JP6346896B2 - カルシウムβ−ヒドロキシ−β−メチルブチレート、タンパク質および低レベルの電解質を含む栄養組成物 - Google Patents
カルシウムβ−ヒドロキシ−β−メチルブチレート、タンパク質および低レベルの電解質を含む栄養組成物 Download PDFInfo
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Description
本出願は、2012年9月21日に出願された米国特許仮出願第61/703,965号、および2012年9月21日に出願された米国特許仮出願第61/703,967号の優先権およびいかなる恩典をも主張する。これらの全内容は、引用によりこの全体が組み込まれる。
本開示の栄養組成物は、少なくともタンパク質を本明細書に記載の金属イオン封鎖型カルシウムHMB、イオン交換型カルシウムHMB、または金属イオン封鎖型カルシウムHMBとイオン交換型カルシウムHMBの両方との組合せで含み、場合により電解質吸収抑制剤含むものである。栄養組成物は液状物、半分液状物、固形物、半分固形物、粉末またはバーの形態であり得る。多くの実施形態では、栄養組成物は液状栄養乳剤の形態である。
一部の例示的な実施形態では、栄養組成物は、金属イオン封鎖型(キレート化)カルシウムHMBを、少なくとも1種類のタンパク質またはタンパク質源との組合せで含み、任意の他のオプションの成分、例えば、電解質吸収抑制剤、炭水化物、脂肪、ビタミン、ミネラルなど含むものである。用語「金属イオン封鎖型カルシウムHMB」は、本明細書で用いる場合、特に指定のない限り、栄養組成物に組み込まれる前に、本明細書に開示、記載または示唆した食品等級の金属イオン封鎖剤に、カルシウムHMB中に存在する二価カルシウム種の少なくとも一部、望ましくは30重量%より多く、またはさらに約40重量%、またはさらに約50重量%、またはさらに約60重量%、またはさらに約70重量%、またはさらに約80重量%、またはさらに約90重量%、またはさらに約95重量%、またはさらに約97重量%、またはさらに約99重量%、またはさらに100重量%が、該カルシウムが高親和性を有する化合物に配位/キレート化/結合されるように供されて該封鎖剤と反応しているカルシウムHMBであって、カルシウムイオンが、拘束されて溶液中に不溶性となっており、溶液中での他の化学反応/相互作用、例えば、溶液中に存在するタンパク質種との化学反応/相互作用に利用可能でないようになっているものをいう。このため、カルシウムHMBを本開示の栄養組成物に添加する場合、これは、既に金属イオン封鎖された形態、またはキレート化/保護/結合された形態である。当業者は、本明細書における開示内容および一般知識に基づいて、本明細書に記載の栄養組成物に含めるための金属イオン封鎖型(キレート化)HMBを調製するのに適切な金属イオン封鎖剤およびカルシウムHMBの具体的な量ならびに適切な反応条件を決定することができよう。
多くの食品等級のカルシウム金属イオン封鎖剤(カルシウムキレート化剤)が、金属イオン封鎖型カルシウムHMBを作製するための本開示に従う使用に適している。カルシウム金属イオン封鎖剤(カルシウムキレート剤)は、カルシウムに(典型的には1対1の関係で)選択的な様式で結合できる(即ち、系内に存在している他の金属イオンに対してよりもカルシウムに対して高い親和性を有する。)ものである。金属イオン封鎖剤によるカルシウム種への結合は、一般的にはカルボン酸基を介して行われ、このため、当業者には認識されるように、溶液のpHがカルシウム結合に影響を及ぼし得る。
例示的な一実施形態では、栄養組成物に含めるのに適切な金属イオン封鎖型カルシウムHMBは、グリシン、グリシン誘導体またはグリシン類似体を金属イオン封鎖剤として使用し、栄養組成物における使用に適したグリシン金属イオン封鎖体またはグリシンキレート(グリシネート)を作製して調製される。グリシンは、75g/mol分子量を有し、天然に存在する金属イオン封鎖剤である非必須アミノ酸である。グリシンを金属イオン封鎖剤として使用する場合、グリシン金属イオン封鎖剤の適切な量は1モルのカルシウムHMBに対して2モルのグリシンである。グリシンによって栄養組成物にもたらされる金属イオン封鎖および関連する安定性の有益性に加えて、グリシンを金属イオン封鎖剤として使用することのさらなる有益性は、栄養組成物に対してさらに、甘味の増大がもたらされ得ることである。このさらなる甘さは、他の甘味剤、例えば、多くの炭水化物の使用の必要性が削減され得るため、多くの栄養組成物用途において好都合であり得る。
別の例示的な実施形態では、栄養組成物に含めるのに適切な金属イオン封鎖型カルシウムHMBは、グルコン酸(一般的にはデキストロン酸またはペンタヒドロキシカプロン酸とも称される。)、グルコン酸誘導体またはグルコン酸類似体を金属イオン封鎖剤として使用し、栄養組成物における使用に適したグルコン酸金属イオン封鎖体またはグルコン酸キレートを作製して調製される。グルコン酸は、カルボン酸基内に5つのヒドロキシル基末端部を有する6炭素鎖であり、196g/molの分子量を有する。グルコン酸は、反応可能なカルボキシル基とヒドロキシル基の両方を有するポリヒドロキシカルボン酸であるため、本開示における金属イオン封鎖剤としての使用のために特に望ましい特性を有する。グルコン酸を金属イオン封鎖剤として使用する場合、グルコン酸の適切な量は1モルのカルシウムHMBに対して2モルのグルコン酸である。
別の例示的な実施形態では、栄養組成物に含めるのに適切な金属イオン封鎖型カルシウムHMBは、アルギネート、アルギネート誘導体またはアルギネート類似体を金属イオン封鎖剤として使用し、栄養組成物における使用に適したアルギネート金属イオン封鎖体またはアルギネートキレートを作製して調製される。一部の例示的な実施形態では、低ゲル化性および/または低粘度のアルギネートが望ましい。一部の例示的な実施形態では、高カルシウム結合性アルギネートが望ましい。本明細書で用いる場合、用語「アルギネート(「alginate」または「alginates」)」は、特に指定のない限り、褐海藻から抽出されたハイドロコロイド水溶性バイオポリマーをいう。アルギネートを金属イオン封鎖剤として使用する場合、アルギネートの適切な量は1モルのカルシウムHMBに対して2モルのアルギネートである。好適なアルギネート金属イオン封鎖剤はFMC Biopolymer(Philadelphia,Pennsylvania)から入手可能である。
別の例示的な実施形態では、栄養組成物に含めるのに適切な金属イオン封鎖型カルシウムHMBは、フィテート、フィテート誘導体またはフィテート類似体を金属イオン封鎖剤として使用し、栄養組成物における使用に適したフィテート金属イオン封鎖体またはフィテートキレートを作製して調製される。好適なフィテートとしては、フィチン酸、イノシトールヘキサキスリン酸、フィテート、フィチンおよびこれらの組合せが挙げられる。フィテートは、カルシウムなどの幾つかのミネラルに対して非常に強力な結合親和性を有する。フィテートは、他の金属イオン封鎖剤と比べて広いpH範囲にわたって有効であるため、本明細書に記載の栄養組成物の幾つかの実施形態において望ましいものであり得、また、溶液中で有意な緩衝効果をもたらす場合があり得、これは、一部の液状栄養組成物では有益であり得る。フィテートを金属イオン封鎖剤として使用する場合、フィテートの適切な量は1モルのカルシウムHMBに対して2モルのフィテートである。
他の例示的な実施形態では、カルシウムHMBは、栄養組成物に組み込まれる前に、カルシウムイオンが、栄養組成物中のタンパク質源との反応性がより低い別のイオンと交換されるよう、カルシウムイオン交換過程に供され得る。イオン交換過程には、イオン交換樹脂、イオン交換ポリマーまたはイオン交換樹脂とイオン交換ポリマーの両方が使用され得る。イオン交換樹脂またはイオン交換ポリマーは、一般的に、例えば、1から2mmの直径のビーズの形態であり得、有機ポリマー基材で製作されたものであり得る不溶性のマトリックスまたは支持構造体である。本開示における使用のための適切な物質は、高度に発達した構造体の細孔を表面上に有し、そこで該細孔は、イオンの捕捉および放出を容易に行うであろう。イオンの捕捉、例えばカルシウムHMBからのカルシウムイオンの捕捉は、他のイオンの同時の放出を伴ってのみ行われる。これは、カルシウムHMBの液状溶液にイオン交換樹脂が導入された場合に起こり、このとき、溶液中のイオンと該樹脂上のイオン間で平衡状態に達する。望ましいイオンの選択係数は、当業者により、適切なイオン交換樹脂、ならびに交換の期間および条件が決定されるように決定され得る。
一部の例示的な実施形態では、栄養組成物に、場合により、栄養阻害成分、例えば、電解質吸収抑制剤(場合によっては電解質枯渇剤と称される。)を含めてもよい。電解質吸収抑制剤は、粉末型栄養組成物ならびに固形栄養組成物、例えば、食事置き換えバー、スナックバーおよび栄養バーにおいて特に適切であり得る。電解質吸収抑制剤は、不要で望ましくない電解質、例えば、ナトリウム、カリウムおよびリンのいずれかの1種類以上が体内に吸収されることを、該電解質が体内に吸収され得ないようにこれに結合することによって最小限にするため、および低減させるために、栄養組成物中に使用され得る。電解質吸収抑制剤は、慢性腎臓機能不全、腎機能不全または高リン血症の個体、ならびにカリウム、ナトリウムおよびリンなどの電解質の摂取量を密にモニタリングすること、および制限することが必要とされる個体による使用に適した栄養組成物において特に有用であり得る。
一部の例示的な実施形態では、本開示の栄養組成物は、タンパク質および金属イオン封鎖型カルシウムHMB、イオン交換型カルシウムHMB、または金属イオン封鎖型カルシウムHMBとイオン交換型カルシウムHMBの両方のうちの1種類に加えて、1種類以上のさらなる主要栄養素、例えば、脂肪、炭水化物または脂肪と炭水化物の両方を含むものであり得る。また、一般的に、栄養組成物における使用に対して既知の、または適切な任意のタンパク質源、脂肪源および炭水化物源も、かかる主要栄養素が本明細書に規定している栄養組成物の構成要素と同様に適合性である限り、本明細書における使用に適切であり得る。
本開示の栄養組成物は、製剤品安定性を改善するため、ならびに貯蔵寿命中における苦味および苦い後味の発現を最小限にするために、選択された量または比率の本明細書において規定される「可溶性タンパク質」を含むものであり得る。
栄養組成物は、製剤品安定性を改善するため、ならびに経時的な苦味および苦い後味の発現を最小限にするために、栄養乳剤中の総可溶性カルシウムに対して選択された重量比の可溶性カルシウム結合能(SCBC)を含むものであり得る。
比=SCBC/[可溶性カルシウム]
SCBC=(0.32×[可溶性シトレート]+0.63[可溶性ホスフェート]+0.013×[可溶性タンパク質])
に従って求められる。
本開示の栄養組成物は、対象ユーザーにおける健常な筋肉の維持を補助するために、さらにビタミンDを含むものであってもよい。ビタミンDの形態としては、ビタミンD2(エルゴカルシフェロール)およびビタミンD3(コレカルシフェロール)、ならびに栄養組成物における使用に適した他の形態が挙げられる。
本明細書に記載の栄養組成物は、さらに、対象集団において使用したとき栄養組成物の物理的、化学的、享楽的もしくは加工成形的特性を改良し得るか、または医薬的もしくは付加的な栄養の成分の機能を果たし得る他のオプションの成分を含むものであってもよい。多くのかかるオプションの成分が知られており、または他の栄養組成物における使用に適しており、かかるオプションの成分が経口投与に対して安全で有効であり、選択された製剤品形態中のこの他の成分と適合性である限り、本明細書に記載の栄養組成物においても使用され得る。
本明細書に記載の栄養組成物は、例えば、慣用的な方法を用いて製造され得る。栄養乳剤の形態の本明細書に記載の栄養組成物は、栄養乳剤(例えば、乳系栄養乳剤)を作製するための任意の既知の、または適切な方法によって製造され得る。
本明細書に記載の栄養組成物は、補給的な、主要な、もしくは単独の栄養源を供給するため、およびまたは個体に本明細書に記載の1つ以上の有益性を提供するために有用である。かかる栄養組成物の使用方法により、栄養組成物は、必要に応じて所望の栄養レベルがもたらされるように、典型的には1日に1回から2回の分量の形態で、1日に1回または2回またはこれ以上の回数の分割用量で経口投与され得る。栄養組成物の1回分量は、典型的には約100mlから約300ml、例えば約150mlから約250ml、例えば約190mlから約240mlの範囲であり、ここで、各1回分量には、1回分量あたり約0.4gから約3g、例えば約0.75gから約2g、例えば約1.5gのカルシウムHMBが含まれている。
実施例1から4は、成分が以下の表に示したものである本開示の栄養乳剤を示す。成分量はすべて、特に指定のない限り、製剤品バッチ1000キログラムあたりのキログラムとして示している。
実施例5から8は、成分が以下の表に示したものである本開示の栄養乳剤を示す。成分量はすべて、特に指定のない限り、製剤品バッチ1000kgあたりのkgとして示している。
実施例9から12は、成分が以下の表に示したものである本開示の栄養乳剤を示す。成分量はすべて、特に指定のない限り、製剤品バッチ1000キログラムあたりのキログラムとして示している。
実施例13から16は、成分が以下の表に示したものである本開示の栄養乳剤を示す。成分量はすべて、特に指定のない限り、製剤品バッチ1000キログラムあたりのキログラムとして示している。
実施例17から20は、成分が以下の表に示したものである本開示の栄養乳剤を示す。成分量はすべて、特に指定のない限り、製剤品バッチ1000キログラムあたりのキログラムとして示している。
この実施例では、種々のレベルのカリウムを有し、金属イオン封鎖剤、例えば、アルギネート、グリシンまたはグルコン酸の添加あり、またはなしの栄養乳剤を調製した。試料の種々の物性および機能特性を分析した。
Claims (18)
- 金属イオン封鎖された形態及び/又はイオン交換された形態のカルシウムβ−ヒドロキシ−β−メチルブチレート及びタンパク質を含む、液状栄養組成物であって、カリウム濃度が800ppm未満であり、ナトリウム濃度が400ppm未満であり、リン濃度が500ppm未満である、液状栄養組成物。
- カリウム濃度が500ppm未満であり、ナトリウム濃度が350ppm未満であり、リン濃度が400ppm未満である、請求項1に記載の液状栄養組成物。
- 脂肪と炭水化物をさらに含む、請求項1又は2に記載の液状栄養組成物。
- 脂肪が、高オレイン酸ベニバナ油、高オレイン酸ヒマワリ油、キャノーラ油、ダイズ油、コーン油及びこれらの組合せからなる群より選択される、請求項3に記載の液状栄養組成物。
- 脂肪が少なくとも1種類の多価不飽和脂肪酸を含む、請求項3に記載の液状栄養組成物。
- 該少なくとも1種類の多価不飽和脂肪酸が、DHA、ARA、EPAおよびこれらの組合せからなる群より選択される、請求項5に記載の液状栄養組成物。
- タンパク質が、乳タンパク質濃縮物、乳タンパク質単離物、ダイズタンパク質濃縮物、ダイズタンパク質単離物、未処理のエンドウ豆タンパク質濃縮物、未処理のエンドウ豆タンパク質単離物、カゼインナトリウム、カゼインカルシウム、乳清タンパク質濃縮物、乳清タンパク質単離物およびこれらの組合せからなる群より選択される、請求項3〜6のいずれか一項に記載の液状栄養組成物。
- 炭水化物が、マルトデキストリン、固形コーンシロップ、コーンシロップ、タピオカデキストリン、イソマルツロース、難消化性マルトデキストリン、スクロモルト、マルチトール粉末、フルクトース、グリセリン、フルクトオリゴ糖、ダイズ繊維、トウモロコシ繊維、グアガム、コンニャク粉、ポリデキストロースおよびこれらの組合せからなる群より選択される、請求項3〜7のいずれか一項に記載の液状栄養組成物。
- さらにダイズ繊維を含む、請求項3に記載の液状栄養組成物。
- さらにプレバイオティクスを含む、請求項3に記載の液状栄養組成物。
- プレバイオティクスが、オリゴフルクトース、フルクトオリゴ糖、ガラクトオリゴ糖、イヌリンおよびこれらの組合せからなる群より選択される、請求項10に記載の液状栄養組成物。
- 約1重量%から約30重量%の量のタンパク質、約3重量%から約65重量%の量の炭水化物、および約1重量%から約20重量%の量の脂肪を含み、該タンパク質が、約1重量%から約20重量%の未処理のエンドウ豆タンパク質を含む、請求項3に記載の液状栄養組成物。
- タンパク質が、未処理のエンドウ豆タンパク質濃縮物、乳タンパク質濃縮物およびダイズタンパク質単離物を含む、請求項12に記載の液状栄養組成物。
- カルシウムβ−ヒドロキシ−β−メチルブチレートが金属イオン封鎖された形態である、請求項1〜13のいずれか一項に記載の液状栄養組成物。
- 金属イオン封鎖された形態のカルシウムβ−ヒドロキシ−β−メチルブチレートが、グリシン金属イオン封鎖、グルコン酸金属イオン封鎖、アルギネート金属イオン封鎖、及びフィテート金属イオン封鎖された形態のうちの少なくとも1つである、請求項14に記載の液状栄養組成物。
- カルシウムβ−ヒドロキシ−β−メチルブチレートがイオン交換された形態である、請求項1〜13のいずれか一項に記載の液状栄養組成物。
- pH5.5〜7.3を有する、請求項1〜16のいずれか一項に記載の液状栄養組成物。
- 代謝障害、糖尿病または慢性腎臓機能不全を有する個体における筋肉減少の低減における使用のための、請求項1〜17のいずれか一項に記載の液状栄養組成物。
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- 2013-09-20 JP JP2015533232A patent/JP6346896B2/ja active Active
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2015
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Also Published As
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SG11201502205SA (en) | 2015-04-29 |
US9757345B2 (en) | 2017-09-12 |
MX2015003660A (es) | 2015-06-05 |
CA2885224C (en) | 2017-09-26 |
BR112015006426A2 (pt) | 2017-07-04 |
HK1212165A1 (en) | 2016-06-10 |
US20150246011A1 (en) | 2015-09-03 |
CN104780786A (zh) | 2015-07-15 |
PH12015500636A1 (en) | 2015-05-11 |
IN2015DN03322A (ja) | 2015-10-09 |
EP2897472A1 (en) | 2015-07-29 |
JP2015530412A (ja) | 2015-10-15 |
WO2014047497A1 (en) | 2014-03-27 |
CA2885224A1 (en) | 2014-03-27 |
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