JP5118965B2 - 植物成分を必要とする治療方法 - Google Patents
植物成分を必要とする治療方法 Download PDFInfo
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- JP5118965B2 JP5118965B2 JP2007525450A JP2007525450A JP5118965B2 JP 5118965 B2 JP5118965 B2 JP 5118965B2 JP 2007525450 A JP2007525450 A JP 2007525450A JP 2007525450 A JP2007525450 A JP 2007525450A JP 5118965 B2 JP5118965 B2 JP 5118965B2
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- JP
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- Prior art keywords
- phytosterol
- phytostanol
- ester
- fish oil
- levels
- 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.)
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Description
本発明は、医学的な状態の治療における機能性食品および補助食品の分野に関する。より具体的には、本発明はフィトステロールを含有する脂質混合物による状態の治療に関するものである。
本出願を通して指摘した全ての刊行物は、そこで引用されている全ての参考文献を含め、参照により本明細書に完全に組み込まれている。
第1の態様では、本発明は、親油性ビタミン類、親油性薬剤、親油性栄養素または任意の親油性医薬有効成分のいずれか1つのバイオアベイラビリティーに悪影響を与えずにフィトステロール療法を必要とする状態を治療する方法であって、食用油もしくは脂肪、またはそれを含む組成物もしくは食品に任意選択で溶解または分散したPS−E(フィトステロールエステル)およびDAG(主に1,3ジグリセリド)の混合物の治療有効量を、それを必要とする対象へ投与することを含む方法を提供する。
食事からのフィトステロールは食物および胆汁のコレステロールの吸収を抑制し、長期にわたるフィトステロールの毎日の摂取は血漿中のコレステロールおよびLDLコレステロールの濃度低下を誘導する。これらの低下は、摂取するフィトステロールの用量、フィトステロールのエステル化、フィトステロールが溶解されるマトリックス、バックグラウンド食事、および遺伝要因を含む2、3の因子に関連する。フィトステロールを投与することの主な望ましくない影響は、それらが脂溶性薬剤と同様にビタミン類(特にカロテノイド)などの他の多くの脂溶性食品成分の吸収に干渉することである。さらに、フィトステロールが溶解されるマトリックスは、フィトステロールのLDLコレステロールを低下させる効力に明らかに影響を及ぼすことができる。腸内での吸収の間、フィトステロールはコレステロールだけでなく他の親油性分子も排出して、混合ミセルへの取り込みによりそれらを置換することができると仮定される。混合ミセル相への分離はエステル化により、およびフィトステロールがその中で摂取される媒体の他の成分により影響され得る。
(ヒト臨床試験設計)
この研究は、無作為化された単純盲検クロスオーバー臨床インターベンション試験として設計された。この実験は、食事の修正が主要な、時に唯一の推奨治療である血清脂質レベルが上昇した中等度の過体重の対象において、非補充食と比較して、普通食に含ませた特定の脂肪酸および/または植物ステロール混合物を含む食物マトリックスのビタミン吸収、および体重増加に及ぼす影響を試験することを含んだ。
LDLコレステロール濃度が>130mg/dLの24人のボランティア(男性11人、女性13人、年齢30〜65歳)がこの研究のために募集された。BMIが21.4〜23kg/m2であった3名の対象を除いて、対象の肥満度指数(BMI)は23〜32kg/m2であった。21人のボランティアが研究を完了した(男性11人、女性10人)。
全てのボランティアは、各4週の5食事相を含む半無作為化ラテン方格クロスオーバーデザインに従って、食事試験を受けた。対照食が最初に提供され、次に他の相が無作為化された。各食事期は4週間のウォッシュアウト期で分離され、その間は、ボランティアは制限なしで彼らの典型的な食事を摂取した。食事組成は、食品および栄養素量に関して類似していた。基本食は、30%のエネルギーを脂肪として(対照食を参照)、80mgコレステロール/1000kcal、12g繊維/1000kcal、15%のエネルギーをタンパク質として、55%を炭水化物として含んでいた。可変成分は、治療油であった。
約200mg/日のベースライン植物ステロールレベル、食事脂肪はオレイン酸増量植物油として70%エネルギー分含まれた。
同じ量のEPAおよびDHAを植物ステロール−魚油エステル食として提供する魚油の7.6g/日。
魚油脂肪酸(EPAおよびDHAを含む)にエステル化した1.7g/日大豆ステロール、ジグリセリドおよびトリグリセリドを含む魚油(市販の魚油、Pronova製造、Lysaker、Norway)に含まれる(総量=9g/d)。
リノール酸(LA)およびOAのような多価不飽和脂肪酸にエステル化した1.7g/dの大豆ステロール、市販のフィトステロールエステル製品に似ている。
オリーブ油脂肪酸(主にオレイン酸)にエステル化した1.7g/日の大豆ステロール、ジグリセリド(DAG)およびトリグリセリドを含むオリーブ油(市販のエキストラバージンオリーブ油、Meshek Eger製造、Yokeneam HaMoshava、Israel)に含まれる(総量=9g/d)。
1日目、2日目、28日目および29日目に、絶食状態で血液サンプルを得た。血漿を直ちに分離して、分析まで−80℃で保存した。各相の1日目、2日目、28日目および29日目に収集したサンプルで、総コレステロール、フィトステロールおよびトリグリセリドレベルを測定した。血漿総コレステロールおよびトリグリセリドのレベルは、酵素試薬(Abbott A−GENT)を用いてAbbott Spectrum CCX Analyzer(Abbott、Dallas、TX)で2反復で自動化方法で測定した。血漿フィトステロール濃度は、GLC(HP5890シリーズII:Hewlett−Peckard)で測定した。ビタミンE(α−トコフェロール)およびビタミンA(レチノール)のレベルは1日目および28日目からの試料で測定して、HPLCを通して定量化した。血漿レプチンレベルは、各相の終わりにラジオイムノアッセイを通して測定した。
以下の測定は、5食事相のそれぞれの開始時(1日目、2日目および3日目)および終了時(27日目、28日目および29日目)に3反復で実施した。体重は、毎日朝食の前に、軽い衣服で靴なしで測定した。身長は、固定されたスタジオメータを用いて頭の頂部から足(靴なし)の底までの距離として測定した。BMIは、体重(kg)を身長(m)の二乗で割って計算した。
(PS−E+DAG−魚(調製物A)のコレステロール低下効果)
高コレステロール血症の過体重ボランティアに4週間、対照食、LC−PUFA油、PS−E+DAG−魚(調製物A)またはPS−Eの食事を与え、その後4週間のウォッシュアウト期および対抗補充が続いた。総コレステロールレベルは、方法で記載されているように各相の開始時および終了時に試験した。結果は、表2に示す。値は、21人の患者における示された時点での総コレステロールレベルおよび変化率%の平均±S.E.Mを表す。変化値の百分率の間の一元配置ANOVAとそれに続くTukeyのpost hoc検定により得られた異なる治療間の統計的有意性は、P値<0.1であった。異なる上付き文字の平均値は、P<0.05で有意に異なる。
(PS−E+DAG−魚(調製物A)のトリグリセリド低下効果)
高コレステロール血症の過体重ボランティアに4週間、対照食、LC−PUFA油、PS−E+DAG−魚(調製物A)またはPS−Eの食事を与え、その後4週間のウォッシュアウト期および対抗補充が続いた。トリグリセリドレベルは、方法で記載されているように絶食条件下で各相の開始時および終了時に試験した。結果は、表3に示す。値は、21人の患者における示された時点でのトリグリセリドレベルおよび変化率%の平均±SEMを表す。一元配置ANOVAとそれに続くTukeyのpost hoc検定により得られた異なる治療間の統計的有意性は、エンドポイント値の間ではP値<0.01で、変化率%の間ではP値<0.001であった。異なる上付き文字の平均値は、P<0.05で有意に異なる。
(血漿脂溶性ビタミンレベル)
高コレステロール血症の過体重ボランティアに4週間、対照食、LC−PUFA油、PS−E+DAG−魚(調製物A)またはPS−Eの食事を与え、その後4週間のウォッシュアウト期および対抗補充が続いた。ビタミンレベルは、方法で記載されているように各相の終了時に試験した。結果を図1および表4に示す。値は表4では21人の患者から得られたビタミンA濃度の平均±SEMを表し、図1では対照食中央値からの変化率%として表す。スチューデントのt検定対のある分析により得られた異なる治療間の統計的有意性は、P値<0.05であった。
(PS−E+DAG−魚(調製物A)の血漿植物ステロール濃度に及ぼす影響)
高コレステロール血症の過体重ボランティアに4週間、対照食、LC−PUFA油、PS−E+DAG−魚(調製物A)またはPS−Eの食事を与え、その後4週間のウォッシュアウト期および対抗補充が続いた。フィトステロールレベルは、方法で記載されているように各相の開始時および終了時に試験した。結果は、表5に示す。値は、21人の患者における示された時点でのβ−シトステロールレベルおよび変化率%の平均±SEMを表す。一元配置ANOVAとそれに続くTukeyのpost hoc検定により得られた異なる治療間の統計的有意性は、エンドポイント値の間ではP値<0.05で、変化率%の間ではP値<0.001であった。異なる上付き文字の平均値は、P<0.05で有意に異なる。
(体重増加)
高コレステロール血症の軽度過体重ボランティアに4週間、対照食、LC−PUFA油、PS−E+DAG−魚(調製物A)、PS−EまたはPS−E+DAG−オリーブ(調製物B)の食事を与え、その後4週間のウォッシュアウト期および対抗補充が続いた。体重レベルは、方法で記載されているように各相の開始時および終了時に試験し、BMI値をその後計算した。女性のBMI結果の変化率%を図2に示す。値は、10人の女性患者におけるBMIの変化率%の平均±S.E.Mを表す。スチューデントのt検定対のある分析により得られた示された治療間の統計的有意性は、P値<0.05であった。
Claims (9)
- フィトステロール療法を必要とする対象における、循環親油性ビタミン類の少なくとも1つのバイオアベイラビリティーおよび/または血中レベルを維持するための医薬組成物の調製における、魚油に溶解または分散したフィトステロールおよび/またはフィトスタノールエステルおよび1,3−ジグリセリドの混合物の使用であって、
前記フィトステロールおよび/またはフィトスタノールエステルはフィトステロールおよび/またはフィトスタノールの魚油脂肪酸エステルであり、前記1,3−ジグリセリドは前記魚油に由来し、前記混合物中のフィトステロールおよび/またはフィトスタノールエステルの量は20から99重量%であり、前記親油性ビタミンはカロテノイドおよびトコフェロールである、使用。 - フィトステロール療法を必要とする対象における、循環親油性ビタミン類の少なくとも1つのバイオアベイラビリティーおよび/または血漿濃度を増加させるための医薬組成物の調製における、魚油に溶解または分散したフィトステロールおよび/またはフィトスタノールエステルおよび1,3−ジグリセリドの混合物の使用であって、
前記フィトステロールおよび/またはフィトスタノールエステルはフィトステロールおよび/またはフィトスタノールの魚油脂肪酸エステルであり、前記1,3−ジグリセリドは前記魚油に由来し、前記混合物中のフィトステロールおよび/またはフィトスタノールエステルの量は20から99重量%であり、前記親油性ビタミンはカロテノイドおよびトコフェロールである、使用。 - フィトステロール療法を必要とする前記対象は癌、良性前立腺肥大症、潰瘍、前立腺炎、心臓血管障害(CVD)、冠状動脈性心疾患(CHD)、アテローム性動脈硬化症、肺結核、ヒト免疫不全ウイルス(HIV)、ストレス誘発性免疫抑制、関節リウマチおよびアレルギー性鼻炎/副鼻腔炎からなる群から選択される状態を患う、請求項1または2に記載の使用。
- 前記カロテノイドはビタミンAである、請求項1〜3のいずれか一項に記載の使用。
- 前記トコフェロールはビタミンEである、請求項1〜3のいずれか一項に記載の使用。
- 前記フィトステロールおよび/またはフィトスタノールエステルおよび前記1,3−ジグリセリドの脂肪酸残基は、エイコサン酸、ドコサヘキサエン酸(DHA)およびエイコサペンタエン酸残基の少なくとも1つである、請求項1〜5のいずれか一項に記載の使用。
- 前記フィトステロールエステルはスチグマステロール、シトステロール、β−シトステロール、ブラシカステロール、カンペステロールおよび/または5−アベナステロールの魚油脂肪酸エステルであり、前記フィトスタノールエステルはβ−シトスタノール、カンペスタノールおよび/またはスチグマスタノールの魚油脂肪酸エステルである、請求項1〜6のいずれか一項に記載の使用。
- 前記混合物中のフィトステロールおよび/またはフィトスタノールエステルとジアシルグリセロールとの間の重量比は15:1から1:1である、請求項1〜7のいずれか一項に記載の使用。
- 前記混合物は、前記魚油に溶解または分散した15重量%の1,3−ジグリセリドおよび25重量%のフィトステロールおよび/またはフィトスタノールエステルからなる、請求項1〜8のいずれか一項に記載の使用。
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IL147942A0 (en) * | 2002-01-31 | 2002-08-14 | Enzymotec Ltd | Method of fractionation of phytosterol esters in oil and products obtained thereby |
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IL155136A0 (en) * | 2003-02-10 | 2003-10-31 | Enzymotec Ltd | A composition for reducing blood cholesterol and triglycerides |
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2005
- 2005-08-10 KR KR1020077005572A patent/KR101323513B1/ko active IP Right Grant
- 2005-08-10 CN CN2005800330833A patent/CN101039585B/zh not_active Expired - Fee Related
- 2005-08-10 EP EP05764602A patent/EP1796726A2/en not_active Withdrawn
- 2005-08-10 RU RU2007108771/14A patent/RU2394576C2/ru active
- 2005-08-10 WO PCT/IL2005/000861 patent/WO2006016363A2/en active Search and Examination
- 2005-08-10 AU AU2005270831A patent/AU2005270831B2/en not_active Ceased
- 2005-08-10 BR BRPI0513461-7A patent/BRPI0513461A2/pt not_active Application Discontinuation
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Also Published As
Publication number | Publication date |
---|---|
KR101323513B1 (ko) | 2013-10-29 |
RU2007108771A (ru) | 2008-09-20 |
CN101039585B (zh) | 2012-03-14 |
AU2005270831B2 (en) | 2011-08-25 |
US20070196440A1 (en) | 2007-08-23 |
IL181234A0 (en) | 2007-07-04 |
CN101039585A (zh) | 2007-09-19 |
RU2394576C2 (ru) | 2010-07-20 |
JP2008509904A (ja) | 2008-04-03 |
WO2006016363A2 (en) | 2006-02-16 |
AU2005270831A1 (en) | 2006-02-16 |
WO2006016363A3 (en) | 2006-03-16 |
US8772270B2 (en) | 2014-07-08 |
EP1796726A2 (en) | 2007-06-20 |
KR20070055528A (ko) | 2007-05-30 |
BRPI0513461A2 (pt) | 2011-05-10 |
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