Combination of isoflavone source and at least one natural extract for treating, preventing or supporting improvement of cognitive symptoms associated with menopause

Abstract

The invention relates to a method for treating or preventing cognitive menopause symptoms. The method comprises administering to a human female suffering from or at risk of the cognitive menopause symptom an effective amount of an isoflavone source in combination with at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calm and alleviating tension. The combination may be administered in a composition further comprising one or more of vitamin B12, vitamin B6, vitamin B complex, iron, magnesium, and / or a freshener / cooling agent. A single or multiple doses of the composition may be administered per day, the multiple doses including a first dose and a second dose. A first dose may be administered to the human female in the morning and a second dose may be administered to the human female at night.

Description

Technical Field

[0001] The present disclosure generally relates to compositions and methods for treating cognitive symptoms associated with menopause. In preferred embodiments, the present disclosure relates to treating cognitive symptoms associated with menopause by administering to a human female suffering from cognitive symptoms associated with menopause a source of isoflavones in combination with at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing stress. Background Art

[0002] Menopause is the absence of menstrual periods for at least 12 consecutive months, signifying the loss of fertility. In the United States, the average age of menopause is 51. An estimated 6,000 American women reach menopause every day, and with increasing life expectancy, they will spend approximately 40% of their lives in the postmenopausal stage.

[0003] Even though menopause is a normal physiological change rather than a pathological condition, it is associated with changes in the body, such as a decrease in estrogen levels, which leads to various symptoms that affect a woman's quality of life. Specifically, menopause is accompanied by hot flashes and night sweats, sleep disturbances, fatigue, tension, anxiety, attention disorders, and memory impairment, leading to overall cognitive impairment and loss of mental acuity.

[0004] To help alleviate these menopausal symptoms, hormone therapies are used. Because long-term use is often associated with side effects, 65% of women in the United States do not consider hormone therapies. Furthermore, long-term use has been linked to uterine and breast cancer, stroke, pulmonary embolism, and various other side effects. Summary of the Invention

[0005] Plant-derived phytoestrogens may be a convenient alternative to hormone therapy for menopausal treatment. Plant-derived phytoestrogens contain isoflavones, which are structurally close to estrogen and bind to estrogen receptors to exhibit estrogen-like effects, thereby improving menopausal symptoms such as hot flashes and night sweats.

[0006] The present disclosure provides a composition that combines isoflavones derived from natural sources with at least one additional natural extract formulated to support cognitive performance and / or promote calmness and reduce stress.

[0007] Red clover, also known as Trifolium pratense, is a plant containing phytoestrogens and isoflavones, and multiple scientific studies support its positive effects on menopausal symptoms. Although combinations of red clover with various ingredients (e.g., hops, pomegranates) have been tested to alleviate menopausal symptoms, applicants have adopted a holistic, integrated approach to address cognitive symptoms associated with menopause. One aspect of the present disclosure provides a composition that combines a red clover extract with additional plant extracts. In some embodiments, the composition combines red clover with an extract from lemon balm (Melissa officinalis), which improves calmness and reduces anxiety. In some embodiments, the composition combines a red clover extract with a ginseng extract (Panax ginseng) that supports cognitive performance.

[0008] Without being bound by any theory, the present inventors believe that a particular combination of red clover extract and at least one of lemon balm extract or ginseng extract has synergistic beneficial effects in menopausal or postmenopausal women or women suffering from cognition-related menopausal symptoms.

[0009] In some embodiments, the composition further comprises at least one of vitamin B6, vitamin B12, vitamin B complex, iron, or magnesium, preferably in a total amount effective to enhance the normal function of the nervous system, thereby creating a unique blend to improve mental health and overall cognition in menopausal women. In some embodiments, a coolant / freshener is added to provide an immediate cooling and refreshing effect to the mouth.

[0010] In another embodiment, the present disclosure provides a method for treating, preventing, reducing the incidence, reducing the frequency and / or reducing the severity of cognitive menopausal symptoms, the method comprising administering a source of isoflavones and at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing tension to a human menopausal woman who is at risk for or already suffering from cognitive menopausal symptoms. In a preferred embodiment, the combination comprises a red clover extract and at least one of a ginseng extract or a lemon balm extract, and is administered in a therapeutically or prophylactically effective amount. Cognitive menopausal symptoms may include at least one of hot flashes, night sweats, sleep disorders, fatigue, tension, anxiety, attention disorders, or memory impairment.

[0011] In another embodiment, the present disclosure provides a method for preparing a food supplement, food or beverage composition for treating, supporting, improving, preventing, reducing the incidence, reducing the frequency and / or reducing the severity of cognitive symptoms associated with menopause. The method comprises adding an effective amount of a source of isoflavones in combination with at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing tension to at least one ingredient selected from protein, carbohydrates and fat. The method may also include providing the food supplement / composition to a human postmenopausal woman who is at risk of or already suffering from cognitive menopausal symptoms.

[0012] In another embodiment, the present disclosure provides a method for preparing a pharmaceutical composition for treating cognitive symptoms associated with menopause, the method comprising adding an effective amount of a source of isoflavones in combination with at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing stress to at least one component selected from a pharmaceutically acceptable carrier, a diluent, and an excipient. The method may also comprise providing the pharmaceutical composition to a human postmenopausal woman who is at risk of or already has cognitive menopausal symptoms.

[0013] One advantage of one or more embodiments provided by the present disclosure is improving symptoms in menopausal women.

[0014] Another advantage of one or more embodiments provided by the present disclosure is the prevention, treatment, and support of improved cognition-related menopausal symptoms.

[0015] Yet another advantage of the present disclosure is to provide a natural treatment and support strategy for menopausal symptoms without the side effects of conventional hormone therapy.

[0016] Yet another advantage of one or more embodiments is providing a synergistic effect that is greater than what would be expected when the red clover or another natural extract containing isoflavones and the additional botanical extract are administered individually.

[0017] Additional features and advantages are described herein and will be apparent upon reading the following detailed description. DETAILED DESCRIPTION

[0018] definition

[0019] Some definitions are provided below. However, definitions may be located in the "Implementation" section below, and the above heading "Definitions" does not indicate that such disclosure in the "Implementation" section is not a definition.

[0020] All percentages expressed herein are by weight based on the total weight of the composition, unless otherwise indicated. As used herein, "about," "approximately," and "substantially" should be understood to refer to numbers within a certain numerical range, such as within the range of -10% to +10% of the referenced number, preferably -5% to +5% of the referenced number, more preferably -1% to +1% of the referenced number, and most preferably -0.1% to +0.1% of the referenced number. All numerical ranges herein should be understood to include all integers or fractions within the range. In addition, these numerical ranges should be understood to provide support for claims involving any number or subset of numbers within the range. For example, a disclosure of 1 to 10 should be understood to support ranges of 1 to 8, 3 to 7, 1 to 9, 3.6 to 4.6, 3.5 to 9.9, etc.

[0021] As used in this disclosure and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "an extract" or "the extract" includes two or more extracts.

[0022] The words "comprising" and "including" are to be construed as inclusive rather than exclusive. Similarly, the terms "including" and "or" are to be construed as inclusive unless the context clearly prohibits such a construction. However, the compositions and methods disclosed herein may be free of any elements not expressly disclosed herein. Thus, disclosures of embodiments using the term "comprising" include disclosures of embodiments "consisting essentially of" or "consisting of" the specified components or steps.

[0023] The terms "at least one of" and "and / or" used in the context of "at least one of X and Y" and "X and / or Y," respectively, should be interpreted as "X without Y" or "Y without X" or "both X and Y." As used herein, the terms "example" and "such as," especially when followed by a list of terms, are exemplary and illustrative only and should not be considered exclusive or comprehensive.

[0024] “A source of isoflavones in combination with at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing stress” encompasses (i) a source of isoflavones and a natural extract for supporting cognitive performance, (ii) a source of isoflavones and a natural extract for promoting calmness and reducing stress, and (iii) a source of isoflavones, a natural extract for supporting cognitive performance, and a natural extract for promoting calmness and reducing stress, and (iv) a first composition comprising the combination of a source of isoflavones and a natural extract for supporting cognitive performance, a second composition comprising the combination of a source of isoflavones and a natural extract for promoting calmness and reducing stress, the first composition and the second composition being administered simultaneously or sequentially (e.g., as separate compositions).

[0025] As used herein, "associated with," "associated with," and "connected with" mean occurring simultaneously, preferably means being caused by the same underlying condition, more preferably means that one of the specified conditions is at least indirectly caused by another specified condition, and most preferably means that one of the specified conditions is directly caused by another specified condition.

[0026] The term "cognitive symptoms" refers to symptoms and conditions that women self-report or are diagnosed with during, but not limited to, their transition to menopause. Such symptoms and conditions can have an indirect or direct impact on mental health and cognitive performance. Symptoms and conditions can include: night sweats, hot flashes, poor sleep quality, fatigue, poor mood, nervousness, anxiety, and brain fog.

[0027] The terms "food," "food supplement," "food product," and "food composition" mean a product or composition that is intended for ingestion by an individual, such as a human, and that provides at least one nutrient to the individual. The compositions of the present disclosure, including the various embodiments described herein, may comprise, consist of, or consist essentially of the elements disclosed herein, as well as any additional or optional ingredients, components, or elements described herein or that may be used in a dietary supplement.

[0028] "Prevention" includes reducing the risk, incidence and / or severity of a disease or disorder. The term "treatment" includes both prophylactic or preventative treatment (preventing and / or delaying the development of a target pathological condition or disorder), and also includes curative, therapeutic or disease-modifying treatment, including curing, delaying, alleviating the symptoms of a confirmed pathological condition or disorder and / or interrupting its progress therapeutic measures; and treating patients who are at risk of contracting a disease or suspected of having contracted a disease, as well as treating patients who are ill or have been diagnosed with a disease or medical condition. The term "treatment" does not necessarily mean that the subject is treated until full recovery. The term "treatment" also refers to health maintenance and / or promotion in individuals who do not have a disease but may be prone to developing unhealthy conditions. The term "treatment" is also intended to include strengthening or otherwise enhancing one or more primary preventive or therapeutic measures. As a non-limiting example, treatment can be performed by a patient, a caregiver, a doctor, a nurse or another healthcare professional.

[0029] As used herein, a prophylactically or therapeutically "effective amount" is an amount that prevents a defect, treats a disease or medical condition in an individual, or more generally, alleviates symptoms, manages the progression of a disease, or provides a nutritional, physiological, or medical benefit to an individual. The relative terms "promote," "improve," "increase," "enhance," and the like refer to cognitive menopausal symptoms in postmenopausal human females following administration of a composition disclosed herein comprising a combination of red clover extract and at least one of ginseng extract or lemon balm extract relative to cognitive menopausal symptoms in postmenopausal human females obtained by administering a composition lacking at least one of red clover extract or ginseng extract or lemon balm extract but formulated in an otherwise identical manner.

[0030] "Menopause" is defined as the point in time 12 months after a woman experiences her last menstrual period and is the result of a natural decline in reproductive hormones. A recipient who is "at risk of cognitive menopausal symptoms" is a human female who has menopause but does not yet have cognitive menopausal symptoms. A recipient who is "in need of" treatment for cognitive menopausal symptoms is a human female who has had cognitive menopausal symptoms (e.g., within one month prior to administration of the composition, within one week prior to administration of the composition, or within one day prior to administration of the composition). In some embodiments, the recipient is a human female who is at least forty-five years old, e.g., at least fifty years old.

[0031] "Extract" means a plant or part thereof that has been separated from other parts of the plant in which it is naturally present to produce a concentrated form of one or more active ingredients of the plant.

[0032] "Red clover" is also known as Trifolium repens and refers to this perennial plant. As used herein, a "red clover extract" comprises at least one of the phytoestrogens biochanin A, formononetin, genistein, and daidzein; preferably at least two of these phytoestrogens, more preferably at least three of these phytoestrogens, and most preferably all four of these phytoestrogens. In some embodiments, the red clover extract further comprises at least one other compound from red clover, such as other isoflavones from red clover and / or other phytoestrogens from red clover. In a particularly preferred embodiment, the red clover extract comprises one or more of the above-mentioned phytoestrogens in a material comprising isoflavones.

[0033] As used herein, the term "isoflavonoids" shall refer to plant-based compounds that mimic the effects of the hormone estrogen.

[0034] "Ginseng" refers to the root of one or more ginseng plants. As used herein, a "ginseng extract" comprises at least one of ginsenosides Rb1, Rb2, Rc, Rd, Re, Rf, or Rg1; preferably at least two of these ginsenosides, more preferably at least three of these ginsenosides, even more preferably at least four of these ginsenosides, still more preferably at least five or at least six of these ginsenosides, and most preferably all seven of these ginsenosides. In some embodiments, the ginseng extract further comprises at least one other compound from ginseng, such as other ginsenosides from ginseng.

[0035] "Lemon balm," also known as melissa officinalis, is a member of the mint family. As used herein, "lemon balm extract" contains at least rosmarinic acid, and preferably contains one or more of volatile compounds (e.g., geranyl aldehyde, neral, citronellal, and geraniol), triterpenes (ursolic acid and oleanolic acid), phenolic acids other than rosmarinic acid (e.g., caffeic acid and chlorogenic acid), and flavonoids (quercetin, rhamnocitric acid, and luteolin).

[0036] As used herein, a "freshener" is any agent that imparts a cooling sensation to the skin and mucous membranes of the body, particularly the mouth, nose, throat, and / or gastrointestinal tract, during drinking.

[0037] As used herein, "night" refers to the time of day after 3 p.m., and "morning" refers to the time of day before 12 p.m.

[0038] As used herein, the term "unit dosage form" refers to a physically discrete unit suitable as a unit dosage for human and animal subjects, each unit containing a predetermined amount of a composition disclosed herein in association with a pharmaceutically acceptable diluent, carrier, or vehicle, in an amount sufficient to produce the desired effect. The specifications of the unit dosage form depend on the specific compound used, the effect to be achieved, and the pharmacodynamics associated with each compound in the host. In one embodiment, the unit dosage form can be a predetermined amount of powder in a sachet.

[0039] As used herein, "kit" means that the specified components are physically associated in or with one or more containers and are considered a unit for manufacture, packaging, sale, or use. Containers include, but are not limited to, bags, boxes, cartons, bottles, outer packaging, shrink wrap, attachments (e.g., bindings, adhesives, etc.), packaging of any type, design, or material, or combinations thereof. A single package can be one or more containers that include the specified components and are physically associated so that they are considered a unit for manufacture, packaging, sale, or use.

[0040] Implementation Plan

[0041] In one aspect of the present disclosure, a composition comprises a source of isoflavones in combination with at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing tension. Some embodiments of the composition comprise an amount of the combination effective to produce the following effects: (i) treating cognitive-related menopausal symptoms in human menopausal women suffering from cognitive-related menopausal symptoms, or (ii) preventing cognitive-related menopausal symptoms in human menopausal women at risk of cognitive-related menopausal symptoms. In another aspect, a method for treating or preventing cognitive-related menopausal symptoms comprises orally administering an effective amount of the composition to an individual at risk or in need thereof.

[0042] The composition can treat, prevent, alleviate or delay cognitive-related menopausal symptoms. Cognitive-related menopausal symptoms may include, but are not limited to, one or more of hot flashes, night sweats, sleep disorders, fatigue, tension, anxiety, attention disorders and memory impairment.

[0043] In some embodiments, the source of isoflavones and at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing stress are the major active ingredients of the composition. For example, the composition may consist essentially of a source of isoflavones and at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing stress.

[0044] Isoflavones source can be from the natural plant extract that is rich in or contains isoflavones.In some embodiments, isoflavones source can be soy extract or red clover extract.Composition can comprise effective amount of isoflavones, for example isoflavones between 0.5mg and 80mg per serving.Specifically, composition can comprise isoflavones between 0.5mg and 4mg, between 4mg and 10mg, between 10mg and 20mg, between 20mg and 30mg, between 30mg and 40mg, between 40mg and 50mg, between 50mg and 60mg, between 60mg and 70mg and between 70mg and 80mg per serving.For example, the unit dosage form of composition can comprise the isoflavones of such amount, and method can comprise the composition of the isoflavones comprising such amount of applying a dose.

[0045] In some embodiments, the source of isoflavones is red clover extract. At least a portion of red clover extract can be commercially available. Additionally or alternatively, at least a portion of red clover extract can be obtained by extracting from the above-ground portion of red clover. In the embodiment of the composition comprising the red clover extract, the composition of each serving size containing the red clover isoflavones between 0.5mg and 80mg can include an effective amount, for example, a red clover extract between 5mg and 800mg. Specifically, the composition can include a red clover extract between 5mg and 40mg, between 40mg and 50mg, between 50mg and 100mg, between 100mg and 200mg, between 200mg and 300mg, between 300mg and 400mg, between 400mg and 500mg, between 500mg and 600mg, between 600mg and 700mg, and between 700mg and 800mg. For example, a unit dosage form of the composition can contain such an amount of red clover extract, and the method can comprise administering a dose of the composition containing such an amount of red clover extract.

[0046] Non-limiting examples of natural extracts for promoting calmness and reducing tension include lemon balm extract, chamomile extract, fennel extract, ashwagandha extract, and combinations thereof. In some embodiments, the natural extract for promoting calmness and reducing tension includes lemon balm extract. Lemon balm extract contains rosmarinic acid and is associated with calmness, anxiety reduction, and better mood. In embodiments of the composition comprising lemon balm extract, the composition may contain at least 18 mg of rosmarinic acid from the lemon balm extract per serving of the composition, e.g., at least 20 mg of rosmarinic acid or at least 22 mg of rosmarinic acid. In some embodiments, a unit dosage form of the composition may contain such an amount of rosmarinic acid from the lemon balm extract, and the method may include administering a dose of the composition comprising such an amount of rosmarinic acid from the lemon balm extract.

[0047] In some embodiments, the natural extracts for supporting cognitive performance can include one or more of green tea extract and ginseng extract. In some embodiments, the natural extracts for supporting cognitive performance include ginseng extract. Ginseng extract contains ginsenosides and is associated with improved cognitive performance, attention, and memory performance. In embodiments of compositions comprising ginseng extract, the composition can include at least 12 mg of ginsenosides from ginseng per serving of the composition, for example, at least 14 mg of ginsenosides or at least 16 mg of ginsenosides.

[0048] In some embodiments, the composition further comprises a freshener. The freshener can be selected from, but is not limited to, fresh natural flavors, menthol, menthol-derived compounds, acyclic and / or cyclic carboxamides, N-substituted p-menthane carboxamides, phosphine oxides, substituted p-menthanes, menthoxypropanes, α-ketoenamine derivatives, N-substituted p-menthane carboxamides, menthyl hemiester derivatives, cubebol, and mixtures thereof.

[0049] In some embodiments, the composition further comprises at least one of vitamin B6, vitamin B12, vitamin B complex, iron, or magnesium. In such embodiments, the composition may consist essentially of the following ingredients: (i) a source of isoflavones, (ii) at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing tension, (iii) at least one of vitamin B6, vitamin B12, vitamin B complex, iron, or magnesium, and optionally (iv) any freshening agent.

[0050] The magnesium may be one or more physiologically acceptable organic and / or inorganic compounds, for example one or more inorganic magnesium salts (such as magnesium chloride, magnesium phosphate, magnesium sulfate, magnesium oxide, magnesium hydroxide and / or magnesium carbonate), organic magnesium salts (e.g., magnesium citrate, magnesium maleate or mixtures thereof) and / or organic components comprising magnesium.

[0051] The composition may comprise fiber. Non-limiting examples of suitable fibers include fructooligosaccharides (FOS), inulin, collagen, collagen peptides, and mixtures thereof.

[0052] The composition may be in any oral nutritional form, for example as a health drink, as a ready-to-use beverage, optionally as a soft drink, including juice, coffee, tea, milkshake, yogurt drink, smoothie or soy-based beverage; in the form of a food bar; a powder, for example in the form of a sachet; or dispersed in any kind of food, such as baked products, cereal bars, dairy bars, snacks, soups, breakfast cereals, oatmeal, candy, tablets, cookies, biscuits, crackers (such as rice cakes), as well as dairy and plant-based products.

[0053] The composition can be in the form of, for example, a tablet, capsule, lozenge, powder or liquid. The composition can also contain protective hydrophilic colloids (such as gums, proteins, modified starches), binders, film formers, encapsulating agents / materials, wall / shell materials, matrix compounds, coatings, emulsifiers, surfactants, solubilizers (oils, fats, waxes, lecithin, etc.), adsorbents, carriers, fillers, co-compounds, dispersants, wetting agents, processing aids (solvents), flow agents, taste masking agents, weighting agents, gelling agents and gel forming agents.

[0054] In some embodiments, the composition (e.g., a unit dosage form of the composition) is in the form of a gummy. Gummy desserts or gummy candies (hereinafter referred to as "gummy," or singular "gummy" or "gummi") can be prepared by molding. Preferred "gummy" are sweet products, dietary supplements, or foods that exhibit, at least in part, a deformable, non-rigid, plastic, rubbery, chewable, and / or gelatinous consistency. Gummy candies may include one or more gelling agents (such as pectin, gelatin), sugar or other sweeteners (such as stevia), flavorings, coatings, and / or coloring agents.

[0055] In some embodiments, the composition (e.g., a unit dosage form of the composition) is a powder, such as a powder in a sachet or other packaging that can be opened for reconstitution of the powder in a diluent (such as water or milk) and oral administration of the resulting beverage. A non-limiting example of a suitable sachet is a small, disposable bag, typically made of a flexible film such as cellophane or paper, preferably capable of being torn at one or both ends, and containing a serving or unit dosage form of the composition.

[0056] The compositions are preferably composed only of natural ingredients to avoid the undesirable side effects of conventional hormone therapy.The compositions of the present disclosure provide treatment for individuals suffering from cognitive symptoms of menopause while avoiding the bleeding, bloating, breast tenderness or enlargement, headaches, mood changes, and nausea associated with synthetic hormone therapy.

[0057] In some embodiments, the composition is vegan. Vegan compositions refer to compositions that do not contain animal products. The composition may contain ingredients primarily derived from plants and other natural sources.

[0058] The composition can be administered to an individual in a portion size at least two days a week, at least three days a week, all seven days a week; for at least one week, at least one month, at least two months, at least three months, at least six months, or even longer. In some embodiments, the composition is administered to an individual continuously for several days. In one embodiment, the composition can be administered to an individual daily for at least 30 consecutive days, 60 days, or 90 days.

[0059] In some embodiments, a single dose of the composition can be administered. In some embodiments, multiple doses of the composition can be administered sequentially on the same day or simultaneously on the same day. For example, a first dose of a source of isoflavones and a combination of at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and alleviating tension can be administered at the first time of a specific day, and a second dose of a source of isoflavones and a combination of at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and alleviating tension can be administered at the second time of the specific day (e.g., at least one hour apart, at least two hours apart, at least three hours apart, at least four hours apart, at least five hours apart, at least six hours apart, at least seven hours apart, or at least eight hours apart, preferably on the same day).

[0060] In a particularly preferred embodiment, a first dose of a composition comprising a source of isoflavones in combination with a natural extract for supporting cognitive performance (optionally without a natural extract for promoting calmness and reducing stress) may be administered in the morning of one or more days; and a second dose of a composition comprising a source of isoflavones in combination with a natural extract for promoting calmness and reducing stress (optionally without a natural extract for supporting cognitive performance) may be administered in the evening of the one or more days wherein the first dose is administered in the morning.

[0061] Another aspect of the present disclosure is a kit comprising a first unit dosage form of a first composition comprising a combination of a first isoflavone source and a natural extract for supporting cognitive performance. The kit also comprises a second unit dosage form of a second composition comprising a combination of an isoflavone source and a natural extract for promoting calmness and reducing tension. The kit is used to administer the second unit dosage form simultaneously or sequentially with the administration of the first unit dosage form. The first composition and the second composition each optionally have one or more different ingredients or amounts of ingredients relative to the other composition (e.g., a natural extract for supporting cognitive performance in the first composition is optionally not present in the second composition, and / or a natural extract for promoting calmness and reducing tension in the second composition is optionally not present in the first composition), but in some embodiments, the first composition and the second composition have the same ingredients and amounts thereof.

[0062] Example

[0063] Example 1: Preparation of a food supplement in the form of gummies

[0064] The following formula was used to prepare the food supplement gummies (Table 1):

[0065]

[0066] Table 1.

[0067] The other ingredients included in the formulation are as follows: fructooligosaccharides, water, pectin, agar, tapioca starch, natural flavors, natural colorants, citric acid, trisodium citrate, and carnauba wax.

[0068] To prepare the food supplement in the form of the above-mentioned soft candies, a mixture of oligofructose, pectin, water, tapioca starch, agar, and magnesium is blended until a smooth and uniform mixture is formed. The herbal blend is then added, followed by colorants, flavors, and vitamins. After reaching the desired pH and Brix levels, citric acid is introduced and the mixture is placed in a starch mold. The soft candies are dried until the desired Brix level is reached, then they are removed from the mold and coated with carnauba wax.

[0069] Example 2: Efficacy Study

[0070] Sample 1 and Sample 2, as prepared in Example 1, were tested for 30 days by American women experiencing cognitive symptoms associated with menopause (referred to as participants). Each participant tested either Sample 1 (80 participants total) or Sample 2 (79 participants total) and expressed a willingness to consume the recommended dose of two gummies daily for the 30-day period.

[0071] In the efficacy study, samples 1 and 2 were evaluated by post-trial investigations to assess the following effects:

[0072] a) The efficacy of the samples in alleviating menopausal symptoms was rated on a scale of 1 to 5 ranging from "completely ineffective", "slightly effective", "partially effective", "very effective" to "extremely effective".

[0073] b) Rate the efficacy of the sample compared to the previously used solution on a scale of 1 to 5 ranging from "much less effective," "less effective," "about the same effective," "more effective," to "much more effective."

[0074] The results of the factors evaluated in part a) are as follows (Table 2):

[0075] assessment Sample 1 Sample 2 Completely ineffective 16.25％ 21.79％ Slightly effective 13.75％ 11.54％ Partially effective 13.75％ 20.51％ Very effective 36.25％ 28.21％ Extremely effective 20％ 17.95％

[0076] Table 2

[0077] As can be observed from Table 2, the majority of participants believed that the samples were "extremely effective" or "very effective" in alleviating their menopausal symptoms (56.25% for Sample 1 and 46.16% for Sample 2).

[0078] The results of the factors evaluated in part b) are as follows (Table 3):

[0079]

[0080]

[0081] Table 3

[0082] As can be observed from Table 3, more than half of the participants believed that the samples were "much more effective" or "more effective" than other solutions in alleviating their menopausal symptoms (62.5% for Sample 1 and 55.13% for Sample 2).

Claims

1. A composition comprising a source of isoflavones in combination with at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing stress.

2. The composition according to claim 1, wherein the composition is in a unit dosage form, the unit dosage form comprising an amount of the composition effective for treating or preventing cognitive menopausal symptoms.

3. A composition according to claim 1 or claim 2, wherein the composition is vegan.

4. The composition according to any one of claims 1 to 3, wherein the isoflavone source is selected from the group consisting of soy extract, red clover extract, and combinations thereof.

5. The composition according to any one of claims 1 to 4, wherein the natural extract for promoting calmness and reducing tension is selected from the group consisting of lemon balm extract, chamomile extract, fennel extract, ashwagandha extract, and combinations thereof.

6. The composition according to any one of claims 1 to 5, wherein the natural extract for supporting cognitive performance is selected from ginseng extract and green tea extract.

7. The composition according to any one of claims 1 to 6, further comprising an additional ingredient selected from the group consisting of inulin, collagen, collagen peptides, oligofructose and combinations thereof.

8. A method for treating or preventing cognitive menopausal symptoms, the method comprising administering to a human female in need or at risk thereof an effective amount of a source of isoflavones in combination with at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing stress.

9. The method of claim 8, wherein the isoflavone source comprises red clover extract.

10. The method of claim 8 or claim 9, wherein the combination comprises a natural extract for supporting cognitive performance, wherein the natural extract for supporting cognitive performance comprises a ginseng extract and is administered to the human female in need or at risk at a dose comprising an amount of the ginseng extract containing at least 12 mg of ginsenosides.

11. The method of any one of claims 8 to 10, wherein the combination comprises a natural extract for promoting calmness and reducing stress, wherein the natural extract for promoting calmness and reducing stress comprises lemon balm extract and is administered to the human female in need or at risk of the condition at a dose comprising an amount of the lemon balm extract comprising at least 18 mg of rosmarinic acid.

12. The method of any one of claims 8 to 11, wherein the combination is administered as a composition further comprising one or more vitamins and minerals selected from vitamin B12, vitamin B6, magnesium, and combinations thereof.

13. The method according to any one of claims 8 to 12, wherein the cognitive menopausal symptoms are selected from the group consisting of hot flashes, night sweats, sleep disturbances, fatigue, tension, anxiety, concentration disorders, memory impairment, and combinations thereof.

14. The method according to any one of claims 8 to 13, wherein the combination is applied as a composition further comprising a freshener.

15. The method according to any one of claims 8 to 14, wherein a single dose of the composition is administered daily.

16. The method of any one of claims 8 to 15, wherein multiple doses of the composition are administered daily, the multiple doses comprising a first dose wherein the combination comprises a first source of isoflavones and a natural extract for supporting cognitive performance, the multiple doses further comprising a second dose wherein the combination comprises a second source of isoflavones and a natural extract for promoting calmness and reducing tension, and the second dose is administered simultaneously or sequentially with the first dose.

17. The method of any one of claims 8 to 15, wherein multiple doses of the composition are administered daily, the multiple doses comprising a first dose wherein the combination comprises red clover extract and ginseng extract, the multiple doses further comprising a second dose wherein the combination comprises red clover extract and lemon balm extract, and the second dose is administered simultaneously or sequentially with the first dose.

18. The method of claim 16 or claim 17, wherein the first dose is administered to the human female in need or at risk in the morning of one of the plurality of days, and the second dose is administered to the human female in need or at risk in the evening of one of the plurality of days.

19. The method of any one of claims 8 to 18, wherein the combination is administered to the human female in need or at risk in the form of a gummies.

20. A composition comprising a red clover extract in combination with at least one of a ginseng extract or a lemon balm extract.

21. The composition of claim 20, wherein the composition is in unit dosage form, the unit dosage form comprising an amount of the composition effective for treating or preventing cognitive menopausal symptoms.

22. A composition according to claim 20 or claim 21, wherein the composition is vegan.

23. The composition according to any one of claims 20 to 22, further comprising an additional ingredient selected from the group consisting of inulin, collagen, collagen peptides, oligofructose, and combinations thereof.

24. A method of preparing a food or food supplement composition for treating or preventing cognitive symptoms associated with menopause, the method comprising adding an effective amount of a red clover extract in combination with at least one of a ginseng extract or a lemon balm extract to at least one ingredient selected from the group consisting of protein, carbohydrates, and fat.

25. The method of claim 24, further comprising providing the food composition to a human postmenopausal female at risk for or already suffering from the cognitive symptoms associated with menopause.

26. A kit comprising a first unit dosage form of a first composition comprising a combination of a source of isoflavones and a natural extract for supporting cognitive performance, the kit further comprising a second unit dosage form of a second composition comprising a combination of a source of isoflavones and a natural extract for promoting calmness and reducing tension, for administration of the second unit dosage form simultaneously or sequentially with administration of the first unit dosage form, wherein the first and second compositions each optionally have one or more different ingredients relative to the other composition.

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