JP2009529044A - 心臓血管健康を改善するための手段 - Google Patents
心臓血管健康を改善するための手段 Download PDFInfo
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Abstract
Description
この出願は、2006年3月3日付けで出願された米国仮出願シリアル番号60/779,135号の優先権の利益を主張する。
以下の図面は、本明細書の一部を形成し、本発明のある種の態様をさらに示すために含まれている。本発明は、本明細書に示された特定の具体例の詳細な記載と組み合わせた1以上のこれらの図面のへの参照によってより良好に理解し得る。
図1.RBCオメガ−3脂肪酸含量−2週間
図2.RBCオメガ−3脂肪酸含量−4週間
図3.RBCオメガ−3脂肪酸含量−8週間
図4.RBCオメガ−3脂肪酸含量−12週間
図5.RBCオメガ−3脂肪酸含量−21.4mg/kg/日のSDA
図6.RBCオメガ−3脂肪酸含量−64.2mg/kg/日のSDA
図7.RBCオメガ−3脂肪酸含量−192.9mg/kg/日のSDA
図8.RBCオメガ−3脂肪酸含量−42.9mg/kg/日のEPA
図9.RBCオメガ−3脂肪酸含量−ヒマワリ油
図10.心臓オメガ−3脂肪酸含量−4週間
図11.心臓オメガ−3脂肪酸含量−8週間
図12.心臓オメガ−3脂肪酸含量−12週間
図13.心臓オメガ−3脂肪酸含量−21.4mg/kg/日のSDA
図14.心臓オメガ−3脂肪酸含量−64.2mg/kg/日のSDA
図15.心臓オメガ−3脂肪酸含量−192.9mg/kg/日のSDA
図16.心臓オメガ−3脂肪酸含量−42.9mg/kg/日のEPA
図17.心臓オメガ−3脂肪酸含量−ヒマワリ油
背景および目的
食事性の長鎖n−3脂肪酸エイコサペンタエン酸(EPA)およびドコサヘキサエン酸(DHA)と関連する多数の健康上の利益がある。詳しくは、一般的に魚および魚油で見出されるEPAおよびDHAの双方は、心臓血管疾患のリスクの低下に有益であるとして広範囲に関係しているとみなされている(Ismail (2005) Frontiers in Bioscience 2005, 10: 1079-88)。魚における可能な汚染物質、魚油の貧弱な美味しさおよび陸に囲まれた領域における集団の一般的な食事の好みを含めた消極的な消費者知覚は、共通の源を用いる食事性のn−3脂肪酸の補足の実現可能性を制限する(Verbekeら (2005) Public Heath Nutrition 8(4): 422-9)。魚中で見出された長鎖n−3脂肪酸に対する実行可能な代替物のステアリドン酸(SDA)は、植物源に由来し、共通の食物に組み込むことができる。SDAは、ヒト治療食を介して投与された場合に、赤血球および血漿中でEPAおよびDPAに有効に変換されることが従前に示されている(Jamesら, 2003)。EPA、DPAおよびDHAでの心臓組織の富化に関してさらにSDAの効力を評価するために、食事試験を、3か月の期間、ビーグル犬においてSDAの摂食がEPA、DPAおよびDHAでの心臓組織の富化を生じるかを決定するために始めた。
試験物品のSDAを、90日間まで、毎日1回、1週間当たり7日、治療食中で、3群(第1群〜第3群)の雄性ビーグル犬に投与した。参考物品のエイコサペンタエン酸(EPA)を、同一投与計画で4群に投与した。SDAおよびEPAの双方をエチルエステルとして供給した。対照物品の食品銘柄の高オレイン酸ヒマワリ油(SFO)を同一投与計画薬で第5群に投与した。また、すべての動物がkg体重当たり同じ容量の油を受け取るようにSFOを第1群〜第4群の食物に加えた。食事性栄養補助食品のビタミンEをすべての治療食に加えた。用量レベルは、21.4、64.2および192.9mg/kg/日のSDA、42.9mg/kg/日のEPAであり、それは、各々、第1、第2、第3および第4群についての体重に基づいて各動物につき計算した。各群は、15匹の雄よりなった。5匹の動物/群を、中間の各剖検(試験週4および8)および12週処処置期間の終わりでの主要な剖検につき予定した。加えて、5匹の動物をベースラインレベルの脂肪酸(予備試験剖検)を確立するために、無作為化および試験物品投与に先立って安楽死させた。
血液試料を予備試験剖検につき選択された5匹のイヌおよび試験2、4、8および12週間のすべての生存しているイヌから採取した。試料を飼育/投与計画に先立ってEDTAを含有するチューブ中にイヌの頚静脈から採取した。赤血球(RBC)を、4℃にて約20分の1500×遠心によって血漿から分離した。血漿をポリプロピレン・チューブに移し、将来の分析のために約−70℃で貯蔵した。バフィーコートを密集させたRBCから取り除き、RBCを2本のチューブにほぼ等しく分けた。
動物をペントバルビタールナトリウムの静脈内注射に続いて放血によって安楽死させた。左心室からの約200mgの心臓組織の2つの試料を採取し、冷却したセーライン中で濯ぎ、アルミ箔で包み、液体窒素中で瞬間凍結し、約−70℃にて貯蔵した。試料を病理学的異常につき分析した。
心臓、肝臓および腎臓の切片を10%中性緩衝ホルマリン中に入れた。組織を整え、パラフィンブロックに入れ、4〜8ミクロンに薄片にし、顕微鏡用スライドガラス上に乗せ、ヘマトキシリン−エオジンで染色した。試料を病理学的異常につき分析した。
体重、体重変化および食料消費データを一元配置ANOVAに付して、集団間の差を決定した。ANOVAが統計的に有意な(p<0.05)集団間の分散を明らかにしたならば、Dunnettのテスト(Dunnett, 1964)を用いて、試験物品で処理された群を対照群に比較した。
すべての動物を予定された剖検まで生存させた。体重または食物消費に対する試験物品関連の臨床所見も効果もなかった。試験物品投与に起因する顕微鏡的所見はなかった。
雄性ビーグル犬に連続する12週間の治療食を介して毎日投与されたステアリドン酸(SDA)は、有効にEPAおよびDPAに変換され、心臓細胞膜および赤血球細胞膜に取り込まれることが判明した。さらに、12週間の192.9mg/kg/日までのSDAの投与は、いずれの有害な臨床効果も示さず、心臓、肝臓および腎臓組織へのいずれの有意な顕微鏡的変化も引き起こさなかった。これは、哺乳動物へのSDAの経口投与がEPAおよびDPAで心臓組織を富化でき、それにより哺乳動物の心臓健康を改善することを決定的に実証する、最初の試験である。
Claims (15)
- 遺伝子組換え作物の内因性種子油のある量を経口投与することを特徴とする哺乳動物に食物を与える方法であって、該種子油は、エイコサペンタエン酸(20:5,ω3)およびドコサペンタエン酸(22:5,ω3)で動物の心臓組織または赤血球を富化するのに十分なステアリドン酸を有する該方法。
- 該哺乳動物がヒトであることを特徴とする請求項1記載の方法。
- 該哺乳動物が伴侶動物であることを特徴とする請求項1記載の方法。
- 投与される該種子油が、ヒト当量ベースで約1mg/kg/日〜約5000mg/kg/日を含むことを特徴とする請求項1記載の方法。
- 投与される該種子油が、約20mg/kg/日〜約2000mg/kg/日を含むことを特徴とする請求項4記載の方法。
- 該種子油が、ダイズ油、トウモロコシ油およびキャノーラ油よりなる群から選択されることを特徴とする請求項1記載の方法。
- 該種子油が、医薬薬剤として送達されることを特徴とする請求項1記載の方法。
- 該種子油が、ベーカリー製品、油ベースの生成物、酪農製品、乳児用調製乳および非酪農飲料よりなる群から選択される食物生成物に存在することを特徴とする請求項1記載の方法。
- 該食物生成物が、パン、ビスケットもしくはクッキー、スナックバー、ミルク、再構成可能な酪農製品、スプレッド(spread)、サラダドレッシング、アイスクリームおよび果汁から選択されることを特徴とする請求項8記載の方法。
- 遺伝子組換え作物の治療上有効な量の内因性種子油を哺乳動物に投与することを特徴とする、哺乳動物の冠状動脈心疾患または脂質代謝異常を治療する方法であって、該内因性種子油は、全脂肪酸の少なくとも5%のステアリドン酸を含有する該方法。
- 該冠状動脈心疾患が、不整脈、血栓症、高血圧症、動脈硬化症/アテローム性動脈硬化およびポスト心筋梗塞を含むことを特徴とする請求項10記載の方法。
- ステアリドン酸を含有すると生成物を宣伝または標識する工程を含むことを特徴とする、哺乳動物の心臓健康を改善すると生成物を促進する方法。
- 生成物の促進が、生成物の販売を増加させるように努めることを含むことを特徴とする請求項12記載の方法。
- 該生成物が、食物生成物、食物性栄養補助生成物および医薬製品よりなる群から選択されることを特徴とする請求項12記載の方法。
- 該広告が、製品ラベル、印刷出版物、ラジオ、テレビおよび他の電子メディアを含む手段により達成されることを特徴とする請求項12記載の方法。
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KR20240012390A (ko) | 2021-04-21 | 2024-01-29 | 애머린 파마슈티칼스 아일랜드 리미티드 | 심부전의 위험을 감소시키는 방법 |
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CA2644154A1 (en) | 2007-09-13 |
MX2008011351A (es) | 2008-09-15 |
US20070207223A1 (en) | 2007-09-06 |
BRPI0708535A2 (pt) | 2011-05-31 |
CN101437508A (zh) | 2009-05-20 |
WO2007103160A3 (en) | 2007-10-25 |
AR059720A1 (es) | 2008-04-23 |
WO2007103160A2 (en) | 2007-09-13 |
EP1991217A2 (en) | 2008-11-19 |
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