progression, nature, or severity of the subject's ailment or delay the onset of the ailment.

The present invention provides a composition consisting of extracts rich in ellagitannins originating from plant extracts of the Fagaceae family, in which said extracts are natural extracts having more than 50% w / w of ellagitannins based on the dry extract or having ellagitannins at a concentration of at least 10% of the total weight of said composition, for use in a method for treating or preventing sexual dysfunction, as well as the use of said composition to improve sexual health or well-being, or for increase sexual potency in both sexes.

The ellagitannins of the invention originate from a plant extract or from a synthesized material. Preferably, said extracts rich in ellagitannins originated from extracts of plants of the family Fagaceae comprise roburins or their derivatives as defined below. More preferably, the plant extracts of the Fagaceae family consist of Quercus robur extracts as defined above.

Another aspect of the invention resides in a composition which, when administered, offers both sexes a safe and natural means of preserving and maintaining sensitivity, duration and sexual enjoyment.

Also encompassed by the present invention is a method for improving the health or sexual well-being of both sexes which comprises administering to a subject in need thereof an effective amount of the composition or medicament of the invention.

The invention also provides a method for increasing sexual potency of males and females which comprises administering to a subject in need thereof an effective amount of the composition or medicament of the invention.

The invention also relates to a method for treating or preventing sexual dysfunction in both sexes which comprises administering to a subject in need thereof an effective amount of the preparation or the medicament according to the invention.

The methods according to the invention increase the level of sexual well-being for both sexes. The composition of the invention is in therapeutically effective amounts such that, when the composition is administered at least daily for a period of time, in a sufficient amount, the level of sexual well-being increases at the end of the period of time.

The methods of the invention also help to achieve greater sexual well-being. The administration includes initially administering a high dose of the composition of the invention to achieve greater sexual well-being at the end of the period of time and subsequently administering a daily dose of the composition containing less amount of the composition than the high dosage and further providing the increased level of sexual well-being.

"Health", both "sexual health" and physical health, is defined as a measure of effective functioning. A person who is sexually adjusted is effective in their ability to think, feel, and behave in a sexual way without embarrassment, embarrassment, or hidden agendas to falsely stimulate their ego or self-esteem. People who achieve and practice this lifestyle are more likely to function effectively in all aspects of their perceptual world. These lucky individuals have more confidence, physically get sick less often, and manage stressful events more satisfactorily. Sexual health is a state of well-being achieved that allows people to carry out better each action in which they are involved. Having this capacity results in people feeling more secure in all situations, whether the couple is involved or not.

The "sexual well-being" of both sexes is the active participation of the individual in his life, solving the different problems involved in sexual health. The procedure defined as sexual well-being is to improve health

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sexual. "Sexual health" is a state of physical, mental and social well-being associated with sexuality. It requires a positive and respectful approach to sexuality and sexual relations, as well as the possibility of having pleasant and safe sexual experiences, free of coercion, discrimination and violence (definition of the WHO 2002). In particular, sexual health is the integration of the somatic, emotional, intellectual, and social aspects of sexual well-being, so that they are enrichingly positive and that they enhance personality, communication, and love. The fundamentals of this concept are the rights to sexual information and the right to pleasure (definition of WHO 1975). Sexual health is inextricably linked to physical and mental health.

The "sexual potency of the male" can be defined as the increase in the hardness of the erection; the increase of self-confidence; improvement of sperm quality, counting and motility (spontaneous movement) and fertility; the increase in libido and sexual impulses; the reinforcement of the level of sexual energy and vitality; the improvement of the problems derived from the sexual performance, that is to say, those due to the aging as well as to the increase of energy and the greater sexual satisfaction with a couple. Men's sexual function is scored using the well-known "International Index of Erectile Function" (IIEF) questionnaire [Rosen et al., Urology. June 1997; 49 (6): 822-30. The international index of erectile function (IIEF): a multidimensional scale for the evaluation of erectile dysfunction], that is, see example 4.
http://www.seekwellness.com/mensexuality/questionnaire.htm

"Female sexual enhancement" defines anything that enhances a woman's sexuality; This includes in particular the increase in libido or sexual impulses. A libido or a low sex drive in women can be produced by numerous factors that vary from one woman to another; fatigue, mild depression, and the multiple roles that women play in daily life can produce psychological problems, which can have an effect on a woman's sexual appetite. Antidepressants, birth control, tranquilizers and mood stabilizers also affect sexual activity, and other ailments such as diabetes, heart disease and poor diet can reduce a woman's sexual impulses. The level of sexuality of women can be determined through the Female Sexual Function Index (FSFI) and the Women's Health Questionnaire (WHQ) that are defined and detailed in Example 4.

"Sexual dysfunction" or sexual malfunction in both sexes refers to the difficulty experienced by an individual or his partner during any stage of normal sexual activity, including desire, excitement or orgasm. Disorders of sexual desire or diminished libido are characterized by a lack or absence during some period of time of desire or sexual libido for sexual activity or sexual fantasies. Disorders of sexual arousal are previously known as frigidity in women and impotence in men, although these have now been replaced by less critical terms. Impotence is now known as erectile dysfunction, and frigidity has been replaced with numerous terms describing specific problems with, for example, desire or excitement. For men and women, these ailments can manifest themselves as an aversion to, and avoidance of, sexual contact with a partner. In men, it may be a partial or complete failure to achieve or maintain an erection, or an absence of excitement and sexual pleasure in sexual activity.

"Erectile dysfunction" or impotence is a sexual dysfunction characterized by the inability to develop or maintain an erection of the penis. The causes of erectile dysfunction can be psychological or physical.

Orgasm disorders are persistent delays or absence of orgasms after a phase of normal sexual arousal. The disorder can have a physical, psychological, or pharmacological origin.

Sexual pain disorders affect almost exclusively women and are known as dyspareunia (painful sexual intercourse) or vaginismus (an involuntary spasm of the muscles of the vaginal wall that interferes with sexual intercourse).

Although drugs for sexual potency may offer a temporary solution or a tempting "quick fix" they are associated with unwanted side effects and can be expensive. The inhibitor mixture / composition according to the present invention, which is a supplement to the natural diet, offers a safe, natural alternative.

Those plant extracts of the composition according to the invention are also referred to as "extracts rich in ellagitannins". The ellagitannins are a diverse type of hydrolysable tannins, a type of polyphenols formed mainly from the oxidative bond of galoflo groups in 1,2,3,4,6-pentagaloyl glucose. The ellagitannins differ from the gallotannins, in which their galoflo groups are bound through C-C bonds, while the galoflo groups of the gallotannins are linked by depsid bonds. The ellagitannins comprise (Roburines A, B, C, D, E, Vescalin, Castalin, Vescalagin, Castalagin).

Preferably, said extracts rich in ellagitannins originating from extracts of plants of the family Fagaceae comprise roburins or their derivatives. Roburines include Roburines A, B, C, D, E. In the present invention the term "roburins" is considered as equivalent to Roburines A, B, C, D, E and are indistinct.

Roburine A is a tannin found, for example, in oak (Quercus robur and Quercus petraea or Quercus alba) or cork oak (Quercus suber). It is a dimeric compound, composed of two subunits of vescagalina probably linked through an ether bond between the defensoflo group of one subunit and the triphenofl group of the other.

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Preferably, the plant extracts of the Fagaceae family are selected from the genera Quercus, Castanea, and Fagus or their mixtures. Among the Fagaceae, particularly worthy of mention are the Fagus grandifolia, the beech (Fagus sylvatica), the chestnut (Castanea sativa) and the English oak (Quercus robur). More preferably, the plant extracts of the Fagaceae family consist of extracts of oak woods. Even more preferably, the plant extracts of the Fagaceae family consist of extracts of Quercus robur.

"Quercus robur" is also known as "oak wood" that belongs to the Fagaceae family and the genus Quercus. Quercus robur (sometimes considered Q. pedunculata) is commonly known as pedunculate oak or English oak. Also included in this definition of "oak wood" is white wood, Quercus alba, Quercus brutia Tenore, Q. pedunculiflora, Q. haas as! like the sessile oak (Q. petraea). In the present invention the term "Quercus robur" will be considered as equivalent to oak as defined above, they are indistinct. Collection: felling of the trees under the control of the National Forestry Office, from October to April, when the sap descends. Oak wood is traditionally used to make wine barrels and is known to provide flavor to wine and contribute to its antioxidant activity. The recent wood chips used for the extract of Biolandes are purchased from a well-known manufacturer of wine barrels (
http://www.dargaud-jaegle.com/) and are obtained from rigorously selected oaks. The extraction process is carried out by extraction with water at low temperature (50 ° C) and spray drying. Petrochemical solvents are not used. The extract of oak wood contains ellagitannins (Roburines A, B, C, D, E, Vescaline, Castalin, Vescalagina, Castalagina) and phenolic acids (galic acid, ellagic acid).

image 1

Vescalin R, = H. R: = OH Vescalagina R | = H. R. = OH Castalin Rj * OHt Rj "H Castalagin R, -OH.R: -H

Grandinina Rt- H, Rj = Lixose Roburina E Ri = H, R. = Xylose

Roburine ARi = H.R, = OH Roburine DRi-OH, Rj-H Roburine BRi = H, R; = Lixose Roburine C Rt = H. Rj = Xilosa

image2

HO

■

H

Eladic acid

Gallic acid

The composition consisting of ellagitannins, present in the preparation of the invention, originates from a vegetable extract or alternatively a partyl of a synthesized material (i.e., synthetic ellagitannins, i.e., roburines).

The rich extracts containing ellagitannins are natural extracts and preferably plant extracts having more than 50% by weight (of dry extracts) of ellagitannins (in particular roburines), more preferably more than 70% by weight and even more preferably more than 75% by weight of ellagitannins (in particular Roburines). Preferably the plant extract according to the present invention originates from extracts of oak wood and more preferably the plant extract is from Quercus robur.

In a preferred embodiment, the composition may contain ellagitannins (in particular roburines) at a concentration of 10% to 100% of the total weight. For example, the composition of the invention can be diluted or concentrated to contain 10%, 20%, 30%, 40%, 50%, 60%, 70%, 75%, 80%, 90% or 95% of ellagitannins ( in particular Roburines). The composition can be carried out using known procedures such as column chromatography or affinity chromatography.

The compositions of the invention may further comprise vitamins, coenzymes, mineral substances, amino acids and antioxidants and / or suitable excipients q.s.p. The composition can be manufactured in the form of

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tablets, lozenges, capsules, pills, granules, syrups, vials or drops.

The suitable excipient of the invention is an acceptable carrier or carrier as defined above. Examples of suitable excipients of the present invention include, but are not limited to, antiadherents, binders (eg, macrocrystalline cellulose, gum tragacanth, or gelatin), coatings, disintegrants, fillers, diluents, softeners, emulsifiers, flavoring agents, agents dyes, adjuvants, lubricants, functional agents (e.g., nutrients), viscosity modifiers, bulking agents, slip agents (e.g., colloidal silica dioxide), surfactants, osmotic agents, diluents, or any other non-active principle, or combinations of them.

For example, the composition of the present invention may further include excipient materials selected from the group consisting of calcium carbonate, coloring agents, bleaches, preservatives, and flavors, triacetin, magnesium stearate, stems, natural or artificial flavors, essential oils , plant extracts, fruit essences, gelatins, or combinations thereof.

Optionally, the composition of the present invention may include other artificial or natural sweeteners, bulk sweeteners, or combinations thereof. Bulk sweeteners include heat and non-caloric compounds. Non-limiting examples of bulk sweeteners include sucrose, dextrose, maltose, dextrin, dried invert sugar, fructose, high fructose corn syrup, levulose, galactose, corn syrup solids, tagatose, polyols (eg, sorbitol) , mannitol, xylitol, lactitol, erythritol, and maltitol), hydrogenated starch hydrolyzate, isomalt, trehalose, and combinations thereof.

In a preferred embodiment of the invention, the suitable excipient is a pharmaceutically acceptable excipient.

The present invention also provides a food preparation, a dietary or nutritional supplement, a nutraceutical, a beverage, a medicament and a topical preparation comprising the composition of the present invention.

Preferably, the diet supplement, the nutraceutical or the medicament of the present invention is administered at a dosage of 5 mg per day to 2,000 mg per day. Preferably from 50 mg to 1,000 mg per day and even more preferably from 100 mg to 400 mg per day.

The preparation, the dietary supplement, the nutraceutical or the medicament of the present invention can be administered orally, parenterally or topically at a dosage of between 5 mg per day to 2,000 mg per day. Preferably between 50 mg to 1,000 mg per day and more preferably between 100 mg to 400 mg per day.

When intended for oral administration, the medicament of the present invention may be in the form of, for example, a tablet, an oval tablet, a pill, a sura or soft capsule, a chewable tablet, a seal, a dispensable powder, granules, a suspension, an elixir, a dispersion, a liquid, or any other form reasonably adapted for said administration. When intended for parenteral administration, it may be in the form of, for example, a solution for intravenous, intramuscular or subcutaneous administration.

The topical preparations according to the present invention may be, but not limited to, a cream, a patch, a gel, an ointment, a lotion, a dye, a spray, a mousse, a cleaning composition or a foam. The topical preparations of the present invention may also be in the form of a suspension or dispersion in solvents or fatty substances, or alternatively in the form of an emulsion or microemulsion, PET emulsions, multiple emulsions, picking emulsions, hydrogels, alcohol gels, lipogels. , monofasic or multifasic solutions or a vesicular dispersion and other usual compositions, which can also be applied by means of feathers, as masks or as sprays. The emulsions may also contain anionic, nonionic, cationic or amphoteric surfactant (s).

The composition of the invention can be used in a food preparation, a diet supplement, a medicament, a nutraceutical, or a beverage.

Preferably, the composition or medicament of the invention is administered orally, parenterally or topically as defined above.

Oral administration of the mixture according to the regimen of administration for a prolonged period of time provides certain benefits, including helping to protect, restore and sustain the health of the blood vessels and improve blood flow in the genital area, enhancing naturally male erections or tumescence in women, naturally enhancing the body's sexual response and improving the health of the sexual vascular system.

By orally administering the composition of the invention, the benefits of sexual health or sexual well-being are realized. That is, over time, the cumulative effect of the leaf mixture results in an increased sense of sexual well-being. The mixture or composition of the present invention may be in the form of a composition, taken both in tablet form and in liquid form. Alternatively, the mixture may be

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in the form of ingredients that are separately, in separate tablets or in liquid form, but packaged together in a kit. In the latter case, the separate ingredients are taken both simultaneously, such as by mixing them together in liquid form, or one after the other if they are in the form of a tablet.

In an embodiment of the invention, the composition or medicament of the invention is administered at a dose of 5 mg per day to 2,000 mg per day. The subject who needs it is a mairnfero, preferably a human being.

The medicament or supplement of the diet of the invention is adapted, for example, for use in the improvement of sexual health or in the well-being of both sexes, for use in improving the sexual potency of man as in the production of sperm or fertility and / or for use in the treatment or prevention of sexual dysfunction in both sexes.

The latter composition is adapted for example for use in the improvement of sexual health or well-being of both sexes, for use in improving the sexual potency of men and women and / or for use in the treatment or prevention of Sexual dysfunction in both sexes.

A unit dosage comprises a therapeutically effective daily amount of the composition of the invention which can be taken as a single daily administration or as multiple small doses taken during a day.

A kit comprising the composition of the invention is also included.

Those skilled in the art will appreciate that the invention described herein is susceptible to variations and modifications other than those specifically described. It should be understood that the invention includes all such variations and modifications without departing from the esprntu or its essential features. The invention also includes all the steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations or any two or more of said steps or features. The present disclosure should therefore be considered in all the illustrated and non-restrictive aspects, the scope of the invention being indicated in the appended claims, and it is intended that all changes included in the meaning and range of equivalences be covered in the previous one.

The above description will be more fully understood with reference to the following Examples. Said examples are, however, illustrative of the methods of practicing the present invention and are not intended to limit the scope of the invention.

Examples

Example 1

one). QR extract for the improvement of female sexual function

Female sexual function was used to evaluate sexual function in women. Female sexual function was scored using the questionnaire of the "Feminine Sex Function Index" (FSFI) / Rosen R, Blown C, Heiman J, Leiblum S, Meston CM, Shabsigh R, Ferguson D, D'Agostino R., Jr. The Female Sexual Function Index (FSFI): A multidimensional self-report instrument for the assessment of female sexual function. Journal of Sex & Marital Therapy. 2000; 26: 191-208J. The questionnaire allows scoring the prevalence of six subcategories (domains) related to female sexual function, with minimum and maximum scores given:

 Wish

 1,2 -6

 Excitement

 CD O

 Lubrication

 CD O

 Satisfaction

 CD OO or '

 Pain

 CD O

 Orgasm

 CD O

FSFI SCORE APPENDIX

1. In the past 4 weeks, ^ how often 5 = Almost always or always

Have you felt sexual desire or interest? 4 = Most of the times (more than half of the

times)

3 = Sometimes (approximately half the time)

2 = A few times (less than half the time)

2. In the past 4 weeks, how do you rate your level (degree) of desire or sexual interest?

3. In the past 4 weeks, how often have you experienced sexual arousal ("activation") during sexual activity or intercourse?

4. In the past 4 weeks, how do you rate your level of sexual arousal ("activation") during sexual activity or intercourse?

5. In the past 4 weeks, what was your confidence in feeling sexually aroused during sexual activity or intercourse?

6. In the past 4 weeks, how have you felt satisfied with your excitement (excitement) during sexual activity or intercourse?

7. In the past 4 weeks, how many times did you feel lubricated ("wet") during sexual activity or intercourse?

8. In the past 4 weeks, how was it difficult to become lubricated ("wet") during sexual activity or intercourse?

9. In the past 4 weeks, how often did you keep your lubrication ("wet") until the end of sexual activity or intercourse?

10. In the past 4 weeks, how was it difficult to maintain your lubrication ("humidity") until the end of sexual activity or intercourse?

11. In the past 4 weeks, when you had sexual stimulation or intercourse, how often did you reach orgasm (climax)?

1 = Almost never or never 5 = Very high

4 = High

3 = Moderate

2 = Low

1 = Very low or none 0 = No sexual activity

5 = Almost always or always

4 = Most of the times (more than half the time)

3 = Sometimes (approximately half the time)

2 = A few times (less than half the time) 1 = Almost never or never

0 = No sexual activity

5 = Very high

4 = High

3 = Moderate

2 = Low

1 = Very low or none

0 = No sexual activity

5 = Very high confidence

4 = High confidence

3 = Moderate trust

2 = Low confidence

1 Very low confidence

0 = No sexual activity

5 = Almost always or always

4 = Most of the times (more than half the time)

3 = Sometimes (approximately half the time)

2 = A few times (less than half the time) 1 = Almost never or never

0 = No sexual activity

5 = Almost always or always

4 = Most of the times (more than half the time)

3 = Sometimes (approximately half the time)

2 = A few times (less than half the time) 1 = Almost never or never

0 = No sexual activity

1 = Extremely difficult or impossible

2 = Very difficult

3 = Diffcil

4 = Little difficult

5 = No difficulty

0 = No sexual activity 5 = Almost always or always

4 = Most of the times (more than half the time)

3 = Sometimes (approximately half the time)

2 = A few times (less than half the time) 1 = Almost never or never

0 = No sexual activity

1 = Extremely difficult or impossible

2 = Very difficult

3 = Diffcil

4 = Little difficult

5 = No difficulty

0 = No sexual activity 5 = Almost always or always

4 = Most of the times (more than half the time)

12. In the past 4 weeks, when you had sexual stimulation or intercourse, how difficult was it for you to reach orgasm (cKmax)?

13. In the past 4 weeks, how were you satisfied with your ability to achieve orgasm (climax) during sexual activity or intercourse?

14. In the past 4 weeks, how were you satisfied with the amount of emotional closeness during sexual activity between you and your partner?

15. In the past 4 weeks, how were you satisfied with your sexual relationship with your partner?

16. In the past 4 weeks, how were you satisfied with the whole of your sexual life?

17. In the past 4 weeks, how often do you experience discomfort or pain during vaginal penetration?

18. In the past 4 weeks, how often do you experience discomfort or pain during vaginal penetration?

19. In the past 4 weeks, how would you rate your level (degree) of discomfort or pain during or after vaginal penetration?

3 = Sometimes (approximately half the time)

2 = A few times (less than half the time) 1 = Almost never or never

0 = No sexual activity

1 = Extremely difficult or impossible

2 = Very difficult

3 = Diffcil

4 = Little difficult

5 = No difficulty

0 = No sexual activity 5 = Very satisfied

4 = Moderately satisfied

3 = About equally satisfied and dissatisfied

2 = Moderately dissatisfied

1 = Very dissatisfied

0 = No sexual activity

5 = Very satisfied

4 = Moderately satisfied

3 = About equally satisfied and dissatisfied

2 = Moderately dissatisfied

1 = Very dissatisfied

0 = No sexual activity

5 = Very satisfied

4 = Moderately satisfied

3 = About equally satisfied and dissatisfied

2 = Moderately dissatisfied

1 = Very dissatisfied

0 = No sexual activity

5 = Very satisfied

4 = Moderately satisfied

3 = About equally satisfied and dissatisfied

2 = Moderately dissatisfied

1 = Very dissatisfied

0 = I do not try coitus

1 = Almost always or always

2 = The majority of the times (more than half the time)

3 = Sometimes (approximately half the time)

4 = A few times (less than half the time) 5 = Almost never or never

0 = I do not try coitus

1 = Almost always or always

2 = The majority of the times (more than half the time)

3 = Sometimes (approximately half the time)

4 = A few times (less than half the time) 5 = Almost never or never

0 = I do not try coitus

1 = Very high

2 = High

3 = Moderate

4 = Low

5 = Very low or none

5

10

fifteen

twenty

25

FSFI DOMAIN SCORES AND COMPLETE SCALE SCORES

You can derive the individual domain scores and the full scale scores (total) of the FSFI from the calculation formula summarized in the following table. For individual domain scores, add the scores of the individual cases that comprise the domain and multiply the sum by the domain factor (see below). Add the scores of the six domains to obtain full-scale punctuation. It should be noted that, included in the individual domains, a domain score of zero indicates that the subject notifies has not had sexual activity during the previous month. Subject scores can be entered in the right column.

 Domain

 Questions Interval of punctuation Factor Minimum punctuation Punctuation maxima Punctuation

 Wish

 1, 2 1 -5 0.6 1.2 6.0

 Excitement

 3, 4, 5, 6 0 -5 0.3 0 6.0

 Lubrication

 7, 8, 9, 10 0 -5 0.3 0 6.0

 Orgasm

 11, 12, 13 0 -5 0.4 0.4 6.0

 Satisfaction

 14, 15, 16 0 (or 1) -5 0.4 0.8 6.0

 Pain

 17, 18, 19 0 -5 0.4 0.4 6.0

 Full-scale punctuation interval

 2.0 36.0

We investigated adult women of all ages who had a score below four points far from the maximum of six points for the six domains.

The research graphically represents the number of responders to the intervention as detailed in Table 8 after four weeks of treatment with a score equal to or greater than four points for the six domains.

Table 8

 QR extract dose

 Number of women responding Total number of women investigated

 0 mg

 0 22

 50 mg

 5 23

 100 mg

 11 24

 200 mg

 16 22

 300 mg

 21 25

Conclusions:

The results show that the QR extract has a dose-related efficacy in improving sexual function in women. The effectiveness increased with the dosage. In addition, it was observed that the six individual FSFI domains related to desire, excitation, lubrication, orgasm, satisfaction and pain all respond favorably to treatment with QR and the improvement of the scores was related to the dosage.

two). QR extract for the improvement of male sexual function

The sexual function of men is scored using the well-known questionnaire of "international erectile function fodice" (IIEF) [Rosen et al., Urology. June 1997; 49 (6): 822-30. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction]. A subset of only 6 questions (No. 1-5 plus 15) of the 30 total questions is related to the erectile function with values ranging from a minimum of zero to 30. The IIEF scores range from [0-30]

In the past 4 weeks: 0 = No sexual activity

1. How many times was he able to have a 5 = Almost always or always

erection during sexual activity? _______ 4 = Most of the times (more than half the time)

3 = Sometimes (approximately half the time)

2. When you had erections with stimulation 0

sexual, ^ how often were his 5

erections hard enough for the 4

penetration? _______ 3

two

one

3. When I try intercourse, ^ how often 0

Was he able to penetrate (enter) his partner? one:

_______ two

3

4

5

4. During intercourse, ^ how often was 0

able to maintain his erection after 1:

to have penetrated (entered) your partner? _______ 2

3

4

5

5. During intercourse, how difficult it was to maintain or

your erection until the end of intercourse? one

_______ two

3

4

5

6. How many times have you tried coitus? 0

_______ one

two

3

4

5

7. When I try intercourse, ^ how often 0

Was it satisfactory for you? _______ 1:

two

3

4

5

8. How much has sex enjoyed? _______ 0

one

two

3

4

5

9. When he had sexual stimulation or intercourse, ^ with 0

How often do I ejaculate? _______ 1:

two

3

4

5

10. When he had sexual stimulation or intercourse, 0

How often did you feel the excitement of 1:

Orgasm or climax? ______ 2

3

4

5

11. How often have you felt desire 1:

sexual? _ 2

3

4

5

12. How do you rate your level of sexual desire? one

_______ two

3

4

5

= A few times (less than half the time)

= Almost never or never = No sexual activity = Almost always or always

= Most of the times (more than half the time) = Sometimes (about half the time) = A few times (less than half the time)

= Almost never or never = I do not try coitus = Almost never / never

= A few times (less than half the time)

= Sometimes (about half the time) = Most of the time (more than half the time) = Almost always or always = I do not try to coitus = Almost never or never

= A few times (less than half the time)

= Sometimes (approximately half the time) = Most of the time (more than half the time) = Almost always or always

= I do not intend to coitus = Extremely difficult = Very difficult = Difficult = Less difficult = No difficulty = Not tried = One to two attempts = Three to four attempts = Five to six attempts = Seven to ten attempts = Eleven or more attempts = I do not try coitus = Almost never / never

= A few times (less than half the time)

= Sometimes (approximately half the time) = Most of the times (more than half the time) = Almost always or always = No intercourse = I do not enjoy anything = I do not enjoy much = I enjoy a lot = I enjoy a lot = I enjoy very much = There was no sexual stimulation or coitus = Almost never or never

= A few times (less than half the time)

= Sometimes (about half the time) = Most of the times (more than half the time) = Almost always or always = No sexual stimulation or coitus = Almost never or never

= A few times (less than half the time)

= Sometimes (approximately half the time) = Most of the time (more than half the time) = Almost always or always = Almost never / never

= A few times (less than half the time)

= Sometimes (about half the time) = Most of the times (more than half the time) = Almost always or always = Very low or none = Low = Moderate = High = Very high

13. How have you felt satisfied with your sexual life as a whole? _______

14. How were you satisfied with your sexual relationship with your partner? _______

15. How do you rate your confidence that you can get and keep an erection? _______

1 = Very dissatisfied

2 = Moderately dissatisfied

3 = Equally satisfied and dissatisfied

4 = Moderately satisfied

5 = Very satisfied

1 = Very dissatisfied

2 = Moderately dissatisfied

3 = Equally satisfied and dissatisfied

4 = Moderately satisfied

5 = Very satisfied

1 = Very low

2 = Low

3 = Moderate

4 = High

The men who participated in the study were having moderate erection problems at the beginning with values of 13-18 and after treatment they obtained a sufficient erection capacity (values of 19 and above). The duration of the treatment was 2 weeks.

5 Number of men who respond with IIEF> 19 to different dosages of QR extract taken during two weeks:

Table 9

 QR extract dose

 Number of men responding with IIEF> 19 Total number of men investigated

 0 mg

 0 23

 50 mg

 6 25

 100 mg

 10 22

 200 mg

 15 22

 300 mg

 200- 26

Conclusions:

10 The results show that the QR extract has a dose-related efficacy in improving sexual function in men. The effectiveness increased with the dosage.

In parallel to the increase in erection function, the number of intercourse increases significantly. The IIEF scores detailed for orgasmic function, sexual desire, coitus satisfaction and complete satisfaction increased significantly.

fifteen

Claims (12)

5 10 fifteen twenty 25 A composition consisting of extracts rich in ellagitannins originated from extracts of plants of the family Fagaceae, in which said extracts are natural extracts having more than 50% w / w of ellagitannins based on the dry extract or having ellagitannins at a concentration of at least 10% of the total weight of said composition, for use in a method of treating or preventing sexual dysfunction in both sexes. 2. The composition for use according to claim 1, wherein said extracts rich in ellagitannins originating from plant extracts of the Fagaceae family comprise roburins or their derivatives. The composition for use according to claim 1 or 2, wherein the plant extracts of the Fagaceae family are selected from the genera Quercus, Castanea, and Fagus or their mixtures. 4. The composition for use according to claim 3, wherein the plant extracts of the Fagaceae family consist of extracts of oak woods. 5. The composition for use according to claim 4, wherein the plant extracts of the Fagaceae family consist of extracts of Quercus robur. 6. The composition for use according to any one of claims 1 to 5, wherein the composition is adapted for oral administration. The composition for use according to claim 6, wherein the oral administration is in the form of a food preparation, a dietary supplement, a nutraceutical, or a beverage. 8. The use of a composition consisting of extracts rich in ellagitannins originated from extracts of plants of the Fagaceae family, in which said extracts are natural extracts having more than 50% w / w of ellagitannins based on the extract dry or having ellagitannins at a concentration of at least 10% of the total weight of said composition, for the improvement of health or sexual well-being or sexual potency in both sexes. 9. The use according to claim 8, characterized in that said extracts rich in ellagitannins originating from extracts of plants of the family Fagaceae comprise roburins or their derivatives. The use according to claims 8 or 9, characterized in that the plant extracts of the Fagaceae family are selected from the genera Quercus, Castanea, and Fagus or their mixtures. The use according to any one of claims 8-10, wherein the plant extracts of the Fagaceae family consist of oak wood extracts. 12. The use according to any one of claims 8-11, wherein the plant extracts of the Fagaceae family consist of extracts of Quercus robur.