Combination of an isoflavone source with at least one natural extract for the treatment, prevention, or aid in the amelioration of cognitive symptoms associated with menopause - Patent Application 20070122999

Abstract

The method treats or prevents menopausal symptoms in cognitive function, and includes administering to a human female experiencing or at risk of menopausal symptoms in cognitive function an effective amount of a combination of an isoflavone source and at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing stress. The combination may be administered in a composition further comprising one or more of vitamin B12, vitamin B6, a vitamin B complex, iron, magnesium, and / or a cooling / cooling agent. A single dose or multiple doses of the composition may be administered per day, with the multiple doses including a first dose and a second dose. The first dose may be administered to the human female in the morning, and the second dose may be administered to the human female in the evening.

Description

[Technical Field]

[0001]

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

[0002]

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

[0003]

[0003] Although menopause is a normal physiological change without pathological consequences, it is associated with bodily changes such as a decline in estrogen levels, resulting in a variety of symptoms that affect a woman's quality of life. Specifically, menopause is accompanied by hot flashes and night sweats, sleep disorders, fatigue, stress, anxiety, impaired concentration, and memory impairment, leading to a general decline in cognitive function and reduced mental agility.

[0004]

[0004] Hormone therapy is available to help alleviate the above-mentioned menopausal symptoms. However, 65% of women in the United States would not consider hormone therapy because long-term use of hormone therapy is often accompanied by side effects. Furthermore, long-term use has been shown to result in uterine cancer, breast cancer, stroke, pulmonary embolism, and various other side effects. Summary of the Invention

[0005]

[0005] Plant-derived phytoestrogens can be a convenient alternative to hormone therapy for treating menopause. Plant-derived phytoestrogens contain isoflavones, which are structurally similar to estrogen and exhibit estrogen-like effects by binding to estrogen receptors, thereby alleviating menopausal symptoms such as hot flashes and night sweats.

[0006]

[0006] The present disclosure provides compositions that combine 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]

[0007] Red clover, also known as red clover (Trifolium pratense), is a plant containing phytoestrogens and isoflavones, and various scientific studies have documented its positive effects on menopausal symptoms. While red clover has been tested in combination with various ingredients (e.g., hops, pomegranate) to alleviate menopausal symptoms, the applicant has adopted a holistic approach to address cognitive symptoms associated with menopause. One aspect of the present disclosure provides compositions combining red clover extract with additional plant extracts. In some embodiments, the compositions combine red clover with an extract from lemon balm (Melissa officinalis). Lemon balm improves calmness and reduces anxiety. In some embodiments, the compositions combine red clover extract with ginseng extract (Panax ginseng), which supports cognitive performance.

[0008]

[0008] Without being bound by any theory, the inventors believe that the particular combination of red clover extract and at least one of lemon balm or ginseng extract provides synergistic benefits 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, B complex vitamins, iron, or magnesium, preferably in a total amount effective to promote normal nervous system function, thereby creating a unique blend for improving mental health and overall cognition in menopausal women. In some embodiments, a cooling / refreshing agent is added to provide a direct cooling and refreshing effect to the oral cavity.

[0010] In another embodiment, the present disclosure provides a method for treating, preventing, reducing the incidence, frequency, and / or severity of cognitive menopausal symptoms, the method comprising administering an isoflavone source and at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing stress to a human postmenopausal woman 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, administered in a therapeutically or prophylactically effective amount. Cognitive menopausal symptoms can include at least one of hot flashes, night sweats, sleep disturbances, fatigue, stress, anxiety, impaired concentration, or memory impairment.

[0011]

[0011] In another embodiment, the present disclosure provides a method for producing a dietary supplement, food, or beverage composition for treating, supporting improvement, preventing, reducing the incidence, frequency, and / or severity of cognitive symptoms associated with menopause. The method comprises adding an effective amount of a combination of an isoflavone source and 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 ingredient selected from the group consisting of protein, carbohydrate, and fat. The method may further comprise providing the dietary supplement / food composition to a human menopausal female at risk for or already experiencing menopausal symptoms in cognitive function.

[0012]

[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 combination of an isoflavone source and 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 the group consisting of a pharmaceutically acceptable carrier, a diluent, and an excipient. The method may further comprise providing the pharmaceutical composition to a human menopausal woman at risk for or already suffering from menopausal symptoms in cognitive function.

[0013] An advantage of one or more embodiments provided by the present disclosure is that it improves the condition of menopausal women.

[0014] Another advantage of one or more embodiments provided by the present disclosure is that they help prevent, treat, or improve cognitive-related symptoms of menopause.

[0015] Yet another advantage of the present disclosure is that it provides natural treatment and support for menopausal symptoms without the side effects of traditional hormone therapy.

[0016] Yet another advantage of one or more embodiments is that they provide a synergistic effect that is greater than would be expected if red clover, or another natural extract containing isoflavones, and the additional plant extract were applied individually.

[0017]

[0017] Additional features and advantages are described herein, and will be apparent from the detailed description that follows. DETAILED DESCRIPTION OF THE INVENTION

[0018]

[0018] Definition

[0019] Below are some definitions. However, definitions may be found in the "Embodiments" section below, and the heading "Definitions" above does not imply that such disclosure in the "Embodiments" section is not a definition.

[0019]

[0020] All percentages set forth herein are by weight of the total composition unless otherwise specified. As used herein, "about," "approximately," and "substantially" are understood to refer to a range of numerical values, e.g., within -10% to +10% of the referenced numerical value, preferably within -5% to +5% of the referenced numerical value, more preferably within -1% to +1% of the referenced numerical value, and most preferably within -0.1% to +0.1% of the referenced numerical value. All numerical ranges herein should be understood to include all integers, whole numbers, or fractions within that range. Furthermore, these numerical ranges should be construed to support claims directed to any number or subset of numbers within that range. For example, a disclosure of 1 to 10 should be construed to correspond to ranges of 1 to 8, 3 to 7, 1 to 9, 3.6 to 4.6, 3.5 to 9.9, etc.

[0020]

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

[0021]

[0022] The terms "comprise," "comprises," and "comprising" should be construed as inclusive rather than exclusive. Similarly, the terms "include," "including," and "or" should all be construed as inclusive unless such interpretation is clearly prohibited by context. Nevertheless, the compositions and methods disclosed herein may lack any element not specifically disclosed herein. Thus, disclosure of embodiments using the term "comprising" includes disclosure of embodiments "consisting essentially of" the specified components or steps, as well as embodiments "consisting of" the specified components or steps.

[0022]

[0023] The terms "at least one" 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", particularly when followed by a list of terms, are merely for purposes of illustration and illustration and should not be considered exclusive or comprehensive.

[0023]

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

[0024]

[0025] As used herein, "related to," "associated with," and "linked with" mean occurring simultaneously, preferably caused by the same underlying condition, more preferably meaning that one of the specified conditions is at least indirectly caused by the other specified condition, and most preferably meaning that one of the specified conditions is directly caused by the other specified condition.

[0025]

[0026] The term "cognitive symptoms" refers to, but is not limited to, symptoms and conditions self-reported or diagnosed by women during the menopausal transition. Such symptoms and conditions may have an indirect or direct impact on mental health and cognitive performance. Symptoms and conditions include night sweats, hot flashes, poor sleep quality, fatigue, poor mood, stress, anxiety, and brain fog.

[0026]

[0027] The terms "food," "dietary supplement," "food product," and "food composition" refer to a product or composition intended for consumption by an individual, such as a human, and providing at least one nutrient to such an individual. The compositions of the present disclosure, including the many embodiments described herein, may comprise, consist of, or essentially consist of the elements disclosed herein, as well as any additional or optional ingredients, components, or elements described or not described herein that are useful in dietary supplements.

[0027]

[0028] "Prevention" includes reducing the risk, incidence, and / or severity of a condition or disorder. The terms "treatment" and "treating" include both prophylactic or preventative treatment (treatment that prevents and / or delays the onset of the pathological condition or disorder in question) and curative, therapeutic, or disease-modifying treatment, including, for example, therapeutic measures to cure, delay, alleviate symptoms, and / or halt the progression of a diagnosed pathological condition or disorder, as well as treatment of patients at risk of or suspected of having a disease, and patients who are unwell or diagnosed with a disease or medical condition. The terms "treatment" and "treating" do not necessarily imply that a subject is treated until fully recovered. The terms "treatment" and "treating" also refer to maintaining and / or promoting the health of individuals who are not affected by the disease but who may be susceptible to an ill-health condition. The terms "treatment" and "treating" are also intended to include the synergism or otherwise potentiation of one or more primary preventative or therapeutic measures. By way of non-limiting example, treatment can be performed by the patient, a caregiver, a doctor, a nurse, or another medical professional.

[0028]

[0029] As used herein, a prophylactically or therapeutically "effective amount" is an amount that prevents a deficiency, treats a disease or medical condition in an individual, or, more generally, reduces symptoms, manages the progression of a disease, or provides a nutritional, physiological, or medical benefit to an individual. The relative terms "promote," "improve," "increase," "promote," and the like refer to menopausal symptoms in cognitive function in menopausal 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) compared to menopausal symptoms in cognitive function in menopausal human females obtained by administration of an otherwise identically formulated composition lacking at least one of red clover extract or ginseng extract or lemon balm extract.

[0029]

[0030] " Menopause " is defined as the time point 12 months after a woman has experienced her last menstrual period, and is the result of the natural decline of reproductive hormones. The recipient of administration "at risk" of cognitive menopausal symptoms is a human female who has undergone menopause but has not yet experienced cognitive menopausal symptoms. The recipient of administration "requires" the treatment of cognitive menopausal symptoms is a human female who suffers from cognitive menopausal symptoms (for example, within one month before administering the composition, within one week before administering the composition, or within one day before administering the composition). In some embodiments, the recipient of administration is a human female who is at least 45 years old, for example, at least 50 years old.

[0030]

[0031] "Extract" means a plant or part thereof that has been separated from other naturally occurring parts to create a concentrated form of one or more active ingredients of the plant.

[0031]

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

[0032]

[0033] As used herein, the term "isoflavones" refers to plant compounds that mimic the effects of the hormone estrogen.

[0033]

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

[0034]

[0035] "Lemon balm," also known as "Melissa officinalis," is a species of the Lamiaceae family. As used herein, "lemon balm extract" includes at least rosmarinic acid and preferably one or more of volatile compounds (e.g., geranial, neral, citronellal, and geraniol), triterpenes (ursolic acid and oleanolic acid), phenolic acids (e.g., caffeic acid and chlorogenic acid) in addition to rosmarinic acid, and flavonoids (quercetin, rhamnocitrin, and luteolin).

[0035]

[0036] A "coolant," as used herein, is any agent that, during ingestion, provides a cooling sensation to the skin and mucous membranes of the body, particularly the mouth, nose, throat, and / or gastrointestinal tract.

[0036]

[0037] As used herein, "night" refers to any time of day after 3:00 PM, and "morning" refers to any time of day before noon.

[0037]

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

[0038]

[0039] As used herein, "kit" means identified components within or physically associated with one or more containers and considered a single unit for manufacture, distribution, sale, or use. Containers include, but are not limited to, bags, boxes, cartons, bottles, packaging of any type or design or material, overwrap, shrink wrap, affixed components (e.g., stapled or glued), or combinations thereof. A single package may be one or more containers containing, and physically associated with, the identified components, and thereby considered a single unit for manufacture, distribution, sale, or use.

[0039]

[0040] Embodiment

[0041] In one aspect of the present disclosure, a composition comprises a combination of an isoflavone source and at least one of a natural extract for supporting cognitive performance and a natural extract for promoting calmness and reducing stress. Some embodiments of the composition comprise the combination in an amount effective to (i) treat cognition-related menopausal symptoms in a human menopausal female having such symptoms, or (ii) prevent cognition-related menopausal symptoms in a human menopausal female at risk for such symptoms. In another aspect, a method for treating or preventing cognition-related menopausal symptoms comprises orally administering an effective amount of the composition to an individual at risk or in need thereof.

[0040]

[0042] The compositions may treat, prevent, alleviate, or delay cognition-related menopausal symptoms, including, but not limited to, one or more of hot flashes, night sweats, sleep disturbances, fatigue, stress, anxiety, difficulty concentrating, and memory impairment.

[0041]

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

[0042]

[0044] The isoflavone source can be derived from natural plant extracts rich in or containing isoflavones. In some embodiments, the isoflavone source can be soy extract or red clover extract. The composition can contain an effective amount of isoflavones, for example, 0.5 mg to 80 mg of isoflavones per serving. Specifically, the composition can contain 0.5 mg to 4 mg, 4 mg to 10 mg, 10 mg to 20 mg, 20 mg to 30 mg, 30 mg to 40 mg, 40 mg to 50 mg, 50 mg to 60 mg, 60 mg to 70 mg, and 70 mg to 80 mg of isoflavones per serving. For example, a unit dosage form of the composition can contain such amounts of isoflavones, and the method can include administering a dose of the composition containing such amounts of isoflavones.

[0043]

[0045] In some embodiments, the isoflavone source is red clover extract. At least a portion of the red clover extract is commercially available. Additionally or alternatively, at least a portion of the red clover extract can be obtained by extraction from the aerial parts of red clover. In embodiments of compositions comprising red clover extract, the composition can include 5 mg to 800 mg of red clover extract per serving, containing an effective amount, for example, 0.5 mg to 80 mg of red clover isoflavones. Specifically, the composition can include 5 mg to 40 mg, 40 mg to 50 mg, 50 mg to 100 mg, 100 mg to 200 mg, 200 mg to 300 mg, 300 mg to 400 mg, 400 mg to 500 mg, 500 mg to 600 mg, 600 mg to 700 mg, and 700 mg to 800 mg of red clover extract per serving. For example, a unit dosage form of the composition can include such an amount of red clover extract, and the method can include administering a dose of the composition including such an amount of red clover extract.

[0044]

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

[0045]

[0047] In some embodiments, the natural extract for supporting cognitive performance may comprise one or more of green tea extract and ginseng extract. In some embodiments, the natural extract for supporting cognitive performance comprises ginseng extract. Ginseng extract contains ginsenosides, which are associated with improved cognitive performance, attention, and memory. In an embodiment of the composition comprising ginseng extract, the composition may comprise at least 12 mg of ginsenosides from ginseng, for example, at least 14 mg of ginsenosides, or at least 16 mg of ginsenosides per serving of the composition.

[0046]

[0048] In some embodiments, the composition further comprises a cooling agent, which may be selected from the group consisting of cooling natural flavors, menthol, menthol derivative compounds, acyclic and / or cyclic carboxamides, N-substituted paramenthane carboxamides, phosphine oxides, substituted p-menthane, menthoxypropane, α-ketoenamine derivatives, N-substituted p-menthane carboxamides, menthyl half acid ester derivatives, cubebol, and mixtures thereof.

[0047]

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

[0048]

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

[0049]

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

[0050]

[0052] The composition can be in any oral nutritional form, for example as a health drink, as a ready-made drink, optionally as a soft drink such as juice, coffee, tea, milkshake, yogurt drink, smoothie, or soy-based drink; it can be a food bar; it can be a powder, for example in sachet form; or it can be dispersed in any kind of food product, for example in baked products, cereal bars, dairy bars, snack foods, soups, breakfast cereals, muesli, candy, tubs, cookies, biscuits, crackers (such as rice crackers), as well as in dairy and plant products.

[0051]

[0053] The compositions may be in the form of, for example, a tablet, capsule, lozenge, powder, or liquid. The compositions may further contain protective hydrocolloids (e.g., gums, proteins, modified starches), binders, film-forming agents, 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, flavoring agents, bulking agents, jellifying agents, and gel-forming agents.

[0052]

[0054] In some embodiments, the composition (e.g., a unit dosage form of the composition) is in a gummy-like form. Gummy sweets or gummy candies (hereinafter also referred to as "gummies" or "gummy" or "gummi") can be prepared by molding. Preferred "gummies" are confectionery products, dietary supplements, or food products that exhibit an at least partially deformable, non-rigid, plastic, rubbery, chewable, and / or jelly-like consistency. Gummies may include one or more gelling agents (e.g., pectin, gelatin), sugars or other sweeteners (e.g., stevia), flavors, coatings, and / or colorants.

[0053]

[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 package that can be opened to reconstitute the powder with a diluent, such as water or milk, and for oral administration of the resulting beverage. A non-limiting example of a suitable sachet is a small, disposable pouch, typically of flexible film, such as cellophane or paper, preferably tearable at one or both ends, that contains a single serving or unit dosage form of the composition.

[0054]

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

[0055]

[0057] In some embodiments, the composition is vegan. A vegan composition refers to a composition that does not contain animal products. The composition may contain ingredients that are primarily derived from plants and other natural sources.

[0056]

[0058] The composition can be administered to an individual at a single serving for at least two days per week, at least three days per week, all seven days per 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 for several consecutive days. In one embodiment, the composition of the present invention can be administered to an individual daily for at least 30, 60, or 90 consecutive days.

[0057]

[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 the combination of an isoflavone source and at least one of the natural extracts for supporting cognitive performance and the natural extracts for promoting calmness and reducing stress can be administered at a first time on a specific day, and a second dose of the combination of an isoflavone source and at least one of the natural extracts for supporting cognitive performance and the natural extracts for promoting calmness and reducing stress can be administered at a second time on the specific day (for example, at least 1 hour apart, at least 2 hours apart, at least 3 hours apart, at least 4 hours apart, at least 5 hours apart, at least 6 hours apart, at least 7 hours apart, or at least 8 hours apart, preferably on the same day).

[0058]

[0060] In particularly preferred embodiments, a first dose of the composition can be administered in the morning of one or more days, the first dose including a combination of an isoflavone source and a natural extract for supporting cognitive performance (optionally not including a natural extract for promoting calmness and reducing stress); and a second dose of the composition can be administered in the evening of one or more days after the first dose was administered in the morning, the second dose including a combination of an isoflavone source and a natural extract for promoting calmness and reducing stress (optionally not including a natural extract for supporting cognitive performance).

[0059]

[0061] Another aspect of the present disclosure is a kit including 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 further includes 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 stress. The kit is for administering the second unit dosage form simultaneously or sequentially with the administration of the first unit dosage form. The first and second compositions each optionally have one or more different ingredients or amounts of ingredients compared to the other composition (e.g., the natural extract for supporting cognitive performance in the first composition is optionally absent from the second composition, and / or the natural extract for promoting calmness and reducing stress in the second composition is optionally absent from the first composition), although in some embodiments, the first and second compositions have the same ingredients and amounts of ingredients.

[0060]

[0062] Example

[0063] Example 1: Preparation of a dietary supplement in gummy form

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

[0061] [Table 1]

[0062]

[0065] The preparation contains the following other ingredients: fructooligosaccharides, water, pectin, agar, tapioca starch, natural flavors, natural colors, citric acid, trisodium citrate, and carnauba wax.

[0063]

[0066] To prepare the above-mentioned dietary supplement in gummy form, a mixture of fructooligosaccharides, pectin, water, tapioca starch, agar, and magnesium is blended until a smooth and consistent mixture is formed.Then, the herb blend is added, followed by the incorporation of coloring, flavoring, and vitamins.After the desired pH and Brix level are achieved, citric acid is introduced and the mixture is poured into starch molds.The gummy candy is dried until the desired Brix level is reached, and then removed from the mold and coated with carnauba wax.

[0064]

[0067] Example 2: Efficacy Testing

[0068] Samples 1 and 2 prepared in Example 1 were tested for 30 days by women (referred to as participants) in the United States experiencing cognitive symptoms associated with menopause. Each participant tested either Sample 1 (80 participants total) or Sample 2 (79 participants total) and indicated a willingness to take the recommended dose of two gummies per day for 30 days.

[0065]

[0069] In the efficacy study, evaluation of Sample 1 and Sample 2 was performed through a post-study survey evaluated as follows:

[0066]

[0070] a) The effectiveness of the samples in alleviating menopausal symptoms was rated on a scale of 1 to 5 ranging from "not at all effective," "slightly effective," "somewhat effective," "very effective," to "extremely effective."

[0067]

[0071] b) The effectiveness of the sample compared to the previously used solution was rated on a scale of 1 to 5 ranging from "much less effective," "lower effective," "about the same effective," "more effective," to "much more effective."

[0068]

[0072] The results of the elements evaluated in section a) are as follows (Table 2).

[0069] [Table 2]

[0070]

[0073] From Table 2, it can be observed that the majority of participants perceived the samples as "extremely effective" or "very effective" in reducing menopausal symptoms (56.25% for Sample 1 and 46.16% for Sample 2).

[0071]

[0074] The results of the elements evaluated in section b) are as follows (Table 3):

[0072] [Table 3]

[0073]

[0075] From Table 3, it can be observed that more than half of the participants perceived the sample as “much more effective” or “more effective” than other solutions in alleviating menopausal symptoms (62.5% in Sample 1 and 55.13% in 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. 10. The composition of claim 1, wherein the composition is in a unit dosage form containing an amount of the composition effective for treating or preventing menopausal symptoms in cognitive function.

3. 3. The composition of claim 1 or 2, wherein the composition is vegan.

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

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

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

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

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

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

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

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

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

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

14. The method of any one of claims 8 to 13, wherein the combination is administered in a composition further comprising a cooling agent.

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

16. 16. The method of any one of claims 8 to 15, wherein multiple doses of the composition are administered per day, the multiple doses including a first dose, wherein the combination comprises a first isoflavone source and a natural extract for supporting cognitive performance, and the multiple doses further including a second dose, wherein the combination comprises a second isoflavone source and a natural extract for promoting calmness and reducing stress, the second dose being administered simultaneously or sequentially with the first dose.

17. 16. The method of any one of claims 8-15, wherein multiple doses of the composition are administered per day, said multiple doses including a first dose wherein the combination comprises a red clover extract and a ginseng extract, and said multiple doses further including a second dose wherein the combination comprises a red clover extract and a lemon balm extract, said second dose being administered simultaneously or sequentially with said first dose.

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

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

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

21. 21. The composition of claim 20, wherein the composition is in a unit dosage form containing an amount of the composition effective to treat or prevent menopausal symptoms on cognitive function.

22. 22. The composition of claim 20 or 21, wherein the composition is vegan.

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

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

25. 25. The method of claim 24, further comprising providing the food composition to a human postmenopausal woman at risk of 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 an isoflavone source and a natural extract for supporting cognitive performance, and further comprising 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 stress, for administration of the second unit dosage form simultaneously or sequentially with administration of the first unit dosage form, wherein the first composition and the second composition each optionally have one or more different ingredients compared to the other composition.

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