JP2019501127A - 組織中の正常値を超える数の顆粒球に関連する障害の治療又は予防において使用するためのカカオポリフェノール及び可溶性食物繊維 - Google Patents
組織中の正常値を超える数の顆粒球に関連する障害の治療又は予防において使用するためのカカオポリフェノール及び可溶性食物繊維 Download PDFInfo
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Abstract
Description
組織中の、好酸球又は肥満細胞などの顆粒球数の増加は、様々な消化管障害、食物アレルギー及びアトピー性皮膚炎といった多くの障害と関連している。
組織中の正常値を超える数の顆粒球に関連する障害を予防又は治療するという問題を解決する新たな代替方法を提供することが本発明の目的である。
「好酸球性消化管障害(EGIDs)」は、大人及び小児が罹り得る慢性の複雑な疾患群である。これらの障害は、消化器系のどこか1箇所以上の特定の場所において、白血球の種類である好酸球及び肥満細胞の量が正常値を超えることが特徴である。肥満細胞は、アレルギー反応の際にヒスタミン脱顆粒に直接関与するため、アレルギー性炎症のエフェクター細胞である。EGIDは、臓器特異的診断結果に更に細分される。例えば、好酸球性胃炎は、好酸球が胃に浸潤していることを意味する。目に見える炎症が必ずしも存在するとは限らず、顕微鏡下で炎症が見られることもある。本発明の意味でのEGIDSは、好酸球性食道炎、好酸球性胃炎、好酸球性胃腸炎、又は好酸球性大腸炎であり得る。
項の見出しは主題を明確化するためのものであり、主題を限定するものと解釈すべきではない。値の範囲が開示されている場合、各個別の値、特に各整数は、その範囲に含まれるものとみなされる。別段の記載がない場合、%で表す値は、重量/重量(w/w)の値に関する。驚くべきことに、カカオポリフェノールと可溶性食物繊維の組み合わせが、好酸球量を減少させるために有用であることが発見された。この発見は、好酸球性食道炎のためのマウスモデルにおいてなされた。したがって、様々な組織(例えば、結腸、食道、皮膚など)中の正常値を超える数の好酸球に関連する障害の治療又は予防において、植物フェノールを使用できると結論付けることができる。
本発明の組成物は、少なくとも2つの成分、植物ポリフェノールと可溶性食物繊維とを含む。いかなる理論にも拘束されることを望むものではないが、本発明者らは、カカオ抽出物中に存在する(植物)ポリフェノールは活性成分(カカオポリフェノール)に相当すると考える。よって、本発明は、植物ポリフェノール、特にカカオ抽出物中に存在する植物ポリフェノールと、発酵性及び/又は可溶性食物繊維と、を含む組成物に関する。発酵性食物繊維は、体系的に炎症効果を発揮する、微生物叢による短鎖脂肪酸(SCFA)の産生をもたらす。
組成物は、少なくとも1種の植物ポリフェノールを含む。植物ポリフェノールは、少なくとも2、3、4、5、又は6個のフェノール基を含む。特に好ましいのは、2個のフェノール基を含む植物フェノールである。植物フェノールは、優先的には、水素、炭素、及び酸素だけからなる。植物フェノールは、優先的には、少なくとも1つのシクロヘキサン基、フェノール基、H−基、OH−基、C=基、CO2H−基、エチル基、又は−O−基からなる群から選択される基を含むか、又はこれらからなる。
組成物はまた、可溶性食物繊維も含む。好ましい可溶性繊維はペクチンである。可溶性食物繊維は、プロバイオティクス細菌とともに、短鎖脂肪酸の産生を含むいくつかの有益な健康効果を促進し、これが次に生物に有益な効果をもたらし得ることが知られている。ここで、カカオ抽出物及び他の植物抽出物中に存在する化合物(例えばポリフェノール)と組み合わせたペクチンは、様々な組織中の正常値を超える数の好酸球に関連する障害における好酸球数に対する相乗効果を促進することを記述する。
上記の組成物は、液体又は固体形態で製剤化することができる。液体形態は、噴霧に好適な形態に、すなわちスプレーの形態に製剤化することができる。これは、組成物を入れたコンパートメントをスプレーノズルに接続することによって達成することができる。液体は、スプレーノズルを通って移送されるときに霧化され、得られた液滴は表面上に均等に分布することができる。スプレーノズルを通して液体を移送するための様々な方法が当業者に公知である。例えば、組成物を入れた容器は、周囲の大気圧と比較して加圧下にあってもよい。あるいは、ポンプ機構によりノズルを通してスプレーを移送してもよい。スプレーの使用により、例えば、口腔を介して食道内に組成物を噴霧し、それにより組成物を食道粘膜に直接接触させることが可能になる。その後、組成物は粘膜に吸収され、次いで体内の全身への分布を達成することができる。
本明細書で使用する場合、用語「栄養組成物」は、完全栄養組成物、部分的又は不完全栄養組成物、及び疾患又は状態に特化した(disease or condition specific)栄養組成物を含むがこれらに限定されない。完全栄養組成物(すなわち、必須の多量栄養素及び微量栄養素を全て含有するもの)は、患者のための唯一の栄養供給源として、又は経口栄養補助食品(ONS)として使用することができる。患者は、その栄養所要量の100%をそのような完全栄養組成物から得ることができる。部分的又は不完全栄養組成物は、必須の多量栄養素及び微量栄養素を全て含有するわけではなく、患者のための唯一の栄養供給源として使用することはできない。部分的又は不完全栄養組成物は、栄養補助食品として使用することができる。経口栄養補助食品(ONS)組成物は、部分的又は完全栄養組成物を提供することができ、又は特許請求されている組成物の必須の活性成分(植物フェノール)を主に又はそれだけを含有することができ、患者の通常の栄養に加えて摂取させることができる。
タンパク質源は、好酸球数に対する組成物の効果を補完又は増強するように選択される。よって、タンパク質源は、乳より低アレルゲン性である、又は低いアレルゲン性を有するべきである。
よって、別の実施形態において、栄養組成物は、1種以上の遊離アミノ酸を更に含む。アミノ酸の非限定例としては、アラニン、アルギニン、アスパラギン、アスパラギン酸、シトルリン、システイン、グルタミン酸、グルタミン、グリシン、ヒスチジン、ヒドロキシプロリン、ヒドロキシセリン、ヒドロキシチロシン、ヒドロキシリシン、イソロイシン、ロイシン、リシン、メチオニン、フェニルアラニン、プロリン、セリン、タウリン、トレオニン、トリプトファン、チロシン、バリンが挙げられる。非タンパク質アミノ酸の例は、シトルリン、HICA(α−ヒドロキシイソカプロン酸)、HIVA(α−ヒドロキシイソ吉草酸)、HIMVA(α−ヒドロキシメチル吉草酸)、又はこれらの組み合わせである。
多くの植物タンパク質は低アレルゲン性であるため、好ましいタンパク質源は植物タンパク質である。完全なタンパク質としての植物タンパク質は、味及びテクスチャーに関して栄養組成物において優れているため、加水分解タンパク質又は遊離型アミノ酸を使用するよりも有利である。よって、植物タンパク質は官能的な優位性を示す。官能的な優位性は、加水分解タンパク質又は遊離型アミノ酸を含む組成物ではやや低い、子供及び10代の若年者の食事療法のコンプライアンスを確実にするために特に重要である。更なる利点は、加水分解タンパク質又は遊離型アミノ酸を含む栄養組成物と比較して、コストが低いことである。更なる利点は、消費者にとってより普通の食事のように思われることである。
タンパク質源は、加水分解タンパク質、好ましくは高度に加水分解されたタンパク質であり得る。加水分解によって小さいペプチド断片、そして最終的にはアミノ酸が生じ、それによって潜在的にアレルゲン性の作用エピトープが除去される。加水分解に好適なタンパク質は、植物、動物及び乳タンパク質である。好ましい部分的に又は高度に加水分解されたタンパク質は、乳タンパク質である。乳タンパク質は、カゼイン又は乳清タンパク質であり得る。
本発明の栄養組成物は、脂肪を更に含む。
更なる実施形態において、栄養組成物は、ミネラル、例えばホウ素、カルシウム、酢酸カルシウム、グルコン酸カルシウム、塩化カルシウム、乳酸カルシウム、リン酸カルシウム、硫酸カルシウム、塩化物、クロム、塩化クロム、ピコリン酸クロム(chromium picolonate)、銅、硫酸銅、グルコン酸銅、硫酸第二銅、フッ化物、鉄、カルボニル鉄、第二鉄、フマル酸第一鉄、オルトリン酸第二鉄、鉄粉(iron trituration)、多糖類鉄、ヨウ化物、ヨウ素、マグネシウム、炭酸マグネシウム、水酸化マグネシウム、酸化マグネシウム、ステアリン酸マグネシウム、硫酸マグネシウム、マンガン、モリブデン、リン、カリウム、リン酸カリウム、ヨウ化カリウム、塩化カリウム、酢酸カリウム、セレン、硫黄、ナトリウム、ドキュセートナトリウム、塩化ナトリウム、セレン酸ナトリウム、モリブデン酸ナトリウム、亜鉛、酸化亜鉛、硫酸亜鉛及びこれらの混合物を含み得る。ミネラル化合物の非限定的な誘導体の例としては、上掲の任意のミネラル化合物の塩、アルカリ塩、エステル、及びキレートが挙げられる。
更なる実施形態において、栄養組成物は、ビタミン、例えばビタミンB1(チアミン、チアミンピロリン酸、TPP、チアミン三リン酸、TTP、チアミン塩酸塩、チアミンモノニトレート)、ビタミンB2(リボフラビン、フラビンモノヌクレオチド、FMN、フラビンアデニンジヌクレオチド、FAD、ラクトフラビン、オボフラビン)、ビタミンB3(ナイアシン、ニコチン酸、ニコチンアミド、ナイアシンアミド、ニコチンアミドアデニンジヌクレオチド、NAD、ニコチン酸モノヌクレオチド、NicMN、ピリジン−3−カルボン酸)、ビタミンB3−前駆体トリプトファン、ビタミンB6(ピリドキシン、ピリドキサール、ピリドキサミン、ピリドキシン塩酸塩)、パントテン酸(パントテナート、パンテノール)、フォレート(葉酸、フォラシン、プテロイルグルタミン酸)、ビタミンB12(コバラミン、メチルコバラミン、デオキシアデノシルコバラミン、シアノコバラミン、ヒドロキシコバラミン、アデノシルコバラミン)、ビオチン、ビタミンC(アスコルビン酸)、ビタミンA(レチノール、酢酸レチニル、パルミチン酸レチニル、他の長鎖脂肪酸をもつレチニルエステル、レチナール、レチノイン酸、レチノールエステル)、ビタミンD(カルシフェロール、コレカルシフェロール、ビタミンD3、1,25,−ジヒドロキシビタミンD)、ビタミンE(α−トコフェロール、酢酸α−トコフェロール、コハク酸α−トコフェロール、ニコチン酸α−トコフェロール、α−トコフェロール)、ビタミンK(ビタミンK1、フィロキノン、ナフトキノン、ビタミンK2、メナキノン−7、ビタミンK3、メナキノン−4、メナジオン、メナキノン−8、メナキノン−8H、メナキノン−9、メナキノン−9H、メナキノン−10、メナキノン−11、メナキノン−12、メナキノン−13)、コリン、イノシトール、6−カロテン及びこれらの任意の組み合わせを更に含む。
一実施形態において、栄養組成物は、乳幼児用栄養補給組成物、フォローアップフォーミュラ、グローイングアップミルク、乳幼児用シリアル、又は乳児用栄養組成物からなる群から選択される。これらの製品は、乳児及び幼児における好酸球性食道炎のような正常値を超える数の好酸球に関連する障害などの障害の症状を予防又は軽減するという問題に対処し解決するために特によく適している。しかしながら、飲料及び粉末(小袋入り)などの他の製品もまた、以下に記載している通り、子供及び大人向けに選択することができる。
栄養組成物が液体である場合、かかる液体の粘度は150mPa・s未満、好ましくは100mPa・s未満、より好ましくは80mPa・s未満、更により好ましくは70mPa・s未満である。粘度は、コーンプレート形状を使用した回転型レオメーターで、20℃にて50 1/sの剪断速度で測定する。
上記の組成物はまた、キットとして提供されてもよい。こうしたキットにおいて、上記組成物の成分の全て又は一部は、別々の(すなわち混合されていない)形態で提供される。本発明のキットは、一方では植物フェノールを、他方では残り全ての成分(可溶性食物繊維など)を別々の形態で含むことができる。本発明のキットは、別々の形態で提供される少なくとも2種又は3種の植物フェノールを含むことができる。代替の実施形態において、キットは、上記組成物の成分のそれぞれを別々の形態で含むことができる。
本発明の組成物又はキットは、様々な組織中の正常値を超える数の好酸球に関連する障害の治療若しくは予防、又は該障害を治療又は予防するための方法において使用することができる。特に、これは、好酸球性消化管障害、アレルギー、特に食物アレルギー、又はアトピー性皮膚炎の予防又は治療に関する。
上記組成物を製造するための方法が提供され、これは、上記植物フェノールのうちの少なくとも1種を用意する工程、可溶性食物繊維を添加する工程、及び、例えば1種以上のアミノ酸、脂肪、又は炭水化物からなる群から選択される、少なくとも1つの更なる成分を任意に添加する工程、少なくとも1種の栄養素又は微量栄養素を任意に添加する工程、担体又は/及び水を添加する工程を含む。
5〜8週齢の雌のBalb/cマウスを、200μgのアレルギー性抽出物を皮膚上に適用することによって感作させた。マウスの背部の小領域を剃毛した。アレルゲンを含む滅菌ガーゼのパッチ(1×1cm)を、バイオ密封透明包帯(bio−occlusive transparent dressing)2461(Johnson and Johnson)及びBand−Aidを用いて皮膚に固定した。パッチは、反応が現れるまで、連続する7日間の感作期間にわたって皮膚に貼り付けたままとし、又は8日目に除去した(8日目〜15日目)。マウスを36日目に麻酔下で鼻腔内負荷(challenge)(100μg)に曝露し、38日目にマウスを採取した。
Claims (26)
- 組織中の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための、少なくとも1種のカカオポリフェノールと、少なくとも1種の発酵性食物繊維と、を含む組成物。
- 前記組織中の正常値を超える数の顆粒球に関連する障害が、好酸球性消化管障害、アレルギー、特に食物アレルギー、消化管症候群、喘息及びアレルギー性鼻炎を含む空中アレルゲンに関連するアレルギー、肺のアレルギー性炎症又はアトピー性皮膚炎である、請求項1に記載の正常値を超える好酸球数に関連する障害の予防又は治療において使用するための組成物。
- 前記好酸球性消化管障害が、食物アレルギー又は空中アレルゲンによって引き起こされる、請求項1又は2に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記好酸球性消化管障害が、好酸球性食道炎、好酸球性胃炎、好酸球性胃腸炎又は好酸球性大腸炎であり、前記好酸球性消化管障害が、好ましくは好酸球性食道炎である、請求項1〜3のいずれか一項に記載の正常値を超える数の好酸球に関連する障害の予防又は治療において使用するための組成物。
- 前記可溶性食物繊維が、ペクチン、β−グルカン、イヌリン、フラクト又はガラクトオリゴ糖、ペクチン、アルギン酸、イヌリンなどのフラクタン、ラフィノース、キシロース、ポリデキストロース、ラクツロース、アカシアガム、グアーガム、乳由来オリゴ糖、加水分解繊維、好ましくはペクチン、より好ましくはシトラスペクチンである、請求項1〜4のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記組成物が、2〜80%、10%〜60%(w/w)、20%〜40%(w/w)、又は25%〜35%(w/w)の発酵性食物繊維を含む、請求項1〜5のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記組成物が、タンパク質源を更に含み、前記タンパク質源が、低アレルゲン性タンパク質及び又は遊離アミノ酸からなる群から任意に選択され、前記低アレルゲン性タンパク質が、完全な植物タンパク質、部分的に又は高度に加水分解されたタンパク質の群から任意に選択される、請求項1〜6のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記植物タンパク質が、ジャガイモタンパク質、米タンパク質、マメ科植物タンパク質(エンドウマメ、ヒヨコマメ、マメ類などであるがこれらに限定されない、マメ科植物以外のタンパク質(野菜)、並びにキビ、キノア、ルピナス、キャノーラ、タピオカ、又はこれらの組み合わせからなる群から選択される、請求項7に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記カカオポリフェノールが、プロシアニジン及び/又はエピカテキンである、請求項1〜8のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記プロシアニジンが、プロシアニジンB1、プロシアニジンB2、プロシアニジンB1でもB2でもないプロシアニジン、プロシアニジンB1、プロシアニジンB2若しくは前記B1でもB2でもないプロシアニジンの1種以上の多量体であって2量体〜10量体のいずれかである多量体、又は前記プロシアニジンの組み合わせからなる群から選択される、請求項9に記載の正常値を超える数の好酸球に関連する障害の予防又は治療において使用するための組成物。
- 前記組成物が、0.01%〜0.5%、又は0.02%〜0.1%、又は0.04%〜0.07%(w/w)のプロシアニジンB1又は前記プロシアニジンの多量体を含む、請求項1〜10のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記組成物が、0.01%〜1.0%、又は0.1%〜0.9%、又は0.2%〜0.3%(w/w)のプロシアニジンB2又は前記プロシアニジンの多量体を含む、請求項1〜11のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記組成物が、0.5%〜10%、又は1%〜5%、又は1.5%〜2%(w/w)の、プロシアニジンB1でもB2でもないプロシアニジン又は前記プロシアニジンの多量体を含む、請求項1〜12のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記組成物が、0.01%〜0.5%、又は0.02%〜0.1%、又は0.04%〜0.07%(w/w)のエピカテキンを含む、請求項1〜13のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記カカオポリフェノールが、植物抽出物又は濃縮物中に含まれる、請求項1〜14のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記組成物が、経口的に、局所経口的に、又はスプレーの形態で投与される、請求項1〜15のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記組成物が、ヒト又は愛玩動物、特にネコ又はイヌに投与される、請求項1〜16のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記ヒトが、出生から1歳までの乳児、1歳から6歳の間の幼児、6歳から18歳の間の子供、又は大人である、請求項17に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記組成物が、栄養組成物、唯一の栄養供給源として若しくは部分的栄養として提供される経口栄養補助食品、完全若しくは不完全栄養製品又は医薬品であり、前記栄養組成物が、任意に、
a.乳幼児用栄養補給組成物、アミノ酸を主成分とする飲料若しくはフォーミュラ、フォローアップフォーミュラ、グローイングアップミルク、乳幼児用シリアル、又は乳児用栄養組成物からなる群から選択される、
b.飲料製品、ヨーグルト製品、プリン製品、発酵乳、フルーツジュース、バー、ムース、スナック菓子、チップス、ミール又はミール代用品からなる群から選択される、
c.経口栄養補給のためのヘルスケア用栄養組成物、経腸栄養補給のための栄養製品又は非経口栄養補給製品である、
請求項1〜18のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。 - 0.5〜3.0kcal/mlのカロリー密度を有する、請求項1〜19のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 10〜40en%のタンパク質、10〜60en%の炭水化物、及び20〜80en%の脂肪を含む、請求項1〜20のいずれか一項に記載の正常値を超える数の好酸球に関連する障害の予防又は治療において使用するための組成物。
- 前記脂肪が、魚油、植物油、中鎖トリグリセリド又はこれらの混合物からなる群から選択される、正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記組成物が脂肪を含み、前記脂肪の0〜70重量%、10〜60重量%、又は20〜50重量%が中鎖トリグリセリドである、請求項1〜22のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記組成物が炭水化物を含み、前記炭水化物が、マルトデキストリン、デンプン、ラクトース、加工炭水化物、糖アルコール、高感度甘味料又はこれらの組み合わせからなる群から選択される供給源から選択される、請求項1〜23のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記組成物がタンパク質源を含み、前記タンパク質源が、それぞれ遊離型又は結合型の必須アミノ酸、半必須アミノ酸及び非必須アミノ酸を含み、各アミノ酸が、全アミノ酸の0.5%〜25%の量で存在する、請求項1〜24のいずれか一項に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
- 前記組成物が非タンパク質アミノ酸を含み、前記非タンパク質アミノ酸が、シトルリン、α−ヒドロキシ−イソカプロン酸(HICA)、α−ケト−イソカプロン酸(KICA)、α−ヒドロキシイソ吉草酸(HIVA)、α−ケト−イソ吉草酸、α−ヒドロキシメチル吉草酸(HIMVA)、α−ケト−メチル吉草酸又はこれらの組み合わせからなる群から選択される、請求項25に記載の正常値を超える数の顆粒球に関連する障害の予防又は治療において使用するための組成物。
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JP2014511871A (ja) * | 2011-04-12 | 2014-05-19 | ネステク ソシエテ アノニム | 分枝鎖脂肪酸を含む栄養組成物及びその使用方法 |
JP2014529603A (ja) * | 2011-08-24 | 2014-11-13 | ネステク ソシエテ アノニム | アレルギーの症状を軽減するためのエピカテキン |
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