WO2015146844A1 - 睡眠の質改善剤 - Google Patents
睡眠の質改善剤 Download PDFInfo
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- WO2015146844A1 WO2015146844A1 PCT/JP2015/058528 JP2015058528W WO2015146844A1 WO 2015146844 A1 WO2015146844 A1 WO 2015146844A1 JP 2015058528 W JP2015058528 W JP 2015058528W WO 2015146844 A1 WO2015146844 A1 WO 2015146844A1
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- sleep quality
- sleep
- lactobacillus casei
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
- A61K31/685—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Definitions
- the present invention relates to an agent for improving sleep quality in poor sleepers.
- Sleep deprivation is said to cause obesity, high blood pressure, poor concentration, depression, diabetes, etc., and it is important to eliminate sleep deprivation.
- Non-patent Document 1 amino acid intake, plant extracts, fragrances, Lactobacillus lactic acid bacteria or fermented products thereof, and phosphatidylserine
- Patent Documents 1 to 5 amino acid intake, plant extracts, fragrances, Lactobacillus lactic acid bacteria or fermented products thereof, and phosphatidylserine
- Non-patent Document 1 Lactobacillus lactic acid bacteria and the like have been reported not to have an effect of shortening the sleep latency (Non-patent Document 1), and have not been reported at all to exhibit an effect of improving difficulty in awakening during the daytime.
- the present invention is to provide a new sleep quality improving agent.
- the present inventor has made various studies to find not only the sleep time but also the quality of sleep, in particular, to find a component that makes it possible to sleep so as not to sleep during the day, and among the Lactobacillus genus, It was found that the quality of sleep, particularly difficulty in awakening during the day, can be significantly improved by ingesting the casei fungus body or a processed product thereof, and the present invention has been completed.
- the present invention provides the following [1] to [28].
- [1] An agent for improving sleep quality comprising Lactobacillus casei cells and / or a processed product thereof as an active ingredient.
- a method for improving sleep quality comprising administering an effective amount of Lactobacillus casei cells and / or a processed product thereof.
- the method according to [22], wherein the Lactobacillus casei is Lactobacillus casei YIT9029 (FERM BP-1366).
- Ingestion of Lactobacillus casei and / or a processed product thereof improves the quality of sleep, and particularly provides an effect of shortening the sleep latency and / or an effect of improving difficulty in awakening during the day.
- the active ingredient of the sleep quality improving agent of the present invention is Lactobacillus casei cells and / or processed products thereof.
- the strain is not particularly limited as long as it is Lactobacillus casei.
- Preferred examples include Lactobacillus casei YIT 9018 (FERM BP-665), Lactobacillus casei YIT 9029 (FERM BP-1366), Lactobacillus casei YIT 10003. (FERM BP-7707) is mentioned, and Lactobacillus casei YIT9029 (FERM BP-1366) is particularly preferable from the viewpoint of the effect of improving sleep quality.
- the treated bacterial cell refers to a bacterium (Lactobacillus casei) to which some treatment is added, and the treatment is not particularly limited.
- the processed product of Lactobacillus casei include cell lysates and the like. Specifically, a disrupted solution by ultrasonication of Lactobacillus casei, an enzyme-treated solution of Lactobacillus casei, and filtration or centrifugation of them. Examples thereof include solid residues separated by solid-liquid separation means such as separation. Further, a nucleic acid-containing fraction obtained by dissolving Lactobacillus casei with a surfactant or the like and then precipitating with ethanol or the like is also included.
- dead cells are also included, and the dead cells can be obtained by, for example, heat treatment, treatment with drugs such as antibiotics, treatment with chemical substances such as formalin, treatment with ultraviolet rays, treatment with radiation such as ⁇ rays. it can. Of these treatments, ultrasonic treatment, enzyme treatment, and heat treatment are particularly preferable.
- living cells are more preferable from the viewpoint of the effect of improving sleep quality.
- Lactobacillus casei cells and / or processed products thereof only need to contain the cells or processed products thereof, but in terms of ease of intake, continuity of intake, sleep quality improvement effect, etc. It is more preferable to use a fermented product containing Lactobacillus casei.
- fermented products include fermented milk, fermented soymilk, fermented fruit juice, fermented vegetable liquid, etc., but fermented milk is more preferable.
- the fermented product containing Lactobacillus casei is, for example, cultivating Lactobacillus casei in milk components such as milk, milk powder, fat milk powder, skim milk powder, etc. at a temperature of 30-40 ° C. for 5-24 hours. Can be obtained. Examples of the culture include standing, stirring, shaking, aeration and the like. More preferably, Lactobacillus casei is inoculated and cultured in a sterilized milk medium alone or simultaneously with other microorganisms, and this is homogenized to obtain a fermented milk base. Next, a separately prepared syrup solution may be added and mixed, homogenized with a homogenizer or the like, and then a flavor may be added to finish the final product.
- a separately prepared syrup solution may be added and mixed, homogenized with a homogenizer or the like, and then a flavor may be added to finish the final product.
- the fermented product includes beverages such as fermented milk and dairy lactic acid bacteria beverages, hard yoghurt, soft yoghurt, plain yoghurt and the like specified by a ministerial ordinance.
- the fermented product of the present invention includes foods and drinks using Lactobacillus casei, such as plain type, flavored type, fruit type, sweetness type, soft type, drink type, solid (hard) type, frozen type, etc. Fermented milk, lactic acid bacteria beverages and the like.
- These fermented products if necessary, in addition to sweeteners such as syrup, various other food materials such as various sugars, thickeners, emulsifiers, various vitamins, antioxidants, stabilizers, etc. These optional components can be blended. Specific examples of these food materials include sugars such as sucrose, glucose, fructose, palatinose, trehalose, lactose, xylose, maltose, sorbitol, xylitol, erythritol, lactitol, palatinit, reduced starch syrup, reduced maltose starch syrup, etc.
- High-sweetness sweeteners such as sugar alcohol, aspartame, thaumatin, sucralose, acesulfame K, stevia, agar, gelatin, carrageenan, guar gum, xanthan gum, pectin, locust bean gum, gellan gum, carboxymethylcellulose, soy polysaccharide, propylene glycol alginate, etc.
- Various thickeners stable), sucrose fatty acid ester, glycerin fatty acid ester, polyglycerin fatty acid ester, sorbitan fatty acid ester, lecithin emulsifier, etc.
- Milk fat such as cream, butter, sour cream
- acidulants such as citric acid, lactic acid, acetic acid, malic acid, tartaric acid, gluconic acid
- various vitamins such as vitamin A, vitamin B, vitamin C, vitamin E, calcium , Magnesium, zinc, iron, manganese and other minerals, yogurt, berry, orange, pear, perilla, citrus, apple, mint, grape, apricot, pair, custard cream, peach, Flavors such as melon, banana, tropical, herbal, tea and coffee can be mentioned.
- microorganisms other than Lactobacillus casei can be used in combination.
- microorganisms include Bifidobacterium breve, Bifidobacterium longum (B. longum), Bifidobacterium bifidum (B. bifidum), Bifidobacterium animalis ( B. animalis), B. suis, B. infantis, B. adolescentens, Bifidobacterium catenulatum (B. catenatum), B. pseudocatenatum, B. lactis Bifidobacterium bacteria such as B. globosum, L. acidophilus, L. plantarum, L. buchneri L.
- Lactis Lactococcus lactis subspecies. Lactococcus genus bacteria such as Lactococcus lactis subsp. Cremoris, Enterococcus faecalis, Enterococcus facilis such as E. faecium, genus Bacillus s. Saccharomyces cerevisiae, Torulaspora derbrueckii, Candida kefyr, etc., Saccharomyces genus belonging to the genus Saccharomyces cerevisiae, Candida kefyr, etc.
- Lactobacillus casei a fermented product produced by using at least one selected from Lactobacillus bacteria, Streptococcus bacteria, and Lactococcus bacteria other than Lactobacillus casei provides high palatability and is easy to ingest This is preferable.
- Specific examples thereof include Yakults such as “Yakult”, “New Yakult”, “Yakult 400”, “Joa”, “Sofur”, “Puyara”, “Pretio”, etc., and especially Lactobacillus casei live bacteria Use of Yakults is preferable because it contains a large number.
- the sleep quality improving agent of the present invention contains phosphatidylserine in addition to the above components.
- the content of phosphatidylserine is preferably 100 mg or more as a daily intake, and more preferably 300 mg or more as a daily intake.
- the phosphatidylserine may be derived from animals or plants, but is preferably derived from plants, and more preferably phosphatidylserine derived from soybeans.
- the Lactobacillus casei microbial cell or a processed product thereof exhibits an excellent sleep quality improving action.
- the sleep quality improvement effect include a sleep sleep latency shortening effect, a daytime awakening difficulty improvement effect, a midway awakening number reduction effect, and the like.
- the daytime awakening difficulty improvement effect is particularly excellent.
- the effect of improving the difficulty in awakening during the day exhibited by the sleep quality improving agent of the present invention is not obtained simply by increasing the sleep time, but is obtained by improving the sleep quality itself. Therefore, it is particularly excellent in that the sleep effect obtained with respect to sleep per unit time is remarkably improved.
- the sleep quality improving agent of the present invention is particularly suitable for humans who feel sleep deprivation, humans who feel poor sleep, humans who wake up during sleep, humans who feel sleepy during the day, etc. It is valid.
- the sleep quality improving agent of the present invention exhibits an excellent sleep quality improving effect on a human having a worse sleep state.
- “The sleep state is bad” means, for example, that the PSQI total score before drinking the improving agent is preferably 4 points or more, more preferably 7 points or more, and particularly preferably 8 points or more.
- the sleep quality improving agent of the present invention preferably ingests Lactobacillus casei as a fermented product containing live Lactobacillus casei as described above, and its daily intake is 10 5 cfu as the number of viable bacteria.
- the above is preferable, 10 8 cfu or more is more preferable, 10 10 cfu or more is more preferable, and 10 11 cfu or more is particularly preferable.
- the number of intake days is preferably 5 days or more, more preferably 2 weeks or more, further preferably 4 weeks or more, and particularly preferably 8 weeks or more.
- the sleep quality improving agent of the present invention can be used either orally or parenterally, but oral administration is preferred.
- the composition containing the active ingredient is mixed with a solid or liquid non-toxic pharmaceutical carrier suitable for administration methods such as oral administration, rectal administration and injection, and administered in the form of a conventional pharmaceutical preparation.
- a solid or liquid non-toxic pharmaceutical carrier suitable for administration methods such as oral administration, rectal administration and injection
- administration methods such as oral administration, rectal administration and injection
- administration methods such as oral administration, rectal administration and injection
- a conventional pharmaceutical preparation such as solid preparations such as tablets, granules, dispersions and capsules, liquid preparations such as solutions, suspensions and emulsions, and freeze-dried preparations. These preparations can be prepared by conventional means on the preparation.
- non-toxic pharmaceutical carrier examples include glucose, lactose, sucrose, starch, mannitol, dextrin, fatty acid glyceride, polyethylene glycol, hydroxyethyl starch, ethylene glycol, polyoxyethylene sorbitan fatty acid ester, amino acid, gelatin, albumin , Water, physiological saline and the like. If necessary, conventional additives such as a stabilizer, a wetting agent, an emulsifier, a binder, an isotonic agent, and an excipient can be appropriately added.
- Production Example 1 (Production of fermented milk containing Lactobacillus casei) A syrup was mixed with skim milk powder solution inoculated with Lactobacillus casei strain YIT 9029, fermented at 37 ° C., added with fragrance, then homogenized and filled into a container to obtain a fermented product.
- the number of Lactobacillus casei bacteria in 100 mL of this fermented product was 10 11 cfu.
- the unfermented thing which did not contain Lactobacillus casei and adjusted the flavor by adding lactic acid equivalent to a fermented product was used.
- about another composition it is the same as a fermented material.
- Test example 1 To 100 men and women in their 30s to 40s (placebo group 50 people, fermented product group 50 people) with a high depression score in the mood profile test (POMS) (depression subscale T score 55 to 75) The placebo or fermented product of Production Example 1 per day (100 mL) was drunk for 8 weeks. Before the start of drinking, and at the 4th and 8th weeks of drinking, a sleep state (PSQI: Pittsburgh Sleep Quality Index) was evaluated by a questionnaire. PSQI is known as a method for clinical diagnosis of sleep quality, and can evaluate sleep quality, difficulty in awakening during the day (sleepiness during the day), and the like.
- PSQI Pittsburgh Sleep Quality Index
- the PSQI total score average before drinking of all subjects was 7.0 points, and it was a subject group with poor sleep state as well as depression score.
- the effect of administration was analyzed by covariance analysis with pre-dose values as covariates, and p values are shown in FIGS.
- the PSQI total score was significantly improved throughout the drinking period (p ⁇ 0.05), and sleep was improved. It was done.
- the effect was found to be particularly remarkable in the effect of improving sleep quality and the effect of improving difficulty in awakening during the day, and these improved effects were also significant throughout the drinking period (sleep quality: p ⁇ 0 .01, difficulty in awakening during the day: p ⁇ 0.05).
- the sleep time scores of the group drinking Lactobacillus casei and the group drinking placebo were equivalent, the above-mentioned excellent effects were obtained,
- the effect exhibited by the sleep quality improving agent of the present invention is not simply due to an increase in sleep time, but is due to an improvement in the sleep quality itself, and the sleep obtained for sleep per unit time. It was confirmed that the effect was remarkably improved.
- Test example 2 16 males and females in their 20s to 40s who have subjective complaints about sleep (PSQI score 4-11 points, average 7.4 points) are divided into two groups, each containing gelatin (PS) (phosphatidylserine) 300mg in different order Gelatin soft capsules containing soft capsules (Saprissim PS, manufactured by Yakult Health Foods Co., Ltd.) or placebo (soybean white squeezed oil) were ingested for 5 days, with a washout period of 9 days.
- PS gelatin
- P phosphatidylserine
- placebo placebo
- both groups were ingested with a fermented milk product (Yakult 400 (Y400), Yakult Honsha Co., Ltd.) containing PS (phosphatidylserine) 300 mg + Lactobacillus casei 4 ⁇ 10 10 cfu for 5 days. It was.
- the subjective sleep quality during the sample intake period was evaluated in a sleep questionnaire.
- the administration effect was judged by the test of the difference with respect to the placebo drinking period (wilcoxon test).
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Abstract
Description
また、ラクトバチルス属乳酸菌等については、入眠潜時短縮効果を奏しないことが報告されており(非特許文献1)、さらに、日中覚醒困難改善効果を奏することについては何ら報告されていない。
従って、本発明は、新たな睡眠の質改善剤を提供することにある。
〔1〕ラクトバチルス・カゼイの菌体及び/又はその処理物を有効成分とする睡眠の質改善剤。
〔2〕ラクトバチルス・カゼイが、ラクトバチルス・カゼイ YIT9029(FERM BP-1366)である〔1〕記載の睡眠の質改善剤。
〔3〕1日摂取量が、ラクトバチルス・カゼイの生菌数として1010cfu以上である〔1〕又は〔2〕記載の睡眠の質改善剤。
〔4〕さらにホスファチジルセリンを含有する〔1〕~〔3〕のいずれかに記載の睡眠の質改善剤。
〔5〕睡眠の質改善剤が、入眠潜時短縮剤、日中覚醒困難改善剤及び中途覚醒数減少剤から選ばれる1種以上である〔1〕~〔4〕のいずれかに記載の睡眠の質改善剤。
〔6〕睡眠の質改善剤が、入眠潜時短縮剤及び/又は日中覚醒困難改善剤である〔1〕~〔5〕のいずれかに記載の睡眠の質改善剤。
〔7〕睡眠の質改善剤が、日中覚醒困難改善剤である〔1〕~〔6〕のいずれかに記載の睡眠の質改善剤。
〔8〕睡眠の質改善剤製造のためのラクトバチルス・カゼイの菌体及び/又はその処理物の使用。
〔9〕ラクトバチルス・カゼイが、ラクトバチルス・カゼイ YIT9029(FERM BP-1366)である〔8〕記載の使用。
〔10〕1日摂取量が、ラクトバチルス・カゼイの生菌数として1010cfu以上である〔8〕又は〔9〕記載の使用。
〔11〕さらにホスファチジルセリンを使用する〔8〕~〔10〕のいずれかに記載の使用。
〔12〕睡眠の質改善剤が、入眠潜時短縮剤、日中覚醒困難改善剤及び中途覚醒数減少剤から選ばれる1種以上である〔8〕~〔11〕のいずれかに記載の使用。
〔13〕睡眠の質改善剤が、入眠潜時短縮剤及び/又は日中覚醒困難改善剤である〔8〕~〔12〕のいずれかに記載の使用。
〔14〕睡眠の質改善剤が、日中覚醒困難改善剤である〔8〕~〔13〕のいずれかに記載の使用。
〔15〕睡眠の質改善用のラクトバチルス・カゼイの菌体及び/又はその処理物。
〔16〕ラクトバチルス・カゼイが、ラクトバチルス・カゼイ YIT9029(FERM BP-1366)である〔15〕記載の菌体及び/又はその処理物。
〔17〕1日摂取量が、ラクトバチルス・カゼイの生菌数として1010cfu以上である〔15〕又は〔16〕記載の菌体及び/又はその処理物。
〔18〕さらにホスファチジルセリンを含有する〔15〕~〔17〕のいずれかに記載の菌体及び/又はその処理物。
〔19〕睡眠の質改善が、入眠潜時短縮、日中覚醒困難改善及び中途覚醒数減少から選ばれる1種以上である〔15〕~〔18〕のいずれかに記載の菌体及び/又はその処理物。
〔20〕睡眠の質改善が、入眠潜時短縮及び/又は日中覚醒困難改善である〔15〕~〔19〕のいずれかに記載の菌体及び/又はその処理物。
〔21〕睡眠の質改善が、日中覚醒困難改善である〔15〕~〔20〕のいずれかに記載の菌体及び/又はその処理物。
〔22〕ラクトバチルス・カゼイの菌体及び/又はその処理物の有効量を投与することを特徴とする睡眠の質改善方法。
〔23〕ラクトバチルス・カゼイが、ラクトバチルス・カゼイ YIT9029(FERM BP-1366)である〔22〕記載の方法。
〔24〕1日摂取量が、ラクトバチルス・カゼイの生菌数として1010cfu以上である〔22〕又は〔23〕記載の方法。
〔25〕さらにホスファチジルセリンを投与する〔22〕~〔24〕のいずれかに記載の方法。
〔26〕睡眠の質改善が、入眠潜時短縮、日中覚醒困難改善及び中途覚醒数減少から選ばれる1種以上である〔22〕~〔25〕のいずれかに記載の方法。
〔27〕睡眠の質改善が、入眠潜時短縮及び/又は日中覚醒困難改善である〔22〕~〔26〕のいずれかに記載の方法。
〔28〕睡眠の質改善が、日中覚醒困難改善である〔22〕~〔27〕のいずれかに記載の方法。
ラクトバチルス・カゼイの処理物としては、菌体分解物等が挙げられ、具体的には、ラクトバチルス・カゼイの超音波などによる破砕液、ラクトバチルス・カゼイの酵素処理液、それらを濾過ないし遠心分離など固液分離手段によって分離した固体残渣等が挙げられる。また、ラクトバチルス・カゼイを界面活性剤等によって溶解した後、エタノール等によって沈殿させて得られる核酸含有画分も含まれる。さらに、前記ラクトバチルス・カゼイの超音波などによる破砕液、細胞の酵素処理液などに対し、例えば各種クロマトグラフィーによる分離などの分離・精製処理をさらに行ったものも含まれる。さらに、死菌体も含まれ、該死菌体は、例えば、加熱処理、抗生物質などの薬物による処理、ホルマリンなどの化学物質による処理、紫外線による処理、γ線などの放射線による処理により得ることができる。これら処理のうち、特に超音波処理、酵素処理、加熱処理が好ましい。
ここで、本発明の睡眠の質改善剤が示す日中覚醒困難改善効果は、単に睡眠時間が長くなること等により得られるものではなく、睡眠の質自体を改善することにより得られるものであるため、単位時間当たりの睡眠に対して得られる睡眠効果が顕著に改善される点で特に優れている。
ここで、本発明の睡眠の質改善剤は、より睡眠状態が悪いヒトに対して優れた睡眠の質改善作用を示す。「睡眠状態が悪い」とは、例えば、当該改善剤飲用前のPSQI総合スコアが4点以上であることが好ましく、7点以上であることがさらに好ましく、8点以上であることが特に好ましい。
ラクトバチルス・カゼイ(Lactobacillus casei)YIT 9029株を接種し、37℃で発酵させた脱脂粉乳溶液にシロップを混合し、香料を添加した後、均質化して容器に充填して発酵物を得た。この発酵物100mL中のラクトバチルス・カゼイの菌数は1011cfuであった。
また、プラセボとして、ラクトバチルス・カゼイを含まず、発酵物と同等の乳酸を添加して風味を調整した未発酵物を用いた。なお、その他の組成については、発酵物と同じである。
気分プロフィール検査(POMS:Profile of Mood States)の抑うつスコアが高め(抑うつ下位尺度T得点55~75)の30~40歳代の男女100名(プラセボ群50名、発酵物群50名)に、製造例1のプラセボ又は発酵物1日1本(100mL)を8週間飲用させた。飲用開始前、飲用4週目および8週目に、睡眠状態(PSQI:Pittsburgh Sleep Quality Index)についてアンケートをして評価した。
ここでPSQIは、睡眠の質の臨床診断をするための方法として知られており、睡眠の質、日中覚醒困難(日中の眠気)等を評価できる。なお、全被験者の飲用前のPSQI総合スコア平均は7.0点であり、抑うつスコアだけでなく睡眠状態の悪い被験者集団であった。なお、投与効果は投与前値を共変量とした共分散分析により解析し、p値を図1~図4に示す。
その結果、図1から図3に示すように、ラクトバチルス・カゼイを飲用した群では、PSQI総合スコアが飲用期間全体を通じて有意に改善し(p<0.05)、睡眠を改善することが示された。また、その効果は睡眠の質の改善効果および日中覚醒困難改善効果において特に顕著であることが判明し、これらの改善効果もまた飲用期間全体を通じて有意であった(睡眠の質:p<0.01、日中覚醒困難:p<0.05)。
ここで、図4に示すように、ラクトバチルス・カゼイを飲用した群及びプラセボを飲用した群の睡眠時間スコアは同等であったにも関わらず、前記の優れた効果が得られたことから、本発明の睡眠の質改善剤が示す効果は、単に睡眠時間が長くなること等によるものではなく、睡眠の質自体を改善することによるものであり、単位時間当たりの睡眠に対して得られる睡眠効果が顕著に改善されることが確認された。
睡眠に自覚的な不満を持つ20~40歳台の男女16名(PSQIスコア4~11点、平均7.4点)を2群に分け、それぞれ異なる順序でPS(ホスファチジルセリン)300mgを含むゼラチンソフトカプセル(サプリズムPS、ヤクルトヘルスフーズ株式会社製)またはプラセボ(大豆白絞油)を含むゼラチンソフトカプセルを5日間ずつ、9日間のウォッシュアウト期間をあけて摂取させた。さらに9日間のウォッシュアウト期間後、両群にPS(ホスファチジルセリン)300mg+ラクトバチルス・カゼイを4×1010cfu含む乳発酵物(ヤクルト400(Y400)、株式会社ヤクルト本社製)を5日間摂取させた。サンプル摂取期間中の主観的な睡眠の質を睡眠に関するアンケートにて評価した。なお、プラセボ飲用期に対する差の検定(wilcoxon検定)により投与効果を判断した。
Claims (28)
- ラクトバチルス・カゼイの菌体及び/又はその処理物を有効成分とする睡眠の質改善剤。
- ラクトバチルス・カゼイが、ラクトバチルス・カゼイ YIT9029(FERM BP-1366)である請求項1記載の睡眠の質改善剤。
- 1日摂取量が、ラクトバチルス・カゼイの生菌数として1010cfu以上である請求項1又は2記載の睡眠の質改善剤。
- さらにホスファチジルセリンを含有する請求項1~3のいずれかに記載の睡眠の質改善剤。
- 睡眠の質改善剤が、入眠潜時短縮剤、日中覚醒困難改善剤及び中途覚醒数減少剤から選ばれる1種以上である請求項1~4のいずれかに記載の睡眠の質改善剤。
- 睡眠の質改善剤が、入眠潜時短縮剤及び/又は日中覚醒困難改善剤である請求項1~5のいずれかに記載の睡眠の質改善剤。
- 睡眠の質改善剤が、日中覚醒困難改善剤である請求項1~6のいずれかに記載の睡眠の質改善剤。
- 睡眠の質改善剤製造のためのラクトバチルス・カゼイの菌体及び/又はその処理物の使用。
- ラクトバチルス・カゼイが、ラクトバチルス・カゼイ YIT9029(FERM BP-1366)である請求項8記載の使用。
- 1日摂取量が、ラクトバチルス・カゼイの生菌数として1010cfu以上である請求項8又は9記載の使用。
- さらにホスファチジルセリンを使用する請求項8~10のいずれかに記載の使用。
- 睡眠の質改善剤が、入眠潜時短縮剤、日中覚醒困難改善剤及び中途覚醒数減少剤から選ばれる1種以上である請求項8~11のいずれかに記載の使用。
- 睡眠の質改善剤が、入眠潜時短縮剤及び/又は日中覚醒困難改善剤である請求項8~12のいずれかに記載の使用。
- 睡眠の質改善剤が、日中覚醒困難改善剤である請求項8~13のいずれかに記載の使用。
- 睡眠の質改善用のラクトバチルス・カゼイの菌体及び/又はその処理物。
- ラクトバチルス・カゼイが、ラクトバチルス・カゼイ YIT9029(FERM BP-1366)である請求項15記載の菌体及び/又はその処理物。
- 1日摂取量が、ラクトバチルス・カゼイの生菌数として1010cfu以上である請求項15又は16記載の菌体及び/又はその処理物。
- さらにホスファチジルセリンを含有する請求項15~17のいずれかに記載の菌体及び/又はその処理物。
- 睡眠の質改善が、入眠潜時短縮、日中覚醒困難改善及び中途覚醒数減少から選ばれる1種以上である請求項15~18のいずれかに記載の菌体及び/又はその処理物。
- 睡眠の質改善が、入眠潜時短縮及び/又は日中覚醒困難改善である請求項15~19のいずれかに記載の菌体及び/又はその処理物。
- 睡眠の質改善が、日中覚醒困難改善である請求項15~20のいずれかに記載の菌体及び/又はその処理物。
- ラクトバチルス・カゼイの菌体及び/又はその処理物の有効量を投与することを特徴とする睡眠の質改善方法。
- ラクトバチルス・カゼイが、ラクトバチルス・カゼイ YIT9029(FERM BP-1366)である請求項22記載の方法。
- 1日摂取量が、ラクトバチルス・カゼイの生菌数として1010cfu以上である請求項22又は23記載の方法。
- さらにホスファチジルセリンを投与する請求項22~24のいずれかに記載の方法。
- 睡眠の質改善が、入眠潜時短縮、日中覚醒困難改善及び中途覚醒数減少から選ばれる1種以上である請求項22~25のいずれかに記載の方法。
- 睡眠の質改善が、入眠潜時短縮及び/又は日中覚醒困難改善である請求項22~26のいずれかに記載の方法。
- 睡眠の質改善が、日中覚醒困難改善である請求項22~27のいずれかに記載の方法。
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