Composition for ameliorating fatigue, sleep disturbance or eye fatigue and menopausal symptoms

Abstract

The objective of this invention is to provide a composition for improving fatigue, sleep disorders, eye strain, and menopausal symptoms. This invention addresses these objectives by using a composition containing *Lactobacillus plantarum* L-137.

Description

Technical Field

[0001] This invention relates to a composition for improving fatigue, sleep disorders, eye strain, and menopausal symptoms. Prior Technology

[0002] Menopausal symptoms are those resulting from decreased ovarian and hormonal function due to aging, and may include: vasomotor symptoms such as hot flashes, headaches, muscle aches, decreased mental and sleep quality, and general fatigue. These symptoms are most common in women, but can also be seen in men. Furthermore, regardless of whether they are menopausal, many modern people suffer from fatigue, sleep disturbances, and eye strain caused by psychological or physical stress. It is known that sprouted and fermented soybean extracts can improve these symptoms (Patent Document 1).

[0003] However, it is completely unknown whether the lactic acid bacterium Lactobacillus plantarum L-137 can treat, prevent or improve fatigue, sleep disorders or eye strain and menopausal symptoms. [Previous Technical Documents] [Patent Literature]

[0004] [Patent Document 1] Japanese Patent Publication No. 2016-526019 Summary of the Invention

[0005] The inventors sought materials that could treat, prevent, or improve fatigue, sleep disorders, eye strain, and menopausal symptoms. After studying numerous materials, they unexpectedly discovered that the lactic acid bacterium *Lactobacillus plantarum* strain L-137 (hereinafter also referred to as "L-137 strain") possessed the desired effects. This was a remarkable discovery by the inventors. The inventors completed this invention through further in-depth research.

[0006] That is, the present invention is as described below. [1] A composition for treating, preventing or improving at least one symptom selected from the group consisting of fatigue, sleep disorders and eye fatigue, the composition containing Lactobacillus plantarum L-137 or a treatment thereof. [2] A composition for treating, preventing or improving menopausal symptoms, which contains Lactobacillus plantarum L-137 or a processed product thereof. [3] The composition according to [2], which is for treating, preventing or improving symptoms of one or more selected from the group consisting of the following (i) to (xii); (i) Vasomotor disorder-like symptoms; (ii) Perceptual disorder-like symptoms; (iii) Insomnia; (iv) Nervousness; (v) Depression; (vi) Dizziness; (vii) General malaise; (viii) Arthralgia and / or myalgia; (ix) Headache; (x) Palpitation; (xi) Formication; and (xii) Eye fatigue. [4] The composition according to any one of [1] to [3], which is a food or drink. [5] The composition according to [4], wherein the food or drink is a food additive or supplements. [6] Use of Lactobacillus plantarum L-137 or a processed product thereof for manufacturing a medicament for treating, preventing or improving at least one symptom selected from the group consisting of fatigue, sleep disorder and eye fatigue. [7] Use of Lactobacillus plantarum L-137 or a processed product thereof for manufacturing a medicament 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 disorder and eye fatigue, which treats, prevents or improves the aforementioned symptoms by administering Lactobacillus plantarum L-137 or a processed product thereof to a subject. [9] A method for treating, preventing or improving menopausal symptoms, which treats, prevents or improves the aforementioned symptoms by administering Lactobacillus plantarum L-137 or a processed product thereof to a subject. Summary of the Invention Problems to be Solved by the Invention Means for Solving the Problems Effects of the Invention

[0007] According to this disclosure, compositions can be provided for the treatment, prevention, or improvement of fatigue, sleep disorders, eye strain, and menopausal symptoms. Furthermore, the compositions of this invention are used for, for example, the treatment, prevention, or improvement of various menopausal symptoms such as vasomotor nerve disorder-like symptoms, sensory disturbance-like symptoms, insomnia, nervousness, depression, dizziness, general malaise, joint pain and / or muscle pain, headache, palpitations, paresthesia, and eye strain. Moreover, according to this disclosure, methods for manufacturing such compositions can also be provided. Implementation

[0008] [Composition for the treatment, prevention, or improvement of symptoms of fatigue, sleep disorders, and / or eye strain] This invention is preferably used for the treatment, prevention, or improvement of fatigue, sleep disorders, and / or eye strain. Generally, fatigue is a state of reduced activity capacity or efficiency resulting from physical or mental overload due to physical or mental reasons; fatigue is the conscious awareness of the existence of this fatigue. Physical fatigue can be exemplified by, but is not limited to, physical exhaustion during strenuous exercise, strength training, or work. Similarly, mental fatigue can be caused by, but is not limited to, interpersonal relationships, work-related anxieties, environmental changes due to moving or job transfers, life changes due to marriage or childbirth, or stressful events. Sleep disorders include, but are not limited to, insomnia, difficulty falling asleep, light sleep, difficulty maintaining sleep, waking up too early, nightmares, sleepwalking, somnolence, abnormal sleep behavior, hypersomnia, narcolepsy, breathing-related sleep disorders, sleep apnea, and circadian rhythm sleep disorders. In this invention, the preferred methods are to treat, prevent, or improve insomnia, difficulty falling asleep, and light sleep, more preferably to treat, prevent, or improve insomnia, but are not limited to these. Eye fatigue includes, for example, visual fatigue, objective or subjective eye fatigue, dry eyes, and itchy eyes, but is not limited to these. Furthermore, eye fatigue is preferably caused by light (so-called blue light) stimulation from office automation (OA) machines such as smartphones or personal computers, but is not limited to these. In this invention, the eye fatigue treated, prevented, or improved is preferably objective or subjective eye fatigue or visual fatigue, but is not limited to these. Furthermore, the objects of the components of this invention are not limited to individuals or groups in menopause and before and after menopause as described later; individuals or groups of all ages can be the objects.

[0009] [Composition for the treatment, prevention, or improvement of menopausal symptoms] This invention is preferably used for the treatment, prevention, or improvement of menopausal symptoms. In this specification, menopause, for women, typically refers to the period approximately five years before and after the cessation of menstruation due to decreased ovarian function (e.g., more than 12 months without menstruation). Women who have undergone oophorectomy may also experience menopausal symptoms. Broadly speaking, it refers to the period of rapid decrease in the secretion of estrogen, a female hormone, but this varies depending on the individual or group (e.g., race, era), and is not limited to this specific period. Furthermore, for men, unlike women, there is no cessation of menstruation. Although there is usually no tendency for a rapid decrease in male hormones, the secretion of testosterone, a male hormone, can decrease due to aging, environmental changes, and stress. Male menopause refers to the period of psychosomatic disorders similar to those experienced in women's menopause, but because it varies depending on the individual or group, it is not limited to this specific period. Furthermore, in this invention, the menopausal symptoms treated, prevented, or improved are preferably, for example, one or more selected from the group consisting of (i) to (xii) below, but are not limited to these symptoms. (i) Vasomotor nerve disorder-like symptoms [e.g., hot flashes (facial flushing, hot flashes, sweating, etc.), chills, tachycardia, bradycardia, etc., but not limited to these], (ii) Sensory disturbance-like symptoms [e.g., numbness, hypersensitivity, paralysis, etc., numbness or dulled sensation in the arms, hands, or lower limbs (groin, thigh, knee, calf, shin, ankle, foot, etc., but not limited to these], (iii) Insomnia, (iv) Nervousness, (v) Depression, (vi) Dizziness, (vii) General fatigue, (viii) Joint pain and / or muscle pain (e.g., pain in one or more of the neck, shoulders, back, waist, hips, feet, arms, hands, etc., but not limited to these), (ix) Headache (e.g., tension headache, migraine, etc., but not limited to these), (x) Palpitation, (xi) Triggering sensation, and (xii) Eye fatigue. Of the symptoms mentioned above, in this invention, the symptoms that are preferred for treatment, prevention or improvement are insomnia and / or general fatigue, but are not limited to these. 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.

[0010] [Lactobacillus plantarum strain L-137] The composition of this invention contains Lactobacillus plantarum strain L-137 (contract number: FERM BP-08607), which is a lactic acid bacterium, or a treatment thereof. The *Lactobacillus plantarum* strain L-137 used in this invention was deposited at the Patent Biology Depository Center of the National Institute of Advanced Industrial Science and Technology (now the Patent Microbiology Depository Center of the Product Evaluation Technology Base Organization; address: Room 120, 2-5-8 Kamisama, Kisarazu City, Chiba Prefecture, Japan 292-0818), under contract number FERM BP-08607 (from FERM P-15317, deposited on November 30, 2018). Furthermore, even if it is a mutant strain of *Lactobacillus plantarum* L-137, if it possesses the characteristics of *Lactobacillus plantarum* L-137, it falls within the category of *Lactobacillus plantarum* L-137. Additionally, *Lactobacillus plantarum* strain L-137 can be included in the composition of this invention along with other lactic acid bacteria.

[0011] In the composition of the present invention, the amount of Lactobacillus plantarum L-137 or its treatment thereof contained in the composition is preferably about 0.0001 to 10% by weight, more preferably about 0.001 to 8% by weight, and even more preferably about 0.002 to 4% by weight, relative to the total amount of the composition. However, it is not limited to these ranges.

[0012] Furthermore, the dosage of Lactobacillus plantarum L-137 or its processed form of the present invention, whether administered orally or by injection, can be determined according to the age and weight of the person taking the product, symptoms, administration time, dosage form, administration method, and combination of drugs. For example, for an adult (approximately 60 kg) per day, when Lactobacillus plantarum L-137 is prepared as dried dead cells, the preferred dosage is approximately 0.5 to 200 mg, more preferably approximately 1 to 100 mg, and even more preferably approximately 2 to 50 mg, but it is not limited to these ranges. Furthermore, for an adult (approximately 60 kg) per day, if we convert *Lactobacillus plantarum* L-137 to live bacteria, the optimal intake is approximately 5 × 10⁸ to 2 × 10¹¹ CFU (colony-forming units), with an even better intake of approximately 1 × 10⁹ to 1 × 10¹¹ CFU. However, this range is not strictly limited. Intake can be divided into one or more daily doses. The aforementioned dosage can be administered or applied in one to several daily doses.

[0013] [Cultivation of Lactic Acid Bacteria] In this invention, Lactobacillus plantarum strain L-137 and other lactic acid bacteria can be cultured using any culture medium, such as natural culture medium, synthetic culture medium, and semi-synthetic culture medium. In this invention, the cultivation of lactic acid bacteria can be carried out according to known methods, methods that are known in themselves, or methods based on such methods.

[0014] The aforementioned culture medium is not particularly limited, but it is preferable to use one containing, for example, a nitrogen source and / or a carbon source. The aforementioned nitrogen source is not particularly limited and may include, for example, meat extract, protein, gluten, casein, yeast extract, or amino acids. The aforementioned carbon source is not particularly limited and may include, for example, glucose, xylose, fructose, inositol, maltose, corn syrup, yeast extract, starch, bagasse, wheat bran, molasses, or glycerol. One or more of these may be used. In addition to the aforementioned nitrogen source and / or carbon source, inorganic substances may also be added to the aforementioned culture medium. The aforementioned inorganic substances are not particularly limited and may include, for example, ammonium sulfate, potassium phosphate, magnesium chloride, salt, iron, manganese, molybdenum, or various vitamins. One or more of these may be used.

[0015] The culture temperature and time for Lactobacillus plantarum strain L-137 and other lactic acid bacteria are not particularly limited as long as efficient culture can be carried out. In one embodiment of the present invention, the culture temperature is typically about 25 to 40 degrees Celsius, preferably about 27 to 35 degrees Celsius, and the culture time is typically about 12 to 48 hours. Furthermore, in one embodiment of the present invention, the culture of lactic acid bacteria can be carried out by aeration and shaking. Also, the pH of the culture medium is not particularly limited, but in one embodiment of the present invention, it is typically about pH 3 to 6, preferably about pH 4 to 6.

[0016] [Processed Lactic Acid Bacteria] Regarding the "processed products" of Lactobacillus plantarum strain L-137, those processed from L-137 strain are preferred, including its culture medium or culture supernatant, residues separated by filtration or centrifugation, and ultrasonic disruption fluid of bacterial cells, but are not limited to these. Furthermore, the processed products of the present invention also include processing solutions after cell wall removal by enzymatic or physical treatment, protein or peptide complexes obtained by pharmaceutical or salting-out treatment, concentrates, dried products, or dilutions of such products, but are not limited to these. Furthermore, strain L-137 can be live cells, dried cells, centrifuged cells, or broken cells, or it can be dead cells. However, from the point of view of stability and ease of handling, dead cells are preferred.

[0017] In this invention, the above-mentioned processed materials can be used undisturbed, or they can be freeze-dried, cryogenically dried, spray-dried, or L-dried, or these methods can be combined to form a powder. Furthermore, these processed materials can be diluted with a suitable solvent (water, ethanol, organic solvents, etc.) and used, or suitable additives can be added to form a gel or solid.

[0018] The following is a detailed explanation of the method for preparing dead cells of Lactobacillus plantarum strain L-137 and other lactic acid bacteria. In this invention, the method for preparing the aforementioned dead bacterial cells is not particularly limited as long as it does not lose the effect of this invention. For example, it can be prepared by any method such as "(I) after the culture is completed, separating the live lactic acid bacteria from the culture medium and then sterilizing or sterilizing the live bacteria to make them into dead bacterial cells", or "(II) sterilizing the live lactic acid bacteria in the culture medium to make them into dead bacterial cells, and then separating the dead bacterial cells from the culture medium". The sterilization system can be carried out by, for example, filtration by a filter. In addition, it can be carried out by known methods, such as gas sterilization by ethylene oxide or hydrogen peroxide, or heat sterilization by gamma ray, electron beam irradiation, or high frequency.

[0019] The method for separating bacterial cells from the culture medium can employ various methods commonly used in this field, without particular limitation. Specifically, in one embodiment of the present invention, a method can be used, for example, to remove the supernatant from the culture medium by centrifugation, and then separate the culture medium and bacterial cells. Furthermore, in this embodiment, after adding distilled water to the culture medium and centrifuging to remove the supernatant, the operation of "adding distilled water to the residue after removing the supernatant and centrifuging" can be repeated several times as desired. In one embodiment of the present invention, the separation operation may include a filtration step. Regarding the aforementioned bacterial cells, dried bacteria can be obtained by a drying operation performed using a spray drying apparatus. Preferred examples of such apparatus include spray drying apparatuses equipped with a microparticle-forming device capable of forming spray droplets of approximately 1 to 10 μm, but these are not limited to.

[0020] The aforementioned sterilization methods are not particularly limited, and examples include: heating, ultraviolet irradiation, and formalin treatment. Furthermore, the aforementioned sterilization treatment can be performed on the live bacterial cells or on the culture medium containing the live bacterial cells.

[0021] When performing the aforementioned heat treatment, the heating temperature is not particularly limited; for example, it is typically about 60 to 100 degrees Celsius, and preferably about 70 to 90 degrees Celsius. The heating method can be any known method, without particular limitation, such as a heater. The heating time is not particularly limited as long as it is sufficient to complete the sterilization process; for example, after the desired temperature is reached, it is typically about 5 to 40 minutes, and preferably about 10 to 30 minutes.

[0022] As a processed product of dead bacterial bodies, it can be obtained by further grinding, crushing, spray drying, low-temperature drying, or freeze-drying the dead bacterial bodies obtained by the operations described above, or by mixing them with other raw materials (such as vitamins, amino acids, oligopeptides, etc.). In this invention, the processed product of dead bacterial bodies is suitable for appropriate use as dead bacterial bodies.

[0023] Preferred examples of the components of this invention are for food and / or pharmaceutical use (including veterinary drugs). In another preferred example, the components of this invention can be used as additives for food and beverages. Components for food and beverage use, food and beverage additive use, or pharmaceutical use can be formulated by further blending the culture supernatant or its processed form, L-137 strain or its processed form, with pharmaceutically permissible carriers, additives, etc. Since the formulation methods or techniques used for this formulation have been well established in the past, they can be followed. For example, for pharmaceutical use, specifically, they can be formulated into oral dosage forms such as tablets, coated tablets, pills, powders, granules, capsules, liquids, suspensions, emulsions, etc., and non-oral dosage forms such as injections, infusions, suppositories, ointments, patches, etc. The proportions of carriers or additives can be appropriately set based on the ranges commonly used in the food, pharmaceutical, or veterinary fields.

[0024] There are no particular restrictions on pharmaceutically permissible carriers or additives. Examples of carriers include various carriers such as aqueous or oil-based bases. Aqueous carriers include, for example, water, physiological saline, ethanol, glycerin, polyethylene glycol, propylene glycol, methylcellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, polyacrylic acid, and polysaccharide gums, which are natural polymers. Oil-based carriers include, for example, petrolatum, squalene, paraffin, and other suitable oils or waxes, but are not limited to these. Examples of additives include: enzymes, pH adjusters, preservatives, bactericides, antioxidants, antifungal agents, shelf-life extenders, bleaching agents, gloss agents, flavorings, sweeteners, acidulants, seasonings, bittering agents, emulsifiers, thickeners, stabilizers, gelling agents, pastes, excipients, binders, disintegrants, lubricants, colorants, and flavoring agents, but are not limited to these. Since such related technologies have been well established in the past, this invention can be based on those established previously.

[0025] Furthermore, when the components of this invention are food products, the food product category includes health foods, functionally labeled foods, foods for specific health purposes, and foods for patients. The form of the food product is not particularly limited; specific examples include tablets, granules, powders, and beverages, which are considered nutritional supplements or nutrients. In addition, examples include beverages such as tea drinks, soft drinks, carbonated drinks, nutritional drinks, fruit drinks, and lactic acid drinks; noodles such as buckwheat noodles, udon noodles, Chinese noodles, and instant noodles; snacks and breads such as maltose, candy, chewing gum, chocolate, biscuits, jelly, jam, whipped cream, baked goods, and bread; processed seafood / livestock products such as ham, sausage, half slices, and chikuwa; dairy products such as processed milk and fermented milk; oils and oil-based processed foods such as salad oil, tempura oil, margarine, mayonnaise, shortening, whipped cream, and dressings; seasonings such as sauces and broths; prepared foods such as curry, stews, donburi, porridge, and zōsei; and frozen desserts such as ice cream, sorbet, and shaved ice, but not limited to these. Since related technologies have been well established in the past, this invention can be based on those established previously. Furthermore, the components of this invention may contain any ingredients known in the fields of medicine, pharmacy, veterinary medicine, animal products, or food, as long as they do not lose the effects of this invention.

[0026] [Improvement in fatigue, sleep disturbances, eye strain, and menopausal symptoms, and methods for confirming its effectiveness] Methods for confirming the effectiveness of the composition of the present invention may include, for example, comparing a composition containing Lactobacillus plantarum strain L-137 or its treatment with a composition not containing L-137 or its treatment, to confirm that it is superior in improving fatigue, sleep disorders or eye fatigue and menopausal symptoms. Specifically, methods for confirming the improvement of fatigue, sleep disorders, eye fatigue, and menopausal symptoms can include, for example, the VAS (Visual Analogue Scale) for measuring subjective fatigue; methods for measuring oxidative stress markers in the blood, time required to fall asleep (sleep latency), and total sleep duration (total sleep time); and, in addition to the forced swim test (FST) in rats or mice; methods for evaluating the effect based on the aforementioned medical history and Kupperman index can also be listed, but are not limited to these. The effects of the components of this invention are not limited to the treatment, prevention, or improvement of menopausal symptoms. Regarding the assessment of menopausal symptoms, known models of menopause, including ovariectomized animals (preferably rats, mice, etc.), can also be used. Furthermore, when assessing eye fatigue, methods such as measuring the cell viability of retinal pigment epithelial cells in humans or animals (e.g., rabbits) when exposed to blue light can be used. For example, when a subject ingests (is given) the composition of the present invention, compared with a control group that has not ingested (or been given) the composition of the present invention, if the measured values ​​of VAS or blood oxidative stress markers are particularly reduced or significantly reduced, or the latency to fall asleep and / or the total sleep time is particularly prolonged or significantly prolonged, the composition of the present invention can be judged to have the desired effect. In addition, evaluation can also be performed using other well-established methods in the field, such as those described above. An example of such methods can be found in the embodiments described later.

[0027] When the components of the present invention are formulated into food, medicine (including veterinary medicine) or quasi-pharmaceutical form, the food, medicine or quasi-pharmaceutical, its instruction manual or its packaging may be labeled with the effect of the components of the present invention as "having the effect of improving fatigue, sleep disorders or eye fatigue and menopausal symptoms".

[0028] [Manufacturing method of the components] The present invention preferably comprises a method for manufacturing a composition for the treatment, prevention or improvement of fatigue, sleep disorders or eye fatigue and menopausal symptoms, the method comprising the step of mixing Lactobacillus plantarum L-137 or its treated form with a carrier and / or excipients.

[0029] Since preferred carriers used in the above steps have been well established in the food or pharmaceutical fields in the past, the present invention can also follow the established methods and can include various carriers such as aqueous or oil-based bases. Aqueous carriers include water, physiological saline, ethanol, glycerin, polyethylene glycol, propylene glycol, methylcellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, polyacrylic acid, polysaccharide gum-based natural polymers, etc.; oil-based carriers include petrolatum, squalene, paraffin, and other suitable oils or waxes, but are not limited to these.

[0030] Furthermore, since preferred excipients for use in the above steps have been well established in the food or pharmaceutical fields in the past, the present invention may also use lactose, white sugar, mannitol, corn starch, powdered cellulose, dicalcium phosphate, calcium carbonate, etc., in accordance with the previously established methods, but is not limited to these.

[0031] The composition of this invention, besides adding Lactobacillus plantarum L-137 or its treatment thereof, can also be appropriately processed and manufactured according to general composition manufacturing methods. That is, this invention includes a method for manufacturing a composition comprising the step of mixing Lactobacillus plantarum L-137 or its treatment thereof with other ingredients as desired.

[0032] As long as the effects of the present invention can be achieved, various combinations of the above-described structures are readily available within the technical scope of the present invention. Furthermore, appropriate modifications can be made to anything falling within the technical scope of the present invention. [Example]

[0033] The following examples and test cases are provided to illustrate the present invention in more detail; however, the present invention is not limited thereto.

[0034] [Trial Example] Human clinical trial using a composition containing Lactobacillus strain L-137 (assessment of menopausal symptoms and eye fatigue) <1. Components Used> As a component of this invention, a commercially available tablet (Japanese trade name: L-137) containing 10 mg of heat-treated dead Lactobacillus plantarum cells per tablet (300 mg) is used. high Lactic acid bacteria L-137 The tablets also contain ingredients other than L-137 (lactose, starch, sucrose fatty acid esters, etc.), but these ingredients have no particular effect on the following experiments.

[0035] <2. Assessment based on the intake of components and menopausal symptom questionnaire> Twenty-two men and women aged 41 to 73 were divided into two groups: a non-ingestion group of 6 (1 male and 5 females) and a dead bacterial strain L-137 ingestion group of 16 (5 males and 11 females). The dead bacterial strain L-137 ingestion group continuously ingested the above-mentioned components one tablet per day for 12 months. Assessments were conducted using the Cooperman Menopausal Symptom Questionnaire before the start of the trial and at 3, 6, and 12 months after ingestion of the components. Furthermore, the change in the questionnaire score from the start of the trial was assessed. The symptoms on the Menopausal Symptom Questionnaire were the following 11 items: (1) vasomotor neuropathy-like symptoms, (2) perceptual disturbance-like symptoms, (3) insomnia, (4) nervousness, (5) depression, (6) dizziness, (7) general malaise, (8) joint pain / muscle pain, (9) headache, (10) palpitations, and (11) paresthesia. The results are shown in Table 1 below.

[0036] [Table 1]

[0037] Investigation: In the categories of “total score of 11 items” (i.e., items (1) to (11) above) and “insomnia” and “general fatigue”, the index of menopausal symptoms in the non-intake group showed a periodic increase, while the index in the intake group showed a particular inhibition of the increase or a tendency to inhibit the increase [two-way ANOVA analysis].

[0038] <3. Assessment conducted through component intake and a medical history of eye fatigue> Twenty-two participants aged 41 to 73 were divided into two groups: a non-ingestion group of 6 (1 male and 5 females) and a dead bacterial strain L-137 ingestion group of 16 (5 males and 11 females). The dead bacterial strain L-137 ingestion group continuously ingested the above-mentioned components once a day for 12 months. Assessments were conducted using a questionnaire about eye fatigue before the start of the trial and at 3, 6, and 12 months after the intake of the components. Furthermore, the change in questionnaire scores from the start of the trial was assessed. The questionnaire about eye fatigue included not only "eye fatigue" but also information about "dry eyes" and "itchy eyes." The results are shown in Table 2 below.

[0039] [Table 2]

[0040] The study found that, compared to the L-137 non-intake group, the index of eye fatigue increased over time, while the L-137 intake group specifically suppressed this increase (2-way ANOVA analysis).

[0041] The results of the above experiments show that the composition containing the L-137 strain of lactic acid bacteria of the present invention has the effect of improving menopausal symptoms and relieving eye fatigue. [Industrial Applicability]

[0042] As described above, the constituent system of the present invention has various useful effects. Therefore, for example, it is used for the treatment, prevention or improvement of (i) vasomotor nerve disorder-like symptoms; (ii) perceptual disorder-like symptoms; (iii) insomnia; (iv) nervousness; (v) depression; (vi) dizziness; (vii) general fatigue; (viii) joint pain and / or muscle pain; (ix) headache; (x) palpitations; (xi) paresthesia; and (xii) eye fatigue, and the constituent system is also used as a food product, medicine, or quasi-pharmaceutical.

Claims

1. The use of Lactobacillus plantarum L-137 for the manufacture of a medicine for the treatment, prevention or improvement of at least one symptom selected from the group consisting of fatigue, sleep disorders and eye fatigue.

2. The use of Lactobacillus plantarum L-137 for the manufacture of medicines for the treatment, prevention or improvement of menopausal symptoms.

3. The use as described in claim 2 is for the treatment, prevention or improvement of one or more symptoms selected from the group consisting of the following (i) to (xii): (i) vasomotor neuropathy-like symptoms; (ii) perceptual disturbance-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) paresthesia; and (xii) eye strain.

4. The use as described in any of claims 1 to 3, wherein, The plant lactobacillus L-137 strain is included in food and beverage products.

5. The use as described in claim 4, wherein, Food additives or supplements are food additives or supplements.