WO2021235278A1 - 閉経後で更年期障害を有しない満40歳以上の女性のためのqol改善用組成物 - Google Patents
閉経後で更年期障害を有しない満40歳以上の女性のためのqol改善用組成物 Download PDFInfo
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- WO2021235278A1 WO2021235278A1 PCT/JP2021/017946 JP2021017946W WO2021235278A1 WO 2021235278 A1 WO2021235278 A1 WO 2021235278A1 JP 2021017946 W JP2021017946 W JP 2021017946W WO 2021235278 A1 WO2021235278 A1 WO 2021235278A1
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- improvement
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- equols
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Definitions
- the present disclosure relates to a composition for improving QOL for females aged 40 years or older who do not have menopausal disorders after menopause.
- Equol is known to have an effect of improving menopausal symptoms (for example, stiff shoulders, hot flashes (hot flashes)) and osteoporosis (Non-Patent Documents 1 and 2). Equol is also known to have the effect of improving female-specific physical and psychological discomfort (premenstrual syndrome (PMS) improvement, pain, negative emotions, concentration, behavioral changes). (Patent Document 1). On the other hand, it is not known that the quality of life (QOL) is improved when equol is ingested by anyone other than those who have the menopausal symptoms and the physical and mental discomfort peculiar to the female.
- PMS menstrual syndrome
- QOL quality of life
- the subject of this disclosure is at least the provision of technology for improving QOL for postmenopausal women aged 40 and over who do not have menopause.
- the improvement of the physical symptoms is the improvement of eyestrain, the pain of the body, the ischemia of the heart, the improvement of fatigue, the improvement of dry mouth, the improvement of skin condition, the improvement of bronchitis, Improvement of gray hair, improvement of autonomic balance, improvement of hearing loss, improvement of swelling, improvement of pollakiuria, improvement of insomnia, maintenance of weight, stomach regulation, improvement of immunity, intestinal regulation, or hair growth, [2] ]
- composition according to [2] wherein the improvement of the mental symptom is improvement of anger, improvement of vitality, improvement of depression, improvement of friendship, improvement of confusion, or improvement of anxiety.
- the QOL is evaluated by an anti-aging QOL common questionnaire.
- the present disclosure can have the effect of providing, at least, a technique for improving QOL for females aged 40 years or older who do not have menopause after menopause.
- One embodiment of the present disclosure is a QOL improving composition containing equols for a postmenopausal woman aged 40 years or older who does not have menopause.
- Equols are represented by the following general formula (1).
- R 1 to R 7 represent hydroxyl groups or hydrogen atoms, respectively.
- Specific examples of the equols include all the compounds contained in the compound represented by the above general formula (1), and specifically, they may be referred to as equol (4', 7-isoflavane diol). ), 5-Hydroxyequol and the like.
- composition for improving QOL may contain equols alone, or other components as long as it can improve the QOL of a female aged 40 years or older who does not have menopausal disorders after menopause. May include. For example, components such as indigestible dextrin, Ca stearate, and silicon dioxide can be mentioned.
- the target for ingesting the QOL improving composition according to this embodiment is a female aged 40 years or older who does not have menopausal disorders after menopause. Moreover, it is preferable that the subject is a person who cannot produce equols. According to the Japan Society of Obstetrics and Gynecology, menopause is a condition in which the activity of the ovaries gradually disappears and menstruation finally stops permanently, and the condition without menstruation continues for 12 months or more. At that time, looking back a year ago, it is said to be menopause. Postmenopausal means menopause and beyond. Menopause can be confirmed by conventional methods.
- menopause is a syndrome similar to autonomic imbalance caused by a decrease in sex hormone secretion. Whether or not the subject has menopause can be confirmed by a conventional method. For example, a simplified menopausal index (SMI) checklist is given, and if the score is 71 or higher, it can be confirmed that the subject has menopause.
- SI menopausal index
- the age of the subject is preferably 40 years or older, more preferably 45 years or older, still more preferably 50 years or older, while preferably 80 years or younger, more preferably 75 years or younger, and further. It is preferably 65 years or younger.
- QOL is an abbreviation for "quality of life", and according to the Ministry of Health, Labor and Welfare, it means extension of healthy life expectancy and quality of life.
- the improvement of QOL in the present embodiment means that the QOL is improved when the subject ingests the equols of the present embodiment than when the subject does not ingest the equols (or when the placebo is ingested).
- the composition for improving QOL according to the present embodiment may be ingested prophylactically in order to suppress a decrease in QOL, or may be ingested in order to maintain QOL.
- the evaluation of the QOL improvement in the present embodiment may be an objective judgment by a doctor or the like, but it is preferably evaluated by an objective scale by an examination or a questionnaire developed by an expert.
- the QOL improvement in this embodiment is preferably an improvement of physical symptoms or an improvement of mental symptoms.
- the improvement of the physical symptoms is preferably improvement of eye strain, improvement of body pain (excluding eye pain, headache, stomach pain), improvement of cardiac ischemia, fatigue (however, eye strain). , Improves eyestrain, Improves dry mouth, Improves skin tone, Improves bronchitis, Improves gray hair, Improves autonomic balance, Improves hearing loss, swelling, Frequent urination Improvement, improvement of sleeplessness, maintenance of weight, stomach regulation, improvement of immunity, intestinal regulation, or hair growth.
- the improvement of eyestrain in the present embodiment is preferably improvement of eye fatigue, improvement of blurred vision, or improvement of eye pain.
- Improvement of body pain (excluding eye pain, headache, and stomach pain) in the present embodiment preferably improves muscle pain, body stiffness (eg, general stiffness, shoulder stiffness, back stiffness). , And the stiffness of the lower back), the lower back pain, or the joint pain.
- the improvement of cardiac ischemia in this embodiment is preferably the improvement of palpitation or the improvement of shortness of breath.
- the improvement of fatigue (excluding eye strain and eye fatigue) in the present embodiment is preferably improvement of physical fatigue or lack of health.
- the improvement of the skin condition in the present embodiment is preferably the improvement of the skin condition.
- Bronchitis in the present embodiment is an improvement in the tendency to cough, an improvement in the tendency to produce sputum, and / or an improvement in the difficulty in cutting sputum.
- the improvement of the balance of the autonomic nerves in this embodiment is preferably improvement of headache, improvement of dizziness, improvement of easy sweating, improvement of hot flashes, or improvement of poor circulation.
- the improvement of deafness in this embodiment is preferably improvement of tinnitus or improvement of difficulty in hearing conversation.
- the gastric regulation in the present embodiment is preferably improvement of anorexia, improvement of stomach tension, or improvement of stomach pain.
- the improvement of immunity in this embodiment is preferably an improvement in the tendency to catch a cold.
- the intestinal regulation in this embodiment is preferably improvement of diarrhea or improvement of constipation.
- Hair growth in this embodiment is preferably improvement of hair loss (hair loss).
- the improvement of the mental symptoms is preferably improvement of anger, improvement of vitality, improvement of depression, improvement of friendship, improvement of confusion, or improvement of anxiety.
- the improvement of anger in this embodiment is preferably an improvement of irritability or an improvement of anger-likeness.
- the improvement of vitality in this embodiment preferably improves the feeling of lack of motivation, the improvement of feeling unhappy, the improvement of feeling worthless, the improvement of feeling that daily life is not enjoyable, and the self-confidence. It is an improvement in feeling lost, or an improvement in feeling that you are not a useful person.
- the improvement in depression in this embodiment is preferably an improvement in depression.
- the improvement in friendship in this embodiment is preferably an improvement in the dislike of talking to a person.
- the improvement of confusion in this embodiment is preferably an improvement of squirming, an improvement of forgetfulness, an improvement of inability to concentrate, an improvement of inability to solve a problem, or an improvement of inability to judge things easily.
- the improvement of anxiety in this embodiment is an improvement of tension, an improvement of anxiety for no reason, or an improvement of feeling some fear.
- the evaluation of QOL improvement in this embodiment is evaluated by an objective scale by a test or a questionnaire developed by an expert
- an example is the anti-aging QOL common questionnaire (Japanese anti-aging medicine). Evaluation by the association).
- the evaluation is performed by the anti-aging QOL common questionnaire, it is possible to evaluate that the QOL is improved by reducing the numerical value of each factor obtained by the evaluation.
- POMS2 includes "POMS2 adult full-item version” and “POMS2 adult shortened version”. Evaluation by POMS2 can be performed according to the manual of POMS2.
- the mental symptom anger, liveliness, depression, friendship, confusion, and anxiety are the "comprehensive mood state” and "anger-hostility” in POMS2, respectively.
- the content of the equols with respect to the total amount of the composition according to the present embodiment is not particularly limited as long as the actions and effects of the equols are exhibited, but the total amount of the equols is preferably 0.001% by mass or more. It is more preferably 0.01% by mass or more, further preferably 0.1% by mass or more, while preferably 20% by mass or less, more preferably 10% by mass or less, still more preferably 5. It is less than mass%.
- the amount of the composition according to the present embodiment is appropriately set according to the age, weight, intake route, intake schedule, form, etc. of the subject, and by ingesting it, the action / effect of the equols in the subject. Is not particularly limited as long as is played.
- the total amount of equols is preferably 1 mg or more, more preferably 2 mg or more, still more preferably 5 mg or more, and on the other hand, preferably 40 mg or less, more preferably 20 mg or less, per day. More preferably, it is 10 mg or less.
- the intake schedule of the composition may be once a day or may be divided into a plurality of times a day. In addition, it may be taken once every few days or weeks, but it is preferable to take it every day.
- the ingestion period is preferably 4 weeks or longer, more preferably 8 weeks or longer, while the upper limit is not particularly limited, but may be, for example, until the age of 100 years old, and may be until death. ..
- composition according to this embodiment can be used as a food or drink (including supplements).
- a food and drink for improving QOL for women aged 40 years or older who do not have menopausal disorders after menopause and contain equols.
- equol When equol is used as a material for foods and drinks, in addition to general foods and drinks, foods for specified health use, dietary supplements, functional foods, foods for the sick, food additives, etc. (these also include beverages). Can be used as.
- the form of the food or drink may be a form other than the plant itself containing equols or the animal itself.
- a form suitable for edible use for example, granules, may be used by conventional means. It may be shaped into granules, tablets, capsules, pastes, etc. and used for food, and various foods such as processed meat foods such as ham and sausage, processed marine foods such as kamaboko and chikuwa, bread and confectionery, etc. It may be added to butter, milk powder, fermented dairy products, or added to beverages such as water, fruit juice, milk, and soft drinks.
- the above foods and drinks can be mainly composed of water, proteins, sugars, lipids, vitamins, minerals, organic acids, organic bases, fruit juices, flavors and the like.
- the protein include animal and vegetable proteins such as full fat powder, skim milk powder, partially skim milk powder, casein, soybean protein, chicken egg protein, meat protein, and hydrolyzates and butters thereof.
- sugars include sugars, modified starches (dextrin, soluble starch, British starch, oxidized starch, starch ester, starch ether, etc.), dietary fiber and the like.
- Examples of the lipid include lard, safflower oil, corn oil, rapeseed oil, coconut oil, fractionated oils thereof, hydrogenated oil, and vegetable fats and oils such as ester exchange oil.
- vitamins include vitamin A, carotene, vitamin B group, vitamin C, vitamin D group, vitamin E, vitamin K group, vitamin P, vitamin Q, niacin, nicotinic acid, pantothenic acid, biotin, inositol, and choline.
- Folic acid and the like, and examples of minerals include calcium, potassium, magnesium, sodium, copper, iron, manganese, zinc, selenium and milky minerals.
- Examples of the organic acid include malic acid, citric acid, lactic acid, tartaric acid and the like. These components may be used in combination of two or more, and synthetic products and / or foods and drinks containing a large amount thereof may be used.
- the above food and drink can be manufactured according to a conventional method.
- the blending amount, blending method, and blending time of equols in foods and drinks can be appropriately selected. Further, if necessary, it can be enclosed in an appropriate container such as a bottle, a bag, a can, a box, or a pack.
- the content of equols with respect to the total amount of the foods and drinks Regarding the content of equols with respect to the total amount of the foods and drinks, the intake amount of the foods and drinks, and the intake schedule of the foods and drinks, the content of equols with respect to the total amount of the composition according to the present embodiment and the composition according to the present embodiment.
- the description of the intake amount of the substance and the intake schedule of the composition according to this embodiment is incorporated.
- equols When equols are used as a material for foods and drinks and are used for each of the above-mentioned uses, they may be foods and drinks describing each use, and may be foods and drinks describing the uses recalled from each use.
- intestinal regulation can be described as “adjusting the condition of the stomach” or “improving communication”.
- improved eye strain can be described as “alleviating the feeling of eye fatigue” or “supporting eye focus adjustment”.
- “improvement of insomnia” can be described as “supporting good quality sleep” and the like.
- improved of fatigue can be described as “reducing mental and physical fatigue” and the like.
- improvement of vitality means “to make a temporarily depressed mood positive”, “to make a temporarily depressed mood a positive mood”, and “to make a temporarily depressed mood lively”. It can be described as “to make you feel” or “to motivate you to feel temporarily depressed”.
- the equols contained in the QOL improving composition according to the present embodiment may be a composition containing equols, and may be, for example, a fermented soybean germ extract containing equols. Therefore, the QOL improving composition according to the present embodiment is a QOL improving composition for a female aged 40 years or older who does not have menopausal disorders after menopause and contains a composition containing equols. good. In addition, the QOL improving composition according to this embodiment is for a female aged 40 years or older who does not have menopausal disorders after menopause and contains a fermented soybean germ extract containing equols. , QOL improving composition may be used.
- the QOL improving composition according to the present embodiment contains equols obtained by fermentation of soybean germ extract, and is used for QOL improving for females aged 40 years or older who do not have menopausal disorders after menopause. It may be a composition for use.
- the soybean germ extract is not particularly limited as long as it contains equols when it becomes a fermented product by fermentation, and examples thereof include soybean germ extracts containing isoflavones. Soybean germ extracts containing such isoflavones can be extracted from soybeans and soybean germs (hypocotyls). Water, ethanol, or hydrous ethanol can be used for the extraction. Further, for example, it can be obtained as described in the document "Development of plant polyphenol-containing material-its functionality and safety-" (published in 2007, published by CMC Publishing Co., Ltd.).
- Isoflavones are one of the classifications of polyphenols, and are flavonoids having isoflavones as the basic skeleton. Isoflavones are abundant in legumes such as soybeans, kudzu, red clover, and licorice. Therefore, the soybean germ extract containing the isoflavones may be an extract of legumes such as kudzu, red clover, and citrus, and may contain isoflavones.
- the soybean germ extract may be one obtained by extracting or purifying its components as long as it contains equols when it becomes a fermented product by fermentation. That is, the soybean germ extract may be isoflavones or a composition containing isoflavones, and may be, for example, a composition containing isoflavones as described in Examples.
- the isoflavones are not particularly limited as long as they become equols by fermentation, and examples thereof include daidzein, genistein, and glycitein.
- the isoflavones include isoflavone aglycones, glycosides thereof, and any derivatives thereof such as malonylation and acetylation.
- the isoflavone aglycone include daidzein, 6-hydroxydaidzein, dihydroxydaidzein, genistein, glycitein, biochanin A, formonetin, and coumestrol.
- the isoflavone aglycone may be isoflavones converted by an enzyme such as ⁇ -glucosidase or a microorganism having ⁇ -glucosidase.
- the glycoside include genistin, glycitin, daidzin, puerarin and the like.
- the isoflavones do not necessarily have to be purified pure products.
- the type, form, degree of purification, and the like of the isoflavones can be arbitrarily selected according to the purpose and use of the equols obtained by fermentation.
- the amount and concentration of the soybean germ extract used for fermentation are not particularly limited as long as they contain equols when the fermented product is fermented. Further, in a preferred embodiment, the amount and concentration of isoflavones used for fermentation when the soybean germ extract contains isoflavones are not particularly limited. Further, the amount and concentration of isoflavones used for fermentation when the isoflavones alone are used in a preferred embodiment are not particularly limited. It can be appropriately set according to the amount of the culture solution and the amount of equols to be produced.
- anaerobic microorganisms are cultivated in a medium containing soybean germ extract.
- the anaerobic microorganism is not particularly limited as long as it is an anaerobic microorganism capable of producing equols at a temperature of around 37 ° C. (for example, 30 to 42 ° C.), but for example, a microorganism belonging to the genus Adlercreutzia and a microorganism belonging to the genus Asaccharobacter.
- Bacteroides, Bifidobacterium, Eggerthella, Enterococcus, Eubacterium, Lactobacillus, Lactococcus, Sharpea, Slackia examples include microorganisms belonging to the genus and microorganisms belonging to the genus Streptococcus. Of these, microorganisms belonging to the genus Adlercreutzia, which belong to the genus Asaccharobacter, are preferable.
- microorganisms belonging to the genus Adlercreutzia include microorganisms belonging to the genus Adlercreutzia equiolifaciens and microorganisms belonging to the genus Adlercreutzia mucosicola.
- microorganisms belonging to the genus Asaccharobacter include microorganisms belonging to the genus Asaccharobacter.
- microorganisms belonging to the genus Bacteroides ovatus include microorganisms belonging to the genus Bifidobacterium animalis, microorganisms belonging to Bifidobacterium breve, microorganisms belonging to Bifidobacterium longum, and microorganisms belonging to the genus Bifidobacterium pseudolongum.
- microorganisms belonging to the genus Lactobacillus include microorganisms belonging to the genus Lactobacillus fermentum, microorganisms belonging to Lactobacillus intestinalis, microorganisms belonging to Lactobacillus plantarum, and microorganisms belonging to the genus Lactobacillus rhamnosus.
- microorganisms include microorganisms belonging to Lactococcus garvieae
- examples of microorganisms belonging to the genus Sharpea include microorganisms belonging to the genus Sharpea azabuensis
- microorganisms belonging to the genus Slackia include microorganisms belonging to the genus Slackia equiolifaciens and microorganisms belonging to the genus Slackia isoflavoniconvertens.
- microorganisms belonging to the genus Streptococcus include microorganisms belonging to the genus Streptococcus constellatus and microorganisms belonging to the genus Streptococcus intermedius.
- microorganisms belonging to Adlercreutzia equiolifaciens include Adlercreutzia equiolifaciens FJC-B9T strains
- examples of microorganisms belonging to Adlercreutzia mucosicola include Adlercreutzia mucosicola Mt1B8 strains.
- Asaccharobacter celatus DSM 18785 strain is mentioned
- Bacteroides ovatus E-23-15 strain is mentioned as a microorganism belonging to Bacteroides ovatus
- Bifidobacterium breve ATCC 15700 strain is mentioned as a microorganism belonging to Bifidobacterium breve, and it belongs to Bifidobacterium longum.
- microorganisms examples include Bifidobacterium longum BB536 strains, examples of microorganisms belonging to the genus Eggerthella include Eggerthella sp. YY7918 strains and Eggerthella sp. D1 strains, and examples of microorganisms belonging to Enterococcus faecalis include Enterococcus faecalis IINA P333 strains. Examples of microorganisms belonging to the genus Eubacterium include Eubacterium sp.
- examples of microorganisms belonging to Lactobacillus fermentum include Lactobacillus fermentum DPPMA114 strains
- examples of microorganisms belonging to Lactobacillus intestinalis include Lactobacillus intestinalis KTCT13676BP.
- Examples of microorganisms belonging to Lactobacillus plantarum include Lactobacillus plantarum DPPMA24W strain, Lactobacillus plantarum DPPMASL33 strain
- examples of microorganisms belonging to Lactobacillus rhamnosus include Lactobacillus rhamnosus INIA P540 strain.
- Lactobacillus rhamnosus DPPMAAZ1 strain is mentioned
- Lactococcus garvieae 20-92 strain is mentioned as a microorganism belonging to Lactococcus garvieae
- Sharpea azabuensis ST18 strain is mentioned as a microorganism belonging to Sharpea azabuensis
- Slackia equiolifaciens is a microorganism belonging to Slackia equiolifaciens.
- Slackia equiolifaciens DZE strain examples of microorganisms belonging to Slackia isoflavoniconvertens include Slackia isoflavoniconvertens HE8 strains, and examples of microorganisms belonging to the genus Slackia include Slackia sp. TM-30 strain, Slackia sp. FJK1 strain, Slackia sp. .NATTS strain, Slackia sp.
- the anaerobic microorganism is cultivated by containing a soybean germ extract in a medium under conditions suitable for the production of equols.
- the conditions suitable for the production of the equols refer to the conditions under which the survival and activity of the anaerobic microorganism having the activity of producing equols is maintained. More specifically, it means that the gas phase condition (anaerobic condition) in which the anaerobic microorganism can survive is maintained, and nutrients for supporting the activity and proliferation of the anaerobic microorganism are provided.
- Various medium compositions suitable for the survival of the anaerobic microorganisms are known. Therefore, those skilled in the art can select an appropriate medium composition when using the anaerobic microorganism. For example, a BHI medium manufactured by Difco, a GAM bouillon medium manufactured by Nissui Pharmaceutical Co., Ltd. used in the examples, or the like can be used.
- a water-soluble organic substance can be added to the medium as a carbon source.
- water-soluble organic substances include saccharides such as sorbose, fructose and glucose; alcohols such as methanol; organic acids such as valeric acid, butyric acid, propionic acid, acetic acid and formic acid.
- concentration of the organic substance added to the medium as a carbon source can be appropriately adjusted in order to efficiently grow the anaerobic microorganism in the medium. In general, excess or deficiency can be avoided by selecting the addition amount from the range of 0.1 to 10 wt / vol%.
- a nitrogen source is added to the medium.
- various nitrogen compounds that can be used for ordinary fermentation can be used.
- Preferred inorganic nitrogen sources are ammonium salts and nitrates. More preferred sources of inorganic nitrogen are ammonium sulfate, ammonium chloride, ammonium phosphate, ammonium hydrogen phosphate, potassium nitrate and sodium nitrate.
- preferred organic nitrogen sources are amino acids, yeast extracts, peptones (eg, polypeptone N, etc.), meat extracts, liver extracts, digested serum powder and the like. More preferred sources of organic nitrogen are arginine, cysteine, citrulline, lysine, yeast extract, peptones (eg, polypeptone N, etc.).
- organic substances or inorganic substances suitable for culturing the anaerobic microorganism can be added to the medium.
- a cofactor such as a vitamin or an inorganic compound such as various salts
- the growth and activity of the anaerobic microorganism may be enhanced.
- the following can be mentioned as microbial growth cofactors derived from inorganic compounds, vitamins, animals and plants.
- Inorganic Compounds Vitamins Potassium Dihydrogen Phosphate Biotin Biotin Magnesium Sulfate Folic Acid Manganese Sulfate Pyridoxin Sodium Chloride Thiamine Cobalt Chloride Riboflavin Calcium Chloride Niacin Acid Zinc Sulfate Pantothenic Acid Copper Sulfate Vitamin B12 Akira thiooctic acid sodium molybdic acid p-aminobenzoic acid potassium chloride boric acid, etc. Nickel chloride nickel tungstate sodium tungstate sodium ferrous sulfate ammonium ferrous
- the medium can be liquid, semi-solid, or solid.
- a preferred medium form is a liquid medium.
- the anaerobic microorganism can be cultured according to a known method for culturing an anaerobic microorganism.
- a continuous fermentation system that can continuously supply a medium or a substrate gas and has a mechanism for recovering a culture is suitable.
- the normally used culture tank can be used as it is.
- a culture tank that can also be used for culturing the anaerobic microorganism is commercially available.
- An anaerobic atmosphere can be created by substituting the oxygen mixed in the culture tank with an inert gas such as nitrogen or a substrate gas.
- a culture tank with additional functions can be used as the culture tank.
- a bubble tower type culture tank, a draft tube type culture tank, and the like can be used.
- the anaerobic microorganism is free-dispersed by the mixed gas blown into the liquid medium, and the anaerobic microorganism and the medium can be sufficiently brought into contact with each other.
- the anaerobic microorganisms are applied to a highly breathable slag such as a biotrickling filter, other ceramic-based inorganic packed materials, or a packed layer of an organic synthetic substance such as polypropylene while dripping water. It can also be inhabited and cultivated while aerating gas there.
- the anaerobic microorganism to be used can also be immobilized on carrageenan gel, alginate gel, acrylamide gel, chitin, cellulose, agar and the like by a conventional method.
- a stirrer or the like can be used to sufficiently stir the medium.
- the chances of contacting the medium components and the substrate gas with the anaerobic microorganisms can be increased, and the efficiency of producing equols can be optimized. It is also possible to supply the substrate gas as nanobubbles.
- the pH of the culture is preferably 5.0 to 8.0, more preferably 6.0 to 7.5, still more preferably 6.5 to 7.5.
- the temperature of the culture tank is not particularly limited, but is preferably 30 ° C to 40 ° C, more preferably 33 ° C to 38 ° C because the amount of equol recovered can be increased.
- the fermentation time can be appropriately set according to the amount of equol produced, the amount of residual soybean germ extract, and the like. For example, 8 to 120 hours, preferably 12 to 72 hours, particularly preferably 16 to 60 hours.
- the hydrogen concentration is not particularly limited.
- the obtained culture solution may be solid-liquid separated by filtration, centrifugation, or the like, and the liquid phase may be recovered.
- the filtration include filtration using a filter paper or an ultrafiltration membrane
- examples of the centrifugation include centrifugation using a centrifuge such as a spardecanter.
- the obtained culture solution may be used as it is without solid-liquid separation.
- the fermented product of the soybean germ extract can be used by solidifying the obtained culture solution by heat-drying treatment, spray-drying treatment, or freeze-drying treatment, if necessary. Both the heat drying treatment and the spray drying treatment can be performed using, for example, a spray drying device.
- the freeze-drying process can be performed using a freeze-drying device.
- the fermented product which has been heat-dried, spray-dried, or freeze-dried may be subjected to a pulverization treatment, if necessary.
- the heat-dried, spray-dried, or freeze-dried fermented product obtained by such a method can contain 0.05 to 50% by mass of equols in the dry powder.
- 0.05 to 50% by mass of equols in the dry powder For example, 0.1%, 0.5%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 20%, 30%, 40%.
- the mass% concentration indicated by the concentration range in which the mass% concentration at two points selected from 50% is the lower limit (-or higher or higher) and the upper limit (-or lower or lower). Is preferable.
- the fermented product of the soybean germ extract was prepared as follows. First, a seed culture solution of an anaerobic microorganism used for fermentation was prepared. That is, 5.9 g of GAM bouillon medium (manufactured by Nissui Pharmaceutical Co., Ltd.) and 1.2 g of L-arginine hydrochloride were dissolved in 100 mL of pure water, and 10 mL each was passed through nitrogen gas in 18 mm test tubes for anaerobic bacteria culture (manufactured by Sanshin Kogyo). ), Covered with a butyl rubber stopper and a plastic cap, and sterilized at 115 ° C for 15 minutes.
- GAM bouillon medium manufactured by Nissui Pharmaceutical Co., Ltd.
- L-arginine hydrochloride L-arginine hydrochloride
- the anaerobic microorganism Asaccharobacter celatus DSM 18785 strain which had been cryopreserved at -80 ° C, was inoculated into this medium, and the gas phase was replaced with hydrogen gas through a sterile filter for 2 minutes or longer. After that (partial pressure partial pressure percent concentration of hydrogen 100%), shaking culture was carried out at 37 ° C. and 250 spm for 18 hours to prepare a seed culture medium.
- isoflavone-80 (manufactured by J-Oil Mills) 11 g, yeast extract 3 g, L-cysteine hydrochloride 0.5 g, hemin 0.002 g, ⁇ -cyclodextrin 16.5 g, L-arginine hydrochloride 12.1 g, olein.
- a medium containing 0.1 g of acid and 0.2 g of antifoaming agent and adjusted to 1000 mL with deionized water to a pH of 7.1, and add 1000 mL to a 2 L pressurized miniger (manufactured by Automatic System Research). After passing through nitrogen gas for 20 minutes or more, the mixture was sterilized at 115 ° C. for 15 minutes.
- the isoflavone-80 (manufactured by J-Oil Mills) contains soy isoflavone glycosides (daidzin, glycitein, and genistin) obtained by domestic extraction and purification from North American soybean germ as a raw material with high purity.
- the equol content was 6.5%.
- the components other than equol in the fermented product were protein 43 g, lipid 3 g, carbohydrate 50 g, sodium 50 mg, and ash content 2 g per 100 g.
- the calorific value of the fermented product was 400 kcal per 100 g.
- Example 1 A test diet for 30 healthy women aged 40 to under 65 who are non-equol producers and do not have postmenopausal menopause (simplified menopause index is 70 points or less) for 12 weeks, 1 Twice a day, one tablet was ingested with water or lukewarm water.
- QOL was evaluated using the anti-aging QOL common questionnaire before and 8 weeks after ingestion. The evaluation was performed according to the manual of the anti-aging QOL common questionnaire. That is, answer in 5 stages of "1. None", “2. Almost none", “3. A little”, “4. Medium”, and "5. Advanced", and 1 point is 1 point. 5 was scored as 5 points.
- the test results were treated as non-parametric data, and the comparison between before and 8 weeks after ingestion was performed by Wilcoxon signed rank test and judged by two-sided test.
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Abstract
Description
一方で、当該更年期症状や当該女性特有の身体的及び精神的不快症状を有する人以外が、エクオールを摂取したときにクオリティオブライフ(QOL)が改善することは知られていない。
〔2〕前記QOL改善が、身体の症状の改善又は心の症状の改善である、〔1〕に記載の組成物。
〔3〕前記身体の症状の改善が、眼精疲労の改善、身体の痛みの改善、心臓の虚血の改善、疲労の改善、口渇の改善、肌の調子の改善、気管支炎の改善、白髪の改善、自律神経のバランスの改善、難聴の改善、むくみの改善、頻尿の改善、不眠の改善、体重の維持、整胃、免疫力の向上、整腸、又は育毛である、〔2〕に記載の組成物。
〔4〕前記心の症状の改善が、怒りの改善、活気の改善、抑うつの改善、友好の改善、混乱の改善、又は不安の改善である、〔2〕に記載の組成物。
〔5〕前記QOLが、抗加齢QOL共通問診票により評価される、〔1〕~〔4〕のいずれかに記載の組成物。
〔6〕前記エクオール類の1日の摂取量が1mg以上である、〔1〕~〔5〕のいずれかに記載の組成物。
〔7〕飲食品である、〔1〕~〔6〕のいずれかに記載の組成物。
エクオール類の具体例としては、上記一般式(1)で表される化合物に含まれる化合物すべてが挙げられ、具体的には、エクオール(4’,7-イソフラバンジオールと称されることもある。)、5-ヒドロキシエクオール等が挙げられる。
閉経とは、公益社団法人日本産科婦人科学会によれば、卵巣の活動性が次第に消失し、ついに月経が永久に停止した状態をいうものとされ、月経が来ない状態が12か月以上続いた時に、1年前を振り返って閉経とされている。閉経後とは、閉経時及びそれ以降をいう。閉経は常法により確認することができる。
更年期障害とは、厚生労働省によれば、性ホルモン分泌量の低下が原因となる自律神経失調症に似た症候群のことをいうものとされている。対象が更年期障害にあるか否かは常法により確認することができる。例えば、簡略更年期指数(SMI)チェック表が挙げられ、71点以上の場合に対象が更年期障害にあると確認できる。
前記対象の年齢は、好ましくは満40歳以上、より好ましくは満45歳以上、さらに好ましくは満50歳以上であり、一方で、好ましくは満80歳以下、より好ましくは満75歳以下、さらに好ましくは満65歳以下である。
本実施態様におけるQOLの改善とは、対象がエクオール類を摂取しないとき(又はプラセボを摂取したとき)よりも、対象が本実施態様のエクオール類を摂取したときの方が、QOLが向上することをいう。
本実施態様に係るQOL改善用組成物は、QOLの低下を抑制するために予防的に摂取するものであってもよいし、QOLを維持するために摂取するものであってもよい。
本実施態様におけるQOL改善の評価は、医師等による客観的な判断であってもよいが、専門家の開発した検査や質問票などにより客観的な尺度によって評価されるものであることが好ましい。
本実施態様における身体の痛み(ただし、眼痛、頭痛、及び胃痛を除く。)の改善は、好ましくは、筋肉痛の改善、身体の凝り(例えば、全身の凝り、肩の凝り、背中の凝り、及び腰の凝り)の改善、腰痛の改善、又は関節痛の改善である。
本実施態様における心臓の虚血の改善は、好ましくは、動悸の改善、又は息切れの改善である。
本実施態様における疲労(ただし、眼精疲労、及び目が疲れることを除く。)の改善は、好ましくは、身体がだるいことの改善、又は健康感がないことの改善である。
本実施態様における肌の調子の改善は、好ましくは、肌の不調の改善である。
本実施態様における気管支炎とは、咳が出やすいことの改善、又は痰が出やすいことの改善及び/又は痰が切れにくいことの改善である。
本実施態様における自律神経のバランスの改善は、好ましくは、頭痛の改善、めまいの改善、汗をかきやすいことの改善、のぼせの改善、又は冷え性の改善である。
本実施態様における難聴の改善は、好ましくは、耳鳴りの改善、又は会話が聞きづらいことの改善である。
本実施態様における不眠の改善は、好ましくは、眠りが浅いことの改善、寝つきが悪いことの改善、又は心配ごとでよく眠れないことの改善である。
本実施態様における体重の維持は、好ましくは、太りやすいことの改善、やせることの改善、又は体重の減少の改善である。
本実施態様における整胃は、好ましくは、食欲不振の改善、胃が張ることの改善、又は胃痛の改善である。
本実施態様における免疫力の向上は、好ましくは、風邪をひきやすいことの改善である。
本実施態様における整腸は、好ましくは、下痢の改善、又は便秘の改善である。
本実施態様における育毛は、好ましくは、抜け毛(脱毛)の改善である。
本実施態様における活気の改善は、好ましくは、意欲がわかないことの改善、幸せと感じないことの改善、生きがいがないと感じることの改善、日常生活が楽しくないと感じることの改善、自信を失ったと感じることの改善、又は自分が役に立つ人間ではないと感じることの改善である。
本実施態様における抑うつの改善は、好ましくは、憂うつの改善である。
本実施態様における友好の改善は、好ましくは、人と話すのが嫌と感じることの改善である。
本実施態様における混乱の改善は、好ましくは、くよくよすることの改善、ど忘れをすることの改善、集中できないことの改善、問題を解決できないことの改善、又は物事を容易に判断できないことの改善である。
本実施態様における不安の改善は、緊張の改善、理由なく不安になることの改善、又は何か恐怖心を感じることの改善である。
抗加齢QOL共通問診票による評価で行う場合、その評価で得られる各因子の数値が減少することでQOLが改善した評価することができる。
前記心の症状の改善をPOMS2による評価で行う場合、前記心の症状、怒り、活気、抑うつ、友好、混乱、及び不安は、それぞれ、POMS2における、「総合的気分状態」、「怒り-敵意」、「活気-活力」、「抑うつ-落込み」、「友好」、「混乱-当惑」、及び「不安-緊張」に相当する。
前記心の症状の改善をPOMS2による評価で行う場合、その評価で得られる「総合的気分状態」、「怒り-敵意」、「混乱-当惑」、「抑うつ-落込み」、「疲労-無気力」、及び「緊張-不安」の各因子の数値が減少することで前記心の症状が改善したと評価することができ、「活気‐活力」及び「友好」の各因子の数値が増加することで前記心の症状が改善したと評価することができる。
例えば、「整腸」は、「おなかの調子を整える」や「お通じを改善する」などと記載することができる。
また、「眼精疲労の改善」は、「眼の疲労感を緩和する」や「目のピント調節をサポートする」などと記載することができる。
また、「不眠の改善」は、「質の良い睡眠をサポートする」などと記載することができる。
また、「疲労の改善」は、「精神的・肉体的疲労感を軽減する」などと記載することができる。
また、「活気の改善」は、「一時的に落ち込んだ気分を前向きにする」、「一時的に落ち込んだ気分を積極的な気分にする」、「一時的に落ち込んだ気分を生き生きとした気分にする」、「一時的に落ち込んだ気分をやる気にする」などと記載することができる。
したがって、本実施態様に係るQOL改善用組成物は、エクオール類を含む組成物を含有する、閉経後で更年期障害を有しない満40歳以上の女性のための、QOL改善用組成物であってよい。
また、本実施態様に係るQOL改善用組成物は、大豆胚芽抽出物の発酵物であってエクオール類を含むものを含有する、閉経後で更年期障害を有しない満40歳以上の女性のための、QOL改善用組成物であってよい。
また、本実施態様に係るQOL改善用組成物は、大豆胚芽抽出物の発酵によって得られたエクオール類を含有する、閉経後で更年期障害を有しない満40歳以上の女性のための、QOL改善用組成物であってよい。
前記イソフラボンアグリコンの例として、ダイゼイン、6-ヒドロキシダイゼイン、ジヒドロキシダイゼイン、ゲニステイン、グリシテイン、ビオカニンA、フォルモネチン、及びクメストロールなどを挙げることができる。イソフラボンアグリコンは、イソフラボン類が、β-グルコシダーゼ等の酵素や、β-グルコシダーゼを有する微生物により変換されたものであってもよい。
前記配糖体の例として、ゲニスチン、グリシチン、ダイジン、プエラリンなどを挙げることができる。
発酵に用いる大豆胚芽抽出物の量や濃度は、発酵により発酵物となった際にエクオール類を含む限り特に限定されない。また、好ましい態様において大豆胚芽抽出物がイソフラボン類を含む場合の発酵に用いるイソフラボン類の量や濃度も特に限定されない。また、好ましい態様においてイソフラボン類単体を用いる場合の発酵に用いるイソフラボン類の量や濃度も特に限定されない。培養液の量や製造しようとするエクオール類の量に応じて適宜設定することができる。
炭素源としての培地に加える有機物の濃度は、培地中の前記嫌気性微生物を効率的に発育させるために適宜調節することができる。一般的には、0.1~10wt/vol%の範囲から添加量を選択することによって、過不足を避けることができる。
一方、好ましい有機窒素源はアミノ酸類、酵母エキス、ペプトン類(例えばポリペプトンNなど)、肉エキス、肝臓エキス、消化血清末などである。より好ましい有機窒素源はアルギニン、システイン、シトルリン、リジン、酵母エキス、ペプトン類(例えばポリペプトンNなど)である。
無機化合物 ビタミン類
リン酸二水素カリウム ビオチン
硫酸マグネシウム 葉酸
硫酸マンガン ピリドキシン
塩化ナトリウム チアミン
塩化コバルト リボフラビン
塩化カルシウム ニコチン酸
硫酸亜鉛 パントテン酸
硫酸銅 ビタミンB12
明ばん チオオクト酸
モリブデン酸ソーダ p-アミノ安息香酸
塩化カリウム
ホウ酸等
塩化ニッケル
タングステン酸ナトリウム
セレン酸ナトリウム
硫酸第一鉄アンモニウム
嫌気性微生物の培養においては、連続培養システム内への酸素の混入を防ぐことが必要である。培養器は通常用いられる培養槽がそのまま利用できる。前記嫌気性微生物の培養にも利用することができる培養タンクが市販されている。培養槽内に混入する酸素を、窒素などの不活性気体あるいは基質ガスなどで置換することにより、嫌気的な雰囲気を作ることができる。
発酵時間は、エクオール類の生成量、大豆胚芽抽出物の残存量等に応じて適宜設定できる。例えば8~120時間、好ましくは12~72時間、特に好ましくは16~60時間である。
加熱乾燥処理、噴霧乾燥処理、又は凍結乾燥処理された発酵物は、必要に応じて粉末化処理に供してもよい。
原料として、エクオール(5 mg)を含む、大豆胚芽抽出物の発酵物(84 mg)、136.8 mgの難消化性デキストリン、6.9 mgのステアリン酸Ca、2.3 mgの二酸化ケイ素をHPMCカプセルに充填し、QOL改善用組成物として製造して、後述する試験に試験食として使用した。
まず、発酵に用いる嫌気性微生物の種培養液を調製した。すなわち、GAMブイヨン培地(日水製薬製)5.9 gとL-アルギニン塩酸塩1.2 gを純水100 mLに溶かし、窒素ガスを通じながら10 mLずつ嫌気性菌培養用18 mm試験管(三紳工業製)に分注し、ブチルゴム栓、プラスチックキャップをして115℃、15分間滅菌した。この培地に-80℃で凍結保存していた嫌気性微生物であるアサッカロバクター・セラツス(Asaccharobacter celatus)DSM 18785株を植菌し、無菌フィルターを通した水素ガスで気相を2分間以上置換した後(水素の分圧パーセント濃度 100%)、37℃、250 spmで18時間振とう培養を行い、種培養液を調製した。
次に、イソフラボン-80(J-オイルミルズ社製)11 g、酵母エキス3 g、L-システイン塩酸塩0.5 g、ヘミン0.002 g、β-シクロデキストリン16.5g、L-アルギニン塩酸塩12.1g、オレイン酸0.1g、消泡剤0.2 gを含み、脱イオン水で1000 mLに合わせたものであって、pH 7.1とした培地を調製し、1000 mLを2 L容加圧ミニジャー(オートマチックシステムリサーチ製)に入れ、窒素ガスを20分間以上通じた後、115℃、15分間滅菌した。ただし、前記イソフラボン-80(J-オイルミルズ社製)は、北米産大豆胚芽を原料に国内で抽出精製して得られた大豆イソフラボン配糖体(ダイジン、グリシチン、及びゲニスチン)を高純度に含む粉末であり(大豆機能性素材(ファイン)、[online]、株式会社J-オイルミルズ、[令和2年5月14日検索]、インターネット<https://www.j-oil.com/product/gyoumu/fine/>)、本試験では、予め市販のβ-グルコシダーゼを用いて前記配糖体を加水分解し、アグリコン化したもの(それぞれ、ダイゼイン、グリシテイン、及びゲニステイン)を用いた。
この培地に上記種培養液20 mLを植菌し、スパージャーより水素/窒素[2:98](体積比)のガスを無菌的に0.1 L/minで通気し、37℃、500 rpm、50 kPaで培養を行った。培養中pHは硫酸で7.2に調整した。48時間後、培養液を取り出した。
培養液を硫酸でpH 5.0に調整後、105℃、1分加熱処理した。室温まで冷却後、15000×g、10 分間、20℃で遠心分離を行った。本上清液をスプレードライすることで、前記発酵物を得た。エクオールの含有量は6.5 %であった。また、前記発酵物におけるエクオール以外の成分は、100gあたり、タンパク質43 g、脂質3 g、炭水化物50 g、ナトリウム50 mg、灰分2 gであった。また、前記発酵物の熱量は100 gあたり400 kcalであった。
満40歳以上満65歳未満のエクオール非生産者で、閉経後で更年期障害を有しない(簡略更年期指数が70点以下である)健康な女性30名を対象に、試験食を12週間、1日2回、水またはぬるま湯で1粒ずつ摂取させた。摂取前、摂取後8週に抗加齢QOL共通問診票を用い、QOLを評価した。
なお、評価は抗加齢QOL共通問診票のマニュアルに沿って行った。すなわち、「1.全くなし」、「2.ほとんどなし」、「3.少しあり」、「4.中程度あり」、「5.高度にあり」の5段階で回答させ、1を1ポイント、5を5ポイントとしてスコア化した。
試験結果は、ノンパラメトリックなデータとして取り扱い、摂取前と摂取後8週の比較をWilcoxonの符号付順位検定し、両側検定で判定した。
結果を表1~3に示す。数値は平均値±標準偏差を示す。本実施例に係るQOL改善用組成物は、被験者のQOLを改善することが分かった。
Claims (7)
- エクオール類を含有する、閉経後で更年期障害を有しない満40歳以上の女性のための、QOL改善用組成物。
- 前記QOL改善が、身体の症状の改善又は心の症状の改善である、請求項1に記載の組成物。
- 前記身体の症状の改善が、眼精疲労の改善、身体の痛みの改善、心臓の虚血の改善、疲労の改善、口渇の改善、肌の調子の改善、気管支炎の改善、白髪の改善、自律神経のバランスの改善、難聴の改善、むくみの改善、頻尿の改善、不眠の改善、体重の維持、整胃、免疫力の向上、整腸、又は育毛である、請求項2に記載の組成物。
- 前記心の症状の改善が、怒りの改善、活気の改善、抑うつの改善、友好の改善、混乱の改善、又は不安の改善である、請求項2に記載の組成物。
- 前記QOLが、抗加齢QOL共通問診票により評価される、請求項1~4のいずれか一項に記載の組成物。
- 前記エクオール類の1日の摂取量が1mg以上である、請求項1~5のいずれか一項に記載の組成物。
- 飲食品である、請求項1~6のいずれか一項に記載の組成物。
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WO1999007392A1 (fr) * | 1997-08-08 | 1999-02-18 | Otsuka Pharmaceutical Co., Ltd. | Compositions contenant de l'isoflavone |
WO2005000042A1 (ja) * | 2003-06-30 | 2005-01-06 | Otsuka Pharmaceutical Co., Ltd. | エクオール産生乳酸菌含有組成物 |
JP2006508942A (ja) * | 2002-10-29 | 2006-03-16 | コロラド ステート ユニバーシティー リサーチ ファウンデーション | アンドロゲンによって仲介される疾患を治療するためのエクオールの使用 |
WO2007066655A1 (ja) * | 2005-12-06 | 2007-06-14 | Otsuka Pharmaceutical Co., Ltd. | エクオール含有大豆胚軸発酵物、及びその製造方法 |
WO2008153158A1 (ja) * | 2007-06-13 | 2008-12-18 | Otsuka Pharmaceutical Co., Ltd. | エクオール含有抽出物及びその製造方法、エクオール抽出方法、並びにエクオールを含む食品 |
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WO1999007392A1 (fr) * | 1997-08-08 | 1999-02-18 | Otsuka Pharmaceutical Co., Ltd. | Compositions contenant de l'isoflavone |
JP2006508942A (ja) * | 2002-10-29 | 2006-03-16 | コロラド ステート ユニバーシティー リサーチ ファウンデーション | アンドロゲンによって仲介される疾患を治療するためのエクオールの使用 |
WO2005000042A1 (ja) * | 2003-06-30 | 2005-01-06 | Otsuka Pharmaceutical Co., Ltd. | エクオール産生乳酸菌含有組成物 |
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JP7159511B1 (ja) * | 2020-11-26 | 2022-10-24 | 株式会社ダイセル | 肌改善用組成物 |
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