WO2020231030A2 - Composition comprenant du lactobacillus acidophilus pour prévenir, atténuer ou traiter la nervosité, les fourmillements, l'insomnie, les vertiges ou la fatigue chez les femmes ménopausées - Google Patents

Composition comprenant du lactobacillus acidophilus pour prévenir, atténuer ou traiter la nervosité, les fourmillements, l'insomnie, les vertiges ou la fatigue chez les femmes ménopausées Download PDF

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WO2020231030A2
WO2020231030A2 PCT/KR2020/005262 KR2020005262W WO2020231030A2 WO 2020231030 A2 WO2020231030 A2 WO 2020231030A2 KR 2020005262 W KR2020005262 W KR 2020005262W WO 2020231030 A2 WO2020231030 A2 WO 2020231030A2
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lactobacillus acidophilus
present
insomnia
fatigue
nervousness
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PCT/KR2020/005262
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English (en)
Korean (ko)
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WO2020231030A3 (fr
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김윤태
남영도
신희순
이소영
김재구
임은영
송은지
엄기안
홍성운
임미형
연성흠
손락호
박채리
음현애
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한국식품연구원
(주)휴온스
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Publication of WO2020231030A3 publication Critical patent/WO2020231030A3/fr

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health
    • A23V2200/322—Foods, ingredients or supplements having a functional effect on health having an effect on the health of the nervous system or on mental function
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2400/00—Lactic or propionic acid bacteria
    • A23V2400/11—Lactobacillus
    • A23V2400/113—Acidophilus

Definitions

  • the present invention relates to a composition for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, including Lactobacillus acidophilus .
  • menopause is regarded as the same meaning as menopause, and after menopause occurs as the beginning of menopause, but menopausal period includes all periods of menopausal transition, menopause, and post-menopause. It is a concept that includes.
  • the main symptoms of menopause include a decrease in female hormones, especially the level of estrogen among female hormones. This estrogen reduction causes various menopausal symptoms, and menopausal symptoms can be divided into acute (acute symptoms), subacute (medium between acute and chronic), and chronic (symptoms slowly progressing), depending on the timing and severity.
  • Acute symptoms include hot flush, insomnia, sweating, systemic muscle and joint pain, anxiety, agitation, and depression.
  • Subacute symptoms include symptoms due to atrophy of the genitourinary system and decreased libido.
  • Chronic symptoms include osteoporosis and heart and cerebrovascular disease.
  • menopausal treatments include non-drug methods, phytoestrogen, hormone therapy, and non-hormonal therapy, depending on symptoms.
  • the non-drug method is to alleviate menopausal symptoms by changing lifestyles through exercise and diet.
  • Vegetable estrogen refers to a substance that has a chemical structure similar to estrogen and thus acts similar to estrogen in the body.
  • Plant estrogens include Isoflavone, Black Cohosh, Pomegranate, Dong Quai, Evening Primrose Oil, Ginseng, and Flaxseed.
  • These phytoestrogens are similar in effect to estrogens, such as relieving menopausal symptoms such as hot flashes and depression, but they are derived from plants and are therefore attracting attention because they are considered to have no side effects.
  • Hormone therapy is most often used to treat menopausal symptoms.
  • long-term administration of hormone therapy has been found to cause cardiovascular disease, breast cancer, coronary artery disease, stroke, ovarian cancer, and the like, and a new treatment is needed.
  • different symptoms may appear depending on the age. The older, the higher the frequency of breast cancer and heart disease. Therefore, older women need caution when using hormone therapy.
  • SSRIs selective serotonin reuptake inhibitors
  • gabapentin is the case. Yes.
  • the present inventors completed the present invention by confirming that menopausal symptoms such as nervousness, ant hallucinations, insomnia, dizziness or fatigue are improved when Lactobacillus acidophilus YT1 is applied to the human body.
  • an object of the present invention is to provide a composition for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, including Lactobacillus acidophilus.
  • the present invention comprises Lactobacillus acidophilus as an active ingredient, prevention of nervous irritability, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women or It provides a food composition for improvement.
  • the food composition may be a health functional food composition.
  • the present invention provides a pharmaceutical composition for the prevention or treatment of neurosensitivity, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, comprising Lactobacillus acidophilus as an active ingredient.
  • the Lactobacillus acidophilus may be a Lactobacillus acidophilus YT1 strain (accession number: KCCM11808P).
  • the present invention provides a method for preventing or ameliorating nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, comprising the step of administering the composition to an individual.
  • the present invention provides a use of the composition for preventing or improving nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women.
  • the present invention provides a use of Lactobacillus acidophilus for the manufacture of a drug for improving nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women.
  • the composition containing the Lactobacillus acidophilus according to the present invention is expected to be useful for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women. do.
  • FIG. 1 is a diagram schematically showing an outline of a human body application test according to an embodiment of the present invention.
  • Figure 2 is a diagram showing the effect of reducing neurological symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention through analysis of changes in individual items of KMI.
  • FIG. 3 is a diagram showing the effect of reducing ant hallucination symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention through analysis of changes in individual items of KMI.
  • FIG. 4 is a diagram showing the effect of reducing insomnia symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention by analyzing the amount of change in individual items of KMI.
  • FIG. 5 is a diagram showing the effect of reducing dizziness symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention through analysis of changes in individual items of KMI.
  • FIG. 6 is a diagram showing the effect of reducing fatigue symptoms according to the intake of Lactobacillus acidophilus YT1 strain in a human application test according to an embodiment of the present invention through analysis of changes in individual items of KMI.
  • the present invention relates to a composition for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women comprising Lactobacillus acidophilus as an active ingredient, Lactobacillus acidophilus ( Lactobacillus acidophilus ) It provides a food composition for preventing or improving menopausal women's nervousness, ant hallucinations, insomnia, dizziness, or fatigue, comprising as an active ingredient.
  • the food composition may be a health functional food composition, but is not limited thereto.
  • the health functional food composition may be used before or after the onset stage of the disease in order to improve the menopausal symptoms, simultaneously with or separately from the drug for treatment.
  • the Lactobacillus acidophilus may be a Lactobacillus acidophilus YT1 strain (accession number: KCCM11808P), but is not limited thereto.
  • the Lactobacillus acidophilus of the present invention When used as a food additive, the Lactobacillus acidophilus may be added as it is or used with other foods or food ingredients, and in a conventional method. It can be used appropriately.
  • the mixing amount of the active ingredient may be appropriately determined according to the purpose of use (prevention, health or therapeutic treatment).
  • Lactobacillus acidophilus of the present invention is 1% to 30% by weight, 1% to 20% by weight, based on the total weight% (100%) of the raw material, It may be added in an amount of 10% to 20% by weight, 10% to 15% by weight, or 15% to 20% by weight, and according to an embodiment of the present invention may be added in 15% by weight, It is not limited, and in the case of long-term intake for the purpose of health and hygiene or for the purpose of health control, the amount may be below the above range, and there is no problem in terms of safety, so the active ingredient may be used in an amount above the above range I can.
  • the type of food There is no particular limitation on the type of food. Examples of foods to which the above substances can be added include meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gums, dairy products including ice cream, various soups, beverages, tea, drinks, There are alcoholic beverages and vitamin complexes, and all health functional foods in the usual sense are included.
  • the health functional food may be formulated as one selected from the group consisting of tablets, pills, powders, granules, powders, capsules, and liquid formulations, including at least one of carriers, diluents, excipients, and additives.
  • the food composition according to the present invention may contain various flavoring agents, natural carbohydrates, or sweetening agents as additional ingredients.
  • the natural carbohydrates described above are monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, polysaccharides such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol and erythritol.
  • sweetener natural sweeteners such as taumatin and stevia extract, and synthetic sweeteners such as saccharin, aspartame, and isomalt can be used.
  • the ratio of the natural carbohydrate is generally about 0.01-0.20 g, or about 0.04-0.10 g per 100 mL of the composition of the present invention.
  • the composition of the present invention includes various nutrients, vitamins, electrolytes, flavoring agents, colorants, pectic acids and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, It may contain a carbonating agent used in carbonated beverages, and may contain yogurt powder.
  • the composition of the present invention may contain flesh for the production of natural fruit juice, fruit juice beverage and vegetable beverage. These components may be used independently or in combination. The proportion of these additives is not very important, but it is generally selected in the range of 0.01-0.20 parts by weight per 100 parts by weight of the composition of the present invention.
  • the present invention provides a pharmaceutical composition for the prevention or treatment of neurosensitivity, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, comprising Lactobacillus acidophilus as an active ingredient.
  • Lactobacillus even know Phil Ruth (Lactobacillus acidophilus) used in the present invention is present in the gastrointestinal tract and oral cavity in humans and animals aerobic lactic acid bacteria. Lactobacillus acidophilus is resistant to low pH in the digestive tract, bile acids, and lysozyme, so it has excellent viability in the digestive tract, and helps to maintain normal flora present in the intestine to prevent harmful microorganisms from settling in the intestine. In addition, Lactobacillus acidophilus is a fermentation bacteria belonging to various foods such as kimchi.
  • the Lactobacillus acidophilus may include all of the Lactobacillus acidophilus strains (accession number: KCCM11808P) of the present invention, as well as the conventionally known Lactobacillus acidophilus strains,
  • the effect of preventing, improving, or treating symptoms of nervousness, ant hallucinations, insomnia, dizziness, or fatigue was first identified.
  • climacterium used in the present invention, also referred to as menopause, refers to a period of menstrual abolition that appears as a sign of loss of a woman's reproductive function.
  • menopause the amount or cycle of menstruation becomes irregular due to a loss of ovarian function, and menstruation is abolished due to the decrease in the secretion of follicle hormone (estrogen) over several months to 3 years, and the autonomic nervous system acts on the autonomic nerve center of the brain. It causes menopausal disorders.
  • the anterior pituitary gland due to malfunction of the anterior pituitary gland, it shows masculinization by promoting adrenal cortex function, and by the influence of thyroid hormones, the function of the thyroid gland is abnormal, resulting in obesity, which is peculiar to menopause. For example, hot flashes ( ⁇ ), palpitations ( ⁇ : the heart beats more than usual, causing the chest to rumble), dizziness, tinnitus, high blood pressure, digestive problems, headache, memory loss, depression, etc. Symptoms may appear.
  • neural hypersensitivity refers to an unstable state of the nervous system that exhibits a sensitive response even to weak stimulation.
  • hallucination refers to a phenomenon in which the person feels or thinks that a non-existent sensation or object that only the person can feel, and "ant hallucination” in the present invention is as if an ant comes out suddenly through the flesh. Means visible hallucinations.
  • insomnia refers to a condition in which sleep cannot be achieved, that is, a condition that does not sleep well at night due to mental excitement, nervous breakdown, mental and physical overwork, etc., or a disease having such condition, and sleep disorder (sleep disturbance), mainly refers to primary insomnia.
  • the primary insomnia is a sleep disorder that complains of the initiation of sleep, difficulty in maintaining sleep, or sleep that is not recoverable, and other psychiatric disorders such as internal medical diseases, depressive disorders, or other factors such as drugs are not the cause.
  • dizziness used in the present invention may also be used as a term “dizziness”, and collectively refers to all symptoms in which one feels as if moving even though oneself or surrounding objects are stationary.
  • fatigue refers to a state of deterioration in mental and physical function ( ⁇ ) that occurs with continuous and repetitive mental and physical work, and the cause is the quality and quality of work, form of work, and Inadequate environment, interpersonal relations, etc., lack of motivation and interest for work, lack of talents, training, inexperience, etc., and inadequate life (sleep, recreation, nutrition, environment, etc.) Can be lifted.
  • the present invention provides a method for preventing or ameliorating nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women, comprising the step of administering the composition to an individual.
  • the present invention provides a use of the composition for preventing or improving nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women.
  • the present invention provides a use of Lactobacillus acidophilus for the manufacture of a drug for improving nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women.
  • “individual” refers to a subject in need of improvement of a disease, and more specifically, human or non-human primate, mouse, rat, dog, cat, horse, and cow It means a mammal of, and preferably refers to a menopausal woman in need of improvement of nervousness, ant hallucinations, insomnia, dizziness, or fatigue.
  • “administration” means providing a given composition of the present invention to a subject by any suitable method.
  • prevention refers to any action that suppresses or delays the onset of the target disease
  • treatment refers to the target disease and the resulting metabolic abnormalities are improved by administration of the pharmaceutical composition according to the present invention. It means all actions that are advantageously altered, and “improvement” means any action that reduces the degree of a parameter related to a desired disease, for example, symptoms by administration of the composition according to the present invention.
  • the pharmaceutical composition according to the present invention may further include suitable carriers, excipients, and diluents commonly used in the preparation of pharmaceutical compositions.
  • the excipient may be, for example, one or more selected from the group consisting of a diluent, a binder, a disintegrant, a lubricant, an adsorbent, a moisturizing agent, a film-coating material, and a controlled release additive.
  • the pharmaceutical composition according to the present invention is a powder, granule, sustained-release granule, enteric granule, liquid, eye drop, el-silic, emulsion, suspension, alcohol, troche, fragrance, limonadese according to a conventional method, respectively.
  • Carriers, excipients and diluents that may be included in the pharmaceutical composition according to the present invention include lactose, dextrose, sucrose, oligosaccharides, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, gum acacia, alginate, gelatin, calcium. Phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, and mineral oils.
  • diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrants, and surfactants that are usually used.
  • the additives of the liquid formulation according to the present invention include water, diluted hydrochloric acid, diluted sulfuric acid, sodium citrate, monostearic acid sucrose, polyoxyethylensorbitol fatty acid esters (twin esters), polyoxyethylene monoalkyl ethers, lanolin ethers, Lanolin esters, acetic acid, hydrochloric acid, aqueous ammonia, ammonium carbonate, potassium hydroxide, sodium hydroxide, prolamine, polyvinylpyrrolidone, ethylcellulose, sodium carboxymethylcellulose, and the like can be used.
  • the syrup according to the present invention may include a solution of white sugar, other sugars or sweeteners, and if necessary, a fragrance, a colorant, a preservative, a stabilizer, a suspending agent, an emulsifier, a viscous agent, and the like may be used.
  • Purified water may be used for the emulsion according to the present invention, and emulsifiers, preservatives, stabilizers, fragrances, etc. may be used as needed.
  • Suspension agents such as acacia, tragacantha, methylcellulose, carboxymethylcellulose, carboxymethylcellulose sodium, microcrystalline cellulose, sodium alginate, hydroxypropyl methylcellulose, 1828, 2906, 2910, etc. may be used as the suspending agent according to the present invention, Surfactants, preservatives, stabilizers, colorants, and fragrances may be used as needed.
  • Injectables according to the present invention include distilled water for injection, 0.9% sodium chloride injection, ring gel injection, dextrose injection, dextrose + sodium chloride injection, PEG, lactated ring gel injection, ethanol, propylene glycol, non-volatile oil-sesame oil Solvents such as cottonseed oil, peanut oil, soybean oil, corn oil, ethyl oleic acid, isopropyl myristic acid, and benzene benzoate; Solubilizing aids such as sodium benzoate, sodium salicylate, sodium acetate, urea, urethane, monoethylacetamide, butazolidine, propylene glycol, tweens, nijeongtinamide, hexamine, and dimethylacetamide; Buffering agents such as weak acids and their salts (acetic acid and sodium acetate), weak bases and their salts (ammonia and ammonium acetate), organic compounds, proteins, albumin, peptone,
  • Suppositories according to the present invention include cacao butter, lanolin, witepsol, polyethylene glycol, glycerogelatin, methylcellulose, carboxymethylcellulose, a mixture of stearic acid and oleic acid, Subanal, cottonseed oil, peanut oil, palm oil, cacao butter+ Cholesterol, lecithin, ranetwax, glycerol monostearate, tween or span, Imhausen, monolen (propylene glycol monostearate), glycerin, Adeps solidus, Butyrum Taego-G (Buytyrum Tego) -G), Cebes Pharma 16, Hexalide Base 95, Cotomar, Hydroxote SP, S-70-XXA, S-70-XX75 (S-70-XX95), Hydro Hydrokote 25, Hydrokote 711, Idropostal, Massa estrarium (A, AS, B, C, D, E, I, T), Massa-MF
  • Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, and these solid preparations include at least one excipient in the extract, such as starch, calcium carbonate, and sucrose. ) Or lactose (lactose), gelatin, etc. are mixed to prepare. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used.
  • Liquid preparations for oral administration include suspensions, liquid solutions, emulsions, syrups, etc.In addition to water and liquid paraffin, which are commonly used simple diluents, various excipients such as wetting agents, sweeteners, fragrances, and preservatives may be included. have.
  • Preparations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, lyophilized preparations, and suppositories.
  • the non-aqueous solvent and suspending agent propylene glycol, polyethylene glycol, vegetable oil such as olive oil, and injectable ester such as ethyl oleate may be used.
  • a pharmaceutically effective amount means an amount sufficient to treat a disease at a reasonable benefit/risk ratio applicable to medical treatment, and the effective dose level is the type of patient disease, severity, drug activity, Sensitivity to drugs, time of administration, route of administration and rate of excretion, duration of treatment, factors including drugs used concurrently, and other factors well known in the medical field can be determined.
  • the pharmaceutical composition according to the present invention may be administered as an individual therapeutic agent or administered in combination with other therapeutic agents, may be administered sequentially or simultaneously with a conventional therapeutic agent, and may be administered single or multiple. It is important to administer an amount capable of obtaining the maximum effect in a minimum amount without side effects in consideration of all the above factors, and this can be easily determined by a person skilled in the art to which the present invention pertains.
  • the pharmaceutical composition of the present invention can be administered to a subject by various routes. All modes of administration can be expected, e.g. oral administration, subcutaneous injection, intraperitoneal administration, intravenous injection, intramuscular injection, peri-spinal space (intrathecal) injection, sublingual administration, buccal mucosa administration, rectal injection, vaginal injection. It may be administered according to intramuscular insertion, ocular administration, ear administration, nasal administration, inhalation, spray through mouth or nose, skin administration, transdermal administration, and the like.
  • the pharmaceutical composition of the present invention is determined according to the type of drug as an active ingredient, along with various related factors such as the disease to be treated, the route of administration, the age, sex, weight, and severity of the disease.
  • a food for human application test containing Lactobacillus acidophilus YT1 strain was prepared (see Example 1), and human application test subjects suitable for the selection criteria were selected (Example 3).
  • Lactobacillus acidophilus of the present invention YT1 It was confirmed that the symptoms of menopausal neurosis, ant hallucinations, insomnia, dizziness, or fatigue were reduced in the test group in which the human body application test food containing the strain was ingested. Or it was confirmed to be available as a composition for preventing, improving, or treating fatigue (see Experimental Example 1).
  • the Lactobacillus acidophilu s YT1 strain deposited with the Korea Microbiological Conservation Center under the accession number KCCM11808P was pre-sold, and a food for human application test was prepared with the raw materials in Table 1 below, and food used as a control (placebo).
  • the raw material of was mixed with 79% (1580mg) of isomalt instead of only the Lactobacillus acidophilus YT1 bacteria in the food raw material for human application test.
  • the food was already, off-white powder without off-flavor, 2g per bag (live bacteria 1.0 ⁇ 10 8 CFU/2g/pack/day) and individually packaged and stored at 2-8°C, once a day, once a It was either taken without water (directly) or with water.
  • This human application test was designed as a multicenter, randomized, double-blind, placebo-controlled parallel test, and the outline of the human application test is briefly shown in FIG.
  • a total of 4 visits were made, and the 1st visit (Screening visit, week -2) explained the process before participation in the human application test and received written consent from the subject, and the 2nd visit 14 days later (Baseline visit, week 0 ), the test food was consumed for a total of 12 weeks.
  • the third visit (Interim visit, week 6) was made within 42 days ( ⁇ 7 days) after the second visit, and the fourth visit (Closing visit, week 12) was made within 84 days ( ⁇ 5 days) after the second visit. lost.
  • test food Lactobacillus acidophilus YT1 lactic acid bacteria
  • test food Lactobacillus acidophilus YT1 lactic acid bacteria
  • the subjects of the human application test were menopausal women aged 40 to 60 years old complaining of menopausal symptoms, and subjects of the human application test that met the following selection criteria were selected.
  • Subjects for the human application test of the present invention were selected according to the above selection criteria, and those who used hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within the last 3 months, taking drugs for the purpose of improving menopausal symptoms
  • hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within the last 3 months, taking drugs for the purpose of improving menopausal symptoms
  • a total of 85 subjects were selected as menopausal female subjects, excluding those who are suffering from diseases or those who are undergoing treatment or taking medicines, and passed through the experiment period for 12 weeks.
  • KMI The Kupperman Index
  • the Kupperman Index is a survey that is widely used in Japan and abroad as a measure to evaluate menopausal symptoms.Kupperman sets representative menopausal symptoms based on their experience in treating menopausal disorders.The sum of the indexes is used to determine the degree of menopausal disorder and It was created to increase the efficiency in the treatment of this disorder by identifying the characteristics.
  • Vasomotor disorders, urinary symptoms, systemic neurological symptoms, motor symptoms, digestive symptoms, and systemic symptoms are classified into 6 areas, and 11 items (facial flushing, numbness in the hands and feet, insomnia, nervousness, depression, dizziness, fatigue, muscle tone) It consists of joint pain, headache, chest palpitations, ant hallucinations).
  • the test group decreased by 1.75 after 6 weeks of intake, and the control group decreased by 0.91, showing a statistically significant difference between the intake groups, and after 12 weeks of ingestion, the test group was 2.00 It decreased, and the control group decreased by 1.37, showing an improvement compared to the control group.
  • the test group decreased by 0.75 after 6 weeks of intake, and the control group decreased by 0.34, showing a statistically significant difference between the intake groups, and 0.81 in the test group after 12 weeks of intake. It decreased, and the control group decreased by 0.51, showing an improvement compared to the control group.
  • menopausal symptoms such as neuropathy, ant hallucinations, insomnia, dizziness, or fatigue symptoms were reduced in the test group ingesting the food for human application test including the Lactobacillus acidophilus YT1 strain of the present invention.
  • Lactobacillus acidophilus may be usefully used as a food composition and pharmaceutical composition for the prevention, improvement, or treatment of nervousness, ant hallucinations, insomnia, dizziness, or fatigue in menopausal women. It is expected to be possible.

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Abstract

La présente invention concerne une composition comprenant du Lactobacillus acidophilus pour prévenir, atténuer ou traiter la nervosité, les fourmillements, l'insomnie, les vertiges ou la fatigue chez les femmes ménopausées. On a observé que l'apport d'une souche de Lactobacillus acidophilus YT1 selon la présente invention dans un aliment consommé par le corps humain permettait d'atténuer la nervosité, les fourmillements, l'insomnie, les vertiges ou la fatigue chez les femmes ménopausées ayant consommé un aliment contenant ladite souche. La composition comprenant le Lactobacillus acidophilus selon la présente invention devrait ainsi pouvoir être utilisée avantageusement pour prévenir, atténuer ou traiter la nervosité, les fourmillements, l'insomnie, les vertiges ou la fatigue chez les femmes ménopausées.
PCT/KR2020/005262 2019-05-14 2020-04-21 Composition comprenant du lactobacillus acidophilus pour prévenir, atténuer ou traiter la nervosité, les fourmillements, l'insomnie, les vertiges ou la fatigue chez les femmes ménopausées WO2020231030A2 (fr)

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KR1020190056539A KR102317304B1 (ko) 2019-05-14 2019-05-14 락토바실러스 아시도필루스를 포함하는 갱년기 여성의 신경과민, 개미환각, 불면증, 현기증, 또는 피로의 예방, 개선, 또는 치료용 조성물
KR10-2019-0056539 2019-05-14

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WO2020231030A2 true WO2020231030A2 (fr) 2020-11-19
WO2020231030A3 WO2020231030A3 (fr) 2021-02-04

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US20240108665A1 (en) * 2021-02-03 2024-04-04 Kookmin University Industry Academy Cooperation Foundation Composition for preventing, alleviating or treating sleep disorders, containing, as active ingredient, gut microbiota or extracellular vesicles derived therefrom

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AU2008233633B2 (en) * 2007-03-30 2013-11-14 Suntory Holdings Limited Medicinal composition, food or drink having effect of enhancing parasympathetic nervous activity
IT1392101B1 (it) * 2008-12-12 2012-02-09 Zuccari Societa A Responsabilita Limitata In Breve Zuccari S R L Composizione comprendente isoflavoni
KR101771692B1 (ko) * 2015-09-03 2017-08-29 호서대학교 산학협력단 꽃송이버섯 및 유산균을 유효성분으로 포함하는 갱년기 또는 폐경기 증상의 예방, 치료 또는 개선용 조성물
KR101845245B1 (ko) * 2016-04-05 2018-04-04 (주)아모레퍼시픽 제주조릿대 추출물을 포함하는 여성 갱년기 증상 개선용 조성물
KR101867768B1 (ko) * 2016-08-12 2018-06-15 한국식품연구원 락토바실러스 아시도필루스를 포함하는 갱년기 예방 또는 치료용 조성물

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WO2020231030A3 (fr) 2021-02-04
KR20200131657A (ko) 2020-11-24

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