Composition for improving fatigue, sleep disorder, eye fatigue and menopausal symptoms
Patent Information
- Application Number
- JP2024561008
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2022-11-29
- Publication Date
- 2025-06-02
- Estimated Expiration
- 2042-11-29
AI Technical Summary
Current treatments and remedies are inadequate for addressing fatigue, sleep disorders, eye fatigue, and menopausal symptoms, which are common and debilitating for both men and women due to hormonal changes and stress.
A composition containing Lactobacillus plantarum L-137 or its processed products is used to treat, prevent, or improve these symptoms, including vasomotor neuropathy-like symptoms, insomnia, nervousness, depression, dizziness, muscle pain, and eye fatigue, by administering it as a food, drink, supplement, or medicament.
The composition significantly reduces subjective fatigue levels, improves sleep quality, and alleviates menopausal symptoms, as demonstrated by clinical trials and animal models, indicating its effectiveness in treating and preventing these conditions.
Abstract
Description
Composition for improving fatigue, sleep disorders or eye fatigue and menopausal symptoms
[0001] The present invention relates to a composition for improving fatigue, sleep disorders or eye fatigue, and menopausal symptoms.
[0002] Menopausal symptoms are symptoms that appear during menopause due to age-related decline in ovarian function and hormone function. Examples include vasomotor symptoms such as hot flashes, pain such as headaches and muscle pain, decreased mental and sleep quality, and general fatigue. While more common in women, they are also seen in men. Regardless of whether they are in menopause or not, many modern people suffer from fatigue, sleep disorders, eye fatigue, and other conditions caused by psychological or physical stress. It is known that germinated fermented bean extracts can improve these symptoms (Patent Document 1).
[0003] However, it has not been known at all that the lactic acid bacteria Lactobacillus plantarum L-137 strain can treat, prevent or improve fatigue, sleep disorders or eye fatigue, and menopausal symptoms.
[0004] Special Publication No. 2016-526019
[0005]
[0006] The present inventors have investigated a large number of materials in search of a material that can treat, prevent, or improve fatigue, sleep disorders, eye fatigue, and menopausal symptoms. As a result, they have surprisingly found that the lactic acid bacterium Lactobacillus plantarum L-137 strain (hereinafter also referred to as "L-137 strain") has such desirable effects. This was a surprising finding made by the present inventors. After further investigations, the present inventors have completed the present invention.
[0007] That is, the present invention is as follows. [1] A composition for treating, preventing, or ameliorating one or more symptoms selected from the group consisting of fatigue, sleep disorders, and eye fatigue, characterized by containing Lactobacillus plantarum L-137 or a processed product thereof. [2] A composition for treating, preventing, or ameliorating menopausal symptoms, characterized by containing Lactobacillus plantarum L-137 or a processed product thereof. [3] The composition according to [2], characterized by being used for treating, preventing, or ameliorating one or more symptoms selected from the group consisting of the following (i) to (xii): (i) vasomotor disorder-like symptoms; (ii) paresthesia-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) feeling of running formicarius; 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 a supplement. [6] Use of Lactobacillus plantarum L-137 or a processed product thereof for the manufacture of a medicament for the treatment, prevention, or amelioration of at least one symptom selected from the group consisting of fatigue, sleep disorders, and eye fatigue. [7] Use of Lactobacillus plantarum L-137 or a processed product thereof for the manufacture of a medicament for the treatment, prevention, or amelioration of menopausal symptoms. [8] A method for treating, preventing, or ameliorating at least one symptom selected from the group consisting of fatigue, sleep disorders, and eye fatigue, by administering Lactobacillus plantarum L-137 or a processed product thereof to a subject. [9] A method for treating, preventing, or ameliorating menopausal symptoms by administering Lactobacillus plantarum L-137 or a processed product thereof to a subject.
[0008] According to the present disclosure, compositions for treating, preventing, or ameliorating fatigue, sleep disorders or eye fatigue, and menopausal symptoms can be provided. Furthermore, the compositions of the present invention are useful for treating, preventing, or ameliorating various menopausal symptoms, such as vasomotor disorder-like symptoms, sensory disorder-like symptoms, insomnia, nervousness, depression, dizziness, general malaise, joint pain and / or muscle pain, headache, palpitations, formication, and eye fatigue. Furthermore, according to the present disclosure, methods for producing these compositions can also be provided.
[0009] [Composition for treating, preventing, or ameliorating symptoms of fatigue, sleep disorders, and / or eye fatigue] Preferably, the present invention is used for treating, preventing, or ameliorating fatigue, sleep disorders, and / or eye fatigue. Fatigue is generally a state of decreased activity capacity and efficiency caused by overload on the mind and body due to physical or mental causes, and fatigue is the subjective sensation of being aware of the presence of such fatigue. Examples of physical fatigue include, but are not limited to, physical fatigue from strenuous exercise, strength training, work, etc. Mental fatigue includes, but is not limited to, stress due to interpersonal relationships, work-related worries, changes in environment due to moving or transfer, changes in lifestyle due to marriage or childbirth, and shocking events. Examples of sleep disorders include, but are not limited to, insomnia, difficulty falling asleep, difficulty sleeping soundly, waking up during the night, early awakening, nightmares, sleepwalking, lethargy, parasomnia, hypersomnia, narcolepsy, respiratory-related sleep disorders, apnea, and circadian rhythm sleep disorders. 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 these. Eye (ocular) fatigue includes, but is not limited to, eye strain, objective or subjective eye fatigue, dry eyes, and itchy eyes. Furthermore, eye fatigue is preferably induced by light (so-called blue light) stimulation from office automation devices such as smartphones and personal computers, but is not limited to these. In the present invention, eye fatigue that is preferably treated, prevented, or improved includes, but is not limited to, objective or subjective eye fatigue and eye strain. The target of the composition of the present invention is not limited to menopausal and perimenopausal individuals or groups described below, but can be applied to individuals or groups of all ages.
[0010] [Composition for treating, preventing, or ameliorating menopausal symptoms] Preferably, the present invention is used for treating, preventing, or ameliorating menopausal symptoms. In this specification, menopause typically refers to the period of approximately five years before and after menopause, when ovarian function declines (e.g., amenorrhea for 12 months or more). However, symptoms may also occur in women who have had their ovaries removed. In a broad sense, menopause refers to the period during which the secretion of the female hormone estrogen rapidly decreases. However, this period differs depending on the individual and group (e.g., race, era, etc.), and is therefore not limited to these periods. Furthermore, unlike women, men do not experience menopause and do not generally tend to experience a rapid decrease in male hormones. However, aging, combined with environmental changes and stress, can sometimes cause a decrease in the secretion of the male hormone testosterone. Menopause refers to the period during which physical and mental disorders similar to those experienced in women occur. However, this period differs depending on the individual and group, and is therefore not limited to these periods. Furthermore, in the present invention, menopausal symptoms that are preferably treated, prevented, or ameliorated include, for example, one or more selected from the group consisting of (i) to (xii) below, but are not limited to these. (i) vasomotor disorder-like symptoms (for example, but not limited to, hot flashes (heatstroke, flushing, sweating, etc.), sensitivity to cold, tachycardia, bradycardia, etc.), (ii) sensory disorder-like symptoms (for example, but not limited to, numbness, hyperesthesia, paresthesia, etc., including numbness and loss of sensation in the arms, hands, or lower limbs (base of the legs, thighs, knees, calves, shins, ankles, feet, etc.)), (i (ii) insomnia, (iv) nervousness, (v) depression, (vi) dizziness, (vii) general fatigue, (viii) joint pain and / or muscle pain (for example, pain in one or more parts of the neck, shoulders, back, lower back, buttocks, legs, arms, hands, etc., but not limited to these), (ix) headache (for example, tension headache, migraine, etc., but not limited to these), (x) palpitations, (xi) feeling of running, and (xii) eye fatigue. Of the above symptoms, in the present invention, symptoms that are more preferably treated, prevented, or improved 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, more preferably for the treatment, prevention, or improvement of menopausal symptoms in women.
[0011] [Lactobacillus plantarum L-137] The composition of the present invention is characterized by containing the lactic acid bacterium Lactobacillus plantarum L-137 (Accession No.: FERM BP-08607) or a processed product thereof. The lactic acid bacterium Lactobacillus plantarum L-137 strain used in the present invention has been deposited at the Patent Organism Depositary of the National Institute of Advanced Industrial Science and Technology (currently the Patent Organism Depositary of the National Institute of Technology and Evaluation; address: Room 120, 2-5-8 Kazusa Kamatari, Kisarazu City, Chiba Prefecture, Japan, 292-0818) under accession number FERM BP-08607 (transferred from FERM P-15317 deposited on November 30, 1995). Mutant strains of Lactobacillus plantarum L-137 that have the characteristics of Lactobacillus plantarum L-137 are also included in the category of Lactobacillus plantarum L-137. Other lactic acid bacteria may be contained in the composition of the present invention together with the Lactobacillus plantarum L-137 strain.
[0012] In the composition of the present invention, the Lactobacillus plantarum L-137 strain or a processed product thereof is preferably contained in an amount of 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, but is not limited to these ranges.
[0013] Furthermore, the intake amount of the Lactobacillus plantarum L-137 strain of the present invention or a processed product thereof, when administered orally or by injection, can be determined depending on the age and weight of the recipient, symptoms, administration time, dosage form, administration method, drug combinations, etc. For example, it is preferable to set the intake amount of Lactobacillus plantarum L-137 strain per adult (approximately 60 kg) per day to preferably about 0.5 to 200 mg, more preferably about 1 to 100 mg, and even more preferably about 2 to 50 mg in terms of dried killed cells, but is not limited to these ranges. Alternatively, it is preferable to set the intake amount of Lactobacillus plantarum L-137 per adult (approximately 60 kg) per day to preferably about 5 x 10 viable cells. 8 ~2 x 10 11 cfu (Colony forming unit), more preferably about 1 x 10 9 ~1 x 10 11 It is preferable to set the dose so that 1000 cfu / day is ingested, but the dose is not limited to this range. The number of doses can be one or more divided doses per day. The dose may be administered or applied once or several times per day.
[0014] [Culturing of Lactic Acid Bacteria] In the present invention, Lactobacillus plantarum L-137 and other lactic acid bacteria may be cultured in any medium, such as a natural medium, a synthetic medium, a semi-synthetic medium, etc. In the present invention, the lactic acid bacteria may be cultured according to a known method, a known method, or a method similar thereto.
[0015] The medium is not particularly limited, and preferably contains, for example, a nitrogen source and / or a carbon source. The nitrogen source is not particularly limited, and examples thereof include meat extract, peptone, gluten, casein, yeast extract, and amino acids. The carbon source is not particularly limited, and examples thereof include glucose, xylose, fructose, inositol, maltose, starch syrup, koji soup, starch, bagasse, bran, molasses, and glycerin. These may be used alone or in combination of two or more. In addition to the nitrogen source and / or carbon source, the medium may further contain inorganic substances. The inorganic substances are not particularly limited, and examples thereof include ammonium sulfate, potassium phosphate, magnesium chloride, salt, iron, manganese, molybdenum, and various vitamins. These may be used alone or in combination of two or more.
[0016] The culture temperature and culture time for Lactobacillus plantarum L-137 and other lactic acid bacteria are not particularly limited as long as the culture can be carried out efficiently. In one embodiment of the present invention, the culture temperature may be, for example, typically about 25 to 40°C, preferably about 27 to 35°C, and the culture time may be, for example, about 12 to 48 hours. In one embodiment of the present invention, the lactic acid bacteria may be cultured by aeration and shaking. The pH of the medium is not particularly limited, but in one embodiment of the present invention, the pH may be typically about 3 to 6, preferably about 4 to 6.
[0017] [Processed Lactic Acid Bacteria] The "processed product" of the lactic acid bacterium Lactobacillus plantarum L-137 strain is preferably a processed product of the L-137 strain, and includes, but is not limited to, its culture solution or culture supernatant, residues obtained by filtration or centrifugation thereof, and sonication of bacterial cells. The processed product of the present invention also includes, but is not limited to, a solution obtained by removing cell walls using an enzymatic or physical treatment, a protein or peptide complex obtained by chemical or salting-out treatment, and concentrates, dried products, or dilutions thereof. The L-137 strain may be in the form of live cells, dried cells, centrifuged cells, disrupted cells, or killed cells, although killed cells are preferred from the standpoints of stability, ease of handling, and the like.
[0018] In the present invention, the processed product may be used as it is, or may be used in powder form by freeze-drying, low-temperature drying, spray-drying, L-drying, or a combination of these. Furthermore, these processed products may be used after being diluted with an appropriate solvent (water, alcohol, organic solvent, etc.), or may be used after being made into a gel or solid preparation by adding appropriate additives.
[0019] Methods for preparing killed cells of Lactobacillus plantarum L-137 and other lactic acid bacteria are specifically described below. In the present invention, the method for preparing the killed cells is not particularly limited as long as the effects of the present invention are not lost. For example, the killed cells may be prepared by any of the following methods: (I) a method in which live lactic acid bacteria cells are separated from the culture medium after the completion of culture and then sterilized or sterilized to kill the live cells; or (II) a method in which live lactic acid bacteria cells are sterilized in the culture medium to kill the cells and then the killed cells are separated from the culture medium. Sterilization can be carried out, for example, by filter filtration, but other known methods, such as gas sterilization with ethylene oxide or hydrogen peroxide, or heat sterilization using gamma rays, electron beam irradiation, or high frequency waves, may also be used.
[0020] The method for separating the bacterial cells from the culture medium may employ various methods commonly used in this field and is not particularly limited. In one embodiment of the present invention, specifically, for example, a method may be employed in which the culture medium and the bacterial cells are separated by removing the supernatant from the culture medium by means of centrifugation or the like. In this embodiment, distilled water is added to the culture medium, followed by centrifugation and then the supernatant is removed. If desired, the procedure of adding more distilled water to the residue after removing the supernatant and then centrifuging may be repeated several times. In one embodiment of the present invention, the separation procedure may include a filtration step. The above-described bacterial cells can be dried using a spray dryer to obtain dried bacteria. A preferred example of the apparatus is a spray dryer equipped with an atomizer capable of forming spray droplets of approximately 1 to 10 μm in size, but is not limited thereto.
[0021] 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 viable bacterial cells, or on a culture solution containing the viable bacterial cells.
[0022] When the heat treatment is carried out, the heating temperature is not particularly limited, but may be, for example, typically about 60 to 100°C, preferably about 70 to 90°C. Heating means can be any known method, and is not particularly limited, but may include, for example, a heater or other means. The heating time is not particularly limited as long as the sterilization treatment is sufficiently completed, but may be, for example, typically about 5 to 40 minutes, preferably about 10 to 30 minutes, after the desired temperature is reached.
[0023] The killed bacterial cells obtained as described above may be further subjected to grinding, crushing, spray drying, low-temperature drying, or freeze-drying, or may be mixed with other raw materials (e.g., vitamins, amino acids, oligopeptides, etc.) to obtain a treated product of killed bacterial cells. In the present invention, treated products of killed bacterial cells can also be suitably used as killed bacterial cells.
[0024] Preferred examples of the composition of the present invention are for use in foods and beverages and / or pharmaceuticals (including veterinary drugs). In another preferred example, the composition of the present invention is used as an additive for foods and beverages. Compositions for foods and beverages, food and beverage additives, or pharmaceuticals can be formulated by appropriately blending the above-described culture supernatant of the present invention or a processed product thereof, or the L-137 strain or a processed product thereof, with pharmaceutically acceptable carriers, additives, and the like. Since formulation methods and techniques for this purpose have been well established, these may be followed. For example, in the case of pharmaceuticals, specific examples include oral preparations such as tablets, coated tablets, pills, powders, granules, capsules, liquids, suspensions, and emulsions, and parenteral preparations such as injections, infusions, suppositories, ointments, and patches. The blending ratio of carriers or additives may be appropriately set based on the ranges commonly used in the fields of foods and beverages, pharmaceuticals, or veterinary medicine.
[0025] Pharmaceutically acceptable carriers or additives are not particularly limited, and examples of carriers include various carriers such as aqueous or oily bases. Aqueous carriers include, for example, water, physiological saline, ethanol, glycerin, polyethylene glycol, propylene glycol, methylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, polyvinylpyrrolidone, polyacrylic acid, and polysaccharide gum-based natural polymers. Oily carriers include, for example, suitable oils and waxes such as petrolatum, squalane, and paraffin, but are not limited thereto. Examples of additives include, but are not limited to, enzymes, pH adjusters, preservatives, disinfectants, antioxidants, antifungals, shelf-life enhancers, bleaching agents, glossing agents, flavorings, sweeteners, acidulants, seasonings, bittering agents, emulsifiers, thickeners, stabilizers, gelling agents, thickeners, excipients, binders, disintegrants, lubricants, colorants, and flavoring agents. Since technologies related to these have been well established, these may be used in the present invention.
[0026] Furthermore, when the composition of the present invention is for use in food and beverage products, the food and beverage products include health foods, functional foods, foods for specified health uses, and foods for patients. The form of the food and beverage products is not particularly limited, but specific examples include tablets, granules, powders, drinks, and the like, which are so-called nutritional supplements or supplements. Other examples include, but are not limited to, beverages such as tea drinks, soft drinks, carbonated drinks, nutritional drinks, fruit drinks, and lactic acid drinks; noodles such as soba, udon, Chinese noodles, and instant noodles; sweets and breads such as candy, candy, gum, chocolate, snacks, biscuits, jelly, jam, cream, baked goods, and bread; processed seafood and livestock foods such as ham, sausage, fish cake, and chikuwa; dairy products such as processed milk and fermented milk; oils and fats and processed oil foods such as salad oil, tempura oil, margarine, mayonnaise, shortening, whipped cream, and dressing; seasonings such as sauces and dressings; retort pouch foods such as curry, stew, rice bowls, porridge, and rice porridge; and frozen desserts such as ice cream, sherbet, and shaved ice. Since the technologies related to these have been well established, they may be used in the present invention. Furthermore, the composition of the present invention may contain any component known in the fields of medicine, pharmacology, veterinary medicine, livestock farming, food, etc., as long as the effect of the present invention is not lost.
[0027] [Effect of Improving Fatigue, Sleep Disorders, Eye Fatigue, and Menopausal Symptoms and Methods for Confirming the Effect] Methods for confirming the effect of the composition of the present invention include, for example, a method for confirming that a composition containing Lactobacillus plantarum L-137 or a processed product thereof is superior in improving fatigue, sleep disorders, eye fatigue, and menopausal symptoms compared to a composition not containing the L-137 strain or a processed product thereof. Specifically, methods for confirming the effect of improving fatigue, sleep disorders, eye fatigue, and menopausal symptoms include, for example, a visual analogue scale (VAS), which is a method for measuring subjective fatigue, blood oxidative stress markers, methods measuring the time it takes to fall asleep (sleep onset latency) and total sleep maintenance time (total sleep time), a forced swim test (FST) using rats or mice, and methods for evaluating the effect based on a questionnaire and the Kupperman index described below, but are not limited to these. The effects of the compositions of the present invention are not limited to the treatment, prevention, or amelioration of menopausal symptoms. For example, ovariectomized animals (preferably rats, mice, etc.) known as menopausal models may be used to evaluate menopausal symptoms. Furthermore, when evaluating eye fatigue, methods such as measuring cell viability when irradiating retinal pigment epithelial cells of humans or animals (e.g., rabbits, etc.) with blue light can be used. For example, when subjects ingest (administer) the compositions of the present invention, the compositions of the present invention can be determined to have the desired effect if the measured values of VAS or blood oxidative stress markers are significantly or significantly lower, or if the sleep onset latency and / or total sleep time are significantly or significantly longer, compared to a control group that does not ingest (or administer) the compositions of the present invention. Evaluation may also be performed according to other well-established methods in the art, such as known methods other than those described above. For examples of these methods, see the Examples below.
[0028] When the composition of the present invention is prepared in the form of a food or drink, a drug (including veterinary medicine), or a quasi-drug, the food or drink, drug, or quasi-drug, or its accompanying instruction manual or packaging box, etc., can indicate that the composition of the present invention has an effect of improving fatigue, sleep disorders or eye fatigue, and menopausal symptoms, in view of the action of the composition of the present invention.
[0029] [Method for Producing Composition] The present invention preferably includes a method for producing a composition for treating, preventing, or ameliorating fatigue, sleep disorders, eye fatigue, and menopausal symptoms, characterized by including a step of mixing Lactobacillus plantarum L-137 or a processed product thereof with a carrier and / or an excipient.
[0030] Preferred carriers used in the above steps have been well established in the food or pharmaceutical fields, and the present invention may also follow these. Examples of suitable carriers include various carriers such as aqueous or oily bases. Examples of aqueous carriers include water, physiological saline, ethanol, glycerin, polyethylene glycol, propylene glycol, methylcellulose, hydroxypropylmethylcellulose, hydroxypropylcellulose, polyvinylpyrrolidone, polyacrylic acid, polysaccharide gum-based natural polymers, etc., and examples of oily carriers include, but are not limited to, appropriate oils and waxes such as petrolatum, squalane, and paraffin.
[0031] Furthermore, preferred excipients used in the above steps have been well established in the food or pharmaceutical fields, and the present invention may also follow these. For example, lactose, sucrose, mannitol, corn starch, powdered cellulose, calcium hydrogen phosphate, calcium carbonate, etc. can be preferably used, but are not limited to these.
[0032] The composition of the present invention can be appropriately processed and produced by a general method for producing a composition, except that Lactobacillus plantarum L-137 or a processed product thereof is added to the composition. That is, the present invention encompasses a method for producing a composition, which includes a step of mixing Lactobacillus plantarum L-137 or a processed product thereof with other ingredients, as desired.
[0033] The present invention includes various combinations of the above-described configurations within the technical scope of the present invention, as long as the effects of the present invention are achieved. In addition, appropriate modifications are possible within the technical scope of the present invention.
[0034] The present invention will be explained in more detail below with reference to examples and test examples, but the present invention is not limited to these.
[0035] Test Example: Human clinical trial using a composition containing Lactobacillus strain L-137 (evaluation of menopausal symptoms and eye fatigue) 1. Composition used As the composition of the present invention, a commercially available tablet (product name: Protective Lactobacillus L-137 Supplement) containing 10 mg of heat-killed Lactobacillus plantarum L-137 strain cells per tablet (300 mg) was used. The tablet also contains ingredients other than the L-137 strain (lactose, starch, sucrose fatty acid esters, etc.), but these ingredients do not particularly affect the following experiment.
[0036] 2. Intake of the composition and evaluation using a menopausal symptom questionnaire Twenty-two men and women aged 41 to 73 were divided into two groups (6 people in the non-ingestion group (1 man, 5 women) and 16 people in the killed bacterial strain L-137 intake group (5 men, 11 women)). The killed bacterial strain L-137 intake group was instructed to take one tablet of the above-mentioned composition daily for 12 consecutive months. Evaluation was conducted using the Kupperman Menopausal Symptom Questionnaire before the start of the study and 3, 6, and 12 months after ingestion of the composition. Furthermore, the amount of change in the questionnaire scores from before the start of the study was evaluated. The symptoms in the menopausal symptom questionnaire were 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 and muscle pain, (9) headache, (10) palpitations, and (11) a feeling of running. The results were as shown in Table 1 below.
[0037]
[0038] Discussion: In 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 indicating menopausal symptoms increased over time in the L-137 non-ingestion group, whereas the L-137 intake group significantly suppressed this increase or showed a tendency to suppress the increase (2-way ANOVA analysis).
[0039] 3. Evaluation of Composition Intake and Eye Fatigue Using a Questionnaire Twenty-two men and women aged 41 to 73 years were divided into two groups (6 people in the non-intake group (1 man, 5 women) and 16 people in the killed bacterial strain L-137 intake group (5 men, 11 women)). The killed bacterial strain L-137 intake group was instructed to take one tablet of the composition per day for 12 months. An evaluation of eye fatigue was conducted using a questionnaire before the start of the study and at 3, 6, and 12 months after intake of the composition. Furthermore, the amount of change in the questionnaire score from before the start of the study was evaluated. The questionnaire regarding eye fatigue included questions regarding "eye fatigue" as well as "dry eyes" and "itchy eyes." The results are shown in Table 2 below.
[0040]
[0041] Discussion: In the L-137 non-administration group, the index of eye fatigue increased over time, whereas in the L-137 administration group, this increase was significantly suppressed (2-way ANOVA analysis).
[0042] The results of the above test examples demonstrate that the composition containing the lactic acid bacteria strain L-137 of the present invention has the effect of improving menopausal symptoms and eye fatigue.
[0043] As described above, the composition of the present invention has various useful effects, and is therefore useful for treating, preventing, or ameliorating, 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) palpitations, (xi) formication, and (xii) eye fatigue, and the composition is useful as a food or drink, a drug, or a quasi-drug, etc.
Claims
1. A composition for treating, preventing, or ameliorating one or more symptoms selected from the group consisting of fatigue, sleep disorders, and eye fatigue, characterized by containing Lactobacillus plantarum L-137 or a processed product thereof.
2. A composition for treating, preventing or ameliorating menopausal symptoms, which comprises Lactobacillus plantarum L-137 or a processed product thereof.
3. The composition according to claim 2, characterized in that it is used for the treatment, prevention, or amelioration of 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) feeling of being trapped; and (xii) eye fatigue.
4. The composition according to any one of claims 1 to 3, which is a food or drink.
5. The composition according to claim 4, wherein the food or drink is a food additive or a supplement.
6. Use of Lactobacillus plantarum L-137 or a processed product thereof for the manufacture of a medicament for the treatment, prevention, or amelioration of at least one symptom selected from the group consisting of fatigue, sleep disorders, and eye fatigue.
7. Use of Lactobacillus plantarum L-137 or a processed product thereof for the manufacture of a medicament for treating, preventing or ameliorating menopausal symptoms.
8. A method for treating, preventing, or ameliorating at least one symptom selected from the group consisting of fatigue, sleep disorders, and eye fatigue, by administering Lactobacillus plantarum L-137 or a processed product thereof to a subject.
9. A method for treating, preventing or ameliorating menopausal symptoms by administering Lactobacillus plantarum L-137 or a processed product thereof to a subject.