JP2019213518A - Testosterone secretion promoter - Google Patents
Testosterone secretion promoter Download PDFInfo
- Publication number
- JP2019213518A JP2019213518A JP2019075695A JP2019075695A JP2019213518A JP 2019213518 A JP2019213518 A JP 2019213518A JP 2019075695 A JP2019075695 A JP 2019075695A JP 2019075695 A JP2019075695 A JP 2019075695A JP 2019213518 A JP2019213518 A JP 2019213518A
- Authority
- JP
- Japan
- Prior art keywords
- prevention
- improvement
- promotion
- testosterone
- euglena
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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Abstract
Description
本発明は、テストステロン分泌促進剤等に関する。 The present invention relates to a testosterone secretagogue and the like.
テストステロンは、筋量、骨密度等の身体構造や、活力等の精神的状態等に影響を与えるホルモンである。テストステロン値は、若年者においては高いものの、加齢に伴い低下する。このため、加齢により、テストステロン値の低下に起因する種々の問題、例えば筋量低下、骨密度低下、活力減退等の問題が生じる。また、これらの問題は、長期的には、糖尿病、高血圧、肥満、メタボリックシンドローム等の代謝疾患に繋がるとされている。よって、上記問題の改善、テストステロン値の向上が重要である。 Testosterone is a hormone that affects body structures such as muscle mass and bone density, and mental states such as vitality. Testosterone levels are higher in young people, but decrease with age. For this reason, with aging, various problems resulting from a decrease in testosterone level, such as a decrease in muscle mass, a decrease in bone density, a decrease in vitality, etc., occur. In addition, these problems are said to lead to metabolic diseases such as diabetes, hypertension, obesity, and metabolic syndrome in the long term. Therefore, it is important to improve the above-mentioned problem and increase the testosterone value.
ユーグレナは、ミドリムシ属（＝ユーグレナ属）に属する微細藻類であり、食品材料として利用されている。また、ユーグレナ抽出物を皮膚に適用することも行われている（特許文献１）。 Euglena is a microalga belonging to the genus Euglena (= Euglena), and is used as a food material. Euglena extract is also applied to the skin (Patent Document 1).
本発明は、テストステロン分泌促進剤を提供することを課題とする。 An object of the present invention is to provide a testosterone secretagogue.
本発明者は、上記課題に鑑みて鋭意研究した結果、ユーグレナ及びパラミロンが、テストステロン分泌促進作用を有することを見出した。この知見に基づいてさらに研究を進めた結果、本発明が完成した。 即ち、本発明は、下記の態様を包含する：
項１． ユーグレナ及び／又はパラミロンを含有する、テストステロン分泌促進剤．
項２． 前記ユーグレナがユーグレナ・グラシリスである、項１に記載のテストステロン分泌促進剤．
項３． 前記ユーグレナがユーグレナ・グラシリスEOD-1株（受託番号FERM BP-11530）である、項１又は２に記載のテストステロン分泌促進剤．
項４． 前記パラミロンがユーグレナ・グラシリス由来のパラミロンである、項１に記載のテストステロン分泌促進剤．
項５． 前記パラミロンがユーグレナ・グラシリスEOD-1株（受託番号FERM BP-11530）由来のパラミロンである、項１又は４に記載のテストステロン分泌促進剤．
項６． テストステロンレベル向上、テストステロンレベル維持、筋組織成長促進、筋組織再生促進、タンパク質合成促進、筋量低下の予防又は改善、筋量増加促進、筋力低下の予防又は改善、筋力増加促進、サルコペニアの予防又は改善、男性更年期障害の予防又は改善、骨密度低下の予防又は改善、骨密度増加促進、性欲減退の予防又は改善、性欲増加促進、性活動減少の予防又は改善、性活動増加促進、勃起障害の予防又は改善、勃起力増加促進、活力低下の予防又は改善、活力増加促進、抑うつの予防又は改善、集中力低下の予防又は改善、集中力増加促進、記名力低下の予防又は改善、記名力増加促進、睡眠障害の予防又は改善、体脂肪増加の予防又は改善、及び貧血の予防又は改善からなる群より選択される少なくとも1種のために用いられる、項１〜５のいずれかに記載のテストステロン分泌促進剤．
項７． ユーグレナ及び／又はパラミロンを含有する、テストステロンレベル向上、テストステロンレベル維持、筋組織成長促進、筋組織再生促進、タンパク質合成促進、筋量低下の予防又は改善、筋量増加促進、筋力低下の予防又は改善、筋力増加促進、サルコペニアの予防又は改善、男性更年期障害の予防又は改善、骨密度低下の予防又は改善、骨密度増加促進、性欲減退の予防又は改善、性欲増加促進、性活動減少の予防又は改善、性活動増加促進、勃起障害の予防又は改善、勃起力増加促進、活力低下の予防又は改善、活力増加促進、抑うつの予防又は改善、集中力低下の予防又は改善、集中力増加促進、記名力低下の予防又は改善、記名力増加促進、睡眠障害の予防又は改善、体脂肪増加の予防又は改善、及び貧血の予防又は改善からなる群より選択される少なくとも1種に用いるための組成物．
項８． 食品組成物である、項１〜６のいずれかに記載のテストステロン分泌促進剤．
項９． 栄養補助食品である、項１〜６及び８のいずれかに記載のテストステロン分泌促進剤．
項１０． 食品添加剤である、項１〜６のいずれかに記載のテストステロン分泌促進剤．
The present inventors have conducted intensive studies in view of the above problems, and as a result, have found that Euglena and paramylon have a testosterone secretion promoting effect. As a result of further research based on this finding, the present invention has been completed. That is, the present invention includes the following embodiments:
Item 1. A testosterone secretagogue comprising Euglena and / or paramylon.
Item 2. Item 2. The testosterone secretagogue according to Item 1, wherein the Euglena is Euglena gracilis.
Item 3. Item 3. The testosterone secretagogue according to Item 1 or 2, wherein the Euglena is Euglena Grasilis strain EOD-1 (Accession No. FERM BP-11530).
Item 4. Item 2. The testosterone secretagogue according to Item 1, wherein the paramylon is a paramylon derived from Euglena gracilis.
Item 5. Item 5. The testosterone secretagogue according to Item 1 or 4, wherein the paramylon is derived from Euglena gracilis EOD-1 strain (Accession No. FERM BP-11530).
Item 6. Increase testosterone level, maintain testosterone level, promote muscle tissue growth, promote muscle tissue regeneration, promote protein synthesis, prevent or improve muscle mass loss, promote muscle mass increase, prevent or improve muscle weakness, promote muscle strength increase, prevent sarcopenia or Improvement, prevention or improvement of male menopause, prevention or improvement of bone density decrease, promotion of bone density increase, prevention or improvement of decreased libido, promotion of libido, prevention or improvement of decreased sexual activity, promotion of sexual activity, erectile dysfunction Prevention or improvement, increase of erection, prevention or improvement of vitality, promotion of increase in energy, prevention or improvement of depression, prevention or improvement of decrease in concentration, promotion of increase in concentration, prevention or improvement of decrease in registration, increase in registration Promotion, prevention or amelioration of sleep disorders, prevention or amelioration of body fat gain, and at least one selected from the group consisting of prevention or amelioration of anemia. Item 6. The testosterone secretagogue according to any one of Items 1 to 5.
Item 7. Increasing testosterone level, maintaining testosterone level, promoting muscle tissue growth, promoting muscle tissue regeneration, promoting protein synthesis, preventing or improving muscle loss, promoting or improving muscle mass, preventing or improving muscle weakness, containing euglena and / or paramylon. , Promotion of muscle strength, prevention or improvement of sarcopenia, prevention or improvement of male climacteric disorder, prevention or improvement of bone density decrease, promotion of bone density increase, prevention or improvement of decreased libido, promotion of libido, prevention or improvement of decreased sexual activity Promotion of sexual activity, prevention or improvement of erectile dysfunction, promotion of erectile dysfunction, prevention or improvement of reduced vitality, promotion of increased vitality, prevention or improvement of depression, prevention or improvement of reduced concentration, promotion of increased concentration, registered ability Prevention or amelioration of decrease, promotion of increase in notation, prevention or amelioration of sleep disorder, prevention or amelioration of body fat increase, and prevention or amelioration of anemia Compositions for use in at least one member more selective.
Item 8. Item 7. The testosterone secretagogue according to any one of Items 1 to 6, which is a food composition.
Item 9. Item 9. The testosterone secretagogue according to any one of Items 1 to 6, which is a dietary supplement.
Item 10. Item 7. The testosterone secretagogue according to any one of Items 1 to 6, which is a food additive.
本発明によれば、テストステロン分泌促進剤を提供することができる。これにより、テストステロンレベル向上、テストステロンレベル維持、筋組織成長促進、筋組織再生促進、タンパク質合成促進、筋量低下の予防又は改善、筋量増加促進、筋力低下の予防又は改善、筋力増加促進、サルコペニアの予防又は改善、男性更年期障害の予防又は改善、骨密度低下の予防又は改善、骨密度増加促進、性欲減退の予防又は改善、性欲増加促進、性活動減少の予防又は改善、性活動増加促進、勃起障害の予防又は改善、勃起力増加促進、活力低下の予防又は改善、活力増加促進、抑うつの予防又は改善、集中力低下の予防又は改善、集中力増加促進、記名力低下の予防又は改善、記名力増加促進、睡眠障害の予防又は改善、体脂肪増加の予防又は改善、貧血の予防又は改善等を図ることができる。 According to the present invention, a testosterone secretagogue can be provided. Thereby, testosterone level improvement, testosterone level maintenance, muscle tissue growth promotion, muscle tissue regeneration promotion, protein synthesis promotion, prevention or improvement of muscle loss, promotion of muscle mass increase, prevention or improvement of muscle weakness, muscle strength increase promotion, sarcopenia Prevention or amelioration, prevention or amelioration of male menopause, prevention or amelioration of bone density decrease, promotion of bone density increase, prevention or amelioration of decreased libido, promotion of sexual desire, prevention or improvement of sexual activity decrease, sexual activity increase promotion, Prevention or improvement of erectile dysfunction, promotion of erectile dysfunction, prevention or improvement of vitality, prevention of or improvement of vitality, prevention or improvement of depression, prevention or amelioration of reduced concentration, promotion of increased concentration, prevention or improvement of reduced name, It is possible to promote the increase of the written power, the prevention or improvement of sleep disorders, the prevention or improvement of increase in body fat, the prevention or improvement of anemia, and the like.
本明細書中において、「含有」及び「含む」なる表現については、「含有」、「含む」、「実質的にからなる」及び「のみからなる」という概念を含む。 In this specification, the expressions “containing” and “including” include the concepts of “containing”, “including”, “consisting essentially of”, and “consisting only of”.
本発明は、その一態様において、ユーグレナ及び／又はパラミロンを含有する、テストステロン分泌促進剤（本明細書において、「本発明の剤」と示すこともある。）に関する。以下に、これについて説明する。 In one aspect, the present invention relates to a testosterone secretagogue (hereinafter, sometimes referred to as "the agent of the present invention") containing euglena and / or paramylon. Hereinafter, this will be described.
1．ユーグレナ
ユーグレナは、ミドリムシ属（＝ユーグレナ属）に属する微細藻類であり、その限りにおいて特に制限されない。ユーグレナとして、具体的には、例えばEuglena gracilis（ユーグレナ・グラシリス）、Euglena longa、Euglena caudata、Euglena oxyuris、Euglena tripteris、Euglena proxima、Euglena viridis、Euglena sociabilis、Euglena ehrenbergii、Euglena deses、Euglena pisciformis、Euglena spirogyra、Euglena acus、Euglena geniculata、Euglena intermedia、Euglena mutabilis、Euglena sanguinea、Euglena stellata、Euglena terricola、Euglena klebsi、Euglena rubra、Euglena cyclopicolaなどが挙げられる。これらの中でも、本発明の効果をより確実に発揮できるという観点から、好ましくはユーグレナ・グラシリスが挙げられ、より好ましくはユーグレナ・グラシリスEOD-1株［2013年6月28日付で独立行政法人製品評価技術基盤機構 特許生物寄託センター｛NITE-IPOD（郵便番号292-0818 日本国千葉県木更津市かずさ鎌足2-5-8 120号室）｝にブダペスト条約の規定下で、受託番号FERM BP-11530として国際寄託済み］が挙げられる。
1． Euglena Euglena is a microalga belonging to the genus Euglena (= Euglena), and is not particularly limited as long as it is a microalga. Specific examples of Euglena include, for example, Euglena gracilis ( Euglena grasilis ), Euglena longa , Euglena caudata , Euglena oxyuris , Euglena tripteris , Euglena proxima , Euglena viridis , Euglena sociabilis , Euglena ehrenberges , Euglena des , Euglena des , Euglena des , Euglena des Euglena acus , Euglena geniculata , Euglena intermedia , Euglena mutabilis , Euglena sanguinea , Euglena stellata , Euglena terricola , Euglena klebsi , Euglena rubra , Euglena cyclopicola and the like. Among these, from the viewpoint that the effects of the present invention can be more reliably exerted, preferably Euglena gracilis is mentioned, and more preferably Euglena gracilis EOD-1 strain [Independent administrative corporation product evaluation dated June 28, 2013] Under the provisions of the Budapest Treaty, the Patent Organism Depositary of the National Institute of Technology, NITE-IPOD (Zip code 292-0818, 2-5-8 Kazusa Kamatari, Kisarazu, Chiba, Japan) under accession number FERM BP-11530 Internationally deposited].
ユーグレナの形態は、ユーグレナの細胞体又はその成分の大半を含むものである限り、特に制限されない。ユーグレナの形態としては、例えばユーグレナの乾燥粉末形態、ユーグレナの懸濁液、ユーグレナエキス等が挙げられ、中でも、好ましくはユーグレナの乾燥粉末形態が挙げられる。 The form of Euglena is not particularly limited as long as it contains most of Euglena cell bodies or components thereof. Examples of the form of Euglena include a dry powder form of Euglena, a suspension of Euglena, an Euglena extract, and the like, and preferably a dry powder form of Euglena.
ユーグレナの乾燥状態におけるパラミロン含有率は、例えば50％以上、好ましくは60％以上、より好ましくは70％以上である。 The paramylon content of Euglena in a dry state is, for example, 50% or more, preferably 60% or more, and more preferably 70% or more.
ユーグレナは、1種単独であってもよいし、2種以上の組み合わせであってもよい。 Euglena may be used alone or in a combination of two or more.
2．パラミロン
パラミロンは、ユーグレナ由来のβ-1,3-グルカンであり、その限りにおいて特に制限されない。
2． Paramylon Paramylon is β-1,3-glucan derived from Euglena, and is not particularly limited as long as it is used.
パラミロンが由来するユーグレナについてはは、上記「1．パラミロン」における説明と同様である。 The euglena from which paramylon is derived is the same as described in “1. Paramylon” above.
パラミロンの質量平均分子量は、特に限定されないが、例えば1×104〜5×106、好ましくは2×104〜1×106、より好ましくは5×104〜1×106、さらに好ましくは1×105〜5×105である。 Although the mass average molecular weight of paramylon is not particularly limited, for example, 1 × 10 4 to 5 × 10 6 , preferably 2 × 10 4 to 1 × 10 6 , more preferably 5 × 10 4 to 1 × 10 6 , still more preferably Is 1 × 10 5 to 5 × 10 5 .
なお、質量平均分子量は、SEC-MALS分析により、以下の条件で測定 することができる：
SEC装置：LC−10AVP system（Shimadzu Co．、日本）、
使用カラム：KD-806M（shodex．、日本）、
MALS検出器：DAWN HELEOSII（wyatt Technologies．、U．S．A．）、
溶離液：1%LiCl/DMI、
流速：0.5 mL/分。
The mass average molecular weight can be measured by SEC-MALS analysis under the following conditions:
SEC equipment: LC-10AVP system (Shimadzu Co., Japan),
Column used: KD-806M (shodex., Japan),
MALS detector: DAWN HELEOSII (wyatt Technologies., USA),
Eluent: 1% LiCl / DMI,
Flow rate: 0.5 mL / min.
パラミロンは、ユーグレナの細胞内において、通常、β-1,3-グルカン鎖が形成する3重螺旋構造体が一定の規則性の基に高度に集積してなるパラミロン粒子として存在している。本発明の効果をより確実に発揮できるという観点から、パラミロンとして、パラミロン粒子を好ましく用いることができる。 Paramylon is usually present in Euglena cells as paramylon particles in which a triple helical structure formed by a β-1,3-glucan chain is highly accumulated under a certain regularity. From the viewpoint that the effects of the present invention can be more reliably exhibited, paramylon particles can be preferably used as paramylon.
パラミロン粒子の形状は、特に制限されないが、通常は、偏平な回転楕円体状である。 The shape of the paramylon particles is not particularly limited, but is usually a flat spheroid.
パラミロン粒子の粒子径分布は、特に制限されないが、例えば0.5〜15μm、好ましくは1〜6μmである。また、パラミロン粒子の平均粒子径も特に制限されないが、例えば1〜10、好ましくは2〜4μmである。 The particle size distribution of the paramylon particles is not particularly limited, but is, for example, 0.5 to 15 μm, and preferably 1 to 6 μm. The average particle diameter of the paramylon particles is not particularly limited, but is, for example, 1 to 10, preferably 2 to 4 μm.
パラミロンの形態は、パラミロンを含むものである限り、特に制限されない。ユーグレナの形態としては、例えばパラミロンの乾燥粉末形態、パラミロンの懸濁液等が挙げられ、中でも、好ましくはパラミロンの乾燥粉末形態が挙げられる。 The form of paramylon is not particularly limited as long as it contains paramylon. Examples of the form of Euglena include paramylon dry powder form, paramylon suspension and the like, and among them, preferably paramylon dry powder form.
パラミロンは、1種単独であってもよいし、2種以上の組み合わせであってもよい。 Paramylon may be used alone or in a combination of two or more.
3．ユーグレナ及びパラミロンの製造方法
ユーグレナは、液体に含まれたユーグレナを培養する工程（培養工程）を含む方法により、大量に調製することが可能である。培養工程は、例えば公知の方法（例えば、特許第5883532号公報に記載の方法）に従って行うことができる。該培養工程では、典型的には、水と、ユーグレナと、ユーグレナが利用できる栄養素とを含む液体（培養液）を撹拌しつつ好気条件でユーグレナ属微細藻類を培養する。
3． Production method of Euglena and paramylon Euglena can be prepared in large quantities by a method including a step of culturing Euglena contained in a liquid (culturing step). The culturing step can be performed, for example, according to a known method (for example, a method described in Japanese Patent No. 5835332). In the culture step, typically, a microalga of the genus Euglena is cultivated under aerobic conditions while stirring a liquid (culture solution) containing water, Euglena, and nutrients that can be used by Euglena.
栄養素としては、糖類（グルコース（ブドウ糖）、フルクトース（果糖）などの単糖類、又は、スクロース（ショ糖）、マルトース（麦芽糖）などの二糖類）、ミネラル類（例えばナトリウム、カリウム、マグネシウム、カルシウム、鉄、亜鉛、モリブデン、銅、リン、窒素、硫黄、又は、ホウ素など）、ビタミンB類（例えばビタミンB1（チアミン）、ビタミンB2（リボフラビン）、ナイアシン、パントテン酸、ビタミンB6（ピリドキシン、ピリドキサール、又はピリドキサミン）、ビタミンB12（シアノコバラミン）、葉酸、ビオチンなど）などが挙げられる。培養液中の栄養素の濃度は、ユーグレナの生存、増殖等が可能な濃度である限り特に制限されない。 As nutrients, sugars (monosaccharides such as glucose (glucose) and fructose (fructose) or disaccharides such as sucrose (sucrose) and maltose (maltose)), minerals (eg, sodium, potassium, magnesium, calcium, Iron, zinc, molybdenum, copper, phosphorus, nitrogen, sulfur, or boron, etc., vitamins B (for example, vitamin B1 (thiamine), vitamin B2 (riboflavin), niacin, pantothenic acid, vitamin B6 (pyridoxine, pyridoxal, or Pyridoxamine), vitamin B12 (cyanocobalamin), folic acid, biotin, and the like. The concentration of nutrients in the culture solution is not particularly limited as long as it is a concentration at which Euglena can survive and proliferate.
培養工程の光条件は特に制限されず、培養工程は明条件と暗条件のいずれで行われてもよい。従属栄養培養にて培養する際には暗条件で培養される。明条件としては、藻類を増殖させるための通常の光強度を採用することができる。暗条件としては、例えば10μmol/m2/s未満、好ましくは光が全く当たらない完全な暗所条件が挙げられる。 The light conditions in the culture step are not particularly limited, and the culture step may be performed under either bright or dark conditions. When culturing in heterotrophic culture, the cells are cultured in dark conditions. As the light condition, ordinary light intensity for growing algae can be employed. Examples of dark conditions include, for example, less than 10 μmol / m 2 / s, preferably complete dark conditions where no light hits.
培養工程における培養温度は、ユーグレナが増殖できる温度であれば、特に限定されない。該培養温度（培養液の温度）としては、例えば、20℃〜35℃が採用される。 The culture temperature in the culture step is not particularly limited as long as Euglena can grow. As the culture temperature (temperature of the culture solution), for example, 20 ° C to 35 ° C is adopted.
培養工程における液体のpHは、ユーグレナが増殖できるpHであれば、特に限定されない。ユーグレナが増殖できるpHとしては、例えば3.0〜5.5が採用される。 The pH of the liquid in the culturing step is not particularly limited as long as Euglena can proliferate. As a pH at which Euglena can grow, for example, 3.0 to 5.5 is adopted.
培養工程の後に、液体の遠心分離や重力分離などによってユーグレナを濃縮することが好ましい。得られたユーグレナは、所望の形態に応じて、追加の処理（例えば、液体への懸濁、水中又は油中への分散、エキス抽出、乾燥粉末化等）に供することができる。 After the culturing step, the euglena is preferably concentrated by centrifugation or gravity separation of the liquid. The resulting euglena can be subjected to additional processing (eg, suspension in liquid, dispersion in water or oil, extraction of extracts, dry pulverization, etc.) depending on the desired form.
パラミロン粒子は、公知の方法（例えば特許第5883532号公報に記載の方法）に従って又は準じて、ミドリムシから分離、単離、又は精製することによって製造することができる。パラミロン粒子は、例えばミドリムシの細胞膜を破壊することによって得られる細胞内容成分を回収することによって、容易に得ることができる。また、必要に応じて、パラミロン粒子を精製してもよい。パラミロン粒子の精製については各種知られており（例えば、特許第5883532号公報）、それらの方法に従って行うことができる。精製工程としては、例えば、界面活性剤処理工程、洗浄工程などが挙げられる。得られたパラミロン粒子は、所望の形態に応じて、追加の処理（例えば、液体への懸濁、水中又は油中への分散、乾燥粉末化等）に供することができる。 Paramylon particles can be produced by separating, isolating, or purifying from Euglena by a known method (for example, the method described in Japanese Patent No. 5835332) or according thereto. Paramylon particles can be easily obtained, for example, by recovering a cell content component obtained by disrupting the cell membrane of Euglena. Moreover, you may refine | purify paramylon particles as needed. Various kinds of purification of paramylon particles are known (for example, Japanese Patent No. 5835332) and can be performed according to those methods. Examples of the purification step include a surfactant treatment step, a washing step, and the like. The resulting paramylon particles can be subjected to additional processing (eg, suspension in a liquid, dispersion in water or oil, dry pulverization, etc.) depending on the desired form.
4．用途
ユーグレナ及び／又はパラミロンは、テストステロン分泌促進作用、より具体的には体液中のテストステロン濃度を促進させる作用を有することから、テストステロン分泌促進剤の有効成分として利用することができる。体液としては、例えば全血、血清、血漿、髄液、唾液、関節液、尿、組織液（気管支肺胞洗浄液を含む）、汗、涙、喀痰、鼻汁等が挙げられる。
Four. Use Euglena and / or paramylon have a testosterone secretion promoting action, more specifically, an action of promoting testosterone concentration in a body fluid, and thus can be used as an active ingredient of a testosterone secretion promoting agent. Examples of the body fluid include whole blood, serum, plasma, cerebrospinal fluid, saliva, synovial fluid, urine, tissue fluid (including bronchoalveolar lavage fluid), sweat, tears, sputum, nasal secretion, and the like.
また、ユーグレナ及び／又はパラミロンは、例えば、テストステロンレベル向上、テストステロンレベル維持（例えばテストステロンレベルの低下（例えば季節変化による低下、加齢による低下等）の抑制）、筋組織成長促進、筋組織再生促進、タンパク質合成促進、筋量低下の予防又は改善、筋量増加促進、筋力低下の予防又は改善、筋力増加促進、サルコペニアの予防又は改善、男性更年期障害の予防又は改善、骨密度低下の予防又は改善、骨密度増加促進、性欲減退の予防又は改善、性欲増加促進、性活動減少の予防又は改善、性活動増加促進、勃起障害の予防又は改善、勃起力増加促進、活力低下の予防又は改善、活力増加促進、抑うつの予防又は改善、集中力低下の予防又は改善、集中力増加促進、記名力低下の予防又は改善、記名力増加促進、睡眠障害の予防又は改善、体脂肪増加の予防又は改善、貧血の予防又は改善等に利用することができる。ユーグレナ及び／又はパラミロンは、好ましくは、これらの用途の内の複数（2つ以上、より好ましくは3つ以上、さらに好ましくは4つ以上、よりさらに好ましくは5つ以上、よりさらに好ましくは6つ以上）の用途を含む包括的な用途に利用することができる。 Euglena and / or paramylon may be used, for example, to increase testosterone level, maintain testosterone level (eg, suppress testosterone level (eg, decrease due to seasonal change, decrease due to aging, etc.)), promote muscle tissue growth, and promote muscle tissue regeneration. , Promotion of protein synthesis, prevention or improvement of muscle mass loss, promotion of muscle mass increase, prevention or improvement of muscle weakness, promotion of muscle strength, prevention or improvement of sarcopenia, prevention or improvement of male menopause, prevention or improvement of bone density decrease , Increase in bone density, prevention or improvement of decreased libido, promotion of libido, prevention or improvement of decreased sexual activity, promotion of sexual activity, prevention or improvement of erectile dysfunction, promotion of erectile dysfunction, prevention or improvement of vitality, vitality Promotion of increase, prevention or improvement of depression, prevention or improvement of concentration loss, promotion of concentration increase, prevention or improvement of reduction in name, Force increase promotion, prevention or amelioration of sleep disorders, prevention or amelioration of body fat increase, can be utilized such as in the prevention or amelioration of anemia. Euglena and / or paramylon are preferably used in more than one of these applications (two or more, more preferably three or more, even more preferably four or more, even more preferably five or more, even more preferably six or more). It can be used for comprehensive applications including the above applications.
なお、「改善」とは、症状又は状態の好転又は緩和、症状又は状態の悪化の防止又は遅延、症状又は状態の進行の逆転、防止又は遅延をいう。 The term “improvement” refers to improvement or alleviation of symptoms or conditions, prevention or delay of deterioration of symptoms or conditions, and reversal, prevention or delay of progress of symptoms or conditions.
本発明の剤の適用対象は、例えば、日常的に高強度の運動を行っている者、日常的には運動を行っていない者等、特に制限されない。該対象は、好ましくは、日常的に高強度の運動を行っている者である。「日常的に高強度の運動を行っている」の程度については、例えば、好ましくは8METs×1回／週以上、より好ましくは8METs×3回／週以上である。 The subject to which the agent of the present invention is applied is not particularly limited, for example, those who exercise regularly at high intensity, those who do not exercise regularly. The subject is preferably a person who performs high intensity exercise on a daily basis. The degree of “exercising a high intensity exercise on a daily basis” is, for example, preferably 8 METs × 1 time / week or more, more preferably 8 METs × 3 times / week or more.
MET（metabolic equivalent）は運動強度の単位であり、快適な温度の条件で測定した活動時のエネルギー消費量を座位安静時の代謝量（3.5mL/kg/分）で除した値である。 MET (metabolic equivalent) is a unit of exercise intensity, and is a value obtained by dividing the energy expenditure during activity measured under comfortable temperature conditions by the metabolic rate at rest (3.5 mL / kg / min).
また、本発明の剤の適用対象年代も特に制限されない。本発明の剤は、テストステロンが低下する年代の人、例えば40歳以上、好ましくは50歳以上、より好ましくは60歳以上、さらに好ましくは65歳以上の人に適用することができる。また、別の分類の観点から、本発明の剤は、例えば中年の人、好ましくは高齢者に適用することができる。 Further, the age to which the agent of the present invention is applied is not particularly limited. The agent of the present invention can be applied to a person of an age at which testosterone is reduced, for example, a person of 40 years or older, preferably 50 years or older, more preferably 60 years or older, even more preferably 65 years or older. In addition, from another viewpoint of classification, the agent of the present invention can be applied to, for example, middle-aged people, preferably elderly people.
本発明の剤は、各種分野において、例えば食品添加剤、食品組成物（健康食品、健康増進剤、栄養補助食品（サプリメントなど）を包含する）、医薬、化粧品、飼料などとして用いることができる。 The agent of the present invention can be used in various fields, for example, as food additives, food compositions (including health foods, health enhancers, dietary supplements (supplements and the like)), medicines, cosmetics, feeds, and the like.
本発明の剤は、通常は経口摂取されるが、これに限定されるものではない。 The agent of the present invention is usually taken orally, but is not limited thereto.
本発明の剤の形態は、特に限定されず、用途に応じて、各用途において通常使用される形態をとることができる。 The form of the agent of the present invention is not particularly limited, and may be a form usually used in each use depending on the use.
本発明の剤の形態としては、用途が食品添加剤、医薬、健康増進剤、栄養補助食品（サプリメントなど）などである場合は、例えば錠剤（口腔内側崩壊錠、咀嚼可能錠、発泡錠、トローチ剤、ゼリー状ドロップ剤などを含む）、丸剤、顆粒剤、細粒剤、散剤、硬カプセル剤、軟カプセル剤、ドライシロップ剤、液剤（懸濁剤、シロップ剤を含む）、ゼリー剤などが挙げられる。 When the use of the agent of the present invention is a food additive, medicine, a health enhancer, a dietary supplement (such as a supplement) or the like, for example, a tablet (eg, a disintegrating tablet inside the mouth, a chewable tablet, an effervescent tablet, and a troche) Pills, granules, fine granules, powders, hard capsules, soft capsules, dry syrups, liquids (including suspensions and syrups), jellies, etc. No.
本発明の剤の形態としては、用途が食品組成物の場合は、液状、ゲル状あるいは固形状の食品、例えばジュース、清涼飲料、茶、スープ、豆乳などの飲料、サラダ油、ドレッシング、ヨーグルト、ゼリー、プリン、ふりかけ、育児用粉乳、ケーキミックス、乳製品（例えば、粉末状、液状、ゲル状、固形状等）、パン、菓子（例えば、クッキー等）などが挙げられる。 As the form of the agent of the present invention, when the use is a food composition, liquid, gel or solid foods such as juices, soft drinks, tea, soups, drinks such as soy milk, salad oil, dressing, yogurt, jelly Pudding, sprinkle, infant milk powder, cake mix, dairy products (eg, powder, liquid, gel, solid, etc.), bread, confectionery (eg, cookies, etc.).
本発明の剤は、必要に応じてさらに他の成分を含んでいてもよい。他の成分としては、食品添加剤、食品組成物、医薬、健康増進剤、栄養補助食品（サプリメントなど）、化粧品、飼料などに配合され得る成分である限り特に限定されるものではないが、例えば基剤、担体、溶剤、分散剤、乳化剤、緩衝剤、安定剤、賦形剤、結合剤、崩壊剤、滑沢剤、増粘剤、着色料、香料、キレート剤などが挙げられる。 The agent of the present invention may further contain other components as necessary. Other ingredients are not particularly limited as long as they can be added to food additives, food compositions, medicines, health promoters, dietary supplements (such as supplements), cosmetics, feeds, and the like. Bases, carriers, solvents, dispersants, emulsifiers, buffers, stabilizers, excipients, binders, disintegrants, lubricants, thickeners, coloring agents, fragrances, chelating agents and the like can be mentioned.
本発明の剤におけるユーグレナ及びパラミロンの合計含有量は、用途、使用態様、適用対象の状態などに左右されるものであり、限定はされないが、例えば0.0001〜100質量％、好ましくは0.001〜50質量％とすることができる。 The total content of Euglena and paramylon in the agent of the present invention depends on the use, the mode of use, the state of the application, and the like, but is not limited thereto. For example, 0.0001 to 100% by mass, preferably 0.001 to 50% by mass. %.
本発明の剤の適用（例えば、投与、摂取、接種など）量は、薬効を発現する有効量であれば特に限定されず、通常は、ユーグレナ及びパラミロンの合計乾燥重量として、一般に一日あたり0.1〜10000 mg/kg体重である。上記適用量は1日1回以上（例えば1〜3回）に分けて適用するのが好ましく、年齢、病態、症状により適宜増減することもできる。 The amount of the agent of the present invention to be applied (for example, administration, ingestion, inoculation, etc.) is not particularly limited as long as it is an effective amount that exhibits a medicinal effect. Generally, the total dry weight of euglena and paramylon is generally 0.1 per day. 〜10000 mg / kg body weight. The above-mentioned application amount is preferably applied once or more (for example, 1 to 3 times) a day, and may be appropriately increased or decreased depending on age, disease state and symptoms.
以下に、実施例に基づいて本発明を詳細に説明するが、本発明はこれらの実施例によって限定されるものではない。 EXAMPLES The present invention will be described in detail below based on examples, but the present invention is not limited to these examples.
製造例1
ユーグレナ・グラシリスEOD-1株（独立行政法人製品評価技術基盤機構 特許生物寄託センター（NITE-IPOD）の乾燥粉末（神鋼環境ソリューション製、パラミロン含有率70％以上）を下記配合でカプセル錠としたものを試験食とし、対照食としてコーンスターチを配合したカプセル錠を製造した。
Production Example 1
Euglena Grasilis EOD-1 strain (NITE-IPOD, National Institute of Technology and Evaluation, NITE-IPOD) dried powder (Shinko Environmental Solutions, paramylon content of 70% or more) into capsule tablets with the following formulation Was used as a test meal, and capsule tablets containing corn starch as a control meal were produced.
試験例1
試験概要は以下のとおりである。
・試験食摂取期間 ： 4週間
・試験食の摂取量 ： ユーグレナ乾燥粉末換算で 500mg/day
・被験者 ： 男性30名
なお、被験者の内、23名は、日常的に高強度の運動（運動強度：8METs×3回／週）を行っている運動群であり、7名は、日常的には運動を行っていない一般群（運動強度：3METs×1回／週）である。
Test example 1
The outline of the test is as follows.
・ Test food intake period: 4 weeks ・ Test food intake: 500 mg / day in terms of Euglena dry powder
・ Subjects: 30 males. Of the subjects, 23 were in the exercise group that regularly exercises high intensity exercise (exercise intensity: 8METs x 3 times / week), and 7 were Is a general group not exercising (exercise intensity: 3METs × 1 time / week).
＜試験内容＞
試験食摂取開始前の被験者から、短いストローを用いて流涎を採取した。得られた唾液中のテストステロン濃度をキット（Testosterone Salivary Immunoassay Kit (1-2402)、Salimetrics社製）を用いて測定した。該測定の翌日から、被験者に試験食の摂取を開始させ、約4週間摂取させた。摂取終了後、摂取前と同様に唾液中のテストステロン濃度を測定した。
<Test contents>
Salivation was collected from the subject before the start of the test meal intake using a short straw. The testosterone concentration in the obtained saliva was measured using a kit (Testosterone Salivary Immunoassay Kit (1-2402), manufactured by Salimetrics). From the day after the measurement, the test subjects were started to take the test food, and were taken for about 4 weeks. After the ingestion, the testosterone concentration in saliva was measured in the same manner as before the ingestion.
＜試験結果＞
得られた結果について、IBM SPSS Statistics 25を使用して統計解析した。検定は、ウィルコクソンの符号順位和検定（Wilcoxon signed-rank test）で実施した。結果を図１〜３に示す。
<Test results>
The obtained results were statistically analyzed using IBM SPSS Statistics 25. The test was performed by Wilcoxon signed-rank test. The results are shown in FIGS.
図１〜３に示されるように、ユーグレナ摂取により、テストステロン値が促進した。このことから、ユーグレナがテストステロン分泌促進作用を有することが示唆された。また、この作用は、ユーグレナが含むパラミロンに起因すると推察された。 As shown in FIGS. 1-3, testosterone levels were enhanced by euglena ingestion. This suggested that Euglena has a testosterone secretion promoting effect. This effect was also presumed to be due to paramylon contained in Euglena.
試験例2
二重盲検プラセボ比較平行群間試験を行った。試験概要は以下のとおりである。また、試験デザイン及び試験フローを図４に示す。図４中、対照食及び試験食は製造例1で製造したカプセル錠である。
Test example 2
A double-blind, placebo-controlled, parallel group study was performed. The outline of the test is as follows. FIG. 4 shows the test design and test flow. In FIG. 4, the control diet and the test diet are capsule tablets produced in Production Example 1.
・試験期間 ： 試験食摂取群及び対照食摂取群それぞれ8週間（秋から冬にかけて）
・試験食の摂取量 ： ユーグレナ乾燥粉末換算で 500mg/day
・対照食の摂取量 ： 試験食と同量
・被験者 ： 男性15名（試験食摂取群8名（平均年齢：70.0歳、SD：3.1歳）、対照食摂取群7名（平均年齢：69.3歳、SD：2.5歳））
・ Test period: 8 weeks each for test food group and control food group (from fall to winter)
・ Test food intake: 500mg / day in terms of Euglena dry powder
・ Consumption of control diet: same as test diet ・ Subjects: 15 males (8 in test food intake group (average age: 70.0 years, SD: 3.1 years old), 7 in control food intake group (average age: 69.3 years old) , SD: 2.5 years old))
＜試験内容＞
摂取開始前（0w）の被験者について、試験例1と同様にして唾液中のテストステロン濃度を測定した。また、0wの被験者について、血液を採取し、得られた血液中のテストステロン濃度をキット（エクルーシス試薬テストステロンII、ロシュ・ダイアグノスティックス社製）を用いて測定した。該測定の翌日から、試験食摂取群には試験食を、対照食摂取群には対照食を、4週間摂取させた。4週間の摂取期間終了の翌日（4w）に、試験前と同様に唾液中及び血液中のテストステロン濃度を測定した。該測定の翌日から、試験食摂取群には試験食を、対照食摂取群には対照食を、さらに4週間摂取させた。計8週間の摂取期間終了の翌日（8w）に、試験前と同様に唾液中及び血液中のテストステロン濃度を測定した。
<Test contents>
Before the start of ingestion (0 w), the testosterone concentration in saliva was measured in the same manner as in Test Example 1. In addition, blood was collected from a 0 w subject, and the testosterone concentration in the obtained blood was measured using a kit (Ecclusis reagent testosterone II, manufactured by Roche Diagnostics). From the day after the measurement, the test food intake group and the control food intake group were ingested the test food for 4 weeks. On the day (4w) following the end of the 4-week ingestion period, testosterone concentrations in saliva and blood were measured in the same manner as before the test. From the day after the measurement, the test food intake group was ingested the test food, and the control food intake group was ingested the control food for another 4 weeks. On the next day (8w) after the end of the 8-week ingestion period, testosterone concentrations in saliva and blood were measured in the same manner as before the test.
＜試験結果＞
得られた結果について、IBM SPSS Statistics 25を使用して統計解析した。試験食摂取群と対照食摂取群間の検定はマンホイットニーU検定（Mann-Whitney U test）で実施し、各群の測定時期間（0w、4w、8w）の検定はウィルコクソンの符号順位和検定（Wilcoxon signed-rank test）で実施した。
<Test results>
The obtained results were statistically analyzed using IBM SPSS Statistics 25. The test between the test food intake group and the control food intake group was performed by the Mann-Whitney U test, and the test for the measurement period (0w, 4w, 8w) of each group was Wilcoxon's sign rank sum test. (Wilcoxon signed-rank test).
唾液中のテストステロンの測定結果を図５に示す。対照食摂取群については、試験期間が経過するに従い、テストステロン値が有意に減少していた。ここで、テストステロン値は秋から冬にかけて大きく減少するという報告がある（Psychoneuroendocrinology (2006) 31, 895-899）。本試験も秋から冬にかけて行われているところ、対照食摂取群におけるテストステロン値の減少はこれに起因するものであると考えられる。これに対して、試験食摂取群については、試験期間が経過してもテストステロン値の有意な減少は見られず、また試験食摂取後（4w、8w）は対照食摂取群よりもテストステロン値が有意に高かった。 FIG. 5 shows the measurement results of testosterone in saliva. In the control diet group, the testosterone level was significantly reduced over the test period. Here, it has been reported that testosterone levels decrease significantly from autumn to winter (Psychoneuroendocrinology (2006) 31, 895-899). This test was also conducted from autumn to winter, and it is considered that the decrease in testosterone level in the control diet group was attributed to this. On the other hand, in the test food group, the testosterone level did not decrease significantly after the test period, and after the test food group (4w, 8w), the testosterone level was lower than in the control group. It was significantly higher.
血液中のテストステロンの測定結果を図６に示す。試験食群について、試験期間が経過するに従い、テストステロン値が有意に上昇していた。 FIG. 6 shows the measurement results of testosterone in blood. As for the test meal group, the testosterone level was significantly increased as the test period elapsed.
これらの結果より、65歳以上の高齢者に対しても、ユーグレナがテストステロン分泌促進作用を有することが示唆された。また、ユーグレナは、テストステロン値の低下を抑制する作用を有することも分かった。なお、これらの作用は、ユーグレナが含むパラミロンに起因すると推察された。 These results suggest that Euglena has a testosterone secretion-promoting effect even in elderly people aged 65 and over. In addition, it was found that Euglena has an effect of suppressing a decrease in testosterone level. These effects were presumed to be caused by paramylon contained in Euglena.
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| WO2022038966A1 (en) * | 2020-08-21 | 2022-02-24 | 株式会社ユーグレナ | Food composition for modulating clock gene expression, cosmetic composition for modulating clock gene expression, clock gene expression modulator, food composition for in-vivo clock modulation, cosmetic composition for in-vivo clock modulation, in-vivo clock modulator, food composition for modulating circadian rhythm, cosmetic composition for modulating circadian rhythm, and circadian rhythm modulator |
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