Composition for improving feeling of fatigue, sleep disorder or asthenopia and climacteric symptoms

By using the composition of Lactobacillus plantarum L-137 strain Lactobacillus plantarum, the problems of fatigue, sleep disorders, visual fatigue and menopause symptoms were solved, and significant symptom improvement effects were achieved.

CN119923266APending Publication Date: 2025-05-02NISSHANG HAOSHI HEALTH FOOD CO LTD +1
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Patent Information

Application Number
CN202280100728.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2022-11-29
Publication Date
2025-05-02

AI Technical Summary

Technical Problem

The prior art is difficult to effectively solve the symptoms of fatigue, sleep disorders, visual fatigue and menopause.

Method used

Lactobacillus plantarum L-137 strain Lactobacillus plantarum or its treatment material is used as part of the composition for the treatment, prevention or improvement of the above symptoms.

Benefits of technology

By using the composition of Lactobacillus plantarum L-137 strain, fatigue, sleep disorders, visual fatigue and menopause symptoms can be significantly improved, including vascular motor neurological disorder-like symptoms, insomnia, systemic burnout, etc.

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Abstract

The technical problem of the present invention is to provide a composition for improving fatigue, sleep disorder or asthenopia and climacteric symptoms. The technical problem is solved by a composition containing lactobacillus plantarum L-137.
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Description

Technical Field

[0001] The invention relates to a composition for improving fatigue, sleep disorder or visual fatigue and menopausal symptoms. Background Art

[0002] Menopausal symptoms are symptoms manifested in menopause due to decreased ovarian function or decreased hormonal function caused by aging, and include, for example, vasomotor disorder-like symptoms such as hot flashes, headaches, muscle pain, decreased mental and sleep quality, and general fatigue. They are more common in women, but can also be seen in men. In addition, regardless of whether it is menopause or not, many modern people have troubles such as fatigue, sleep disorders, and visual fatigue caused by psychological or physical stress. It is known that germinated fermented bean extracts can improve these symptoms (Patent Document 1).

[0003] However, it is not known at all that the lactic acid bacteria Lactobacillus plantarum L-137 strain can treat, prevent or improve fatigue, sleep disorders or visual fatigue and menopausal symptoms.

[0004] Prior art literature

[0005] Patent Literature

[0006] Patent Document 1: Japanese Patent Publication No. 2016-526019 Summary of the invention

[0007] 1. Technical issues to be resolved

[0008] (II) Technical solution

[0009] The inventors of the present application sought materials that could treat, prevent or improve fatigue, sleep disorders, visual fatigue and menopausal symptoms, and studied a great number of materials. As a result, it was surprisingly found that the lactic acid bacteria Lactobacillus plantarum L-137 strain ( Lactobacillus plantarum L-137. Hereinafter, it is also referred to as "L-137 strain") has the above-mentioned desired effect. This is a surprising insight obtained by the inventors of the present application. The inventors of the present application further conducted repeated research and completed the present invention.

[0010] That is, the present invention is as follows.

[0011] [1] A composition for treating, preventing or ameliorating one or more symptoms selected from the group consisting of fatigue, sleep disorders and visual fatigue, comprising Lactobacillus plantarum L-137 or a processed product thereof.

[0012] [2] A composition for treating, preventing or ameliorating menopausal symptoms, comprising Lactobacillus plantarum L-137 or a processed product thereof.

[0013] [3] The composition according to [2], characterized in that the composition is used to treat, prevent or improve one or more symptoms selected from the group consisting of the following (i) to (xii):

[0014] (i) vasomotor disorder-like symptoms; (ii) sensory disorder-like symptoms; (iii) insomnia; (iv) nervousness; (v) depression; (vi) dizziness; (vii) general malaise; (viii) joint pain and / or muscle pain; (ix) headache; (x) palpitations; (xi) a sense of ants and (xii) visual fatigue.

[0015] [4] The composition according to any one of [1] to [3], which is a food or beverage.

[0016] [5] The composition according to [4], wherein the food or beverage is a food additive or a supplement.

[0017] [6] Use of Lactobacillus plantarum L-137 or a processed product thereof in the preparation of a medicament for treating, preventing or ameliorating at least one symptom selected from the group consisting of fatigue, sleep disorders and visual fatigue.

[0018] [7] Use of Lactobacillus plantarum L-137 or its processed products in the preparation of a drug for treating, preventing or improving menopausal symptoms.

[0019] [8] A method for treating, preventing or improving at least one symptom selected from the group consisting of fatigue, sleep disorders and visual fatigue, which comprises administering Lactobacillus plantarum L-137 or a processed product thereof to a subject to treat, prevent or improve at least one symptom selected from the group consisting of fatigue, sleep disorders and visual fatigue.

[0020] [9] A method for treating, preventing or improving menopausal symptoms, comprising treating, preventing or improving menopausal symptoms by administering Lactobacillus plantarum L-137 or a processed product thereof to a subject.

[0021] (III) Beneficial effects

[0022] According to the present disclosure, a composition for treating, preventing or improving fatigue, sleep disorders or visual fatigue and menopausal symptoms can be provided. In addition, the composition of the present invention can be used for treating, preventing or improving various menopausal symptoms such as vasomotor disorder-like symptoms, sensory disorder-like symptoms, insomnia, nervousness, depression, dizziness, general fatigue, joint pain and / or muscle pain, headache, hyperpalpitations, antsy feeling and visual fatigue. In addition, according to the present disclosure, a method for preparing such a composition can also be provided. DETAILED DESCRIPTION

[0023] [Composition for treating, preventing or improving symptoms of fatigue, sleep disorders, and / or visual fatigue]

[0024] The present invention is preferably used for the treatment, prevention or improvement of fatigue, sleep disorders, and / or visual fatigue. Fatigue is generally a state of decreased physical strength or efficiency caused by excessive load on the mind and body due to physical or mental factors, and fatigue is the feeling of self-perception of the presence of this fatigue. As physical fatigue, for example, physical fatigue during intense exercise or muscle training, work, etc. can be listed, but it is not limited to this. In addition, as mental fatigue, for example, fatigue caused by stress caused by environmental changes due to interpersonal relationships, work troubles, moving or changing jobs, changes in life due to marriage or childbirth, and events that shock people can be listed, but it is not limited to this.

[0025] Sleep disorders include, but are not limited to, insomnia, sleep onset disorder, deep sleep disorder, awakening, early awakening, nightmare, somnambulism, hypersomnia, abnormal sleep behavior, hypersomnia, narcolepsy, breathing-related sleep disorder, sleep apnea syndrome, and circadian rhythm sleep disorder. In the present invention, preferably, insomnia, sleep onset disorder, and deep sleep disorder are treated, prevented, or improved, and more preferably, insomnia is treated, prevented, or improved, but is not limited to this.

[0026] Visual (eye) fatigue is, for example, eye fatigue, objective or subjective eye fatigue state, eye dryness state, eye itching state, but is not limited to this. In addition, visual fatigue is preferably visual fatigue induced by light (so-called blue light) stimulation brought by OA equipment such as smartphones or computers, but is not limited to this. In the present invention, the visual fatigue that is preferably treated, prevented or improved is an objective or subjective eye fatigue state, eye fatigue, but is not limited to this.

[0027] In addition, the target of the composition of the present invention is not limited to individuals or groups in menopause and before and after menopause described below, and individuals or groups of all age groups can be targeted.

[0028] [Composition for treating, preventing or improving menopausal symptoms]

[0029] The present invention is preferably used for the treatment, prevention or improvement of menopausal symptoms. In this specification, in the case of women, menopause is usually a period of about 5 years before and after menopause (for example, no menstruation for more than 12 months) with decreased ovarian function, but women who have had their ovaries removed will also observe symptoms, and in a broad sense, it refers to a period during which the secretion of estrogen, a female hormone, decreases sharply, but there are differences among individuals or groups (for example, race, era, etc.), and therefore, it is not limited to the above period. In addition, in the case of men, unlike women, there is no menopause, and there is usually no tendency for male hormones to decrease sharply, but there are cases where the secretion of testosterone, a male hormone, decreases due to environmental changes or stress on the basis of aging. Male menopause refers to a period during which the above-mentioned psychosomatic disorders similar to female menopause occur, but there are differences among individuals or groups, and therefore, it is not limited to this period.

[0030] In the present invention, the menopausal symptoms preferably treated, prevented or improved are, for example, one or more selected from the group consisting of the following (i) to (xii), but are not limited thereto.

[0031] (i) symptoms similar to vasomotor neurosis (such as hot flashes (hot flashes, hot flashes), sweating, chills, tachycardia, bradycardia, etc., but not limited to these), (ii) symptoms similar to sensory disorders (such as numbness, hyperesthesia, loss of sensation, etc., such as numbness or decreased sensation in the arms, hands or lower limbs (groin, thighs, knees, calves, shins, ankles, feet, etc.), but not limited to these), (iii) ) insomnia, (iv) nervousness, (v) depression, (vi) dizziness, (vii) general malaise, (viii) joint pain and / or muscle pain (for example, pain in one or more of the neck, shoulders, back, waist, buttocks, feet, arms, hands, etc., but not limited to these), (ix) headache (for example, tension headache, migraine, etc., but not limited to these), (x) palpitations, (xi) tingling sensation, and (xii) visual fatigue.

[0032] Among the above symptoms, the symptoms that are more preferably treated, prevented or improved in the present invention are insomnia and / or general malaise, but are not limited thereto.

[0033] Furthermore, the present invention is preferably used for the treatment, prevention or improvement of menopausal symptoms in women and men, and more preferably for the treatment, prevention or improvement of menopausal symptoms in women.

[0034] [Lactobacillus plantarum L-137 strain ( Lactobacillus plantarum L-137)]

[0035] The composition of the present invention is characterized in that it contains Lactobacillus plantarum L-137 strain ( Lactobacillus plantarum L-137, deposit number: FERM BP-08607) or its processed product.

[0036] The lactic acid bacteria Lactobacillus plantarum L-137 strain used in the present invention ( Lactobacillus plantarum L-137) is deposited with the Patent Biological Preservation Center of the National Institute of Advanced Industrial Science and Technology (now: Patent Biological Preservation Center of the National Institute of Product Evaluation Technology, address: Room 120, 2-5-8, Kazusa Kamata, Kisarazu City, Chiba Prefecture, Japan, with the deposit number: FERM BP-08607 (transformed from FERM P-15317 deposited on November 30, 1997) under ... Patent Biological Preservation Center of the National Institute of Advanced Industrial Science and Technology (now: Patent Biological Preservation Center of the National Institute of Product Evaluation Technology, address: Room 120, 2-5-8, Kazusa Kamata, Kisarazu City, Chiba Prefecture, Japan, zip code 292-0818). In addition, even if it is a variant strain of plant lactobacillus L-137, as long as it has the characteristics of plant lactobacillus L-137, it is also included in the category of plant lactobacillus L-137. In addition, plant lactobacillus L-137 strain can be included in the composition of the present invention together with other lactic acid bacteria.

[0037] The composition of the present invention preferably contains about 0.0001 to 10% by weight, more preferably about 0.001 to 8% by weight, and still more preferably about 0.002 to 4% by weight of Lactobacillus plantarum L-137 strain ( Lactobacillus plantarum L-137) or its processed product, but is not limited to the above range.

[0038] In addition, the plant lactobacillus L-137 strain of the present invention ( Lactobacillus plantarum L-137) or its processed product, when administered orally or by injection, depends on the age and weight of the person taking it, symptoms, administration time, dosage form, administration method, combination of drugs, etc. For example, it is preferably set as follows: one adult (about 60 kg) preferably takes about 0.5 to 200 mg, more preferably about 1 to 100 mg, and further preferably about 2 to 50 mg of plant lactobacillus L-137 strain as a dried dead cell body per day, but it is not limited to the above range. Alternatively, it is preferably set as follows: one adult (about 60 kg) preferably takes about 5×10 8 ~2×10 11 cfu (Colony forming unit), preferably about 1×10 9 ~1×10 11 cfu of Lactobacillus plantarum L-137, but is not limited to this range. The frequency of intake can be set to once a day or divided into multiple times. The above-mentioned administration amount can be administered or used once to several times per day.

[0039] [Cultivation of lactic acid bacteria]

[0040] In the present invention, Lactobacillus plantarum L-137 strain ( Lactobacillus plantarum L-137) and other lactic acid bacteria can be any strain cultured in a natural medium, a synthetic medium, a semi-synthetic medium, etc. In the present invention, the culture of lactic acid bacteria can be carried out according to a known method, a method known per se, or a method based on these methods.

[0041] The culture medium is not particularly limited, for example, it is preferred to use a culture medium containing a nitrogen source and / or a carbon source. The nitrogen source is not particularly limited, for example, meat extract, peptone, gluten, casein, yeast extract or amino acids can be listed. The carbon source is not particularly limited, for example, glucose, xylose, fructose, inositol, maltose, starch syrup, koji juice, starch, bagasse, bran, molasses or glycerol can be listed. The above substances can be used alone or in combination of two or more. In addition to the nitrogen source and / or carbon source, inorganic substances can be further added to the culture medium. The inorganic substance is not particularly limited, for example, ammonium sulfate, potassium phosphate, magnesium chloride, salt, iron, manganese, molybdenum or various vitamins can be listed, and these inorganic substances can be used alone or in combination of two or more.

[0042] As long as the culture can be carried out effectively, the plant lactobacillus L-137 strain ( Lactobacillus plantarum L-137) and other lactic acid bacteria are not particularly limited in the culture temperature and culture time. In one embodiment of the present invention, the culture temperature can be set to about 25 to 40 degrees (°C), preferably about 27 to 35 degrees, and the culture time can be set to about 12 to 48 hours. In addition, in one embodiment of the present invention, the culture of lactic acid bacteria can be implemented by ventilation and oscillation. In addition, the pH of the culture medium is not particularly limited, but in one embodiment of the present invention, it can be set to about 3 to 6, preferably about 4 to 6.

[0043] [Processed products of lactic acid bacteria]

[0044] Lactobacillus plantarum L-137 strain ( Lactobacillus plantarum The "processed material" of L-137) refers to a material preferably obtained by processing the L-137 strain, and examples thereof include, but are not limited to, the culture solution or culture supernatant thereof, the residue obtained by filtering or centrifuging these materials, and the ultrasonic crushing liquid of the bacterial cells. In addition, the processed material of the present invention includes, but is not limited to, a processed liquid obtained by removing the cell wall by enzyme or physical treatment, a complex of a protein or peptide obtained by chemical reagent or salting-out treatment, and a concentrate, dried product or diluted product of these materials.

[0045] In addition, the L-137 strain may be live cells, dried cells, centrifuged cells, crushed cells, etc., or may be dead cells. From the perspectives of stability and ease of handling, dead cells are preferred.

[0046] In the present invention, the above-mentioned processed products can be used directly, or can be used after being made into powder by freeze drying, low temperature drying, spray drying or L-drying, or a combination of these drying methods. In addition, these processed products can be used after being diluted with a suitable solvent (water, alcohol, organic solvent, etc.), or can be used after adding a suitable additive to make a gel or solid preparation.

[0047] Next, the plant lactobacillus L-137 strain ( Lactobacillus plantarum L-137) and other lactic acid bacteria dead cells will be specifically described.

[0048] In the present invention, as long as the effect of the present invention is not impaired, the method for preparing the dead bacteria is not particularly limited, and for example, the dead bacteria can be prepared by any of the following methods: (I) after the culture is completed and the live bacteria of lactic acid bacteria are separated from the culture solution, the live bacteria are sterilized or sterilized to become dead bacteria; (II) the live bacteria of lactic acid bacteria are sterilized in the culture solution to become dead bacteria, and then the dead bacteria are separated from the culture solution. Sterilization can be carried out, for example, by filtering through a filter, and can also be carried out by a known method, such as gas sterilization using ethylene oxide or hydrogen peroxide, heating sterilization using gamma rays, electron beam irradiation, high frequency, etc.

[0049] As a method for separating the bacterial cells from the culture solution, various methods commonly used in this field can be adopted without particular limitation. In one embodiment of the present invention, specifically, for example, a method of separating the culture solution from the bacterial cells by removing the supernatant from the culture solution by centrifugation or the like can be adopted. In addition, in this embodiment, after adding distilled water to the culture solution and removing the supernatant after centrifugation, the operation of further adding distilled water to the residue from which the supernatant has been removed and centrifuging can be repeated multiple times as needed. In one embodiment of the present invention, a filtration step may be included as a separation operation. For the above-mentioned bacterial cells, dried bacteria can be obtained by implementing a drying operation using a spray drying device. As an apparatus, a spray drying apparatus having a micronizing device capable of forming spray droplets of about 1 to 10 μm can be preferably cited, but it is not limited to this.

[0050] The sterilization method is not particularly limited, and examples thereof include heating, ultraviolet irradiation, formalin treatment, etc. The sterilization may be performed on the collected living cells or on a culture solution containing the living cells.

[0051] When the heat treatment is performed, the heating temperature is not particularly limited, for example, it can be generally set to about 60 to 100 degrees (°C), preferably about 70 to 90 degrees. As a heating method, a known method can be used without particular limitation, for example, it can be a heater or the like. As long as the sterilization treatment can be fully completed, the heating time is not particularly limited, for example, the heating time can be generally set to about 5 to 40 minutes after reaching the desired temperature, preferably about 10 to 30 minutes.

[0052] The dead cells obtained in the above manner may be further ground, crushed, spray-dried, low-temperature dried or freeze-dried, or mixed with other raw materials (such as vitamins, amino acids, oligopeptides, etc.) to prepare a processed dead cell. In the present invention, the processed dead cell can also be suitably used as the dead cells.

[0053] Preferred examples of the composition of the present invention are for food and drink and / or for medicine (including medicine for animals). As other preferred examples, the composition of the present invention can be used as an additive for food and drink. For food and drink, for food and drink additives or for medicine compositions, it is possible to prepare by appropriately blending the above-mentioned culture supernatant of the present invention or its processed material, or L-137 strain or its processed material, and pharmaceutically allowed carriers, additives, etc. The preparation method and preparation technology at this time have been fully established in the past, so it can be implemented according to the preparation method and preparation technology. For example, when used for medicine, it can be specifically made into oral preparations such as tablets, coated tablets, pills, powders, granules, capsules, liquid preparations, suspensions, emulsions, etc.; injections, infusions, suppositories, ointments, patches, etc. Non-oral preparations. About the blending ratio of carriers or additives, it can be appropriately set according to the range commonly used in food and drink, medicine or veterinary fields.

[0054] There are no particular restrictions on pharmaceutically acceptable carriers or additives. Examples of carriers include various carriers such as aqueous or oily bases. Examples of aqueous carriers include water, physiological saline, ethanol, glycerol, polyethylene glycol, propylene glycol, methylcellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, polyacrylic acid, polysaccharide gum-based natural polymers, and the like. Examples of oily carriers include appropriate oils or waxes such as vaseline, squalane, and paraffin, but are not limited thereto.

[0055] Examples of additives include enzymes, pH adjusters, preservatives, bactericides, antioxidants, mildew preventers, preservatives, bleaching agents, glossing agents, spices, sweeteners, acidulants, flavoring agents, bittering agents, emulsifiers, thickeners, stabilizers, gelling agents, pastes, excipients, binders, disintegrants, lubricants, colorants, flavoring agents, etc., but are not limited thereto. The relevant technologies have been well established in the past, so the present invention can be implemented according to these technologies.

[0056] In addition, when the composition of the present invention is used for food and drink, the food and drink include health food, functional label food, specific health food, and patient food. The form of the food and drink is not particularly limited, and specifically includes tablets, granules, powders, and beverage preparations such as so-called nutritional supplements or supplements. In addition, for example, beverages such as tea drinks, soft drinks, carbonated drinks, nutritional drinks, pulp drinks, lactic acid drinks, etc. can be listed; noodles such as buckwheat noodles, udon noodles, Chinese noodles, instant noodles, etc.; desserts and breads such as sugar, candy, chewing gum, chocolate, snacks, biscuits, jelly, jam, cream, baked snacks, bread, etc.; processed seafood and livestock products such as ham, sausage, fish cake, bamboo rolls, etc.; dairy products such as processed milk and fermented milk; oils and fats such as salad oil, tempura oil, margarine, mayonnaise, shortening, whipped cream, sauces, etc. and processed oil foods; seasonings such as sauces and seasonings; retort and packaged foods such as curry, stew, rice bowl, porridge, vegetable porridge, etc.; ice desserts such as ice cream and ice cream, etc., but are not limited to this. The relevant technology has been fully established in the past, so it can be implemented in accordance with these technologies in the present invention.

[0057] The composition of the present invention may further contain any components known in the fields of medicine, pharmacy, veterinary medicine, livestock, or food, for example, unless the effects of the present invention are impaired.

[0058] [Effects on improving fatigue, sleep disorders, visual fatigue, and menopausal symptoms and how to confirm it]

[0059] As a method for confirming the effect of the composition of the present invention, for example, there can be mentioned: confirming that the composition contains Lactobacillus plantarum L-137 strain ( Lactobacillus plantarum L-137) or its processed product is superior to a composition not containing L-137 strain or its processed product in improving fatigue, sleep disorders, visual fatigue and menopausal symptoms.

[0060] The following methods are specific examples of methods for confirming the effects of improving fatigue, sleep disorders, visual fatigue, and menopausal symptoms, but are not limited to them: for example, VAS (Visual Analogue Scale) as a test method for subjective fatigue; methods for measuring blood oxidative stress markers, the time required to fall asleep (sleep latency), and the total sleep duration (total sleep time); a forced swim test (FST) using rats or mice; and the method for evaluating the effects based on the evaluation scale and Kupperman Menopause Index described later.

[0061] The effect of the composition of the present invention is not limited to the treatment, prevention or improvement of menopausal symptoms. In the evaluation related to menopausal symptoms, for example, ovariectomized animals (preferably rats, mice, etc.) known as menopausal models can also be used. In addition, when implementing the evaluation related to visual fatigue, for example, a method for measuring the cell survival rate after irradiating blue light to the retinal pigment epithelial cells of humans or animals (such as rabbits, etc.) can be used.

[0062] For example, after a subject ingests (is administered to a subject) the composition of the present invention, when the measured values ​​of VAS or blood oxidative stress markers are significantly or significantly lower, and the sleep latency and / or total sleep time are significantly or significantly longer, compared to a control group that has not ingested (or been administered) the composition of the present invention, etc., it can be judged that the composition of the present invention has the desired effect.

[0063] In addition, the evaluation may be performed according to a well-established method in the field, such as a known method other than the above. As an example of this method, reference can be made to the following Examples.

[0064] When the composition of the present invention is made into the form of food, medicine (including medicine for animals) or quasi-drug, in view of the effect of the composition of the present invention, it can be indicated on the accompanying instructions or its packaging box of the food, medicine or quasi-drug that it has the effect of improving fatigue, sleep disorder or visual fatigue and menopausal symptoms.

[0065] [Method for preparing the composition]

[0066] The present invention includes a method for preparing a composition for treating, preventing or improving fatigue, sleep disorders or visual fatigue and menopausal symptoms, characterized in that it preferably includes a step of mixing Lactobacillus plantarum L-137 or a processed product thereof with a carrier and / or an excipient.

[0067] The preferred carriers used in the above processes have been well established in the food or pharmaceutical fields in the past, and the present invention can simply follow them. For example, various carriers such as aqueous or oily bases can be cited. As the aqueous carrier, for example, water, physiological saline, ethanol, glycerol, polyethylene glycol, propylene glycol, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, polyacrylic acid, polysaccharide gum-based natural polymers, etc. can be cited. As the oily carrier, for example, appropriate oils or waxes such as petrolatum, squalane, paraffin, etc. can be cited, but it is not limited thereto.

[0068] In addition, the preferred excipients used in the above processes have been well established in the food or pharmaceutical fields in the past, and the present invention can simply follow them. For example, lactose, sucrose, mannitol, corn starch, powdered cellulose, calcium hydrogen phosphate, calcium carbonate, etc. can be preferably used, but it is not limited thereto.

[0069] In addition to adding Lactobacillus plantarum strain L-137 ( Lactobacillus plants L-137) or its treated product to the composition, the composition of the present invention can be appropriately processed and prepared by a conventional method for preparing a composition. That is, the present invention includes a method for preparing a composition comprising a step of mixing Lactobacillus plantarum strain L-137 ( Lactobacillus plantarum L-137) or its treated product with other components contained as needed.

[0070] As long as the effects of the present invention are achieved, the present invention includes solutions obtained by various combinations of the above configurations within the technical scope of the present invention. In addition, as long as it belongs to the technical scope of the present invention, appropriate modifications can be made.

[0071] Examples

[0072] Examples and test examples are given below to further specifically illustrate the present invention, but the present invention is not limited thereto.

[0073] [Test Example] Human clinical trial using a composition containing Lactobacillus strain L-137 (evaluation of menopausal symptoms and asthenopia)

[0074] <1. Composition used>

[0075] As the composition of the present invention, a commercially available tablet (product name: Lactobacillus L-137 Supplement for Strengthening Protection) containing 10 mg of heat-treated dead cells of Lactobacillus plantarum strain L-137 per tablet (300 mg) was used. The tablet also contains components other than strain L-137 (lactose, starch, sucrose fatty acid ester, etc.), but these components do not have any influence on the following experiments.

[0076] <2. Intake of the composition and implementation of evaluation based on the menopausal symptom evaluation scale>

[0077] 22 males and females aged 41 to 73 were divided into two groups (a non-ingestion group of 6 (1 male and 5 females) and a killed bacterial strain L-137 ingestion group of 16 (5 males and 11 females)). The killed bacterial strain L-137 ingestion group was allowed to ingest the above composition one tablet per day for 12 months.

[0078] Evaluation based on the Kupperman Menopause Symptom Rating Scale was performed before the start of the test and at 3, 6, and 12 months after taking the composition. Furthermore, the change in the score on the evaluation scale relative to the score before the start of the test was evaluated. The symptoms in the Menopause Symptom Rating Scale are 11 items: (1) vasomotor disorder-like symptoms, (2) sensory disorder-like symptoms, (3) insomnia, (4) nervousness, (5) depression, (6) dizziness, (7) general fatigue, (8) joint pain / muscle pain, (9) headache, (10) hyperpalpitations, and (11) ants.

[0079] The results are shown in Table 1 below.

[0080] [Table 1]

[0081]

[0082] Investigation: For the "total score of 11 items" (i.e., the above-mentioned items (1) to (11)) and the items related to "insomnia" and "general fatigue", the index representing menopausal symptoms in the group not taking L-137 increased over time, but the increase was significantly suppressed in the group taking L-137, or showed a tendency to suppress the increase (two-way analysis of variance).

[0083] <3. Intake of the composition and implementation of evaluation using an evaluation scale related to eye fatigue>

[0084] 22 males and females aged 41 to 73 were divided into two groups (a non-ingestion group of 6 (1 male and 5 females) and a killed bacterial strain L-137 ingestion group of 16 (5 males and 11 females)). The killed bacterial strain L-137 ingestion group was allowed to ingest the above composition one tablet per day for 12 months.

[0085] Before the start of the test and 3, 6, and 12 months after taking the composition, an evaluation based on an evaluation scale related to eye fatigue was performed. Furthermore, the change in the score on the evaluation scale before the start of the test was evaluated. In addition to "eye fatigue", the evaluation scale related to eye fatigue also records contents related to "dry eyes" and "itchy eyes".

[0086] The results are shown in Table 2 below.

[0087] [Table 2]

[0088]

[0089] Investigation: The index related to eye fatigue increased over time in the L-137 non-ingestion group, but the increase was significantly suppressed in the L-137 ingestion group (two-way ANOVA).

[0090] The test results above show that the composition containing the lactic acid bacteria L-137 strain of the present invention has an effect of improving menopausal symptoms and visual fatigue.

[0091] Industrial Applicability

[0092] As described above, the composition of the present invention has various useful effects. Therefore, it can be used for, for example, (i) vasomotor disorder-like symptoms; (ii) sensory disorder-like symptoms; (iii) insomnia; (iv) nervousness; (v) depression; (vi) dizziness; (vii) general malaise; (viii) joint pain and / or muscle pain; (ix) headache; (x) hyperpalpitations; (xi) ants crawling; and (xii) treatment, prevention or improvement of visual fatigue, and the composition can also be used as a food, beverage, medicine or quasi-drug, etc.

Claims

1. A composition for treating, preventing or improving one or more symptoms selected from the group consisting of fatigue, sleep disorders and visual fatigue, characterized in that: Contains Lactobacillus plantarum L-137 or a processed product thereof.

2. A composition for treating, preventing or improving menopausal symptoms, characterized in that: Contains Lactobacillus plantarum L-137 or a processed product thereof.

3. The composition according to claim 2, characterized in that The composition is used to treat, prevent or improve one or more symptoms selected from the group consisting of the following (i) to (xii): (i) vasomotor disorder-like symptoms; (ii) sensory disorder-like symptoms; (iii) insomnia; (iv) nervousness; (v) depression; (vi) dizziness; (vii) general malaise; (viii) joint pain and / or muscle pain; (ix) headache; (x) palpitations; (xi) a sense of ants and (xii) visual fatigue.

4. The composition according to any one of claims 1 to 3, which is a food or beverage.

5. The composition according to claim 4, wherein Food and beverage products are food additives or supplements.

6. Use of Lactobacillus plantarum L-137 or a processed product thereof in the preparation of a medicament for treating, preventing or improving at least one symptom selected from the group consisting of fatigue, sleep disorder and visual fatigue.

7. Use of Lactobacillus plantarum L-137 or its processed product in the preparation of a medicine for treating, preventing or improving menopausal symptoms.

8. A method for treating, preventing or improving at least one symptom selected from the group consisting of fatigue, sleep disorders and visual fatigue, which comprises administering Lactobacillus plantarum L-137 or a processed product thereof to a subject to treat, prevent or improve at least one symptom selected from the group consisting of fatigue, sleep disorders and visual fatigue.

9. A method for treating, preventing or improving menopausal symptoms, comprising treating, preventing or improving menopausal symptoms by administering Lactobacillus plantarum L-137 or a processed product thereof to a subject.

Citation Information

Patent Citations

  • A composition for the prevention and treatment of menopausal symptoms, containing a soybean extract containing coumestrol as an active ingredient.

    JP2016526019A